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Redefining Leadership In The Evolving Landscape Of MedTech

HealthPad
Directory:
Medical Technology
Tags:
commentary
M&A
Medtech
R&D
  • Many large diversified MedTechs are experiencing stagnate growth and aging products in slow growing markets
  • Initially, MedTech expansion leveraged disruptive technologies and underserved markets
  • As MedTechs’ evolved they shifted from innovation-led to financed-focused management taking advantage of low interest rates and cheap money
  • M&A substituted for innovation as a growth strategy
  • Today, MedTechs grapple with volatile politico-economic environments, stringent regulations, ethics, and increasing patient demands
  • The solution lies in visionary leaders driving R&D-focused growth, and more strategic M&A
  • This requires leaders able to blend finance, innovation and patient-centricity
  
Redefining Leadership in the Evolving Landscape of MedTech
Balancing Innovation, Profitability, and Patient Care
 
Preface
 
Over the past four decades the medical technology (MedTech) sector has experienced substantial transformation. Its initial rapid growth was driven by sophisticated devices, unmet clinical needs, entry barriers, and available funding. Later, expansion was primarily fueled by mergers and acquisitions (M&A), the integration of technology, market consolidation and financial undertakings. Decades of low interest rates, cheap money, and, the pursuit of top-line revenue growth, rather than profitability, led to an overemphasis on M&A, which enlarged the industry without equivalent enhancements in R&D. Over time, many large diversified MedTechs faced challenges associated with legacy products in slow-growth markets, and an overreliance on M&A. While the industry maintains ~6% compound annual growth rate (CAGR), much of this progress comes from smaller players. The industry’s maturity brings new challenges distinct from those of its early days. M&A, once effective for diversification, now struggles to sustain growth for larger companies. The industry’s financialization has shifted leaders’ focus from vision to short-term gains, creating a void in leadership. Amid current headwinds - political uncertainties, commercial pressures, stringent regulations, ethics, and patient empowerment - successful navigation requires visionary leaders committed to patient care over short-term gains. Emerging leaders must combine financial expertise with innovation. The next decade calls for a break from an overreliance on M&A-centred growth, embracing research-based, value-driven solutions and services, which enhance patient outcomes and reduce healthcare costs. This transformation demands leaders skilled in business strategy, R&D, and patient-centered approaches.
  
In this Commentary

This Commentary is comprised of four sections. Part 1 draws a distinction between leaders and managers and suggests that while both roles are necessary for a successful commercial enterprise, it is important for executives to balance the two roles. Part 2 describes the merits of M&A, the financialization of the MedTech industry, and its repercussions on leadership and innovation. Notably, financialization and M&A activities shifted executive focus away from innovation towards transactions. Part 3 explores the interplay between transactional proficiency and innovation and discusses the implications of M&A-focussed expansion on R&D and patient outcomes. Part 4 suggests a strategy for enterprises to reignite their stagnating values and slow growth rates, which entails less M&A-driven expansion and more innovation-centred growth. Achieving this involves developing leaders with a blend of financial and R&D acumen.
 
Part 1
 
Leaders and Managers

Leaders and managers play important roles in the success of commercial enterprises, each having distinctive yet interconnected functions. However, leadership and management differ, and this differentiation is important to understand their respective contributions to the medical technology industry.
 
Leadership, which has evolved over time, involves guiding, influencing, and motivating individuals and groups towards shared objectives. It includes envisioning a direction, making strategic choices, and inspiring growth within organizations. Leaders prioritize people, nurture relationships, and understand individual strengths, and motivations. This enables them to empower others to embrace change and achieve their potential. They adopt a forward-looking, longer-term strategic perspective, fostering innovation while being prepared to take calculated risks for growth. Effective leadership influences a company’s trajectory, culture, and efficacy. It fosters productivity, innovation, and a positive attitude to work. In an environment characterized by technological advancements, constant organizational change, and market shifts, leadership is crucial. Under such conditions, embracing change rather than resisting it not only brings stability but also reduces stress and prevents chaos. Leadership is essential for guiding enterprises and employees through uncertainty, fostering innovation, creative thinking, and stability. Leaders often possess a combination of leadership and managerial skills; and they know how to balance these and have the capacity to navigate dynamic environments which require adaptability, agility, and inspiring visions.
 
Conversely, management, revolves around organizing, planning, and efficiently controlling resources to attain specific goals. Managers address operational challenges, and focus on processes, structures, and day-to-day operations, ensuring tasks adhere to plans. Their strength lies in executing business plans, maintaining stability, control, and consistency in operations to ensure that organizations function smoothly. Managerial skills excel when supervising daily operations, allocating resources, and completing tasks efficaciously. Managers perform well in project-oriented environments, overseeing planning, execution, and monitoring to achieve objectives. They allocate budgets, personnel, and equipment optimally, managing risks and performance to ensure stability.
 
Part 2
 
The Rise of Financialization in MedTech

The financialization of the MedTech industry took root over several decades when interest rates were low and access to affordable capital was relatively easy. This encouraged corporate executives to lean away from developing innovative scientific devices for expansion and lean in on M&A to provide growth. One recent period during which central banks maintained low interest rates, and adopted accommodative monetary policies, is the aftermath of the global financial crisis of 2008. In response to the crisis, central banks, including the US Federal Reserve, (Fed) implemented measures to stimulate economic growth and stabilize financial markets. One of the primary tools used was reducing interest rates to near-zero. For instance, the Fed held its federal funds rate [the benchmark interest rate] at near-zero levels from December 2008 to December 2015. The purpose of this was to encourage borrowing and investment, which in turn was expected to stimulate economic activity, job creation, and consumer spending.
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Such extended periods of low interest rates encouraged MedTech executives to explore growth opportunities beyond conventional R&D investments. With significantly reduced financing expenses, and a large, underserved, fast growing sector, managers turned to M&A to bolster their resources and expansion efforts. This trend was further buoyed by investors seeking higher returns amid limited profitability in low-interest rate environments. Consequently, MedTechs gravitated toward M&A and financial activities, which promised near-term gains and broader market reach. This shift diverted executive focus away from innovation-centered expansion to transactional approaches for growth, ultimately reshaping the industry's trajectory toward financialization. M&A opportunities initially helped companies to strengthen their presence in underserved, rapidly expanding market segments. By merging with, or acquiring, near adjacent enterprises, MedTechs accessed new customer bases, technologies, and product portfolios, which allowed their executives to consolidate company resources, increase market share, and achieve economies of scale, which drove growth.
Perceived benefits of M&A

This shift towards M&A and financial optimization did not diminish the significance of scientific progress and innovation; but it did incentivize many MedTech executives to recalibrate their reliance on R&D. As the industry evolved, several factors encouraged executives to prioritize M&A and financial engineering as their principal drivers of growth. These included the increasingly stringent regulatory landscape for medical devices, which extended the time and costs associated with new product launches. Executives recognized the value of acquiring readily available innovations with existing regulatory approvals. Additionally, M&A offered the opportunity for MedTechs to streamline their operations, eliminate redundancies, cut costs, and enhance financial performance.
 
Over time, intensifying financial activities increased the industry’s global competition, and many MedTechs employed M&A to expand internationally and gain access to new markets. Simultaneously, acquisitions facilitated the diversification of product offerings, which lowered risks associated with relatively narrow product portfolios. Publicly traded corporations faced pressure from investors to deliver near-term financial results and shareholder value, which further steered executives to lean in on M&A for quick returns and access to a wider talent pool and complementary technologies.
 
Impact on leadership dynamics

The rise of M&A activities and the financialization of the MedTech industry reshaped leadership dynamics. While the sector was initially driven by innovation-focused leaders, the shift we describe has led to a gradual transition towards transaction-oriented managers taking control. Visionary figures like Willem Einthoven, a Dutch physiologist and Noble Laureate for Medicine, Thomas Fogarty, an American inventor, innovator, and cardiothoracic surgeon, Patricia Bath, an American ophthalmologist, and inventor and Robert Langer, an American engineer, scientist, and entrepreneur, are just four  among many others  who laid foundations for the industry's growth with their pioneering medical technologies. For instance, Einthoven's invention of the electrocardiogram (ECG) changed cardiology, Fogarty's embolectomy catheter, (balloon catheter), transformed vascular treatments, Bath’s Laserphaco Probe, disrupted cataract surgery, and Langer's work on biomaterials led to several breakthrough medical devices.
 
Notwithstanding, over time, M&A pursuits by companies altered resource allocation, diverting attention away from R&D towards activities like due diligence and integrations. This shift redirected budgets and talent away from innovation, affecting the creative and scientific progress of enterprises. Metrics tied to M&A outcomes gained precedence over those that encouraged internal innovative momentum. Further, the growing financial acumen of MedTech executives overshadowed R&D capabilities, emphasizing short-term gains over longer-term strategic innovative initiatives. After decades of successful M&A, changes in economic, financial, and technological landscapes prompted concerns about the industry’s sustained growth and innovation-centric leadership.
 
Consequences of M&A for innovation and R&D

Prioritizing financial transactions over R&D in a fast-paced industry can undermine innovation, sustainable growth, and competitive advantage. Companies favouring financial activities at the expense of R&D have tended to show diminished ability to create novel medical technologies, which results in fewer disruptive solutions and a weakened ability to address evolving healthcare challenges. The significance of R&D for longer-term sector growth cannot be overstated. A disproportionate focus on financial transactions leads to short-term mindsets, which tend to neglect opportunities for organic growth through innovation, and thereby disadvantaging companies by hindering their adaptation to economic trends and market dynamics.
 
Companies with robust R&D cultures attract scientific talent. Conversely, leaning away from innovation makes it difficult to attract and retain top researchers, engineers, and experts. An enterprise's reputation is tied to its innovation and scientific capabilities, while an overemphasis on financial transactions projects profit-centric motives, which can erode stakeholder trust and credibility. In the rapidly advancing technology landscape, neglecting R&D invites obsolescence. Companies not allocating sufficient resources to innovation run the risk of falling behind competitors as new breakthroughs emerge, jeopardizing their market share. Over emphasising M&A introduces dependence on external factors such as regulations, negotiations, and integration challenges, which can disrupt an enterprise’s growth predictability. While financial transactions may promise more immediate gains, they tend to divert resources away from longer-term strategies and R&D, which can compromise sustained growth and value added. This shift risks a company losing a core identity, which can undermine employee motivation and reduce stakeholder alignment. Further, prioritizing financial transactions can create discord within an organization between transaction-focused executives and innovation-aligned employees, which could impede strategy execution. Thus, leaning away from R&D for financial gains can jeopardize innovation, growth, and competitive edge, ultimately hampering a company's longer-term success.
 
Part 3
 
The Implications of M&A-Centric Growth

The implications of M&A-centric growth are multifaceted and extend beyond the immediate area of financial transactions. A trend that emerges within MedTechs as they prioritize M&A activities over R&D, is an innovation gap, which can introduce strains within leadership dynamics as resources are disproportionately allocated to financial pursuits rather than fostering technological advancements. Reallocating resources in this way can stifle the development of innovative technologies. Moreover, often the shift is accompanied by a transformation in executive skill sets, where financial acumen takes precedence over the ability to drive R&D. Consequently, there is a shift in the overall performance metrics of companies. Short-term gains resulting from transactional activities, often overshadow longer-term, research-driven achievements that are essential for innovation, growth, and competitive advantage.
The change in company culture is another potential consequence of this growing inclination toward financial activities. The once-pervasive values of creativity calculated risk-taking, and scientific exploration, which have historically fueled innovation, start to wane. This is further exemplified by a shift in talent attraction strategies. The attraction of financial expertise can eclipse the allure of nurturing disruptive innovation, thereby resulting in a dearth of fresh perspectives that could potentially drive growth and value.
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As decision-making processes prioritize short-term financial outcomes, there is a gradual sidelining of research-driven innovations that are needed for the sustained growth and relevance of MedTech companies. The ramifications of this choice are significant. Entities that opt for transactional expansion rather than innovative evolution may find themselves trailing behind competitors who continue to invest in R&D endeavours. This divergence in strategy could lead to a subsequent loss of market share and a gradual erosion of overall relevance. Innovation remains important to address the adaptive challenges that arise from evolving healthcare demands, increased patient voices, rapidly advancing technology, and increasingly stringent regulatory requirements. The transformation of MedTech companies into entities that prioritize financial outcomes run the risk of leaving them ill-equipped to effectively navigate these headwinds. A reduced focus on innovation tends to render companies vulnerable, impairing their capacity to anticipate and effectively respond to future industry and societal trends.
 
The importance of striking a balance between short-term financial goals and longer-term innovation objectives cannot be overstated. Companies that are unable to reconcile these contrasting perspectives risk compromising their ability to anticipate and adapt to the evolving healthcare landscape. In essence, the ramifications of an M&A-centric growth approach are not solely confined to fiscal aspects; they extend to the core of a company's competence to foresee, adapt to, and thrive within a rapidly evolving MedTech sector.
 
Reduced R&D resources impact on patient care and outcomes

The impact of diminished R&D resources on patient care and outcomes can be significant. At its core, a vibrant and forward-thinking MedTech industry is essential for the development and successful deployment of medical technologies, diagnostics, and treatments that increase the efficacy of healthcare and improve patient outcomes. The combination of innovation and healthcare can translate into tangible benefits for patients. For instance, personalized medicine therapies, which are outcomes of R&D, offer a transformative approach that enhances patients’ therapeutic journeys, and minimizes adverse effects.
 
Smart devices often mean swift and precise diagnoses, which pave the way for timely and effective interventions. Beyond this, innovation extends to healthcare accessibility. Remote monitoring and telehealth technologies reduce geographical barriers, bringing healthcare within reach of those in remote and underserved regions. This can reduce disparities in healthcare access, leveling the playing field for all individuals, regardless of their location, ethnicity, or socioeconomic status. Further, the shift toward minimally invasive technologies not only fosters quicker recovery times but also shortens hospital stays. The combination of improved healthcare protocols that promote better adherence and more efficient, cost-effective medical procedures helps to make quality healthcare accessible to more people.
 
Concern arises when MedTech innovation takes a back seat, which tends to perpetuate outdated medical devices that can result in suboptimal outcomes and the continuation of existing healthcare disparities. The neglect of innovative R&D endeavours delays the development of disruptive technologies, thus prolonging inequitable healthcare access and outcomes. In this context, companies that lean away from innovation could find themselves deepening divisions between different patient outcomes. The role of healthcare providers is associated with the availability of advanced technologies. Optimal care requires the integration of innovative technologies into medical practices, and the neglect of this can limit access to care, and potentially compromise patient outcomes. It is important to stress that the direction of the MedTech industry has an impact on the quality of healthcare that a society can provide. By placing innovation at the forefront of strategic priorities, companies are more likely to enhance treatments, patient experiences, and the overall efficiency of the healthcare ecosystem. Neglecting innovation, on the other hand, can result in stagnation that perpetuates inequalities, delays healthcare access, and slows the development of patient-centered care. The symmetry between financial considerations and the pursuit of innovation is important. The consequences of overlooking either aspect have effects, which can extend beyond company balance sheets into the health and wellbeing of patients who depend on the MedTech industry to provide leadership for a healthier and more equitable future.
 
Part 4
 
A Strategic Approach for MedTech Transformation

The phase of MedTech's growth driven by M&A has now matured, necessitating a fresh perspective and refined strategy. The transition from visionary leaders to financial managers has, in many medical technology companies, created a void in leadership, especially given the current headwinds faced by the industry. To improve patient outcomes and foster sustainable growth, a recalibration is required, which places innovative leadership and patient-centric care initiatives at the forefront. A synergy between financial and R&D strategies is important for success. Only by reconciling financial operations with innovation endeavours, can the potential for competitive advantage and improvements in patient care take place.
Strategic allocation of resources, particularly towards dedicated innovation efforts, drives research. Notwithstanding, the realization of this relies on company executives leaning in on the transformative potential of R&D endeavours. To counterbalance any undue focus on short-term gains, it is essential to develop and implement a balanced set of performance metrics that connect financial milestones with innovation breakthroughs. This provides the basis for a strategy, which fuses financial decision-making with the promotion of innovation-driven initiatives. Further, to help executives develop diverse and adaptable mindsets, enterprises might consider increasing collaborations with research institutions and start-ups, with the aim to gain access to talent and knowhow that complements internal capabilities.


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The establishment of structured innovation frameworks, closely tethered to fiscal objectives, should help to provide a consistency of purpose. Safeguarding innovations requires robust intellectual property (IP) strategies, and regular evaluations, attuned to prevailing market trends, and assisting with the ongoing alignment of a company’s strategy with exogenous trends.  This nuanced approach hinges on executives being able to balance essential financial imperatives with innovations to create a balance, which, in turn, is expected to contribute to sustainable growth, heighten competitiveness, improved patient outcomes and reduced healthcare costs.
 
Cultivating leaders with balanced expertise

Successfully blending transactional expertise with R&D capabilities requires leaders with vision and purpose able to develop and implement strategies that harmonize with an enterprise’s goals and politico-economic trends, evolving stakeholders’ demands and changes in healthcare systems. Let us briefly suggest a roadmap to achieve this.
 
First, develop cross-functional leadership teams that unite financial and R&D experts, and are expected to help ensure that decisions become grounded in both fiscal considerations and innovative pursuits. Advocating for innovation within finance and R&D units, helps to foster alignment between financial choices and R&D priorities. Developing and implementing key performance indicators (KPIs) is crucial. These should measure both financial outcomes, and advancements in innovations. Consider incorporating into performance evaluations metrics such items as newly filed patents, and the delivery of product launches and impactful R&D projects on-time and within budget.
 
Establish a dedicated venture fund to drive and reward innovation. Facilitate collaborative workshops that bring together finance, R&D, marketing, and other functions to ideate transformative solutions and services. Such endeavours should aim to increase growth, enhance enterprise value, improve patient outcomes, and reduce the cost of care. Align financial objectives with innovation goals, linking bonuses to achievements in both financial performance and successful innovation. When contemplating M&A, give precedence to targets that enhance a company’s innovative capabilities by aligning with R&D expertise and novel product portfolios, thus amplifying innovation.
 
Create small cross-functional review groups to assess innovation projects for alignment with business goals and fiscal viability. Establish agile committees to oversee resource allocation and to ensure consistent R&D funding. Implement programmes to recognize and celebrate employees who contribute to innovative ventures to help cultivate a culture of inventiveness. Set up platforms to facilitate interdepartmental sharing of creative ideas. Actively involve financial specialists in innovation discussions. Cultivate external partnerships to infuse fresh perspectives into R&D initiatives. Foster communication channels between financial and R&D teams and encourage regular exchanges of insights and opportunities. Provide training to enhance financial experts' understanding of R&D processes and offer financial literacy training to R&D teams. By integrating transactional expertise and R&D acumen, MedTechs can more effectively balance financial growth and innovation, to help enhance competitiveness, adaptability, and industry-leading innovation.
 
Reviving visionary leadership

This Commentary started by describing differences between leaders and managers to highlight the prevalence of transactional management during a period of M&A-driven growth, which in turn diminished the demand for visionary leadership. As the industry has reached a mature phase, and facing significant headwinds, a juncture arises that calls for leaders capable of bridging the gap between financial success and technological advancement. This involves aligning financial strategies with a broader vision of innovation and patient-centric progress. In doing so, visionary leaders establish a framework that both augments a company's financial performance, and drives healthcare technology forward, ultimately enhancing patient outcomes. This strategic evolution depends on leaders embracing a forward-thinking mindset that extends beyond immediate gains and helps to steer enterprises towards sustained innovation and growth.
 
Central to this transformation is the synchronization of financial goals with a company's longer-term vision. This ensures that financial policies are conducive to fostering transformative technologies. Cultivating an innovative culture within an organization, leaders instill a spirit of expansive thinking, experimentation, and the pursuit of innovative technological solutions and services that address healthcare challenges. Acknowledging the need for strategic investments in R&D, these leaders allocate resources optimally to bolster novel solutions and services. Furthermore, they have an awareness of market trends, emerging technologies, and evolving patient needs. This equips them to anticipate shifts in both the market and technology landscapes, which enables them to strategically position their companies to take advantage of emerging opportunities. By balancing innovation and astute risk management, leaders blend calculated risk-taking with prudent financial decisions, thereby contributing to stability and improved competitiveness. With a focus on the longer-term impact of their actions, visionary leaders understand the interplay between present-day technological advances and a company's future standing.
 
In the dynamic ecosystems of contemporary medical technology, visionary leaders exhibit adaptability in navigating change, guiding companies forward by skilfully adopting new technologies and strategies. Their longer-term strategic outlook attracts top talent from both finance and technology. Inherently collaborative, these leaders forge alliances with other companies, start-ups, research institutions, and industry experts, which increase the potential for accelerating the pace of technological innovations from the bench to the bedside. Harnessing novel technologies to create distinctive solutions and services, they lead their organizations to prominence within a competitive market. Upholding ethical considerations, these leaders ensure that technological progress not only yields financial gains but also has benefits for patients and healthcare systems. Investors tend to gravitate towards enterprises with visionary leaders. The ability to articulate a compelling narrative that emphasises how innovation drives future growth and financial returns enhances their allure. Thus, visionary leaders orchestrate a successful synergy between financial acumen and technological ingenuity, encouraging an ecosystem where strategic foresight translates into substantial dividends.
 
Takeaways

The evolution of the medical technology sector over the past four decades has presented a dual-edged transformation that healthcare professionals must now grapple with. The shift from pioneering innovators to adept managers within the industry reflects the interplay between economic, technological, regulatory, and ethical factors. As these converge, healthcare companies face significant headwinds that demand leadership rather than management. The financialization of the industry, driven by prolonged periods of low interest rates and accessible capital, has had a significant influence on the industry’s ecosystem, accelerating growth while simultaneously steering priorities away from innovation towards financial pursuits. This shift opened a new era, characterized by an abundance of skilled managers but a deficit of visionary leaders. Today, the MedTech industry stands at a juncture, with the demand for strategic foresight and innovative thinking never more acute. The need to pivot towards sustained growth and enhanced enterprise value necessitates leaders who can balance the strategic imperatives of R&D and the financial acumen required for M&A. The future trajectory of the medical technology sector hinges on the ability of healthcare professionals to recalibrate leadership dynamics. By addressing the scarcity of visionary leaders, the industry can leverage its potential to overcome the headwinds it currently faces and pioneer transformative innovations that redefine the landscape. As healthcare professionals navigate the future, their collective efforts will determine whether the MedTech sector continues to evolve along its current trajectory or takes a bold new direction towards enhanced growth, innovation, and added value.
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8 months ago

Transforming Women's Health

HealthPad
Directory:
Medical Technology
Tags:
commentary
endometriosis
menopause
reproductive medicine
women's healthcare
  • Women's health needs are linked to their biological, physiological and psychosocial makeup, setting them apart from men and requiring specialized care
  • Women's health has been inadequately addressed
  • Gender inequalities continue and lead to uneven healthcare accessibility, resulting in postponed diagnosis and less than optimal treatment outcomes 
  • Women play a pivotal role in families, communities, workforces and society
  • Investing in comprehensive lifetime care for women, rather than disparate, periodic interventions, is a human right, a social responsibility and an astute economic strategy
 
Transforming Women's Health
Pioneering a Comprehensive Lifelong Healthcare Paradigm
 
Preface
 
In a significant shift, gender issues pertaining to women’s health, are experiencing change driven by women’s growing refusal to accept secondary status. This change is accompanied by the substantial contributions women make to economic growth, stemming from their expanding presence in the workforce and their influential roles within families, communities, and society. While pharmaceutical and medical technology sectors have developed specialized treatments for certain women’s disorders, there remains a need for a proactive, lifelong approach to women’s healthcare. Although efforts to address conditions like menopause and breast cancer are commendable, they risk commodifying women’s health. To meet their diverse health needs and acknowledge the pivotal roles they play in both developed and developing economies, a comprehensive and sustainable healthcare model is necessary. This is more than episodic interventions and calls for an understanding of, and sensitivity towards the unique physiological and psychological challenges women encounter throughout their lives. A proactive paradigm prioritizing prevention, early detection, and treatment is mooted. Realizing this calls for collaboration among healthcare providers, institutions, advocacy groups, governments, and payers. While commercial enterprises may think that participating in a comprehensive lifelong strategy for women’s health is beyond their scope, the changing business environment, shaped by concerns related to Environmental, Social, and Governance (ESG) matters, highlights the ethical, social, and commercial importance of supporting a holistic approach to women’s healthcare.
 
In this Commentary
 
This Commentary is in three parts. It starts by briefly describing what constitutes women's health and suggests why women’s healthcare is important, which is followed by a short historical perspective and mention of gender disparities that still exist despite improvements. Part 2 describes a comprehensive lifetime healthcare strategy for women, to replace current disparate, episodic interventions, and contends that such a holistic approach has the potential to yield substantial health, wellbeing, and socio-economic benefits. The size of the global women’s healthcare market and some of the leading companies participating in it are described in Part 3. Takeaways follow and stress the significance of a comprehensive, lifetime healthcare model for women. 
 
Part 1

Women’s health

Women's health is a critical and multifaceted area of healthcare that focuses on their specific biological, physiological, and psychosocial needs throughout their lifetime. It encompasses a wide range of conditions, from reproductive and gynecological health to hormonal changes, pregnancy, and menopause. Reproductive health includes family planning, contraception, and fertility management. Providing information about birth control and fertility treatments helps women to make informed decisions about their reproductive choices. Addressing issues related to sexual health, such as sexually transmitted infections (STIs) and sexual dysfunction, encourages women maintain a healthy intimate life. Gynecological health is another key component of women’s health, involving the prevention, diagnosis, and treatment of conditions affecting the female reproductive system. Routine screenings like Pap smears and mammograms help in early detection of cervical and breast cancers. Healthcare professionals should be adept at managing common gynecological conditions such as menstrual disorders, polycystic ovary syndrome (PCOS), endometriosis, and uterine fibroids. Throughout a woman's life, hormonal changes influence her physical and emotional wellbeing. Addressing concerns related to menstruation, hormonal imbalances, and menopause is important. Additionally, pregnancy and childbirth require prenatal care, delivery support, and postpartum care for both mother and baby. Sensitivity, empathy, and a patient-centered approach are essential. Only by recognizing and addressing the needs and challenges faced by women, can healthcare providers effectively contribute to female patients' overall wellbeing and quality of life.
 
The importance of women’s health 

Historically, women’s health has predominantly revolved around reproductive aspects due to their perceived primary role. Despite enduring years of inadequate representation and underfunding in medical practice and research, the importance of prioritizing women’s health is a crucial step towards reducing gender disparities, optimizing outcomes, and fostering societal equity. Overlooking the holistic consideration of women’s distinctive lifelong attributes can lead to undetected or untreated disorders. Central to this is women’s reproductive and maternal wellbeing, which not only molds their own health but resonates across generations, influencing the wellbeing of their offspring. Thus, ensuring ample prenatal care, maternal nutrition, and birthing support is pivotal in securing favourable results for mother and infants.

Prioritizing women’s health leads to the reduction of preventable diseases. Comprehensive female health programmes encompassing screenings, vaccinations, and early detection of conditions such as breast and cervical cancers play a crucial role in disease prevention and prompt treatment, thereby amplifying overall health and longevity. Women’s wellbeing is a foundation for personal wellness, gender parity, and societal advancement. Optimal female health empowers women to confidently engage in decision-making, pursue education, seize economic opportunities and more. By concentrating on women’s health, we not only champion proactive care and lifestyle adjustments benefitting individuals and future generations, but also alleviate the large and rapidly growing burdens on healthcare systems.
 
Brief history

Over time, women's healthcare has experienced gradual advancements and improvements. In ancient times knowledge about women's health was passed down through oral traditions and informal practices. Women relied on natural remedies and herbal medicine for managing reproductive health, childbirth, and general wellbeing. During the medieval and Renaissance periods, women's healthcare was mainly in the hands of midwives and female healers. Their expertise in childbirth was valued, but formal medical education and knowledge were limited. As medical knowledge advanced during the 18th and 19th centuries, some progress was made in understanding women's anatomy and reproductive health. However, societal norms and prejudices often hindered women from either accessing formal medical education or seeking medical attention, which resulted in continued reliance on midwives and home remedies. The mid-19th century brought changes. In 1849 Elizabeth Blackwell, a British-American, became the first woman in US to earn a medical degree, and the first woman on the Medical Register of the General Medical Council for the UK. Florence Nightingale, best known for her pioneering work in nursing, played a significant role in the Crimean War (1853-1856), where she improved nursing care for wounded soldiers and established modern nursing practices, which have had a lasting impact on nursing and public health. Their achievements, and those of others, subsequently laid the foundations for the involvement of women in the field of medicine. However, societal attitudes still posed obstacles to women's healthcare advancements.
 
The 20th century saw progress in women's healthcare. With the suffrage movement and feminist activism, women's rights and health issues gained attention. In the early 1900s, the first birth control clinics were established, allowing greater control over reproductive choices. Further progress was made during the mid-20th century. In 1960, the US Food and Drug Administration (FDA) approved the first oral contraceptive pill, which changed family planning and reproductive rights. In the following decades, women’s movements advocated access to safe and legal abortion. Women's healthcare expanded further in the latter half of the 20th century, with increased research and understanding of women-specific health concerns. Breast cancer screenings, cervical cancer screenings (Pap smears), and other preventive measures became more widely available.
 
In the 21st century, women's healthcare continued to progress, with an emphasis on preventive care, and early diagnosis. Advances in medical technologies and research further improved women's health outcomes. Efforts were made to address disparities in healthcare access for different populations of women, including those based on ethnicity, socio-economic status, and geographical location. Initiatives to improve maternal health, reduce maternal mortality, and provide better support during childbirth gained momentum. Awareness campaigns focusing on issues, such as breast and cervical cancers, helped in early detection and treatment. Taboo and often misunderstood subjects like menopause are now widely discussed, primarily to educate people. Additionally, women's mental health received more attention, leading to increased resources and support. While challenges remain, the activities of healthcare professionals, researchers, advocates, policymakers, and commercial enterprises continue to help shape a healthier future for women.
 
Gender disparities in healthcare

Despite advances in women’s healthcare, gender disparities have been a persistent and concerning issue, with women often facing underrepresentation in medical research and practice. Such differences result in unequal access to healthcare services, delayed diagnosis, and suboptimal treatment outcomes. Women's health concerns have often been underrepresented in clinical trials, which results in a lack of evidence-based treatment options tailored to female physiology and health risks. This disparity can be pronounced in conditions such as heart disease, where symptoms and risk factors may differ between men and women. Women often face barriers in accessing comprehensive reproductive health services, including contraception, family planning, and safe abortion services. Some regions have limited availability of these services due to legal, cultural, or religious factors, which can impact women's control over their reproductive choices and health. In many parts of the world, maternal mortality rates are disproportionately high, particularly in low-income countries. Every two minutes, a woman dies from preventable causes related to pregnancy and childbirth. Lack of access to appropriate prenatal care, skilled birth professionals, and emergency obstetric care are contributory factors, reflecting a significant gender-based health inequity. Some chronic autoimmune diseases, such as lupus and psoriatic arthritis are more prevalent in women, yet diagnosis and treatment can be delayed or less effective due to gender biases in medical research and practice. Studies have shown that women's pain is often undertreated compared to men's, potentially due to biases in healthcare providers' perceptions of pain and discomfort. This can lead to inadequate pain relief and poorer health outcomes. While mental health problems affect both genders, women frequently encounter distinct challenges. These encompass conditions like postpartum depression and anxiety, which are primarily linked to hormonal imbalances, but also associated with factors such as insufficient sleep and inadequate support systems. Societal stigma around mental health, combined with gender norms, can discourage women from seeking help and support for their mental wellbeing.

In some societies, limited education and information about healthcare can lead to women having less knowledge about preventive measures, symptoms, and treatment options, which can result in delayed or inadequate care for certain conditions. Gender-based violence has health consequences, including physical injuries, mental health issues, and increased risk of sexually transmitted infections. Limited access to safe spaces, support services, and legal protection can hinder women's ability to escape such situations. Further, women tend to live longer than men, but they may also face difficulties accessing appropriate healthcare and support in their later years. Consequently, elderly women often experience greater social isolation, limited financial resources, and increased prevalence of certain health conditions.
 
Part 2

Comprehensive lifetime care

With increasing recognition of the contributions women make to economic growth and stability, their health has gained relevance. The emergence of women's economic influence and direct participation in the workforce has prompted a shift in our approach to women's health. The pharmaceutical and medical technology industries have made progress by developing medications and devices targeting specific health issues. Notwithstanding, it seems timely to move beyond such approaches and focus on a comprehensive care model that supports women throughout their lives.
 
Pharmaceutical and MedTech companies have tapped into the women’s healthcare market by focusing on high-volume areas, like mensuration, menopause, and breast cancer. While such efforts are improvements, women deserve better. In recognition of the significant contributions they make to society, and the changing perspectives of corporate social responsibility, it is time to pivot towards a new approach to women's health. Rather than focusing on reactive healthcare policies to address specific disorders, a comprehensive and proactive care model is required to address women's diverse healthcare needs. Women's health encompasses more than just the treatment of certain illnesses and diseases. It involves addressing the unique physiological and psychological aspects they experience throughout their entire lives. Thus, a shift towards providing lifetime care and support for women seems timely.
 
According to the World Health Organization (WHO), “Health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity”. Achieving this for women requires a collaborative effort from healthcare providers, institutions, organizations, governments, and payers. This should aim to break down barriers, improve access to quality care, and foster health equity for all women, regardless of their socioeconomic status or geographical location. Certain businesses may view participating in a comprehensive women’s health approach as beyond their commercial interests. However, with ESG concerns reshaping the landscape, collaborating in a women’s holistic healthcare strategy becomes ethically, socially, and commercially logical.
 
Benefits of a lifetime health programme

A proactive lifetime healthcare approach would result in long-term cost savings by identifying health concerns early and reducing expensive treatments, benefiting individuals, and trimming large and rapidly growing healthcare burdens. This allows resources to be reallocated for other needs. Moreover, enhanced women's health has a positive economic impact. Countries like the US and UK have relatively high female workforce participation rates: ~57% and ~72% respectively. A healthier workforce contributes to higher productivity, benefiting both businesses and economies.
 
Investing in women's lifetime healthcare also helps narrow gender pay gaps by providing access to consistent healthcare, promoting career advancement, financial security, and workplace parity. Prioritizing prevention and addressing women's health needs drives demand for innovative solutions and services, potentially leading to advancements in pharmaceuticals, medical technologies, and healthcare practices. Nation’s investing in holistic women's health can gain a competitive edge with an educated, committed female workforce, which supports stability, and innovation. Additionally, effective women's healthcare reduces reliance on public aid, channeling fiscal savings toward societal wellbeing.
 
The women's health market holds significant growth potential. Unique concerns provide opportunities for innovative solutions and services such as advanced fertility treatments and personalized therapies. Telemedicine and digital healthcare platforms expand access, especially in underserved regions. Amid competition from established players, newcomers can thrive by emphasizing innovation, patient-centered care, and technology integration. Adhering to safety standards and addressing cultural norms are crucial for building trust. Overcoming stigmas through education and targeted campaigns encourages women to prioritize their health. By collaborating in a comprehensive lifetime approach and strategic R&D, companies can gain a competitive edge.
 
Part 3

Women’s healthcare market

According to Grand View Research, in 2022, the global women’s health market was valued at ~US$41bn, and is expected to grow at a compound annual growth rate (CAGR) of ~5.4% over the next decade. Market growth is attributed to aging populations of women, and the increasing prevalence of women-centric diseases such as osteoporosis, menopause, and breast cancer. The World Health Organization (WHO) reports that breast cancer is the biggest killer of women, but only ~50% of them realize this. In 2020, there were 2.3m new cases of the disease globally and ~685,000 deaths.

There are many companies marketing products for women’s health. Pfizer, one of the world's largest pharmaceutical companies has a presence in women's health. They have developed and market contraceptives, hormone replacement therapies, and treatments for menopause-related symptoms. Merck & Co. is a global healthcare company that offers a range of products for women's healthcare, including fertility treatments, contraceptives, and medications for conditions like human papillomavirus (HPV) and osteoporosis. Johnson & Johnson, a diversified healthcare company, offers medicines for menopause, products for menstrual health, and contraceptives. Bayer, a multinational pharmaceutical company known for its contributions to women's healthcare, produce intrauterine devices (IUDs), and medications for various women's health conditions and wellbeing. AbbVie has offerings that include treatments for endometriosis and hormone replacement therapies. Hologic, a MedTech specializing in women's health, produces imaging systems, diagnostic tools, and surgical equipment for gynecological and breast health, including mammography and biopsy solutions. Medtronic, a global healthcare technology leader, provides medical devices for gynecological surgeries and treatments for urinary incontinence. CooperSurgical, a dedicated women's health company, offers a wide range of medical devices and products for gynecological procedures, fertility treatments, and obstetrics.
 
Takeaways

In a world where gender-specific health disparities persist, companies engaged in women’s health have the capacity to make an impact on women’s overall wellbeing. The growing recognition of distinct healthcare requirements for women emphasizes the significance of committing resources to women’s health, suggesting a choice that is both commercially astute and socially just. In addition to reactive interventions, businesses might consider partnering with stakeholders to support a comprehensive healthcare strategy tailored to women’s individual life journeys. This requires leadership, investing in R&D, and harnessing the potential of emerging technologies like digital health platforms, telemedicine, and AI-driven data analytics. Such an endeavour has the potential to change healthcare accessibility, amplify diagnostic precision, and refine disease management exclusively for the female demographic. By participating in such an approach, companies not only position themselves as leaders in an important market segment but also contribute to fostering a healthier, more equitable world for women throughout their entire lifespan.
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8 months, 2 weeks ago

PPG technology: Unlocking the Potential of Healthcare

HealthPad
Directory:
Medical Technology
Tags:
commentary
Photoplethysmography
PPG technology
TBI
traumatic brain injury
  • Photoplethysmography, commonly referred to as PPG, is a simple, non-invasive, and affordable technology used for monitoring heart rate, blood oxygen saturation, and other physiological parameters
  • PPG uses light to measure and analyze changes in blood volume, enabling the tracking of vital signs and assessment of cardiovascular health
  • With a growing interest in non-invasive physiological monitoring and a shift towards continuous and ubiquitous patient care, PPG has gained significant attention and provides alternatives to expensive, time-consuming, and invasive healthcare modalities
  • Many giant tech companies, including Apple, Google-Fitbit, and Samsung produce wearable products that incorporate PPG technology
  • PPG-driven devices are used by millions and have established a significant presence in healthcare and wellbeing
  • Despite its potential, PPG faces challenges that include signal variability, noise and artifact interference, which can distort the signal and hinder reliable information extraction
  • Overcoming these challenges will pave the way for pervasive adoption of PPG technology throughout healthcare
 
PPG technology: Unlocking the Potential of Healthcare
A Journey of Non-invasive Precision
 
This Commentary describes how photoplethysmography (PPG) has become a valuable tool in continuous vital sign monitoring, and exercise physiology, making it a promising avenue for improving patient care and empowering individuals to take better care of their health and wellbeing. PPG has the potential for many more non-invasive and affordable healthcare applications, providing alternatives to expensive, time consuming, and invasive methods. The technology benefits not only from the large and rapidly growing interest in non-invasive physiological tracking, but also from the paradigm shift in healthcare towards continuous and pervasive patient monitoring beyond traditional in-hospital care. This Commentary describes PPG, explores its applications in healthcare, highlights its advantages over traditional methods, and suggests that it has potential to disrupt the diagnosis and treatment of traumatic brain injury.
 
Photoplethysmography (PPG)
 
PPG is a non-invasive and straightforward measurement technology that utilizes a light source and a photodetector placed on the skin's surface to assess the variations in blood volume. Typically used for blood oxygen (SpO2) and heart rate monitoring, PPG sensors are commonly placed on the wrist or fingertip, where blood flow is close to the skin's surface. A light-emitting diode (LED) emits light into the tissue, and the photodetector captures the reflected or transmitted light, detecting changes in light absorption or reflection caused by fluctuations in blood volume. These fluctuations in light intensity are converted into electrical signals, which can be processed to determine SpO2 or heart rate levels.
 
The PPG signal, also known as the photoplethysmogram, is based on the principle that blood absorbs light, and this absorption changes as blood volume fluctuates with each heartbeat. When the heart pumps blood into the arteries during systole, the volume of blood in the arteries increases, leading to more light absorption. Conversely, during diastole when the heart relaxes, the blood volume in the arteries decreases, resulting in less light absorption. Analyzing these variations in transmitted or reflected light, the PPG signal provides information about pulsatile changes in blood flow and offers insights into peripheral vascular function, arterial stiffness, and other vascular characteristics.
 
PPG has several advantages, including its non-invasiveness, simplicity, and portability. Unlike other methods, it does not require needles or complex equipment, making it suitable for continuous monitoring in various settings. By providing physiological information about the cardiovascular system, PPG finds applications in vital sign monitoring, sleep apnea screening, exercise physiology, blood flow assessment, and continuous health tracking. The technology's convenience, affordability, and accessibility contribute to improved patient care and empower individuals to take a more proactive role in monitoring their health and wellbeing.
 
It is important to note that PPG provides only indirect measurements and does not offer detailed information about the underlying cardiovascular system. Its primary focus is on changes in blood volume. For accurate measurements in medical applications, calibration and validation against other gold standard techniques are necessary. Notwithstanding, PPG remains a healthcare technology with wide-ranging applications, serving as a valuable tool in enhancing healthcare monitoring and management.
 
Brief history

PPG has a history that spans several decades, with advancements and refinements in both the technique and its applications. Its foundations were laid in the 1930s when researchers began investigating the transmission and reflection of light through human tissues. The first PPG measurements were performed using mercury-filled plethysmographs and light sources like incandescent lamps. During this period, the technology was primarily used for studying changes in blood volume and its correlation with physiological events. In the 1950s, Karl Matthes invented the first practical PPG sensor, which utilized a red light-emitting diode (LED) and a phototransistor. Matthes's device was initially designed for measuring pulsations in the extremities and evaluating peripheral circulation. The technology gained further recognition in the 1970s with the introduction of pulse oximetry, when a combined PPG sensor and spectrophotometer were used to measure oxygen saturation (SpO2) non-invasively, providing a breakthrough in patient monitoring. Pulse oximetry enabled continuous SpO2 monitoring and changed the management of respiratory and cardiovascular conditions. In the 1980s and 1990s, the technology found applications beyond pulse oximetry, when its sensors were integrated into devices for measuring heart rate variability, blood pressure, and assessing autonomic nervous system functions. The use of PPG in wearable devices and ambulatory monitoring systems became more prevalent during this period. The 2000s saw miniaturization and the integration of PPG sensors into consumer electronics. Wearable fitness trackers, smartwatches, and pulse oximeters became popular, bringing PPG-based monitoring to the mainstream. The advent of smartphones further accelerated the adoption of PPG-based applications, with various health and wellness apps utilizing the technology for heart rate tracking and stress monitoring. Today, PPG continues to evolve with developments in sensor technology, signal processing algorithms, and expanding applications in healthcare, sports, and wellness monitoring. Ongoing research aims to enhance the accuracy and reliability of its measurements and explore its potential in areas such as vascular health assessment, sleep monitoring, early disease detection and the diagnosis and management of traumatic brain injury.
 
PPG applications

PPG applications include: (i) monitoring blood oxygen levels and heart rate in various healthcare settings, including hospitals, clinics, and homecare, to provide real-time information about a patient's cardiovascular status, allowing healthcare professionals to detect abnormalities or assess the effectiveness of treatments, (ii) sleep studies to detect respiratory events such as apnea [temporary cessation of breathing] and hypopnea [shallow breathing]. By monitoring changes in blood volume, the signals can identify disruptions in breathing patterns during sleep and help in diagnosing sleep-related disorders, (iii) fitness and sports settings to measure heart rate, assess the intensity of physical activity, and provide immediate feedback to individuals, helping them optimize their workout routines and monitor their cardiovascular response during exercise, (iv) assessing peripheral vascular functions to identify conditions like arterial stiffness or endothelial dysfunction, and (v) enabling continuous monitoring of heart rate and SpO2 levels, which facilitates early detection of potential health issues and encourages proactive healthcare management.
Over the past two decades, the increased adoption of PPG monitoring in medical technology has led to enhanced patient care, improved early detection of various health conditions, and facilitated remote patient monitoring, all contributing to more personalized and efficient healthcare delivery. This increased interest is underscored by the rise in research publications related to PPG over the past two decades. In 2000 the annual number of papers indexed in PubMed using the keywords "Photoplethysmography" or "Photoplethysmogram" was <50, but by 2022, had increased to ~500; an increase of ~900%. 

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PPG products

Most tech giants have developed and commercialized PPG products. For instance, Apple has incorporated PPG sensors into its Apple Watch, which allow users to monitor their heart rate and receive notifications for abnormal heart rhythms. The latest Apple smartwatch (Apple 7) includes a US Food and Drug Administration (FDA) approved electrocardiogram (ECG), which employs an electrical heart sensor capable of alerting its user to abnormal heart rhythms. In January 2021, Google acquired Fitbit for US$2.1bn, and integrated PPG technology into its wearable fitness trackers. In 2022, Fitbit received clearance from the FDA for a new PPG-driven algorithm to identify atrial fibrillation (AF). Huawei, a leading Chinese multinational, has also implemented PPG sensors in its smartwatches and fitness bands. The Massimo Corporation, a MedTech known for its development of innovative monitoring solutions, has created PPG sensors, which are used in hospitals and medical settings to measure SpO2, pulse rate, and perfusion index. Garmin, a company in the field of GPS navigation and fitness technology, has incorporated PPG sensors into its smartwatches and fitness trackers. Garmin's PPG products also offer sleep and stress monitoring. Samsung a global South Korean electronics company, has also integrated PPG technology into its wearable devices, including smartwatches like its Galaxy Watch series. The company’s offerings provide similar functionalities to the products described here, allowing users to track their heart rate, monitor stress levels, and receive alerts for abnormal heart rate patterns. All these companies have leveraged PPG technology, coupled with complimentary technologies, to create wearable devices that provide users with health and wellness insights and enable individuals to monitor their vital signs conveniently and track their overall wellbeing.
 
Advantages of PPG devices

Non-invasive PPG-driven devices offer painless monitoring without invasive procedures or body sensors. By simply placing optical sensors on the skin, patients experience minimal discomfort, reduced infection risks, and uninterrupted daily activities. Comfortable for extended wear, these devices enhance patient compliance and overall experience. Compared to invasive techniques, PPG-driven devices are cost-effective and eliminate the need for expensive disposable sensors or frequent laboratory tests. Portable and incorporated into wearable devices like smartwatches or fingertip pulse oximeters, they enable remote monitoring, reducing hospital visits and providing accessibility, especially for patients in remote areas.
 
The technology provides real-time data and rapid feedback for most conditions it currently monitors. It allows healthcare professionals to quickly detect abnormalities and make timely decisions, while patients receive immediate feedback, empowering them to manage their wellbeing proactively. PPG data can be seamlessly integrated into healthcare systems to enhance efficiency. For instance, data can be wirelessly transmitted to electronic health records (EHR) for convenient analysis. Integration with telemedicine platforms enables remote consultations and real-time communication. By combining PPG data with other diagnostics, such as ECG or sleep monitoring, it supports accurate diagnoses.
 
Additional information carried by the PPG signal

The PPG signal carries additional diagnostic information, which includes pulse rate and rhythm analysis, blood pressure estimation and peripheral vascular assessment, and assessment. Pulse rate and rhythm analysis involve analyzing the timing and intensity of pulsations in blood vessels to assess the regularity and irregularity of the heartbeat. Abnormalities in pulse rate and rhythm can indicate cardiac conditions, such as arrhythmias, tachycardia [rapid heart rate], or bradycardia [slow heart rate]. Utilizing the PPG signal, blood pressure estimation can be performed by analyzing changes in blood volume and arterial pulsations, which is helpful for monitoring and managing hypertension or hypotension without the need for complicated procedures. The PPG signal facilitates the assessment of peripheral vascular functions by examining the shape, amplitude, and timing of pulsations in peripheral blood vessels, which help to detect conditions like peripheral artery disease and other vascular abnormalities. Also, insights into the functioning of the autonomic nervous system can be obtained from the PPG signal.
 
Challenges for PPG adoption

Notwithstanding the advantages of PPG-driven devices, they face challenges, which include, limited standardization and variability in PPG signal acquisition, noise, and artifact interference, regulatory considerations, and validation and user acceptance. Let us briefly consider these.
 
The lack of standardization in signal acquisition and processing is an obstacle for the further adoption of PPG devices. Different manufacturers may use varying sensor technologies, placement locations, or algorithms that lead to inconsistencies in the PPG signal quality and measurements, and this can affect the accuracy and reliability of PPG data, making it challenging to compare results across different devices or settings. Standardization efforts and guidelines are needed to ensure consistent and reliable PPG signal acquisition and interpretation.
 
Further, PPG signals are susceptible to various forms of noise and artifact interference, which can distort the signal, posing challenges to obtain reliable and accurate information. Environmental factors, such as ambient light, motion artifacts, and poor sensor contact with the skin, can introduce noise into the PPG signal. Additionally, physiological factors like skin pigmentation, tattoos, vasoconstriction, or motion-induced variations can also impact the quality of the PPG signal. Techniques for noise reduction, artifact detection, and signal processing are essential to improve the reliability of PPG measurements.
 
PPG-driven devices intended for medical use need to comply with regulatory requirements and undergo validation to ensure their safety, accuracy, and effectiveness. Obtaining approvals can be a complex and time-consuming process, requiring clinical studies and proof against gold standard methods. Adhering to official standards is necessary to establish the credibility and trustworthiness of PPG-driven devices in healthcare settings.
 
The adoption of any new technology in healthcare relies on user acceptance and trust. Users, including patients, healthcare professionals, and caregivers, may have reservations regarding the accuracy, reliability, and privacy of PPG-devices. Educating users about the benefits, limitations, and evidence supporting PPG technology is important to build trust and acceptance. Ensuring data security, privacy, and addressing concerns about data misuse or unauthorized access are also factors in fostering user acceptance and adoption of PPG devices.


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PPG and traumatic brain injury

Given that these challenges can be effectively addressed, PPG technology is well positioned as a potential disruptive force in several fields of medical diagnostics and monitoring. For instance, PPG technology could transform the diagnosis and treatment of traumatic brain injury (TBI), a global public health concern. Each year, TBI impacts >50m individuals worldwide, creating a substantial economic burden, estimated at ~US$400bn annually. The US alone reports ~1.5m TBI survivors annually, with ~0.23m individuals enduring severe TBI resulting in hospitalizations, which each year costs ~US$32bn. The UK faces comparable challenges, with ~0.16m hospital admissions for TBI annually, costing the UK government ~£15bn (~US$19.3bn), accounting for ~0.8% of the nation's GDP.
A pivotal aspect in effectively managing TBI patients lies in the continuous monitoring of intracranial pressure (ICP), given its potential to cause complications. Despite the historical dominance of invasive modalities, such as monitoring ICP through a drilled hole in the patient's skull, progress in non-invasive alternatives has remained relatively stagnant over the past four decades. It seems reasonable to suggest that this is not solely due to technological limitations, but rather stems from insufficient investment in relevant R&D driven partly by the commercial interests of medical technology companies. Invasive techniques, although associated with drawbacks and risks, have maintained their market supremacy due to early development and commercialization.
 
Non-invasive measurement of ICP necessitates interdisciplinary collaboration, innovative approaches, and substantial research efforts. Inadequate R&D investment and support have hindered progress in this field, making it challenging to overcome inherent complexities and develop effective non-invasive methods. Governments bear a responsibility for public health and have a vested interest in discovering affordable and accessible methods for TBI diagnosis and treatment. By actively supporting PPG R&D, administrations can encourage innovation, stimulate healthy competition, and encourage patient-centric healthcare solutions. Non-invasive ICP measurement techniques offer several advantages for the management of TBI patients, which include minimized patient discomfort, reduced risk of infection, lower healthcare costs, and the capacity for continuous monitoring, enabling early detection of ICP fluctuations and timely interventions to prevent crises and further brain damage.
 
The recognition of these potential advantages underscores the necessity for increased R&D. Backing research into PPG technology aligns with broader objectives of promoting sustainable and cost-effective healthcare solutions. Non-invasive approaches, exemplified by PPG technology, have the capacity to reduce healthcare costs associated with invasive procedures, extended hospital stays, and post-operative care. Such potential advantages provide governments with an incentive to invest in PPG technology research, ultimately fostering enhanced quality of care for individuals affected by TBI while benefiting healthcare providers.
 
Takeaways

The benefits of PPG-driven technology in healthcare include non-invasiveness, patient comfort, and real-time data acquisition. Cost-effective and portable, PPG devices offer real-time feedback to patients and providers, improving healthcare efficiency and accessibility. Currently, PPG delivers advantages in various medical fields, such as cardiology, respiratory care, neurology, and fitness monitoring. In both inpatient and outpatient settings, the technology plays a role in diagnosing, monitoring, screening, and improving healthcare and wellbeing. It enables fast and accurate diagnoses of medical conditions, continuous monitoring of vital signs, and early detection of diseases like sleep apnea and hypertension. In addition, PPG supports fitness and wellness monitoring, providing real-time feedback for optimized workouts and overall wellbeing. Overcoming PPG’s challenges of standardization, noise interference, regulations, and user acceptance are crucial to unlocking its full potential.
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9 months ago

The Future Of Regenerative Medicine

HealthPad
Directory:
Medical Technology
Tags:
3D bioprinting
commentary
CRISPR-Cas
electro-stimulation
gene therapy
nanotechnology
regenerative medicine
stem cell therapies
tissue engineering
  • The field of regenerative medicine is experiencing significant advancements and has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life
  • Key technologies shaping its future include stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology
  • The progress of these technologies varies, raising the question of which will dominate the field in the next decade
  • Convergence of these technologies will play a pivotal role in transforming regenerative medicine
  • Advantages and challenges exist for each technology, and dominance will depend on scientific breakthroughs, clinical success, regulations, and patient acceptance
  • MedTech companies must intensify their R&D efforts in regenerative medicine to remain relevant
  • Collaboration between disciplines, institutions, and industry partners is crucial
  • Staying informed about emerging trends and breakthroughs is essential
  • Proactively identifying synergies and areas of collaboration can accelerate progress
  • MedTechs can actively shape the future of regenerative medicine by exploring and integrating evolving technologies
 
The Future of Regenerative Medicine
Navigating Evolving Technologies and the Imperative for MedTech Companies
 
In the rapidly evolving realm of modern medicine, regenerative medicine has emerged as a transformative and powerful force. With several innovative developments at its core, it has the potential to change our approach to healing and restoration. The long-awaited promise of personalized, curative, and transformative therapies appears to be within reach, giving hope to patients who have been waiting for breakthroughs.
 
Over the past decade, this broad field of medicine has witnessed significant developments, with various technologies emerging as promising avenues for medical innovation. Stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology have all demonstrated their potential in addressing complex medical conditions. However, these technologies are progressing at different rates, and are often used complementarily, giving rise to a key strategic question for MedTechs investing in regenerative medicine research and development (R&D): Which technology or combination of regenerative medicine technologies will ultimately dominate the field in the next decade?
 
As this market segment gains momentum, it seems reasonable to suggest that many MedTechs have yet to fully grasp the magnitude and pace of these technological developments. To establish a presence or expand their footprint in this arena, companies must intensify their R&D efforts and monitor developments across the full range of these technologies to ensure they are not caught off guard. Time is of the essence, and those who fail to recognize this, risk being left behind.
 
Regenerative medicine

Regenerative medicine encompasses a broad range of approaches aimed at repairing, replacing, or regenerating damaged or diseased tissues and organs in the body. It draws upon principles from biology, engineering, and other scientific disciplines to restore both the structure and function of compromised tissues and organs. The concept underlying regenerative medicine involves utilizing the body's innate healing mechanisms to facilitate tissue repair and regeneration. This incorporates various techniques used either independently or together, and include stem cell therapy, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology, which either stimulate the body's natural regenerative processes or provide external support for tissue regeneration.
 
Brief history

Regenerative medicine has a rich history, driven by humanity's quest to heal and restore damaged tissues and organs. From ancient civilizations to modern times, medical science has continually evolved, seeking solutions to overcome the limitations of conventional treatments. This pursuit has given rise to the field of regenerative medicine. Early healers in ancient civilizations explored various remedies and techniques to promote tissue repair, ranging from herbal medicines to primitive surgical interventions. These practices laid the groundwork for our understanding of the body's inherent regenerative capacity.
 
In the 20th century, scientific advancements began unlocking new possibilities. The discovery of stem cells in the 1960s marked a breakthrough, revealing a versatile cell population capable of self-renewal and differentiation into specialized cell types. This discovery represented a paradigm shift in medical research and served as the foundation for modern regenerative medicine. The isolation and cultivation of human embryonic stem cells in the early 2000s was a significant milestone, offering potential for regenerative therapies. However, ethical concerns surrounding their use prompted scientists to search for alternative approaches. This led to the discovery of induced pluripotent stem cells (iPSCs) in 2006, which could be derived from adult cells and reprogrammed to resemble embryonic stem cells, thus bypassing the ethical concerns.
 
In recent years, regenerative medicine has experienced a surge of new and rapidly evolving medical technologies. Tissue engineering, biomaterials, gene editing techniques [a method for making specific changes to the DNA of a cell or organism], and advanced imaging modalities have impacted the field, enabling the creation of 3D tissue constructs, the bioengineering of organs, and direct tissue regeneration within the body. Regenerative medicine has expanded beyond traditional approaches, encompassing a wide range of therapeutic strategies, including cell-based therapies, gene therapies, electro-stimulation, and the utilization of growth factors and biomaterials. This multidisciplinary approach, leveraging the expertise of scientists, bioengineers, and clinicians, aims to develop transformative therapies for previously untreatable conditions. 
 
In this Commentary

This Commentary explores the rapidly evolving technologies that have propelled regenerative medicine to the forefront of medical research and their potential implications for the future of healthcare. We describe the contributions to regenerative medicine of stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bio printing, and nanotechnology. The Commentary discusses some of the challenges and ethical considerations facing the field and draws attention to governments actively pursuing regenerative medicine R&D. We stress that technologies, which contribute to this field are progressing at different rates and are often used complementarily. This raises a strategic question for MedTechs investing in regenerative medicine R&D: “Which technology or combination of regenerative technologies will ultimately dominate the field in the next decade?”. Answering this question should provide MedTechs, either contemplating entering this market segment or with established regenerative medicine franchises, with insights to guide their strategic decision-making and to assist in their long-term success in this rapidly evolving field.
 
Stem cell research

Stem cell research has changed regenerative medicine, opening new possibilities for tissue repair and disease treatment. One significant advancement is the development of Induced Pluripotent Stem Cells (iPSCs). These are created by reprogramming adult cells and can differentiate into any cell type, making them invaluable for personalized therapies. Unlike embryonic stem cells, iPSCs alleviate ethical concerns. However, ethical issues related to human cloning persist (see below). Nonetheless, iPSCs serve as a crucial tool, offering safer and more efficient techniques for studying diseases, screening drugs, and developing personalized therapies. They also enable the replacement of damaged cells and the creation of functional tissues and organs, providing opportunities for organ transplantation and personalized tissue replacement treatments. Researchers have also achieved success in transdifferentiation, rapidly generating desired cell types for regenerative and transplantation therapies. The gene-editing tool CRISPR-Cas9, (see below), further enhances stem cell research by allowing precise modifications for disease correction and improved traits. Clinical trials have demonstrated the potential of stem cell-based therapies in various areas, including spinal cord injuries, neurodegenerative disorders, heart disease, blood disorders, and diabetes. Advancements in bioengineering and microfluidics have further improved stem cell growth and differentiation, bringing us closer to fully harnessing the power of stem cell-based regenerative medicine.
 
Several companies and research institutions have made contributions to stem cell R&D. Mesoblast, an Australian biopharmaceutical company founded in 2004, focuses on developing cellular medicines based on mesenchymal lineage adult stem cells. They are actively involved in creating regenerative therapies for cardiovascular diseases, orthopedic disorders, and immune-mediated inflammatory diseases. Novartis, a Swiss pharmaceutical company, has made substantial investments in stem cell research and is dedicated to developing treatments for conditions such as macular degeneration and heart failure. Cellular Dynamics International (CDI), a biotech based in Japan and a subsidiary of Fujifilm, specializes in producing human iPSCs for use in drug discovery, toxicity testing, and disease modeling. Athersys, a biotech based in Cleveland, Ohio, US, focuses on developing innovative stem cell-based therapies. Their leading offering, MultiStem®, is a patented, adult-derived stem cell therapy platform designed to treat various disease states, including neurological disorders, cardiovascular diseases, and inflammatory conditions. Athersys has received Fast Track designations from the US Food and Drug Administration (FDA) for acute respiratory distress syndrome (ARDS), stroke, and transplant support. In 2022, Vertex Pharmaceuticals, based in Boston, US, acquired ViaCyte, a US biotech, for US$320m in cash. ViaCyte specializes in delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). This acquisition provides Vertex with additional human stem cell lines, intellectual property related to stem cell differentiation, and manufacturing facilities for cell-based therapies, which can accelerate the company's T1D programmes. ReNeuron, a UK-based biotech focuses on developing cell-based therapies, for conditions like stroke disability, retinal diseases, and peripheral limb ischemia. Osiris Therapeutics, founded in 1993, developed Grafix®, a cryopreserved placental membrane used for wound healing and tissue repair. In 2019, the company was acquired by Smith & Nephew plc, a global medical technology business, for US$660m.
 
Tissue Engineering

Tissue engineering is a field that combines biology, engineering, and medicine to create functional tissues and organs. It has made advancements recently, such as the development of organoids used for studying diseases and personalized medicine. Biomaterials, like hydrogels, nanofibers, and 3D-printed scaffolds, play a role by providing support for cell growth. One challenge tissue engineering faces is creating blood vessels to ensure the tissues receive enough nutrients and oxygen. Researchers are using techniques like 3D bioprinting (see below), to create networks of tiny blood vessels within engineered tissues. 3D bioprinting allows for precise placement of cells and materials to create complex tissue structures. Decellularization, which removes cellular components from donor organs and replaces them with patient-specific cells, has also been successful in organ regeneration. Microfluidics and organs-on-a-chip platforms are used to mimic organ functions for studying diseases and testing drugs. Gene editing technologies like CRISPR-Cas9 (see below) show promise for modifying cells, enhancing tissue regeneration, and correcting genetic disorders.
Tissue engineering has achieved successes in various areas. Bladder tissues, tracheal replacements, skin substitutes, cartilage constructs, and liver models are some examples. In 1999, scientists successfully engineered and implanted bladder tissues in patients with bladder disease. In 2008, a tissue-engineered trachea was successfully implanted in a patient with a damaged airway. Tissue-engineered skin is commonly used for treating burn injuries, and advanced skin substitutes that closely resemble natural skin. Cartilage constructs show promise for repairing joints, and miniaturized liver models mimic liver function for drug testing. While these developments are promising, further research and clinical trials are needed to refine and expand the applications of tissue engineering in medical practice.



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Tissue Regenix, a UK-based company, that was spun out of the University of Leeds in 2006, employs decellularization and extracellular matrix technologies to create a range of products for wound care and orthopedic applications. Vericel, a Nasdaq traded US biotech based in Cambridge, Massachusetts, is focused on the development and commercialization of cell-based therapies. Its products include MACI [autologous cultured chondrocytes on porcine collagen membrane] for the repair of cartilage defects in the knee and Epicel [cultured epidermal autografts] for the treatment of severe burns. Medtronic, a giant American MedTech, has moved into regenerative medicine with the  acquisition of MiroSurge AG, a Swiss company working on tissue engineering. Medtronic aims to develop regenerative therapies for the treatment of conditions like degenerative disc disease. Stryker, an American MedTech involved in orthopedics and tissue engineering, has a presence in the regenerative medicine through its subsidiary, Sage Products, which focuses on the development of advanced wound care and regenerative products.
 
Electro-stimulation

Electro-stimulation, also known as electrical stimulation or electrotherapy, offers a non-invasive and safe method to enhance tissue regeneration and repair. It involves the use of specialized devices that deliver controlled electrical impulses to specific areas of the body. While electro-stimulation has a range of applications in medicine, one area where it shows promise is in tissue regeneration and enhancing the body's ability to heal itself. A common application is for the stimulation of nerves and muscles. Applying electrical currents to these tissues can restore or improve their function. For instance, in patients with nerve damage or muscle weakness, the technology can help to reactivate the nerves or strengthen the muscles, leading to improved mobility and functionality. Electrotherapy also promotes tissue healing and regeneration by enhancing cellular activity. Electrical currents can stimulate the production of growth factors, which are substances that promote cell growth and tissue repair. Additionally, the therapy can increase blood flow to a treated area, bringing oxygen and nutrients that are essential for tissue healing. In some cases, electro-stimulation is used in combination with other regenerative therapies, such as stem cell treatments. Electrical currents can help guide and enhance the differentiation and integration of stem cells into damaged tissues thereby accelerating the healing process. While further research is still needed to fully understand its mechanisms and optimize its use, electro-stimulation holds potential for improving outcomes in regenerative medicine and helping patients recover from various injuries and conditions.
 
Several MedTechs are involved in electro-stimulation R&D for regenerative medicine. Medtronic has developed neurostimulation systems to manage chronic pain and improve neurological functions, which also can be used in regenerative medicine applications, such as nerve and muscle regeneration. Abbott Laboratories have made contributions to electro-stimulation devices for regenerative medicine. Their product portfolio includes implantable neurostimulation systems to manage chronic pain, movement disorders, and other neurological conditions and can aid in the regeneration of damaged nerves and muscles. Boston Scientific has developed a range of electrical stimulation systems for various applications, including chronic pain management, deep brain stimulation for movement disorders, and spinal cord stimulation, and can potentially contribute to regenerative medicine by stimulating tissue healing and facilitating the regeneration process. Nevro Corp specializes in the development of high-frequency spinal cord stimulation systems for chronic pain management. Their devices deliver electrical pulses to the spinal cord, modulating pain signals and providing relief to patients, and have the potential to aid in regenerative medicine by promoting tissue healing. Bioventus, established in 2012 and based Durham, North Carolina, US, is focused on ortho-biologic solutions for musculoskeletal healing. The company has developed a portable electro-stimulation device called the Exogen Ultrasound Bone Healing System, which has shown efficacy in promoting bone regeneration and is used in various clinical settings.


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Gene therapies
Gene Editing

Gene editing is a field of research that holds potential to change regenerative medicine. At its forefront is CRISPR-Cas9, a powerful tool that allows scientists to make precise modifications to our genetic material. By combining gene editing with gene therapy, new avenues for treating genetic disorders and diseases can be explored. CRISPR-Cas9, derived from bacteria, acts like molecular scissors, enabling researchers to modify specific genes efficiently and cost-effectively, which means they can introduce beneficial changes, remove, or replace faulty genes, and correct genetic mutations.
Gene therapy, a key component of regenerative medicine, involves introducing functional genes into a patient's cells to compensate for defective or absent genes that cause specific disorders. There are two primary approaches to gene therapy: in vivo, which delivers therapeutic genes directly into the patient's body, and ex vivo, which modifies the patient's cells outside the body before reintroducing them.

Gene therapy has shown success in treating Leber Congenital Amaurosis (LCA), a rare disorder causing vision loss in children. Luxturna, the first FDA approved gene therapy for LCA, delivers a functional copy of the RPE65 gene into retinal cells, restoring vision in patients. Another example is gene therapy for Severe Combined Immunodeficiency (SCID), also known as "bubble boy disease". By using a modified retrovirus, this treatment restores immune function in infants with SCID caused by a deficiency in the enzyme adenosine deaminase. Promising results have also been observed in the treatment of inherited blood disorders such as Beta-Thalassemia and sickle cell disease, both caused by mutations in the hemoglobin genes. Clinical trials are focused on editing patients' own hematopoietic stem cells to correct these genetic mutations. Despite successes, there are still challenges to overcome, which include improving delivery methods, ensuring long-term safety, managing immune responses, and increasing treatment accessibility.
 
Several companies are engaged in gene therapy R&D. Novartis developed Kymriah, the first FDA-approved gene therapy product. Kymriah utilizes the body's own T cells to fight certain types of leukemia. bluebird bio, another prominent company, focuses on developing gene therapies for severe genetic diseases and cancer. They obtained FDA approval for Zynteglo, a gene therapy used to treat transfusion-dependent beta-thalassemia patients. Spark Therapeutics, known for Luxturna, mentioned above, continues to operate as an independent subsidiary after being acquired by Hoffmann-La Roche. They are actively pursuing gene therapy treatments for inherited retinal diseases and other disorders. uniQure, a Dutch-based company, is a pioneer in gene therapy for rare genetic diseases and has developed Glybera, the first approved gene therapy in Europe. Pfizer, a global pharmaceutical company, has also made substantial investments in gene therapy, acquiring Bamboo Therapeutics, which is focussed on rare diseases related to neuromuscular conditions and the central nervous system. Sangamo Therapeutics, a biotech company based in California, US, specializes in gene editing and gene regulation technologies, with ongoing research in therapies for hemophilia and lysosomal storage disorders.
 
Organ Regeneration

Organ regeneration is a field in regenerative medicine that offers hope for patients in need of new organs. For instance, in the US, currently, there are ~114,000 people waiting for organ transplants, ~60% (70,000) will not receive the organ they need, and each day ~20 people die due to the lack of available organs. Through advancements in bioengineering and organ transplantation techniques, functional organs can now be developed to restore health and enhance quality of life. Stem cells and tissue engineering play a role in creating organs that mimic the structure and function of natural ones. Additionally, innovations in 3D printing and biomaterials have provided solutions for successful organ transplantation.

The liver has shown regenerative capabilities, and surgeons can transplant a portion of a healthy liver into a recipient, enabling regeneration and restoring the organ's function. Researchers have explored approaches to stimulate cardiac regeneration, such as using stem cells and biomaterial scaffolds to repair damaged heart tissue. While these techniques are still in development, they hold promise for treating heart diseases and reducing the burden of heart failure.
 
In the pursuit of overcoming the limitations of traditional organ transplantation, several companies are engaged in organ regeneration R&D. For instance, Miromatrix Medical utilizes decellularization techniques to create fully functional organs and tissues by removing cellular material from donor organs while preserving the extracellular matrix. United Therapeutics and its subsidiary Lung Biotechnology focus on bioengineering lungs using technologies like tissue engineering, stem cell therapy, and gene editing. CellSeed Inc., a Japanese biotech, has developed a technology called "cell sheet engineering" that uses patient-derived cells to promote tissue repair and regeneration.
 
3D Bioprinting

3D bioprinting is a technology in regenerative medicine that facilitates the creation of complex tissue structures with precision and customization. Significant progress in the filed has been made in the past decade, including the development of advanced bio-inks that consist of biocompatible materials and living cells. These bio-inks can be deposited layer by layer, resulting in 3D tissue constructs that closely resemble natural tissues in complexity and functionality. The resolution and speed of 3D printers have also improved, enabling the production of detailed structures at a faster pace. By integrating imaging technologies like MRI and CT scans, patient-specific models can be created, optimizing the design and production of customized implants and prosthetics. One of the key advantages of 3D bioprinting is its ability to recreate intricate tissue structures with vascular networks that ensure nutrient supply and waste removal, which are vital for the survival and functionality of larger constructs. This technology has created new possibilities in personalized medicine, particularly in the development of customized implants and prosthetics. By utilizing patient-specific data, such as medical images, 3D bioprinting can fabricate implants and prosthetics that perfectly fit an individual's anatomy, leading to improved comfort and functionality. Further, biologically active substances like growth factors can be incorporated into the printed structures, allowing for localized and controlled release. This targeted therapy promotes tissue regeneration at the site of implantation.
 

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Several companies have recognized the potential of 3D bioprinting and invested in R&D programmes to advance the field. Organovo, EnvisionTEC, the BICO Group,  Aspect Biosystems, RegenHU, and Poietis are among enterprises driving innovation in 3D bioprinting. They all develop technologies and platforms to create functional human tissues, print biomaterials, offer standardized bio-inks, and provide advanced bio fabrication solutions. Their efforts aim to change regenerative medicine and contribute to the development of functional tissue constructs for therapeutic applications.
Nanotechnology

Nanotechnology has influenced regenerative medicine by enabling precise manipulation of matter at the nanoscale. This technology has led to breakthroughs in targeted drug delivery systems and the development of innovative nanomaterials for tissue regeneration and wound healing. Nanoparticles and nano-carriers, designed through nanotechnology, can encapsulate drugs, and deliver them directly to affected tissues or cells, improving treatment efficacy while minimizing side effects. These targeted drug delivery systems have reduced the required dosages, making treatments more effective and less toxic. The technology has also facilitated the development of advanced nanomaterials like nanostructured scaffolds, which mimic the natural extracellular matrix of tissues, and provide a supportive framework for cell growth and tissue regeneration. With high surface area-to-volume ratio and tunable mechanical properties, nanostructured scaffolds release bioactive compounds or growth factors in a controlled manner, promoting tissue regeneration in various areas like bone, cartilage, nerve, and skin. Additionally, nanotechnology has contributed to the creation of smart wound dressings that actively enhance the wound healing process by exhibiting antimicrobial properties, moisture management, and controlled release of therapeutics.
 
Several companies are involved in nanotechnology R&D for regenerative medicine. Nanobiotix focuses on nanoparticle-based solutions for cancer therapy, while Arrowhead Pharmaceuticals uses a nanoparticle-based delivery system to transport RNA interference (RNAi) therapeutics into target cells. Athersys [a biotech mentioned in the stem cell section above] incorporates nanotechnology-based methods in their allogeneic stem cell product, MultiStem. Capsulution Pharma AG offers customized nanoparticle-based solutions for targeted drug delivery, including applications in tissue engineering and wound healing. Capsulation’s nano capsules are invisible to the human eye. A pin head, which is ~1.5mm across, could contain ~3bn capsules. NanoMedical Systems specializes in implantable drug delivery systems with potential applications in regenerative medicine.
  
Challenges and ethical considerations

It is important to acknowledge the challenges and ethical issues, which accompany the field of regenerative medicine. One of its primary challenges is the complex and intricate nature of the human body. Developing therapies that can effectively repair and regenerate damaged tissues and organs is a daunting task that requires extensive scientific knowledge and technological expertise. The limited understanding of cellular behaviour, tissue interactions, and the intricacies of organ development present significant hurdles in translating regenerative medicine from the laboratory to clinical applications. In addition, regenerative medicine faces ethical considerations. One concern revolves around the use of embryonic stem cells, which are derived from human embryos. The destruction of embryos in the process raises ethical concerns, as it involves the termination of potential human life, which necessitates balancing the pursuit of medical advancements and respecting the moral value attributed to embryos. iPSCs have overcome ethical concerns associated with embryonic stem cells but raise ethical concerns of their own that are associated with their ability to clone humans, which we highlighted in the stem cell section above. Similarly, gene editing technologies like CRISPR-Cas9 have introduced new possibilities for manipulating genes and altering the genetic makeup of organisms, including humans. While gene editing presents significant opportunities for treating genetic diseases, it raises ethical questions about the modification of the germline, hereditary traits, and the potential for unintended consequences. International ethical frameworks need to be established to guide the responsible use of gene editing techniques and ensure that the potential benefits outweigh the associated risks.
 
Regulatory issues play a role in shaping the future of regenerative medicine. As the field progresses and new therapies emerge, regulatory bodies must establish clear guidelines and frameworks to evaluate the safety and efficacy of these treatments. Striking the right balance between fostering innovation and protecting patients' wellbeing is important for the development and implementation of regenerative medicine approaches. Public acceptance and understanding are paramount for the widespread adoption of these technologies. Educating the public about the science, potential benefits, and ethical considerations is essential to foster informed discussions and garner support. Building trust between the scientific community, regulatory agencies, and the public is essential to navigate the challenges and dilemmas inherent to regenerative medicine. Only with careful deliberation, collaboration, and responsible stewardship, will regenerative medicine contribute its full potential for solutions that improve health and wellbeing.
 
A role for governments
 
Government support for regenerative medicine is important for the development of innovative therapies for disabilities and diseases with limited treatment options. Administrations investing in R&D can result in therapies that address unmet medical needs and offer hope to patients. Many disabilities and diseases severely impact individuals' quality of life, hindering their daily activities and overall wellbeing. Governments have a public health obligation to foster the development of regenerative medicine, as it has the potential to restore or regenerate damaged tissues and organs, ultimately improving the lives of millions. In addition to the health benefits, regenerative medicine is a rapidly growing sector with significant economic potential. Appropriate support for R&D in this field can stimulate economic growth by creating high-skilled jobs and attracting investment from biotech and pharmaceutical companies. The successful development and commercialization of regenerative medicine therapies can also reduce healthcare costs, as they offer more effective treatments and alleviate the burden on healthcare systems.
 
Governments that prioritize R&D in regenerative medicine contribute to scientific advancements and potentially help to establish their countries as leaders in this emerging field. R&D facilitates collaboration between academia, industry, and healthcare institutions, driving innovation. This support aligns with principles of equity, access to healthcare, and the pursuit of scientific progress, demonstrating an administration's social and ethical responsibility to promote health and wellbeing among its citizens. Aging populations and increasing rates of chronic diseases and disabilities pose significant challenges to healthcare systems worldwide. Continuous treatments, hospitalizations, and long-term care result in substantial healthcare costs. By investing in R&D for regenerative medicine, governments can develop therapies that offer long-term solutions, reducing the need for costly and continuous interventions. This can lead to significant healthcare savings over time.
 
An international perspective

Countries worldwide are actively supporting R&D in regenerative medicine. The US is a leader in the area, with significant investment in R&D through organizations like the National Institutes of Health (NIH). Japan has established itself as a global leader with substantial funding, and supportive regulation with a streamlined approval process for regenerative medicine therapies. South Korea has also emerged as a prominent player, establishing dedicated centres and institutes to promote regenerative medicine and foster collaboration between academia and industry. The UK is committed to supporting R&D in the field and encouraging collaboration between various stakeholders. Germany invests in regenerative medicine R&D through research centres and institutes, while China has launched initiatives, established research centres, and has a rapidly growing regenerative medicine industry. These countries, and others, are actively engaged in advancing the field through funding, regulations, and collaboration, which aim to accelerate the development and commercialization of regenerative therapies.
 
Takeaways
 
We have presented a range of regenerative medicine technologies and described their advantages and challenges. We also mentioned that these technologies are developing at different rates and are often used together to create one therapy. So, what can MedTechs do to answer the question we posed at the beginning of this Commentary: Which technology or combination of regenerative medicine technologies will ultimately dominate in the next decade? While it is difficult to predict the future, it seems reasonable to suggest that the convergence of these evolving technologies will play a pivotal role in the transformation of regenerative medicine. Each technology brings both advantages and challenges, and their ultimate dominance will depend on several factors, including scientific breakthroughs, clinical success, regulatory considerations, and patient acceptance. To remain relevant and succeed in this arena, companies must recognize the urgency of intensifying their R&D efforts in regenerative medicine. This requires not only investing in cutting-edge technologies but also fostering collaboration between disciplines, institutions, and industry partners. By cultivating a comprehensive understanding of the evolving landscape, MedTechs can position themselves to either establish a significant presence or expand their footprints in regenerative medicine. It is important for them to closely monitor advancements across a range of relevant technologies. With the rapid pace of innovation, staying informed about emerging trends, breakthroughs, and disruptive technologies is essential to avoid being caught off guard. By proactively identifying potential synergies and areas of collaboration, enterprises can leverage their expertise and resources to accelerate progress.
 
Over the next decade, regenerative medicine has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life. MedTechs have an opportunity to help drive this transformation, but they must embrace the challenge of exploring and integrating various rapidly evolving and complex technologies. Will they be brave and agile enough to do this?
 

#stemcellresearch #tissueengineering #electro-stimulation #genetherapy #organregeneration #3Dbioprinting #nanotechnology
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9 months, 2 weeks ago

Unleashing MedTech's Competitive Edge through Transformational Technologies

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big data
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digitalization
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transformational technologies
  • Digitalization, big data, and artificial intelligence (AI) are transformational technologies poised to shape the future of MedTech companies over the next decade
  • Fully embracing these technologies and integrating them in all aspects of a business will likely lead to growth, and competitive advantage while treating them as peripheral add-ons will likely result in stagnation and decline
  • MedTech executives’ analogue mindsets and resource constraints prevent them from fully embracing transformational technologies
  • There are also potential pushbacks from employees, patients, providers and investors
  • Notwithstanding, there are unstoppable structural trends forcing governments and payers throughout the world to oblige healthcare systems to leverage digitalization, big data, and AI to help reduce their vast and escalating healthcare burdens
  • Western MedTechs are responding to the rapidly evolving healthcare landscape by adopting transformational technologies and attempting to increase their presence in emerging markets, particularly China
  • To date, MedTech adoption and integration of digitalization, big data, and AI have been patchy
  • To remain relevant and enhance their value, Western MedTechs need to learn from China and embed transformational technologies in every aspect of their businesses
 
Unleashing MedTech's Competitive Edge through Transformational Technologies
Digitalization, Big Data, and AI as Catalysts for MedTech Competitiveness and Success
 
 
In the rapidly evolving landscape of medical technology, the integration of digitalization, big data, and artificial intelligence (AI) [referred to in this Commentary as transformational technologies] has emerged as a pivotal force shaping the future of MedTech companies.  Such technologies are not mere add-ons or peripheral tools but will soon become the lifeblood that fuels competition and enhances the value of MedTechs. From research and development (R&D) to marketing, finance to internationalization, and regulation to patient outcomes, digitalization, big data, and AI must permeate every aspect of medical technology businesses if they are to deliver significant benefits for patients and investors. To thrive in this rapidly evolving high-tech ecosystem, companies will be obliged to adapt to this paradigm shift.
 
Gone are the days when traditional approaches would suffice in the face of escalating complexities and demands within the healthcare industry. The convergence of transformational technologies heralds a new era, where innovation and success are linked to the ability to harness the potential of digitalization, big data, and AI. MedTech companies that wish to maintain and enhance their competitiveness must recognize the imperative of integrating these technologies across all facets of their operations. From improving their R&D processes by utilizing advanced data analytics and predictive modeling, to optimizing internal processes through automation and machine learning algorithms. Embracing such technologies opens doors to enhanced marketing strategies, streamlined financial operations, efficacious legal and regulatory endeavours, seamless internationalization efforts, and the development of innovative offerings that cater to the evolving needs of patients, payers, and healthcare providers.
 
This Commentary aims to stimulate discussion among MedTech senior leadership teams as the industry's competitive landscape continues to rapidly evolve, and the fusion of digitalization, big data, and AI becomes not only a strategic advantage but a prerequisite for survival in an era defined by data-driven decision-making, personalized affordable healthcare, and a commitment to improving patient outcomes.
 
In this Commentary

This Commentary explores digitalization, big data, and AI in the MedTech industry. It presents two scenarios: one is to fully embrace these technologies and integrate them into all aspects of your business and the other is to perceive them as peripheral add-ons. The former will lead to growth and competitive advantage, while the latter will result in stagnation and decline. We explain why many MedTechs do not fully embrace transformational technologies and suggest this is partly due to executives’ mindsets, resource constraints and resistance from employees, patients, and investors. Despite these pushbacks, the global healthcare ecosystem is undergoing an unstoppable transformation, driven by aging populations and significant increases in the prevalence of costly to treat lifetime chronic conditions. Western MedTechs are responding to structural shifts by adopting transformational technologies and increasing their footprints in emerging markets, particularly China. To date, company acceptance of AI-driven strategies has been patchy. We suggest that MedTechs can learn from China and emphasize the need for organizational and cultural change to facilitate the comprehensive integration of transformational technologies. Integrating these technologies into all aspects of a business is no longer a choice but a necessity for companies to stay competitive in the future.
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Transformational technologies in MedTech

Digitalization in the MedTech industry involves adopting and integrating digital technologies to improve healthcare delivery, patient care, and operational efficiency. It transforms manual and paper-based processes into digital formats, enabling electronic health records, connected medical devices, telemedicine, and other digital tools. This allows for seamless data exchange and storage, improving clinical processes, decision-making, and patient empowerment. Big data in the MedTech industry refers to the vast amount of healthcare-related information collected from various sources. It includes structured and unstructured data such as patient demographics, clinical notes, diagnostic images, and treatment outcomes. Big data analysis identifies patterns, correlations, and trends that traditional methods may miss. They aid medical research, drug discovery, personalized medicine, clinical decision support, evidence-based care, population health management, and public health initiatives. Data privacy, security, and ethical use are crucial considerations. Artificial Intelligence (AI) in the MedTech industry uses computer algorithms to simulate human intelligence. AI analyzes medical data to identify patterns, make predictions, and improve diagnoses, treatment plans, and patient outcomes. It assists in medical imaging interpretation, personalized medicine, and patient engagement. In R&D, AI accelerates the development of devices and the discovery of new therapies and has the capacity to analyze scientific literature and molecular data. The technology serves as a tool to augment healthcare professionals' expertise and support decision-making.
With the proliferation of large language AI models (LLM) and to borrow from a recent essay by Marc Andreeseen - an American software engineer, co-author of Mosaic, [one of the first widely used web browsers] and founder of multiple $bn companies - everyone involved with medical technology, including R&D, finance, marketing, manufacturing, regulation, law, international etc., “will have an AI assistant/collaborator/partner that will greatly expand their scope and achievement. Anything that people do with their natural intelligence today can be done much better with AI, and we will be able to take on new challenges that have been impossible to tackle without AI, including curing all diseases.”

Two scenarios

We suggest there are only two scenarios for MedTechs: a company that fully embraces transformational technologies and one that does not. The former, will benefit from strengthened operational efficiencies, improved patient outcomes, and enhanced innovations, which will lead to increased market share and investor confidence. By leveraging digital technologies, such as remote monitoring devices, telemedicine platforms, LLMs, and machine learning, a company will be able to offer more personalized, effective and affordable healthcare services and solutions. An enterprise that integrates these technologies into their strategies and business models will, over time, experience improved growth prospects, increased revenues, and potentially higher profitability. These factors will contribute to a positive perception in the market, leading to an increase in company value. MedTechs that fail to fully embrace digitalization, big data, and AI will face challenges in adapting to the rapidly evolving healthcare landscape. They will struggle to remain competitive and relevant in a market that increasingly values transformational technologies and data-driven approaches. As a result, such companies will experience slower growth, lower market share, and limited investor interest, which will lead to a stagnation or decline in their value.
 
The analogue era's influence on MedTechs

If the choice is so stark, why are many MedTechs not grabbing the opportunities that transformational technologies offer? To answer this question let us briefly remind ourselves that the industry took shape in an analogue era, which had a significant effect on how MedTech companies evolved and established themselves. During the high growth decades of the 1980s, 1990s, and early 2000s, the medical technology industry operated with limited access to the technologies that have since radically changed healthcare. The 1980s marked a period of advancements, which included the widespread adoption of medical imaging such as computed tomography (CT) scans and magnetic resonance imaging (MRI). These modalities provided detailed visualizations of the human body, supporting more accurate diagnoses. Medical devices like pacemakers, defibrillators, and implantable cardioverter-defibrillators (ICDs) were developed and improved the treatment of heart conditions. The 1990s witnessed further advancements, with a focus on minimally invasive procedures. Laparoscopic surgeries gained popularity, allowing surgeons to perform operations through small incisions, resulting in reduced patient trauma and faster recovery times. The development of laser technologies enabled more precise surgical interventions. The decade also saw the rise of biotechnology, with the successful completion of the Human Genome Project and increased emphasis on genetic research. The early 2000s saw the emergence of digital transformation in some quarters of the medical technology industry. Electronic medical records (EMRs) began to replace paper-based systems, increase data accessibility and upgrade patient management. Telemedicine, although still in its nascent stages, started connecting healthcare providers and patients remotely, overcoming geographical barriers. Robotics and robotic-assisted surgeries gained traction, enabling more precise and less invasive procedures. During these formative decades, the medical technology industry focused on enhancing diagnostic capabilities, improving treatment methods, and streamlining healthcare processes. The industry had yet to witness the transformational impact of digitalization, big data and AI that would emerge in subsequent years, enabling more advanced analytics, personalized medicine, and interconnected healthcare systems.
 
From analogue to digital

During these formative analogue years, MedTechs experienced significant growth and expansion, where innovative medical technologies changed healthcare practices and improved patient outcomes. Companies thrived by leveraging their expertise in engineering, biology, and clinical research and developed medical devices, diagnostic tools, and life-saving treatments. For MedTechs to experience similar growth and expansion in a digital era, they must fully harness the potential of transformational technologies, and to achieve this, there must be a receptive mindset at the top of the organization.
 
According to a recent study by Korn Ferry, a global consulting and search firm, the average age of CEOs in the technology sector is 57, and the average age for a C-suite member is 56. Thus, as our brief history suggests, many MedTech executives advanced their careers in a predominantly analogue age, prior to the proliferation of technologies that are transforming the industry today. Thus, it seems reasonable to suggest that this disparity in experience and exposure colours the mindsets of many MedTech executives, which can lead to them underestimating and under preparing for the significant technological changes that are set to reshape the healthcare industry over the next decade. Senior leadership teams play a pivotal role in developing the strategic direction of companies and driving their success. Without a proactive mindset shift, these executives may struggle to fully comprehend the extent of the potential disruptions and opportunities that digitalization, big data, and AI bring.
 
By embracing such a mindset shift, senior leadership teams could foster a culture of innovation and agility. But they must recognize the urgency of preparing for a future fueled by significantly different technologies from those they might be more comfortable with. Such urgency is demonstrated by a March 2023 Statista report, which found that in 2021, the global AI in healthcare market was worth ~US$11bn, but forecasted to reach ~US$188bn by 2030, increasing at a compound annual growth rate  (CAGR) of ~37%. As these and other facts (see below) suggest, the integration of digitalization, big data, and AI has already begun to redefine healthcare delivery, patient engagement, and operational efficiency and is positioned to accelerate in the next decade. To remain competitive and relevant in this rapidly evolving high-tech world, MedTechs must foster a culture of openness to change and innovation. Leaders should encourage collaboration, both internally and externally, and create cross-functional teams that bring together expertise from various domains, including AI and data analytics. This multidisciplinary approach facilitates the integration of transformational technologies into all aspects of the business, ensuring that the organization remains at the forefront of the evolving industry.
 
Implementation and utilization

Limited resources, such as budgets and IT infrastructure, can hinder the adoption and utilization of digitalization, big data, and AI, especially for smaller companies. Compliance with healthcare regulations like HIPAA and GDPR adds complexity and can slow down technology implementation. Resistance to change from employees, healthcare providers, and patients also poses challenges. Fragmented and unstandardized healthcare data limit the effectiveness of AI-driven strategies. The expertise gap can be bridged through collaboration with academic institutions and technology companies. Demonstrating the tangible benefits of digitalization, big data and AI is essential to address concerns about return on investments (ROI). Strategic planning, resource investment, collaboration, and cultural change are necessary for the successful implementation and utilization of transformational technologies in MedTech companies. 
 
Organizational and cultural changes

MedTechs must embrace agility and innovation to harness the potential benefits from transformational technologies. This requires fostering a culture that encourages risk-taking and challenges conventional practices. Creating cross-functional teams and promoting collaboration nurtures creativity and innovative solutions. Transitioning to data-driven decision-making involves establishing governance frameworks, ensuring data quality, and leveraging analytics and insights from big data. Talent development and upskilling are crucial, necessitating training programmes to improve digital literacy and add analytics skills. Collaboration and partnerships with external stakeholders facilitate access to cutting-edge technologies. Enhancing patient experiences through user-friendly interfaces and personalized solutions is essential. Investing in agile technology infrastructure, including cloud computing and robust cybersecurity measures is necessary. MedTechs must navigate complex regulatory environments while upholding ethical considerations, transparency, and patient consent to gain credibility and support successful technology adoption.
 
Investors

A further potential inhibitor to change is MedTech investors who may harbour conservative expectations that tend to discourage companies from taking risks, such as fully embracing and integrating digitalization, big data, and AI across their entire businesses. This mindset also can be traced back to the formative analogue decades on the 1980s, 1990s, and early 2000s when investors became accustomed to growing company valuations. During that time, most MedTechs catered to an underserved, rapidly expanding market largely focussed on acute and essential clinical services in affluent regions like the US and Europe, where well-resourced healthcare systems and medical insurance compensated activity rather than patient outcomes. However, the landscape has since undergone a radical change. Aging populations with rising rates of chronic diseases have significantly increased the demands on over-stretched healthcare systems, which have turned to digitalization, big data, and AI in attempts to reduce their mounting burdens. These shifting dynamics now demand a more forward-thinking approach, but investor expectations often remain fixed on a past traditional model, which impedes the adoption and full integration of transformational technologies into MedTech enterprises.

To overcome investor conservatism and reluctance to embrace transformational technologies requires a concerted effort by MedTechs to demonstrate the tangible benefits of these technologies on the industry. Companies can focus on providing evidence of improved patient outcomes, increased efficiency, cost savings, and competitive advantages gained through the integration of digitalization, big data, and AI. Engaging in open and transparent communications with investors, showcasing successful case studies, and highlighting the long-term potential and sustainability of a technology-driven approach can help shift investor expectations and encourage a more receptive attitude towards risk-taking and innovation.
Global structural drivers of change

For decades, Western MedTechs have derived comfort from the fact that North America and Europe hold 68% of the global MedTech market share. These wealthy regions have well-resourced healthcare systems, which, as we have suggested, for decades rewarded clinical activity rather than patient outcomes, and MedTech’s benefitted by high profit margins on their devices, which contributed to rapid growth, and enhanced enterprise values. Today, the healthcare landscape is significantly different. North America and Europe are experiencing aging populations, and large and rapidly rising incidence rates of chronic diseases in older adults. Such trends are expected to continue for the next three decades and have forced governments and private payers to abandon compensating clinical activity and adopt systems that reward patient outcomes while reducing costs. This shift has put pressure on healthcare systems to adopt transformational technologies to help them cut costs, increase access, and improve patient journeys. MedTech companies operating in this ecosystem have no alternative but to adapt. Their ticket for increasing their growth and competitiveness is to adopt and integrate digitalization, big data, and AI into every aspect of their business, which will help them to become more efficient and remain relevant.
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Most developed economies are experiencing aging populations, which affect everything from economic and financial performance to the shape of cities and the nature of healthcare systems. Let us illustrate this with reference to the US. According to the US National Council on Aging, ~56m Americans are ≥65 and this cohort is projected to reach ~95m by 2060. On average, a person ≥65 is expected to live another 17 years. Older adult Americans are disproportionately affected by costly to treat lifetime chronic conditions such as cancer, heart disease, diabetes, respiratory disorders, and arthritis. ~95% of this older adult cohort have at least one chronic disease, and ~80% have two or more. Multiple chronic disorders account for ~66% of all US healthcare costs and ~93% of Medicare spending.

According to a May 2023, Statista report, the US spends more on healthcare than any other country. In 2021, annual health expenditures stood at US$4.2trn, ~18% of the nation’s Gross Domestic Product (GDP). The demographic trends we described in the US are mirrored in all the principal global MedTech markets. Many of which, particularly Japan, are also experiencing shrinking working age populations resulting from a decline in fertility rates, and curbs on immigration. This shrinkage further impacts a nation’s labour force, labour markets, and tax receipts; all critical for resourcing and paying for healthcare services.
 
MedTechs’ response to structural changes

Western MedTechs’ response to these structural challenges have been twofold: (i) the adoption of transformational technologies, which contribute to lowering healthcare costs, improving innovation, and developing affordable patient-centric services and solutions and (ii) targeting emerging markets as potential areas for growth and development. As we have discussed the first point, let us consider briefly the second. Decades ago, giant MedTechs like Johnson and Johnson (J&J), Abbott Laboratories and Medtronic established manufacturing and R&D centres in emerging economies like Brazil, China, and India, where markets were growing three-to-four times faster than in developed countries. Notwithstanding, many MedTechs, were content to continue serving wealthy developed regions - the US and Europe - and either did not enter, or were slow to enter, emerging markets. More recently, as a response to the trends we have described, many MedTechs are either just beginning or accelerating their international expansions. However, such initiatives might be too late to reap the potential commercial benefits they anticipate. Establishing or expanding a footprint in emerging economies is significantly more challenging today than it was two decades ago. 

For instance, two decades ago, China lacked medical technology knowhow and experience and welcomed foreign companies’ participation in its economy. Today, the country has evolved, enhanced its technological capacity and capabilities, and is well positioned to become the world’s leading technology nation by 2030. No longer so dependent on foreign technology companies, the Chinese Communist Party (CCP) raised barriers to their entry. In 2017, government leaders announced the nation's intention to become a global leader in AI by putting political muscle behind growing investment by Chinese domestic technology companies, whose products, services and solutions were used to improve the country's healthcare systems. Over decades, the CCP committed significant resources to developing domestic STEM skills, and research to achieve “major technological breakthroughs” by 2025, and to make the nation a world leader in technology by 2030, overtaking its closest rival, the US. According to a 2023 AI Report from the Stanford Institute for Human-Centered Artificial Intelligence, in 2021, China produced ~33% of both AI journal research papers and AI citations worldwide. In economic investment, the country accounted for ~20% of global private investment funding in 2021, attracting US$17bn for AI start-ups. The nation’s AI in the healthcare market is fueled by the large and rising demand for healthcare services and solutions from its ~1.4bn population, a large and rapidly growing middle class, and a robust start-up and innovation ecosystem, which is projected to grow from ~US$0.5bn in 2022 to ~US$12bn by 2030, registering a CAGR of >46%. 

>4 years ago, a HealthPad Commentary described how a Chinese internet healthcare start-up, WeDoctor, founded in 2010, bundles AI and big data driven medical services into smart devices to help unclog China’s fragmented and complex healthcare ecosystem and increase citizens’ access to affordable quality healthcare. The company has grown into a multi-functional platform offering medical services, online pharmacies, cloud-based enterprise software for hospitals and other services. Today, WeDoctor owns 27 internet hospitals, [a healthcare platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients], has linked its appointment-making system to another 7,800 hospitals across China (including 95% of the top-tier public hospitals) and hosts >270,000 doctors and ~222m registered patients. It is also one of the few online healthcare providers qualified to accept payments from China's vast public health insurance system, which covers >95% of its population. WeDoctor, like other Chinese MedTechs, has expanded its franchise outside of China and has global ambitions to become the “Amazon of healthcare”. China’s investment in developing and increasing its domestic transformational technologies and upskilling its workforce has made the nation close to technological self-sufficiency and has significantly raised the entry bar for Western MedTechs wishing to establish or extend their presence in the country.

China's progress in AI and digital healthcare underscores the urgent need for Western MedTechs to adopt and implement these technologies. To remain relevant and survive in a rapidly changing global healthcare ecosystem, Western MedTechs might do well to learn from China's endeavours in leveraging AI, big data, and digitalization to drive innovation, enhance competitiveness, and ultimately contribute to the transformation of the global healthcare landscape. Notwithstanding, be minded of the ethical concerns Western nations have regarding China’s utilization of big data and AI in its healthcare system and its potential to compromise privacy and individual rights due to the CCP's extensive collection and analysis of personal health data.
 
Takeaways

Digitalization, big data, and AI are transformational technologies that have the power to influence the shape of MedTech companies over the coming decade, and their potential impact should not be underestimated. Fully embracing these technologies and integrating them into every aspect of a business is necessary for growth and competitive advantage. On the other hand, treating them as peripheral add-ons will likely lead to stagnation and decline. However, the path towards their full integration in companies is not without its challenges. MedTech executives, hindered by their analogue mindsets and resource constraints, often struggle to fully embrace the potential of digitalization, big data, and AI. Moreover, there may be pushbacks from various stakeholders including employees, patients, healthcare providers, and investors. These concerns and resistances can impede the progress of transformation within the industry. Nonetheless, governments and payers across the globe are being compelled by unstoppable structural trends to enforce the utilization of digitalization, big data, and AI within healthcare systems. The large and escalating healthcare burdens facing economies throughout the world leave them with little choice but to leverage these technologies to reduce costs, improve patient access and outcomes. In response to the rapidly evolving healthcare landscape, Western MedTechs are making efforts to adopt transformational technologies and expand their presence in emerging markets, particularly China. They recognize the need to stay ahead of the curve and adapt to the changing demands of the industry. However, the adoption and integration of digitalization, big data, and AI by companies thus far have been inconsistent and patchy. To remain relevant and enhance their value, Western MedTechs, while being mindful of ethical concerns about China’s use of AI-driven big data healthcare strategies, might take cues from their Chinese counterparts and embed these transformational technologies in every aspect of their businesses. The transformative impact of digitalization, big data, and AI on MedTech companies cannot be overstated. While challenges and resistance may arise, the inexorable drive towards leveraging these technologies is unstoppable. MedTech companies should shed their analogue mindsets and resource constraints and fully embrace the potential of these transformational technologies.
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10 months, 3 weeks ago

The Financialization Dilemma of MedTechs

HealthPad
Directory:
Medical Technology
Tags:
AI
commentary
financialization
M&A
MedTech
R&D
  • MedTechs have experienced significant transformation through mergers and acquisition (M&A) to achieve steady growth, diverting resources from innovative research and development (R&D) initiatives
  • The industry’s M&A activities were fueled by a prolonged period of low interest rates and easy access to capital
  • Consequently, R&D efforts focussed on incremental improvements rather than breakthrough innovations
  • This financial-centric business model led to risk-averse bureaucracies among many MedTechs, resulting in a strategic deadlock with limited growth prospects
  • Adding to the challenges, the current era witness’s debt and asset prices surpassing productivity and economic output
  • For many MedTechs, these macro-economic conditions potentially pose funding constraints, reduced market demand, tightening regulatory challenges, cost pressures, and market volatility, further hindering their ability to overcome the deadlock
  • To address these issues and help MedTechs break free from their strategic deadlocks and create long-term value we propose seven strategic initiatives
 
The Financialization Dilemma of MedTechs
 
In the 1990s and 2000s, medical technology companies received praise for their rapid growth. However, they currently find themselves at a crucial juncture, facing challenges of low and stagnant growth rates. Additionally, an uncertain long-term outlook looms over them due to the expansion of global balance sheets surpassing GDP, as well as debt and asset prices outpacing productivity and economic output. This Commentary aims to shed light on how many MedTechs reached this strategic deadlock. It also proposes strategies that these companies can pursue to break free from this predicament, which have the potential to significantly enhance growth rates, improve balance sheet health, and foster value creation.
 
An era of low interest rates and cheap capital

The financialization of MedTechs has played a significant role in their current strategic deadlock, and the most viable solution lies in accelerating productivity. This financialization was facilitated by a prolonged period of low interest rates and easy access to inexpensive capital. Over the span of four decades, starting from the 1980s to the early 2020s, interest rates steadily declined across most industrialized nations. In the aftermath of the 2008-09 financial crisis, many countries adopted a low interest rate environment to stimulate economic recovery and restore liquidity in their banking systems. For example, the US Federal Reserve Board (Fed) lowered short-term interest rates from 4.25% in December 2007 to nearly zero by December 2008, registering the lowest rate in the Fed's history.
 
During the era of persistently low interest rates and readily available capital, MedTechs experienced a surge in merger and acquisition (M&A) activities, primarily targeting companies in near-adjacent sectors to capitalize on low-risk opportunities for incremental growth. This trend fostered a culture of consolidation, driven by the desire to access new technologies and broaden product portfolios. While M&A activities bolstered short-term profits and shareholder value, they often led to a neglect of research and development (R&D) initiatives. Acquisitions were perceived as a less risky and quicker avenues for expanding product lines, overshadowing investments in R&D. Consequently, many MedTechs adopted a risk-averse approach, channeling their R&D efforts towards incremental improvements of existing products rather than pursuing ground-breaking innovations that could significantly improve patient outcomes and disrupt the industry. Moreover, the increasingly stringent regulatory environment for medical devices, particularly in Europe, further discouraged companies from investing in R&D due to longer development timelines and escalated costs.
 
Over the years, these policies resulted in the consolidation of power and resources among a few large players, leading to the emergence of market oligopolies and the decline in industry diversity. This scenario posed challenges for smaller companies with innovative ideas, as they struggled to compete with established enterprises, thereby impeding both innovation and healthy competition. Moreover, established MedTechs benefited from the significant and rapidly growing healthcare demands in affluent Western markets, particularly North America and Europe, which account for ~65% of the global medical device market. In these markets, compensation was often tied to medical and surgical procedures rather than focussing on patient outcomes, further favouring the established industry players. While M&A can be an effective growth strategy, it is important for companies to strike a balance and prioritize innovation alongside their consolidation efforts to ensure sustainable success and drive meaningful advancements in the industry.
 
An era of surging prices and low productivity

We have now entered a distinct era that differs significantly from the previous era characterized by low interest rates, and easily accessible funds. Starting from March 2022, the Fed has implemented 10 consecutive rate hikes, bringing its benchmark rate to 5.25%. These increases, coupled with high leverage in the corporate sector, escalating geopolitical tensions and  instability in the banking world triggered by the Silicon Valley Bank (SVB) collapse in March 2023, compounds the challenges faced by MedTechs. Furthermore, global balance sheets have expanded at a much faster pace than Gross Domestic Product (GDP). Debt and asset prices have surged far more rapidly than productivity and economic output. This trend is underscored by a report published in May 2023 by the McKinsey Global Institute, which reveals that the past two decades have resulted in the creation of US$160trn in paper wealth but have been marked by sluggish growth and the rise of inequality. According to the report, every US$1 invested has generated US$1.9 in debt.
 
Strategic initiatives to adapt and thrive

When global balance sheets expand at a faster rate than GDP and debt and asset prices outpace productivity, it becomes a concerning sign for MedTechs who find themselves trapped in a strategic deadlock characterized by sluggish growth and a fading belief in long term value creation. Under these conditions, companies should expect to encounter funding limitations, decreased market demand, stricter regulatory obstacles, cost pressures, and increased market volatility. In such a testing business environment, it is important for MedTechs to adopt bold adaptive strategies and navigate wisely to ensure continuous growth and enhanced value. We suggest seven such initiatives that are likely to help MedTechs break free from their strategic cul-de-sacs. By implementing these with vigour, companies can position themselves for success in an ever-changing and demanding economic and geopolitical landscape.
1. Revamp R&D
 
In recent times, costs associated with MedTech R&D have escalated. A study published in the September 2022 edition of the Journal of the American Medical Association (JAMA), and carried out by the US government’s Office of Science and Technology Policy, found that the development cost for a complex therapeutic medical device, from proof of concept through post approval stages, is US$522m. Significantly, the nonclinical development stage accounted for 85% of this cost, whereas the US Food and Drug Administration (FDA) submission, review and approval stage comprised 0.5%.
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Re-imagining healthcare
Thus, MedTechs have the potential to optimize their R&D processes, enabling them to develop more swiftly and economically ground-breaking devices that result in enhanced patient outcomes and expanded market share. To achieve this, companies may consider the following strategies to improve their R&D processes: (i) Integrating artificial intelligence (AI), machine learning, and big data techniques into their R&D endeavours and harnessing the power of these advanced technologies. (ii) Collaborating with academic institutions and start-ups to gain access to novel innovations and expertise. This collaboration can involve joint development and co-creation of innovative offerings. To tap into a diverse pool of expertise and resources, companies should consider a platform-based approach to R&D, which potentially improves the capacity to drive breakthrough advancements that improve patient care. (iii) Implementing agile methodologies to accelerate the R&D process, which involves breaking projects into smaller, more manageable segments and swiftly iterating based on stakeholder feedback. (iv) Engaging patients in the design process to ensure that newly developed offerings cater specifically to their needs, ultimately enhancing patient satisfaction.
 
2. Emphasize patient-centric care
 
Enhancing patient-centric care to improve outcomes is a crucial factor in the future of healthcare provision. There is a growing body of evidence indicating that patient choices will have an increased influence on the provision of healthcare over the next decade. With patients having more options and autonomy, MedTechs can leverage patient-centric strategies to better understand and address their needs, ultimately leading to improved market share. To achieve this, companies must prioritize effective communication, product education, and support services to build stronger relationships with patients. This requires increased utilization of electronic health records, advanced AI, data analytics capabilities, active engagement with patient communities, leveraging social media platforms, establishing patient advisory boards, and forging partnerships with payers and providers.
 
Further, embracing value-based care models is important for MedTechs. By prioritizing positive patient outcomes over quantity, companies can contribute to the development of sustainable care. As global healthcare systems transition toward value-based care, MedTech companies should align their offerings accordingly. Emphasizing solutions that enhance patient outcomes, reduce healthcare costs, and provide overall value positions, MedTechs become indispensable partners in the evolving healthcare landscape. This also may involve developing outcome-based pricing models, implementing remote monitoring solutions, and demonstrating real-world evidence of product effectiveness.
 
3. Revitalize organizational and operating models
 
Revitalizing organizational and operating models is essential for MedTechs to boost their growth rates and adapt to a rapidly evolving market. While companies experienced significant growth in the past, recent trends have shown a shift towards risk-averse bureaucracies, accepting modest annual growth rates as the "new normal". To overcome this stagnation and meet evolving customer demands, traditional MedTechs should consider embracing agile and flexible structures.
 
By flattening hierarchies and fostering cross-functional teams, organizations can facilitate faster decision-making processes. Implementing lean manufacturing and optimizing operational processes can reduce waste, enhance productivity, accelerate time to market, and lower costs. Leveraging AI-driven data analytics enables the extraction of valuable insights from vast datasets, empowering MedTechs to anticipate customer needs and market trends.
 
4. Harness the power of digital, AI and big data
 
Digital transformation has become a necessity rather than a choice. Although companies like Stryker and Siemens have championed digitalization, widespread implementation still remains a challenge. Indeed, Siemens’ suggests digitalization is “something that is often talked about but not fully implemented”. Previous Commentaries have shown how MedTechs can employ digital technologies to improve products, streamline operations, enhance customer experiences, and reduce costs. Streamlining operations and optimizing costs without compromising quality is crucial in the face of escalating economic pressures. This may involve re-evaluating supply chains, improving manufacturing processes, and adopting digital solutions.
 
In today's rapidly evolving digital age, investing in digital and analytics capabilities has become indispensable for companies as they shape their R&D, hone their processes and shift to a customer-centric stance. The seamless integration of digital and AI-driven techniques, along with data-driven decision processes, has emerged as a crucial factor in maintaining and improving competitiveness. For MedTechs, it is imperative to cultivate a culture of innovation that encourages and rewards experimentation and risk-taking. By doing so, organizations create an environment where employees are empowered to explore ideas, learn from failures, and ultimately drive meaningful innovations.  Therefore, actively seeking external partnerships with technology companies, start-ups and academic institutions is a strategic move for MedTechs to access cutting-edge technologies and expertise in digital and analytics. By embracing these capabilities as core rather than adjunct components of their strategies, fostering an innovation-centric culture, and investing in talent development and retention, corporations position themselves optimally to leverage the transformative potential of digital and analytical technologies. This, in turn enables them to thrive in an increasingly interconnected and data-driven healthcare ecosystem.
 
5. Talent acquisition and retention
 
The rapidly changing landscape of globalization, the increasing influence of AI techniques, and the demands of a new generation of consumers seeking personalized experiences have compelled MedTechs to reassess their approach to talent acquisition and retention. To keep up with the pace of change, it is crucial for these companies to attract and retain highly skilled professionals with expertise in technology, healthcare, and business. A talented workforce plays a vital role in driving innovation, ensuring efficient and safe processes, navigating complex market dynamics, and effectively executing growth strategies. To achieve this, companies should invest in the development of their employees, foster a culture of innovation, and offer competitive compensation packages to attract and retain top performers.
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According to a study published by the Harvard Business Review in January 2020, retaining top talent has become increasingly challenging for employers. The study revealed that in 2018, 25% of employed Americans left their jobs, with approximately 33% of this turnover attributed to unsupportive management and a lack of development opportunities. MedTech companies are not exempt from this trend, and to acquire and retain talent, they must strategically revamp their value propositions to align with the evolving needs and expectations of the modern workforce.
A crucial step in this direction is fostering a purpose-driven culture that highlights the significant impact medical technology companies have on improving people's lives. By instilling a sense of purpose, employees are more likely to develop a strong connection to the company's mission, inspiring them to consistently deliver their best work. Furthermore, providing ample career development opportunities is essential in empowering employees to enhance their skills and progress in their professional journeys. This can be achieved through training programmes, mentoring initiatives, and leadership development schemes.
 
Recognizing the importance of work-life balance is also critical. MedTechs can prioritize flexible working hours, a 4-day week, remote work options, generous vacation policies, allowing employees to effectively balance their personal and professional lives. By creating a supportive environment that promotes overall well-being and job satisfaction, companies can foster employee loyalty.
 
Competitive compensation and benefit packages are essential. Additionally, a commitment to diversity and inclusion is pivotal for MedTechs aspiring to become employers of choice. By emphasizing diversity in hiring practices and cultivating an inclusive work environment where every individual feels valued and respected, corporations can attract and retain a diverse array of talent. This, in turn, creates an environment conducive to enhanced innovation, creativity, and problem-solving.
 
Despite best efforts, there may be instances where companies are unable to attract and retain individuals with the necessary capabilities. In such cases, strategic partnerships, joint ventures, licensing agreements, and co-development initiatives allow MedTechs to tap into external expertise and resources, which can be employed to enhance product portfolios and gain access to new markets.
 
6. Realize global opportunities
 
MedTechs, traditionally reliant on most of their revenues from affluent US and European markets, now have the chance to expand their horizons and explore the untapped potential of the rapidly growing markets in Asia, Middle East and Africa, and Latin America. These regions boast transitioning demographics, with aging populations and a surge in chronic diseases. Additionally, their large and expanding middle-class populations demand advanced care, prompting governments to increase their healthcare expenditures significantly. By venturing into and expanding their footprints in these markets, Western MedTechs can diversify their revenue streams and leverage the growth opportunities stemming from the escalating demand for cutting-edge medical technologies and services.
 
Expanding into emerging markets not only provides a means to mitigate risks associated with economic volatility and changing regulatory environments but also necessitates acquiring new capabilities, fostering a change in executive mindsets, and embracing flexible pricing models. By adapting to the unique demands and challenges of these markets, MedTechs can position themselves strategically to tap into the vast potential they offer. This expansion serves as a catalyst for sustained growth and allows companies to seize opportunities that would otherwise remain untapped, thus bolstering their long-term success.
 
7. Align with rising ESG standards
 
To fully leverage their capabilities and resources and meet rising standards in ESG (Environmental, Social, and Governance), MedTechs might consider taking bold actions that: (i) embrace sustainable manufacturing practices to minimize their environmental impact, which entail reducing waste, water, and energy consumption, as well as transitioning to renewable energy sources. Such practices contribute to environmental conservation and mitigate a company’s carbon footprint, (ii) adopt circular economy principles, which involve designing products with a focus on reusability and recyclability. Additionally, establishing take-back programmes for end-of-life products, which ensure responsible disposal and encourage the reuse of valuable materials, thereby reducing waste and promoting sustainability, (iii) develop products that improve patient health, safety, and overall quality of life. This requires a patient-centric mindset, discussed above, that emphasizes the social impact and positive contributions MedTechs can make to society, (iv) produce offerings that are accessible and affordable to all segments of society. By addressing underserved communities and partnering with them to provide better healthcare solutions, companies can contribute to reducing healthcare disparities and promote equitable access to quality care, (v) enhance transparency and accountability, which includes setting clear targets, regularly measuring and reporting progress, and disclosing ESG performance, and (vi) engage with stakeholders, such as investors, customers, payers, employees, and patients, to better understand their expectations and concerns regarding ESG issues. Such a bold proactive approach to ESG issues contributes to a more sustainable and equitable world, strengthens a company’s reputation, and fosters its long-term success.
 
Takeaways
 
In today's rapidly evolving and technology-driven world, a successful pivot for MedTechs, which have been financialized and now find themselves in a strategic cul-de-sac, requires a simultaneous introduction of the suggested strategic initiatives, rather than a sequential approach. To regain high growth rates and create long-term value, MedTechs must:
  1. Revamp R&D efforts to develop innovative solutions and services that address evolving market needs, prioritizing cost-effectiveness, and improved patient outcomes as primary drivers of value creation.
  2. Prioritize patient-centric care by delivering solutions and services that significantly enhance outcomes, establishing a reputation for consistent value provision.
  3. Revitalize outdated organizational and operating models through increased collaboration with industry stakeholders, enabling accelerated technology development and adoption. This ensures alignment with patient needs and facilitates swift market entry.
  4. Harness the transformative power of digital technologies, AI, and big data to unlock new possibilities for innovation, efficiency, and personalized healthcare experiences.
  5. Attract, retain, and develop talent equipped with 21st-century capabilities while fostering a purpose-driven culture that fuels innovation and drives organizational success.
  6. Recognize and capitalize on the vast and rapidly expanding opportunities present in emerging markets, approaching them with a strategic mindset.
  7. Align with ascending ESG standards, demonstrating a commitment to sustainability, ethical practices, and social responsibility, which reinforces the credibility and long-term viability of MedTechs.
By embracing these strategies simultaneously, corporations position themselves to navigate policy shifts, overcome global uncertainties, and take advantage of evolving technologies, which stand them in good stead to enhance their growth rates, and significantly improve their value.
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11 months, 2 weeks ago

3D bioprinting and the advanced wound care market

HealthPad
Directory:
Medical Technology
Tags:
3D bioprinting
commentary
wound care
wound care market
  • Advanced wound care is a large and fast-growing global market currently dominated by North America and Europe  
  • In the next decade, Asia-Pacific, the Middle East and Africa and South America regions are expected to become significant wound care markets
  • Price sensitive Western MedTechs with wound care franchises might be challenged to penetrate these under-served rapidly growing emerging regional markets
  • Innovative technologies that currently contribute to advanced wound care include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting
  • Each has technical and clinical challenges likely to present obstacles for their future growth
  • 3D bioprinting however appears well positioned to eclipse competing technologies and disrupt the global advanced wound reconstruction market in the next decade
  
3D bioprinting and the advanced wound care market

3D bioprinting is a relatively new and innovative medical technology. Although in its infancy, it has established a market presence of ~US$1.3bn, and, over the next four years, its market value is projected to increase at a compound annual growth rate (CAGR) of ~21% and reach >US$3bn by 2027. An earlier Commentary drew attention to the technology’s likelihood to impact several aspects of healthcare. Here we assess 3D bioprinting’s potential near-term influence on the advanced wound care market compared with competing technologies.
 
A silent epidemic

Chronic wounds have become a large and fast-growing silent epidemic. They are difficult to heal because of aggravated underlying causes such as diabetes, obesity, and an aging population. Such wounds increase morbidity and mortality and inflict substantial medical, economic, and social burdens on healthcare systems globally. For instance, the mortality rate of neuropathic foot ulcers, the commonest wound associated with diabetes, is comparable to that of cancer (~30%), and cost more to treat. In the US, ~10% of the population (~30m) have diabetes, and $1 out of every $4 in healthcare costs is spent on caring for people with the condition, and the total annual cost of diabetes ~US$327bn. Further, each year, ~2m people living with the condition develop a diabetic foot ulcer (DFU) or other difficult to heal wounds. The US National Institutes of Health (NIH) estimate the annual cost of treating DFUs to be between ~US$9bn and US$13bn, which is in addition to the cost of treating diabetes and excluding the huge costs associated with treating venous leg ulcers and pressure ulcers each year. The US government has increased its effort to introduce new and advanced products for chronic wounds, with the aim to offer effective and affordable treatment to a large and growing pool of elderly patients. By 2060, the nation’s geriatric population is projected to be >77m, suggesting an increase in the 2% of Americans currently suffering chronic wounds. Similarly in England, where >11m people, (~19% of the population) are ≥65 years. A 2017 study estimated that the annual cost of managing chronic wounds and associated comorbidities for seniors by the country's National Health Service (NHS) was £5.3bn.
 
Rapidly developing therapies

Without appropriate care chronic wounds may not heal properly, leading to pain, decreased mobility, other long-term complications, and death. Wound healing is a dynamic and complex process of repairing or replacing damaged or lost tissue and its goal is to restore the structure and function of an affected tissue as closely as possible to its pre-injury state. Over the past two decades there have been significant advances in technologies to treat chronic wounds, some of which are reviewed in this Commentary. Today, >3000 products have been developed to treat different types of wounds by targeting various aspects of the healing process. There are several approaches to wound repair, including the use of advanced wound dressings, skin substitutes, growth factors, and regenerative medicine techniques.

However, despite decades of R&D and advances in the management of chronic wounds, they remain an under-served, yet fast growing, therapeutic area. This is partly due to the lack of comprehensive assessment and diagnostic tools and the significant time and medical resources that their management consume. However, artificial intelligence (AI) techniques are beginning to be used to help medical professionals and institutions automate wound care assessment and thereby save valuable resources. For example, KroniKare, a start-up based in Singapore, has developed the KroniKare Wound Scanner, a handheld tool that employs multi-spectral scanning techniques that can assess a chronic wound in ~30 seconds, which enables quick and accurate treatment. The scanner has been clinically validated by the Singapore government’s Health Sciences Authority as a Class-B registered diagnostic AI device.
 
In this Commentary

This Commentary provides a brief history of the wound reconstruction market. North America and Europe represent the largest share of the advanced wound care market, which is currently valued at ~US$11bn, growing at a CAGR of ~5.7%, and projected to reach ~US$16bn by 2028. We draw attention to the fact that the market is changing with a growing presence of the Asia-Pacific, the Middle East, and Africa and South America regions: all with vast and rapidly growing populations, expanding middle-class segments demanding enhanced wound care and governments committed to increasing their expenditures on wound healing. Traditional US MedTechs, which currently dominate the wound care market, may struggle to increase their franchises in these emerging markets due to a range of factors including regulatory complexities, unique healthcare challenges, price sensitivity, and logistical challenges. The Commentary describes several innovative wound care products and the leading corporations developing and marketing them. These offerings include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting. For each we briefly describe the main technical and clinical obstacles they need to overcome to increase their impact on the chronic wound care market. The Commentary concludes by summarising the limitations of several advanced wound care offerings and suggests reasons why, in the next decade, 3D bioprinting is likely to eclipse competing technologies and disrupt the global wound reconstruction market.
  
Brief history

Complex wound reconstruction is a relatively new field that has emerged over the last few decades. Advances in medical devices and clinical techniques have allowed for the successful treatment of wounds that were previously considered untreatable. In the early 1990s, the concept of wound bed preparation was introduced, which emphasized the need to prepare a wound before applying any kind of dressing or treatment. This involved removing dead tissue, and controlling infection, to promote healthy tissue growth. In the late 1990s and early 2000s, tissue engineering and regenerative medicine emerged as promising fields for complex wound healing. These focused on using biological materials, such as stem cells and growth factors, to stimulate tissue growth and regeneration.
In 1996, the US Food and Drug Administration (FDA) approved the Integra Dermal Regeneration Template, a manufactured collagen matrix with a claim of regenerative dermal tissue designed as a skin replacement, and initially used in patients with extensive burns with insufficient donor tissue for coverage. In 1998, Apligraf became the first commercially available, FDA approved, product containing living cells, to treat venous ulcers that failed to respond to conventional treatments. It is a synthetic skin created from harvested infant foreskins and produced and marketed by Organogenesis, a US corporation based in Massachusetts. In 2000, the product obtained further approval for the treatment of diabetic foot ulcers. In the years since, other products containing living cells for wound healing have gained regulatory approval and are used to treat a range of complex wounds.

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In addition to advances in technology and treatment options, there has also been a growing recognition of the importance of a multidisciplinary approach to complex wound reconstruction. This involves teams of healthcare professionals, including wound care specialists, plastic surgeons, and rehabilitation professionals, working together to develop comprehensive personal treatment plans for individual patients.
 
Despite these advances, the clinical assessment and management of chronic wounds remain challenging owing to their long-term treatment regimens and complex wound healing mechanism. Various conventional approaches including cell therapy, gene therapy, growth factor delivery, wound dressings, and skin grafts are being utilized to promote healing in different types of wounds. However, such therapies are not satisfactory for all wound types, which creates a need to develop newer and innovative treatments. In recent years, innovative wound healing technologies have made progress and continue to evolve. These include stem cell therapies, bioengineered skin grafts, and 3D bioprinting, which all focus on skin regeneration with minimal side effects. According to a 2023 report by Tracxn, a MedTech research platform, globally there are ~580 companies producing wound care offerings.
 
A fast-growing global market

Wound reconstruction is a large and rapidly growing segment of the medical technology industry. According to a 2022 Fortune Business Insights report, the global advanced wound care market is projected to grow from ~US$11bn in 2021 to ~US$16bn in 2028 at a CAGR of ~5.7% in forecast period. Its expansion is driven by several factors, including: (i) an aging global population: ~10% of the world’s ~8bn people are ≥65 years and this age group is expected to increase to ~17% by 2050. Older adults are more prone to chronic wounds due to decreased skin elasticity, poor circulation, and other factors, (ii) increasing worldwide prevalence of chronic wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers, (iii) advances in wound care technologies, including growth factors, stem cell therapies, biomaterials, and regenerative medicine approaches, (iv) increasing healthcare spending: governments and healthcare systems throughout the world are investing more in advanced wound care, and (v) increased public awareness of the importance of wound healing.
 
Significant regional markets

Advanced wound reconstruction markets vary in different regions of the world. Currently, North America is the largest, and expected to be valued at ~US$5bn by 2027, followed by Europe, which is currently valued >US$3bn with a projected 4.2% CAGR over the next four years. Here we draw attention to emerging markets of the Asia Pacific, Middle East and Africa (MEA) and South America regions.
 
The Asia-Pacific region has substantial growth potential particularly in India, China, and Southeast Asia. These regions have vast, aging populations, governments increasing healthcare expenditure, high incidence of chronic diseases, and a rising awareness of the importance of wound care among large and rapidly growing middle classes. In China (population >1.4bn), for instance, the wound reconstruction market is expected to grow significantly driven by: (i) an aging population - by 2040, ~402m people, (28% of the population) are expected to be >60 years, (ii) national efforts to improve healthcare infrastructure, (iii) increasing investment in medical research, and (iv) rising incidence of chronic diseases that require wound management. India (population ~1.4bn), is also a substantial potential market with a growing demand for advanced wound care solutions, increasing healthcare expenditure, and a rising number of government initiatives to improve healthcare services. Southeast Asia, which includes Indonesia (population ~280m), Malaysia (population >32m), Thailand (population >70m) and Vietnam(population ~100m), also represent significant growth potential for the wound reconstruction market. 
 
The Middle East and Africa (MEA) region is expected to have substantial growth potential for wound healing due to increasing medical management expenditure, improving healthcare infrastructure, and a rising number of government initiatives to improve wound care. Although this region is a diverse and complex healthcare market, there are several countries within it with significant growth potential for wound care. For instance, in the Middle East, the United Arab Emirates (population ~9.5m) is a wealthy market with a rapidly developing healthcare infrastructure, increasing demand for advanced wound healing solutions, and a high prevalence of diabetes-related wounds. Saudi Arabia too is a substantial potential market, driven by a large and growing population (~36m), increasing healthcare expenditure, and rising awareness of the importance of wound care management. In Africa, South Africa (population >61m) has a large and advanced healthcare system, increasing demand for complex wound care solutions, and a high prevalence of diabetes-related wounds.
 
South America is expected to experience significant growth in the wound reconstruction market, driven by increasing awareness of its importance, rising demand for advanced wound recovery solutions, and a growing number of government initiatives. Several countries in the region have substantial market growth potential, including: (i) Brazil, the largest economy in the region, with a population of ~217m and high incident rates of chronic wounds, (ii) Argentina (population >46m), which has a large healthcare sector and a growing demand for advanced wound care products and services, and (iii) Colombia, with a growing economy and a large population (>52m), is emerging as a key regional player in wound care solutions and services.
 
Leveraging opportunities in emerging markets
 
Many Western MedTechs are ill equipped to leverage the opportunities in emerging regions of the world with underserved, growing advanced wound care markets. North America and Europe account for ~55% of the global medical technology market and provide the largest share of MedTechs’ revenues. It is in these wealthy regions that most company executives have spent most of their professional careers and therefore have had little or no in-country experience of emerging economies. For decades, North American and European healthcare systems rewarded medical activity rather than patient outcomes and this drove high growth rates, significant profit margins, and industry expansion without much risk or in-depth strategic thinking. Such conditions, complemented by substantial periods of low interest rates and cheap money, encouraged the financialization of the medical technology industry: companies used mergers and acquisitions (M&A) to pursue scale and consequently became bigger but not necessarily better. Today, the ten largest medical device corporations account for >40% of the sales in a global market of ~US$490bn. The market has become an oligopoly, which emphasizes size and tends to blunt competition. Although such conditions are changing and having international experience, a global mindset, and R&D knowhow are increasingly valued, there is still a significant reliance on legacy products marketed predominantly in wealthy Western nations. Even now, relatively few company leaders have had in-depth experience of emerging regions of the world, where differences in language, competition, regulations, and culture create barriers to their ability to understand and navigate the nuances of these markets.
 
Wound healing technologies
 
The development of new wound healing technologies is an area of active R&D in the medical device industry, which aim to accelerate the healing process and improve outcomes for patients. Here we provide a flavour of these.
 
(i) Growth factors and cytokines
 
A promising area of research to stimulate wound healing is the use of growth factors and cytokines. These are naturally occurring proteins in the body that play a key role in the healing process. Researchers are exploring ways to use these proteins in wound care products to promote tissue regeneration and accelerate wound repair.
 
There are several MedTechs with offerings in this area. UK based Smith & Nephew markets a range of wound healing products, including biologic agents that contain growth factors and cytokines. The company’s REGRANEX Gel, which contains recombinant platelet-derived growth factors (PDGF), received FDA approval in 1997, and is used to treat diabetic neuropathic foot ulcers. Acelity, a Texas-based privately held company founded in 1976, manufactures and markets several advanced wound care products, including biologic agents that contain growth factors and cytokines. The company’s VAC VeraFlo Therapy with Prontosan, received CE Mark in 2017 and combines negative pressure wound therapy [a method of drawing out fluid and infection from a wound to help it heal] with a solution that contains cytokines and growth factors to help promote wound healing. Nasdaq traded Integra LifeSciences develops and markets wound healing products. The Integra Flowable Wound Matrix contains growth factors and is used to treat chronic wounds. Osiris Therapeutics, founded in 1993 and based in Maryland, USA, specializes in regenerative medicine and has a range of products to promote wound healing, including Grafix, a human placental membrane that contains growth factors and cytokines. NYSE traded MedTech, Stryker markets numerous advanced wound care products, including biologic agents that contain growth factors and cytokines. Its key product in this area is MIST Therapy, which is a painless, non-contact, low-frequency ultrasound treatment delivered through a saline mist containing cytokines and growth factors to promote wound healing.
 
Challenges
Growth factors and cytokines are proteins that are produced naturally by the body. Replicating their production in a laboratory setting can be challenging and result in high production costs and thereby limit their accessibility and affordability. Also, these molecules are quickly broken down and cleared from wound sites, which limits their effectiveness to promote healing. Developing methods to increase their stability and longevity is crucial to improving their efficacy.
 
While growth factors and cytokines have shown promise in preclinical studies, clinical trials have not always demonstrated consistent benefits in wound healing, and this raises some concerns about their potential for adverse effects such as allergic reactions or immune system activation. The success of these molecules in promoting wound healing depends on their ability to effectively interact with a complex network of cells in a precise and targeted manner, which can be challenging to achieve.
 
(ii) Stem Cells
 
In recent years, stem cell-based therapies for wound healing and skin regeneration have garnered much interest owing to their potential to morph into different types of cells that promote tissue regeneration and accelerate wound healing. Researchers are exploring the use of various types, such as mesenchymal stem cells (MSCs) [multipotent stem cells found in bone marrow]; adipose (body fat)-derived stem cells (ASCs), [a subset of MSCs, which can be obtained easily from adipose tissues and possess many of the same regenerative properties as other MSCs], and pluripotent stem cells (iPSCs) [cells that can develop into many different types of cells or tissues in the body]. These present the main sources of stem cells that are utilized for wound healing and skin regeneration.
 
While there are many products on the market, the leading MedTechs using stem cells for wound healing include Acelity, whose flagship offering is the RECELL Autologous Cell Harvesting Device, which uses patients’ skin cells to promote healing in chronic wounds and burn injuries. Organogenesis’s Apligraf, mentioned above, contains stem cells. Integra LifeSciences’s Dermal Regeneration Template, also mentioned above, is a matrix of bovine collagen and glycosaminoglycan molecules that contains autologous stem cells [stem cells removed from a person, stored, and later given back to the same person] to promote tissue regeneration. And Smith & Nephew’s PICO Single Use Negative Pressure Wound Therapy System, which uses a proprietary dressing with stem cells to promote healing in chronic wounds.
 
Challenges
Despite stem cell-based therapies being common and effective for the promotion of wound healing, there are challenges associated with their source, genetic instability, potential immunogenicity, risks of infection and carcinogenesis and high processing costs. Stem cells are a complex and heterogeneous population of cells that are sensitive to their environment, and replicating their production in a laboratory can be technically demanding and costly. They have the potential to differentiate into various cell types and promote tissue regeneration, but if not appropriately controlled, they can form tumours. Developing methods to ensure the safety and efficacy of stem cell-based therapies and minimising the risk of tumour formation are crucial to their future impact on the wound care market.
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(iii) Tissue engineering
 
Tissue engineering is another approach being explored for wound healing. This involves a combination of cells, engineering, materials, methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissue. Researchers have developed tissue-engineered skin substitutes that can be used to promote wound healing and tissue regeneration in patients with chronic wounds. Leading MedTechs with advanced products in this area include Acelity, Organogenesis, Integra LifeSciences and Smith and Nephew.
Challenges
There are non-trivial challenges associated with the production and maintenance of functional and viable tissue engineered constructs in a laboratory setting. The technology requires the growth of cells on scaffolds or matrices that mimic the extracellular matrix of the target tissue. The process of creating these involves multiple steps, including cell isolation, seeding, differentiation, and integration with the host tissue. Ensuring the quality and functionality of these constructs is demanding, and replicating such processes in a large-scale production setting is time consuming and costly. Another technical challenge is the need for a vascular network to support the growth and survival of the engineered tissue. The lack of blood vessels can limit the delivery of oxygen and nutrients to the cells within the tissue construct, which can result in cell death and impaired tissue function. Developing methods to vascularize tissue constructs and integrate them with the host vascular system is crucial to the success of tissue engineering in wound reconstruction. Clinical success depends on offerings not being rejected by a patient’s immune system and being able to integrate with a complex network of cells in a precise and targeted manner, which can be difficult to achieve.
 
(iv) Regenerative medicine approaches
 
Regenerative medicine approaches such as platelet-rich plasma (PRP) and extracellular matrix (ECM) are being developed for their potential to promote wound healing. The former is an autologous biological product containing higher amounts of platelets [small cells that circulate within your blood and bind together when they recognize damaged blood vessels]. Compared to circulating blood, PRP contains an increased concentration of growth factors, which is a prerequisite for wound healing. The approach involves isolating platelets from a patient's blood, which, when introduced into a wound has the potential to stimulate and accelerate tissue healing. In recent years, PRP has attracted a lot of research attention.
 
ECM is an extensive three-dimensional scaffold made from natural or synthetic materials that provides structural integrity and can be used to promote tissue regeneration and accelerate wound healing. Because of the nature of chronic wounds, recovery is reduced by a lack of functional ECM in the dermal matrix, which is responsible for stimulating healing. The restoration of functional ECM in wounds contributes to their reconstruction and closure. Both PRP and ECM technologies show promise in promoting tissue regeneration.
 
MedTech leaders in this field include Osiris, Terumo, Stryker and Zimmer Biomet. Osiris Therapeutics specializes in regenerative medicine approaches for wound healing, including ECM products. Grafix, the company’s key offering, is a cryopreserved placental membrane product that is designed to promote tissue regeneration in chronic wounds. Terumo, a Japanese corporation founded in 1921, opened its first overseas office in the US in 1971 and subsequently became a global player. The company is now a leader in blood management technologies and offers a range of products specializing in wound healing, including PRP systems. Its main offering, the Terumo BCT COBE Spectra Apheresis System, is used to collect and process blood components, including platelets, for use in wound healing. Stryker’s flagship ECM product is the MatriStem UBM Wound Matrix, which is derived from porcine urinary bladder tissue and is designed to promote tissue regeneration in chronic wounds. Zimmer Biomet is a global leader in musculoskeletal healthcare and offers a range of products for wound healing, including PRP systems. Its principal product is the EBI Bone Healing System, which is used to promote healing in fractures and other musculoskeletal injuries.
 
Challenges
Regenerative medicine approaches for wound healing require an in-depth understanding of the underlying mechanisms of tissue regeneration, which is complex. A precise understanding of multiple signaling pathways, cell types, and extracellular matrix components are crucial, and how these interact is fundamental to the development of effective therapies. For regenerative medicine treatments to be successful they need appropriate delivery of cells, growth factors, and other biological molecules to the site of injury. Achieving this requires a careful consideration of the biological and physical factors at play, which can be challenging.
 
(v) Three dimensional (3D) bioprinting
 
In recent years, three dimensional (3D) bioprinting has emerged as a rapid and high throughput automated technology that significantly reduces the limitations of other wound healing and regenerative medicine technologies that depend on manual processes and are hindered by the time it takes for them to reconstruct large chronic wounds. 3D bioprinting is an automated process that allows for the creation of three-dimensional structures using living cells and biomaterials. It involves the layer-by-layer deposition of bio-inks, which contain living cells and other biological components, using a specialized printer. The resulting structures can then be implanted into the body to promote tissue regeneration and wound healing. Advances in the technology have led to the development of more complex tissue constructs, such as skin, bone, and cartilage. In the near to medium term, 3D bioprinting has the potential to eclipse established and evolving wound healing technologies and disrupt the advanced wound care market.

Centres of excellence
There are several scientists, institutions, and start-ups, which have made significant contributions to the field of complex wound reconstruction using bioprinting. Here we mention a few. A pioneer in the area is Anthony Atala, founding Director of the Wake Forest Institute for Regenerative Medicine, which is part of the Wake Forest School of Medicine in North Carolina, USA. The Institute is a world-renowned centre of excellence for research in 3D bioprinting and wound healing. Professor Atala, a bioengineer, urologist, and pediatric surgeon, is recognized for his work in the area. One of Atala’s most notable contributions is the development of the first 3D bio printed human bladder, which he created using a combination of patient cells and biomaterials and then successfully implanted the constructs into several patients with bladder disease. Atala’s pioneering work in 3D bioprinting has paved the way for new treatments and therapies for patients suffering from complex wounds and tissue damage.
 
The Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, New Hampshire, USA, is a public-private partnership with a specific focus on 3D bioprinting research and has developed innovative techniques to create living tissues and organs. ARMI collaborates with academic institutions, government agencies, and industry partners to accelerate the translation of 3D bioprinting research into clinical applications. Another leading institution is the Tissue Engineering and Regenerative Medicine International Society (TERMIS), which is a global organisation that aims to promote research, education, and clinical translation in the field of tissue engineering and regenerative medicine. It has >50 chapters worldwide and organises annual conferences to bring together experts in the field. TERMIS plays a significant role in advancing 3D bioprinting research by providing a platform for collaboration and knowledge exchange.
 
One example of a start-up specializing in advanced wound care that is using 3D bioprinting is Pandorum Technologies, founded in 2011 and based in Bengaluru, India. Its flagship offering CorneaGen, is a 3D-bioprinted cornea that can be used to replace damaged or diseased corneas in patients. The cornea is made up of a bio ink composed of corneal cells and hydrogels that mimic the natural extracellular matrix of the cornea. The company has also developed a bio printed skin that can be used for wound healing research and drug development. It is composed of layers of living cells that mimic the structure and function of human skin. Pandorum has R&D initiatives in India and in the US located in the Medical University of South Carolina (MUSC) at Charleston and MBC BioLabs, in the San Francisco Bay Area, USA.
 
Challenges
The success of 3D bioprinting depends on its ability to create structures that can support the growth and differentiation of cells into functional tissue. Identifying and developing biomaterials that can mimic the extracellular matrix of the target tissue, while providing the necessary mechanical and biological cues to support cell growth is technically demanding. The process of 3D bioprinting involves the deposition of multiple layers of cells and biomaterials to create a three-dimensional structure. Achieving the desired geometry and spatial organisation of these layers can be challenging and requires precise control over the printing process. A challenge for the technology regarding wound healing is the time it takes to obtain autologous cells to fabricate skin constructs for patients with extensive burn wounds, which require rapid treatment.
 
Can 3D bioprinting disrupt the advanced wound care market?

Although it is difficult to predict the future of any technology with certainty, it seems reasonable to suggest that 3D bioprinting could become the dominant technology in the field of advanced wound reconstruction in the next decade. Bioprinting has several advantages over other technologies, briefly described in this Commentary, and currently used in wound reconstruction. Traditional methods such as skin grafting and tissue engineering using scaffolds, have limitations in terms of their ability to produce complex tissue structures and patient-specific treatments. 3D bioprinting, on the other hand, allows for precise control over the placement of cells and biomaterials, and can produce highly complex and customized tissue constructs. The technology is rapidly advancing, and new developments are being made at an unprecedented rate. Researchers are continuously developing new biomaterials, improving the resolution and speed of bioprinters, and exploring new applications. 3D bioprinting appears to have the potential to meet the large and growing demand for advanced wound reconstruction by allowing for the creation of customized tissue constructs tailored to the specific needs of individual patients. Further, it can reduce the need for multiple surgeries and treatments, improve patient outcomes and reduce healthcare costs.
 
Takeaways
 
Over the next decade, advanced wound care markets are expected to grow and change due to the increasing influence of the purchasing power in emerging regions of the world and advances in technology.  While wealthy North America and Europe, with ~14% of the global population, will continue to be commercially significant for the medical device industry, the Asia-Pacific, MEA, and South America regions, where >80% of the world’s population live, are likely to become important wound care markets because of the growing incident rates of chronic conditions and related wounds requiring treatment, expanding middle classes demanding improved care and governments’ commitment to enhancing their healthcare systems.
 
While it is unlikely that non-bioprinting technologies will disappear from the field of complex wound reconstruction, there are several reasons, which we have briefly described, why they are likely to have a reduced influence on the market as it evolves over the next decade. By contrast, the advantages offered by 3D bioprinting, combined with the rapid pace of its R&D, the growing demand for personalized affordable treatments in emerging economies, and the universal need to reduce healthcare costs, suggest that the technology is well positioned to disrupt the advanced wound care market in the next decade.
 
Will traditional MedTechs with wound care franchises be agile enough to benefit from these new market and technology opportunities?
 
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1 year ago

Healthcare disrupters

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  • MedTech growth strategies have taken advantage of low interest rates and cheap money to debt finance acquisitions of near adjacent companies with existing tried and tested products
  • This allowed companies to expand their product portfolios, geographic reach, and customer bases
  • Many MedTechs preferred such a growth strategy to investing in R&D to develop disruptive technologies that maybe outside their immediate field of interest
  • These technologies include 3D bioprinting, robotics, virtual reality, biometric devices and wearables, digital therapeutics, and telemedicine
  • All are patient-centric software driven technologies rather than hardware devices that serve the needs of hospitals
  • All are positioned to influence the shape of healthcare systems over the next decade
  • Many MedTech R&D investments are devoted to making small improvements to legacy products that prioritize the interests of large healthcare organizations over the needs of patients
  • Traditional MedTech M&A-driven growth strategies that have benefitted from an era of low interest rates and cheap money may now be challenged in the current period of higher interest rates, stagnate growth and rapidly evolving disruptive healthcare technologies.
  
Healthcare disrupters
 
On March 10, 2023, the Silicon Valley Bank (SVB) collapsed after a series of ill-fated investment decisions triggered a run on its assets. It was the largest bank failure since the 2008 financial crisis and the second largest in US history. The demise of SVB triggered a subsequent free fall in the shares of the Silvergate Bank, the Signature Bank, and the First Republic Bank. Then, on March 17, Credit Suisse shares crashed. Despite a US$54bn lifeline from theSwiss National Bankon  March 19, the bank collapsed and was ‘acquired’ by UBS for ~US$3bn. This banking crisis could create a weakness in corporate balance sheets more generally. Especially in MedTechs that have borrowed heavily in an era of low interest rates and cheap money, and now might be challenged by higher rates, economic stagnation, and rapidly advancing software driven healthcare technologies. These include, 3D bioprinting, robotics, virtual reality (VR), biometric devices and wearables, digital therapeutics, and telemedicine. All are positioned to influence the shape of healthcare over the next decade by: (i) changing the way healthcare is delivered, (ii) improving patient outcomes, (iii) lowering healthcare costs, (iv) increasing access to care, and (v) creating new business models as value shifts from hardware to software. Should the banking collapse be a warning to traditional MedTechs whose preferred growth strategies have been debt financed acquisitions of near adjacent companies with physical product offerings optimised for hospitals?
 
In this Commentary

This Commentary explores the potential vulnerability of some MedTechs that have taken advantage of the recent period of low interest rates and cheap money to pursue growth strategies dominated by the acquisition of near adjacent companies, and have not balanced this with investments in innovative technologies. These may not fit neatly into their existing product portfolios and business models but are positioned to have a significant influence on the medical technology industry and healthcare systems over the next decade. Such technologies include: 3D bioprinting, robotics, virtual reality (VR), biometric devices and wearables, digital therapeutics, and telemedicine. Before describing these, we briefly outline the causes of the recent banking crisis and suggest how it might signal a weakness in corporate balance sheets more generally.
 
The demise of SVB

Founded in 1983, headquartered in Santa Clara, California, USA, SVB was the preferred bank of the large and rapidly growing tech sector, and it quickly grew to become the 16th largest bank in America. Tech companies used SVB to hold their cash for payroll and other business expenses, which resulted in a significant inflow of deposits. Banks only keep a portion of such deposits as cash and invest the rest. Like many other banks, SVB invested billions in long-dated US government bonds. [Bonds are debt obligations, where an investor loans a sum of money (the principal) to a government or company for a set period, and in return receives a series of interest payments (the yield). When the bond reaches its maturity, the principal is returned to the investor]. Bonds have an inverse relationship with interest rates; when rates rise, bond yields and prices fall. During the past decade of historically low interest rates, bonds became a preferred investment vehicle. SVB’s problem arose when central banks throughout the world increased rates to curb inflation, partly caused by the hike in energy prices following the Ukraine war. For instance, in 2022, the American Federal Reserve raised interest rates seven times; from ~0 to 4.5%. As interest rates rose, SVB’s large bond portfolio lost money and the bank was forced to sell its bonds at a loss. On March 8, SVB announced a US$1.75bn capital raise to plug the gap caused by the sale of its loss-making bonds. This alerted customers to SVB’s financial challenges. They started withdrawing their deposits, which triggered a run on the bank.
MedTech growth strategies

Sudden hikes in interest rates may sound alarm bells for some traditional MedTechs that have pursued debt financing to acquire near adjacent companies rather than invest in R&D to develop disruptive technologies and innovative offerings. While R&D is a critical component of the industry, it is a complex and costly process, which often takes years to yield a product that can be marketed and generate revenue. By contrast, M&A activity allows companies to acquire existing products and technologies that have already been developed and tested, which reduces the risk and uncertainty of R&D. Further, with the industry becoming increasingly competitive, MedTechs need to achieve scale and market share to remain relevant. This can be achieved by the acquisition of near adjacencies, which allows acquirers to quickly expand their product portfolios, geographic reach, and customer base.

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The recent era of low interest rates and cheap money reinforced debt financed acquisitions as a growth strategy. Between 2011 and 2021, there were 2,365 M&A deals in the MedTech industry globally. However, to the extent that MedTechs focussed their acquisitions on near adjacencies, they may have missed out on acquiring innovative technologies positioned to reshape the industry over the next decade. This is because disruptive technologies often come from outside a company's core business and may not be immediately obvious to its leaders. Further, indebted companies facing high interest rates, might feel obliged to increase their revenues, which could result in them doubling down on cost cutting and optimizing their legacy products rather than investing in innovative R&D to drive revenue growth. Companies that adopt such business models could be at risk of having a dearth of technologies to drive future growth in a significantly more competitive healthcare ecosystem and challenging financial markets.
 
Disruptive technologies

The disruptive technologies we mention above shift the needle from hardware to software, from the needs of organizations to the needs of patients. While most of these are in their infancy, they all have the potential to transform healthcare in the next decade by providing new treatments for a variety of diseases and injuries, advancing drug development, enabling personalized medicine, reducing healthcare costs and improving medical training and surgical procedures. Let us explore these in a little more detail.

3D bioprinting

Three dimensional (3D) bioprinting is a relatively new technology, which involves the creation of 3D structures using living cells and holds promise for the future of regenerative medicine. The technology is an additive manufacturing process like 3D printing, which uses a digital file as a design to print an object layer by layer. However, 3D bioprinters print with cells and biomaterials, creating organ-like structures that let living cells multiply.

In 1999, a group of scientists at the Wake Forest Institute for Regenerative Medicine led by Anthony Atala, a bioengineer, urologist, and pediatric surgeon, created the first artificial organ with the use of bioprinting. Soon afterwards, bioprinting companies like Cellink (Sweden), Allevi (Italy), Regemat (Spain), and RegenHU (Switzerland) evolved. In 2010, Organovo, a biotech company founded in 2007 and based in San Diego, California, USA, introduced the first commercial bioprinter capable of producing functional human tissues that mimic key aspects of human biology and disease. In 2014, the company was the first to successfully engineer commercially available 3D-bioprinted human livers and kidneys. In 2019, researchers at Rensselaer Polytechnic Institute, New York, USA developed a way to 3D bioprint living skin, complete with blood vessels. Also in 2019, researchers at Tel Aviv University in Israel announced the creation of a 3D bioprinted heart using a patient's own cells. Today, 3D bioprinting is used to create a wide range of tissues and organs, including skin, bone, cartilage, liver, and heart tissue.
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One of the most promising applications of 3D bioprinting is the creation of replacement organs using a patient's own cells. This could potentially eliminate the need for organ donors and reduce the risk of rejection. The technology also can be used to create complex tissues and structures, such as blood vessels, skin, and bone, which could be useful for patients with severe burns or injuries, as well as those with degenerative diseases. Further, 3D bioprinting can be used to create realistic models of human tissues for drug development and testing, which could help to reduce the cost and time associated with drug development, as well as reduce the need for animal testing. 3D bioprinting could enable the creation of customized implants and prosthetics that are tailored to a patient's unique anatomy.

According to findings of a 2023 report by MarketsandMarkets, in 2022, the global 3D bioprinting market was ~US$1.3bn, and expected to grow at a compound annual growth rate (CAGR) of ~21% and reach >US$3bn by 2027.
Robotics

Medical and surgical robotics have a relatively short history. The first robot-assisted surgical system, the PUMA 560, [Programmable Universal Machine for Assembly], was developed in 1985 by the engineering firm Unimation, and used to perform a neurosurgical biopsy. A decade later, in 1994, the FDA approved the first robotic system for laparoscopic surgery, the Automated Endoscopic System for Optimal Positioning (AESOP), which was superseded in 2001 by the ZEUS Robotic Surgical System. In the late 1990s and early 2000s, researchers began exploring miniature in vivo robots for minimally invasive procedures. In 2000, the first robotic system designed for spinal surgery, SpineAssist, was developed by Mazor Robotics, an Israeli company, which Medronic’s acquired in 2018. In the mid-2000s, researchers began developing robots for use in orthopaedic surgery. Perhaps the biggest influence on robotic surgery was made by  Intuitive Surgical, an American company founded in 1995. Intuitive developed the da Vinci Surgical System, which was approved by the FDA in 2000 and quickly became the most widely used surgical robot in the world. It has been used in millions of procedures across a wide range of specialities. Today, Intuitive Surgical is a Nasdaq traded company with a market cap of >US$84bn, annual revenues >US$6bn and >12,000 employees.
Medical and surgical robotics continue to evolve, with new technologies and applications being developed all the time. Such technologies offer the potential for more precise, efficient, and less invasive procedures, reduced operating times, improved accuracy, and fewer surgical complications. Demand for surgical robotics is increasing as are investments in robotic surgery companies and an increasing number of hospitals around the world are investing in robots. In the US, >250 hospitals use surgical robots for complex operations. Europe has also seen an increase in the number of hospitals that utilize robots for medical purposes. In 2016, there were over 7,000 medical robots in use globally, today there are >20,000.


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According to a Verified Market Research report, in 2021 the global market for medical robots was ~US$11bn and is expected to reach ~US$35bn by 2030. Scientists are developing the next generation of microbots, which are small enough to seamlessly travel through the human body performing repairs.
 
Virtual reality

The use of virtual reality (VR) in healthcare has been growing rapidly in recent years, but its history only dates from the early 1990s, when the first VR applications in healthcare focused on pain management and distraction therapy. In the late 1990s and early 2000s, researchers began exploring the use of VR for a wider range of medical applications, including surgical simulation, medical education, and mental health therapy. In recent years, the technology has been used in pain management, physical therapy, treatment of phobias and anxiety disorders, and to improve quality of life for hospice patients. During the Covid-19 pandemic, VR was used to help healthcare workers train for and cope with the challenges of the pandemic, as well as to provide virtual healthcare visits to patients who were unable to receive in-person care.

VR healthcare start-ups have attracted attention from major players. For example, in February 2020, Medtronic acquired UK start-up Digital Surgery for >US$300m. Founded in 2013 by two former surgeons, Digital Surgery first made waves with an app to help train surgeons using a database of common procedures. It also developed VR software to train doctors as well as AI tools for surgeons in the operating room. OxfordVR is also a British VR start-up. Founded in 2017 by Daniel Freeman, Professor of Clinical Psychology at Oxford University, the company is focused on mental health applications and has successfully automated psychological therapy. Users are guided by a virtual coach instead of a real-life therapist, which allows the treatment to reach significantly more patients. Another notable VR start-up is Firsthand Technology, founded in 2016 and headquartered in California, USA.  The company's flagship product is a VR distraction therapy (VRDT) that offers immersive experiences designed to distract patients from the discomfort and anxiety associated with medical procedures. The company's offerings demonstrate the importance of addressing the psychological and emotional factors that impact health and well-being. In January 2020, Pear Therapeutics, a leader in digital prescriptions acquired Firsthand.

Over the next decade, expect VR to improve medical/surgical training by providing immersive, realistic simulations for medical students and health professionals, allowing them to practice procedures and techniques in a safe and controlled environment. In addition to helping patients to reduce pain and anxiety during medical procedures, VR can help to overcome barriers to care, such as distance and mobility, by providing virtual healthcare visits and remote monitoring of patients. Also, the technology is positioned to improve surgical planning. By providing surgeons with 3D models of patients' anatomy, allowing for more precise surgical planning, and reducing the risk of complications. Further, it can be used in physical therapy to improve patient engagement and motivation, leading to faster recovery times.

According to a 2021 Verified Market Research report, the VR healthcare market was valued at ~US$3bn in 2019, and is projected to reach ~US$57bn by 2030.
 
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Biometric devices and wearables

Biometric devices and wearable technologies aim to empower people with granular data that leads to actionable healthcare insights. It gives people the ability to collect their own health data and report them in a digital format to physicians, thus eliminating the need for in-person appointments for simple check-ups. Insurers and providers have also bought into wearable devices, relying on data collected from them to inform personalized health plans. Corporations too have adopted them to encourage healthy habits among employees working from home.
The use of biometric devices and wearables in healthcare has a relatively short, but influential history. In the early 2000s, the first commercial monitors were introduced, which allowed athletes to track their heart rates during exercise. The technology can provide a wealth of data about a patient's health, allowing healthcare providers to tailor treatment plans to individual patients, monitor chronic disorders, detect changes in real-time and intervene expeditiously. Biometric devices and wearables can help to detect early signs of illness or disease and can help patients to take a more active role in their own health and wellness. The technology has the potential to reduce the cost of care by enabling remote monitoring, preventing hospital readmissions, and reducing the need for in-person visits. Further, it can provide researchers with large amounts of patient data to facilitate AI-driven research into disease prevention and treatment.
 
One successful biometric device company is Fitbit, which was founded in 2007 and is headquartered in San Francisco, California, USA. Fitbit offers a range of wearable devices that track physical activity, heart rate, sleep patterns, and other biometric data. The company’s products include smartwatches, activity trackers, and wireless headphones that integrate with its mobile app and web-based platform to provide users with personalized health and fitness insights. The company has developed partnerships with insurers and healthcare providers to use its products as part of employee wellness programmes. Since its founding, the company has sold >120m devices. In 2019, Fitbit was acquired by Google for US$2.1bn, which is a testament to the value of biometric data and the potential of wearables to transform healthcare.
 
The Apple Watch is the other market leader. Its first edition, launched in 2010, included features for tracking physical activity, heart rate, and other health metrics. An upgraded version, released in April 2015, helped to establish the health tracking market, which led to the mass adoption of wearable technologies. From the outset, the Apple Watch was conceptualized as a device that would help people stay connected in less invasive ways than with smartphones. Each iteration since its inception has increased the watch’s focus on improving health and wellbeing. In 2018, it was approved by the FDA as a medical device capable of alerting users to abnormal heart rhythms. Today there are ~150m Apple Watch users.
 
Another leader in the wearable sensor market is Abbott Laboratories, which provides a range of services for diabetes and cardiology. In November 2018, the company received FDA clearance for its FreeStyle Libre, a glucose reader smartphone app. Oura Health, a Finnish company founded in 2013, has launched a health wearable product in the form of a small ring that tracks activity, heart rate, body temperature, respiratory rate, and sleep data. As the technology continues to evolve, biometric devices and wearables are likely to play an increasing role in healthcare by helping people to participate in their own health and wellness, improving medical outcomes, and reducing healthcare costs.
 
According to findings from a 2019 ResearchandMarkets report, the wearable health technology industry is projected to see a CAGR >25% between 2020-2027, and annual sales are expected to reach ~US$60bn by 2027.
 
Digital Therapeutics
 
Digital therapeutics (DTx) are software-based interventions that aim to prevent, manage, or treat medical conditions by modifying patients’ behaviours. The therapeutics are delivered through mobile apps, virtual reality, or digital platforms. Their use in healthcare is growing, and the history of DTx can be traced back to the late 1990s when the first digital intervention for substance abuse was developed. In the early 2000s, a few digital interventions were introduced to manage chronic conditions such as diabetes and hypertension. However, it was not until the 2010s when the use of DTx started to gain momentum, driven by technological advances, the growing prevalence of chronic diseases, and the need for more cost-effective healthcare solutions.
 
In the November 2020 edition of Scientific America, DTx were ranked in the top-10 emerging technologies, which have demonstrated an ability to prevent and treat a variety of chronic conditions. In September 2017, Pear Therapeutics’ digital software programme, reSET, became the first FDA-approved DTx for substance use disorders (SUD) involving alcohol, cocaine, marijuana, and stimulants. According to the US Centers for Disease Control and Prevention (CDC) >40m Americans, ≥12 years presented with SUDs in 2022. In 2020, Pear received FDA clearance for Somryst, an insomnia therapy app. The company has a pipeline of DTx offerings for a wide range of conditions, including multiple sclerosis, epilepsy, post-traumatic stress disorder and traumatic brain injury. In 2020, the FDA approved EndeavorRx, which is produced by Boston based Akili Inc and is the first DTx delivered as a video game for children with attention deficit hyperactivity disorder (ADHD). Omada Health, is another digital therapeutics start-up, founded in 2011 and headquartered in California, USA, which provides personalized coaching and support to individuals with chronic health conditions.

Given that DTx are evidence-based and personalized, they can be tailored to meet the unique needs of each patient. This individualized approach can lead to enhanced patient outcomes and improved quality of life. DTx are often more cost-effective than traditional therapies, as they eliminate the need for in-person visits and reduce the need for expensive medications. This could help to lower healthcare costs. Digital therapeutics can be accessed from anywhere, any time and on any device, making them particularly useful for patients in remote or underserved regions. This could help to improve access to healthcare for millions of people. DTx can be integrated with other healthcare technologies, such as wearables, mobile health apps, and electronic health records, to provide a comprehensive approach to healthcare. This could lead to improved coordination of care and better health outcomes. Further, DTx could bring about a shift in treatment paradigms and change the way we approach chronic diseases: instead of relying solely on medications, patients could use digital therapeutics to manage their conditions and improve their overall health.

The FDA has created a new classification for digital therapeutics, which is likely to make it easier for more DTx solutions and services to obtain regulatory approval. In a 2020 survey of MedTech leaders by Deloitte, a consulting firm, 63% of respondents agreed that DTx will have a significant impact on the industry over the next 10 years. A report by Grand View Research, suggested that the global digital therapeutics market was valued at US$4.20bn in 2021, and is estimated to grow at a CAGR of ~26% from 2022 to 2030. 
 
Telemedicine

The practice of using telecommunications and information technologies to provide remote medical services, has a history dating back to the early 20th century. In 1924, the first radiologic images were transmitted by telephone between two towns in West Virginia, USA. In the 1950s and 1960s, the technology began to advance, and the first video consultation between a patient and a physician was conducted. In the 1970s, NASA began using telemedicine to provide medical care to astronauts in space. In 2001, the Indian Space Research Organization successfully linked large city hospitals and healthcare centres in remote rural areas. With the development of the internet in 1990s, remote healthcare exchanges became more widespread, particularly in rural areas where access to medical services were limited. In 1993, the American Telemedicine Association (ATA) was founded to promote the use of the technology. Since then, telemedicine has continued to evolve and expand.
The Covid-19 pandemic led to a surge in telemedicine usage as healthcare providers looked for ways to provide care while minimizing in-person contact. Based on a survey by McKinsey, a consulting firm; before the pandemic in 2019, ~11% of US patients used telehealth services. After COVID, that number had grown to ~50%. Some estimates suggest that during the height of the pandemic, the number of telemedicine appointments increased by 5,000%. According to McKinsey’s, 76% of US consumers report that they are interested in using telehealth in the future as a way to complement in-person physician visits.In August 2020, digital health history was made with the merger of two of the largest publicly traded virtual care companies Teladoc and Livongo. The former, a multi-billion-dollar market leader in telemedicine founded in 2002, and the latter, a multi-billion-dollar market leader in remote patient monitoring. The deal created a US$38bn entity, which was the market’s first full-stack virtual health company. Today, virtual health is a rapidly growing field, and combines virtual physician visits, remote patient monitoring, chatbots, algorithms, and analytics.
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Over the next decade, AI-powered telemedicine tools are likely to become more prevalent, helping to streamline and automate many aspects of the care delivery process, such as triage, diagnosis, and treatment plans. Remote patient monitoring technologies are likely to become more advanced and widespread, allowing healthcare providers to monitor patients’ health and vital signs remotely, which can improve outcomes and reduce hospitalizations. Expect healthcare providers to increasingly work as part of virtual care teams, collaborating with other health professionals, including specialists, to deliver care to patients in real-time, regardless of location. Telemedicine will continue to improve access to care, particularly for underserved populations such as those in rural and remote areas, and those with limited mobility or poor transportation options. The technology will also facilitate more personalized and patient-centred care, as providers will be able to tailor care plans to the specific needs and preferences of individual patients.

According to a report by MarketResearchFuture, the current global telemedicine market size is valued at ~US$67bn and is expected to reach >US$405bn by 2030, exhibiting a compound annual growth rate of >22%.
 
Takeaways

We have described six evolving software driven technologies positioned to significantly influence healthcare systems in the next decade. Note that all are software driven and focused on patients to make care more personalized and sensitive to specific needs of individuals. Such technologies are in stark contrast to traditional medical devices, which overwhelmingly are physical devices designed to serve hospitals, rather than individual patients. Such a focus can lead to a lack of innovation, higher costs for patients, lower quality of care, and less personalized treatment options. A shift towards technology optimized to deliver patient-centered care is necessary to improve the quality of healthcare and ensure that patients receive the best possible outcomes. From our analysis it is not altogether clear whether traditional MedTechs are well positioned to achieve this.
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1 year, 1 month ago

Re-imagining healthcare

HealthPad
Directory:
Medical Technology
Tags:
Artificial Intelligence
big data
commentary
Machine Learning
  • Recently, Peter Arduini, CEO of GE Healthcare, proclaimed that the software development business “is central to our growth strategy”
  • Although AI is in its infancy, AI technology has become embedded in all aspects of care journeys: from diagnosis to recuperation at home; from prevention to improved lifestyles
  • Notwithstanding, many established MedTech leaders still advocate the production of physical devices for episodic surgical interventions marketed by B2B business models in wealthy regions of the world
  • Jenson Huang, a key opinion leader from the AI industry recently stressed how rapidly AI technologies have advanced over the past decade and predicts that AI “will revolutionize all industries” over the next decade
  • If Huang is right and more MedTech leaders bet their future growth on innovative AI driven strategies, healthcare systems will be soon re-imagined

Re-imagining healthcare
 
On 16 February 2023, a Wall Street Journal article announced, “GE Healthcare Makes Push into Artificial Intelligence”. The company, spun-out of General Electric (GE) in January 2023, is now an independent enterprise traded on Nasdaq, and Peter Arduini, its Chief Executive, says that the software development business “is central to our growth strategy”. In the first instance, GE Healthcare is planning to apply artificial intelligence (AI) and machine learning (ML) techniques to masses of disparate data generated by hospitals during patients’ therapeutic journeys, to enhance hospital services, improve patient outcomes and reduce healthcare costs.
 
Arduini is right. However, to fully appreciate the future potential impact of AI technologies on the medical technology industry and healthcare systems, we need to engage with key opinion leaders (KOL) from the AI industry. One such leader is Jenson Huang, a Taiwanese-American electrical engineer, founder, president and CEO of Nvidia, a semiconductor company launched in 1993. Today, it is a world leading, Nasdaq traded AI technology enterprise with a market cap of ~US$509bn, annual revenues of ~US$27bn and >26,000 employees. To put this into a perspective: if AI was the mid-19th century gold rush in the US, then Nvidia would be the producer of pickaxes for the hundreds of thousands of prospectors drawn to Sutter's Mill in Coloma, California. But before engaging with Huang, let us get a better understanding of the state of healthcare systems, AI and ML.
 
In this Commentary

This Commentary discusses Arduini’s proposition that AI big-data driven software strategies, which aim to enhance patient outcomes and reduce healthcare costs, are key to the growth of medical technology companies. This raises a question whether traditional MedTechs, producing physical devices, and marketing them with B2B business models will create sufficient growth and value over the next decade to satisfy their investors. Although AI technologies are in their infancy, they have already entered many areas of healthcare and are well positioned to play a significant role in future, re-imagined healthcare systems. The Commentary describes AI and ML, provides a brief history of AI, outlines its recent uptake in healthcare and notes how AI technologies have been used by both agile start-ups and giant techs to develop ‘big ideas’ with the potential to disrupt the medical technology market. We briefly describe six start-ups that have leveraged AI to enter the MedTech market and by doing so, increased the competitive pressure on traditional enterprises. Although AI technologies have only recently been introduced to healthcare systems, they are embraced by the FDA and feature in many aspects of patients’ therapeutic journeys: from diagnosis and treatment to recovery and rehabilitation at home. The Commentary takeaways suggest that the actions of industry leaders like Peter Arduini will have a significant impact of the shape on healthcare systems over the next decade.
 
Healthcare in crisis

Healthcare systems throughout the world are in crisis and experiencing large and rapidly growing care gaps,which we have described in previous Commentaries. These are created by growing shortages of health professionals and a vast and rapidly growing demand for care from aging populations; a significant proportion of which present with chronic lifetime diseases, such as heart disorders, diabetes, and cancer, that require frequent physician visits and more resources to treat. Such care gaps result in millions of people having difficulties gaining prompt access to health services, which delay diagnosis, worsen patient outcomes, and increase treatment costs. 

Addressing such issues requires re-imagining healthcare systems. Commercial enterprises have a role to play. Like GE Healthcare, agile start-ups and giant techs have embraced new and evolving AI technologies to create innovative offerings that provide solutions to care gaps predicated upon patient-centric, AI big-data strategies. However, many traditional medical technology companies have not developed software offerings and continue to focus on the production of physical devices, and B2B business models to support episodic hospital-based surgical interventions.  
 
Brief history of AI

AI refers to the development of computer systems that can perform tasks, which typically require human intelligence, such as decision making and natural language processing. The technology is based on the premise that machines can learn from data, identify patterns, and make recommendations with minimal human intervention. ML algorithms [instructions carried out in a specific order to perform a particular task] build mathematical models based on sample data, referred to as "training data", to make predictions or decisions without being explicitly programmed to do so.
 
AI has been around since the 1950s. The term was coined by computer scientist John McCarthy in 1956 at the Dartmouth Workshop in Hanover, New Hampshire, USA. In the early days of AI, scientists focused on building computers that could think, reason, and solve problems like humans. In the 1960s and 1970s, AI research concentrated on developing more advanced algorithms and techniques for programming computers to solve tasks. This resulted in expert systems, which used knowledge-based decision making to solve complex problems. In the 1980s, AI shifted towards ML, which allowed computers to learn from experience by enabling them to recognize patterns and make decisions based on data. In the 1990s, AI developed methods for robots to interact with their environment and learn from experience. This led to autonomous robots that can navigate and perform tasks in the real world. Today, AI research is focused on creating more intelligent and autonomous systems and is used in a wide range of applications, and increasingly in healthcare.
 
AI and healthcare

AI’s use in healthcare can be traced back to the 1970s, when researchers developed expert systems that could diagnose and treat certain medical conditions. Early AI healthcare applications were limited by the availability of data and the dearth of computer power. In the 1990s, as computing power increased and the internet became more widely available, AI began to be used more extensively in healthcare. One of the early applications was in radiology, where it was used to interpret medical images. Other applications included decision support systems for medical diagnoses and treatments, and natural language processing systems for medical documentation. In the 2000s, the use of AI continued to expand, with the development of ML algorithms that could analyze large datasets to identify patterns and make predictions. These were used in a variety of healthcare applications, including personalized medicine, drug discovery and medical imaging.
 
Today, AI benefits a wide range of healthcare applications from faster diagnosis to the prediction of pandemics, from clinical decision support to digital therapeutics. The aspiration of AI driven solutions and services in healthcare is super-human performance, free from errors and inconsistencies, and scalable to provide expert-level care across entire health systems. AI technologies have the potential to provide services that improve the accuracy and speed of medical diagnoses and treatments, monitor conditions, assist with recovery, support medicine regimens, facilitate personalized healthcare and reduce costs for providers. These functions are relevant in the context of attempts to narrow care gaps, but they require vast amounts of computing power, which most companies do not have in-house.
 
This is where cloud computing, and Nvidia's new solution come in. Dubbed "DGX Cloud", Nvidia’s offering is an AI supercomputer accessible via a web browser. The company has partnered with various cloud providers, including Microsoft, Google, and Oracle to develop the service, which provides enterprises easy access to the world’s most advanced AI platform and allows them to run large, demanding ML and deep learning workloads on graphic processing units (GPUs) to generate and implement ‘big ideas’.
 
Big ideas

New entrants to the medical technology market - agile start-ups and giant techs - often have ‘big ideas’; innovations with the potential to inspire stakeholders and disrupt the industry. By contrast, traditional MedTechs who do not employ AI strategies tend to have a dearth of big ideas and mainly focus their R&D spend on incremental improvements to their legacy devices. By contrast, new entrants have accelerated the use of AI, ML, and data analytics to help diagnose diseases earlier and monitor patients remotely. Further, they have championed wearable devices like Fitbits and Apple Watches that help people track their health metrics and allows them to make smarter decisions about their wellbeing. This is helping to transform the modality of healthcare from ‘diagnosis and treatment’ to ‘prevention and lifestyle’. 
 
Start-ups with big ideas
 
There are hundreds of healthcare start-ups with big ideas predicated upon innovative AI technology. To provide a flavour of these we briefly describe six.
 
Biofourmis
Boston based Biofourmis was founded in 2015. Its Biovitals™ Analytic Engine brings patient-specific data and ML together to provide the right care, to the right patients, at the right time. Advanced analytics process continuous and episodic data, notify clinicians of changes in patients’ conditions, and enable early intervention. With digital medicine, modular treatment algorithms (based on a patient’s disorder) enable the delivery of optimal medication.
 
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TytoCare
TytoCare is a New York-based medical technology start-up, founded in 2012, which aims to transform primary care by enabling people to have 24-7 medical examinations with a physician from the comfort of their home. The company has developed a suite of easy-to-use medical devices with built-in guidance technology and ML algorithms to ensure accuracy, which replicate face-to-face clinician visits. The devices include a hand-held modular tool for examining the lungs, throat, heart, skin, ears, and body temperature, and a health platform link to the cloud for storing, analysing, and sharing health data derived from the examinations.
 
Doctolib
Doctolib is a French digital health company founded in 2013. Its main product is a software-as-a-service platform for health professionals, which allows patients to book in-person and video consultations with healthcare providers. In January 2021, Doctolib acquired Tanker, a French start-up that developed the world’s first end-to-end encryption platform in the cloud, which Doctolib had been using since 2019. The Tanker platform is designed to be used by developers with no cryptographic skills and enables online businesses to easily encrypt their user’s sensitive data at the source: directly on end-users' devices. In October 2021, Doctolib acquired Dottori, an Italian online medical appointment scheduling service. The company is currently valued at >US$6bn, and  is used by ~300,000 healthcare professionals and ~70m patients in Europe.
 
CMR Surgical
CMR Surgical develops equipment and systems that aid in minimal access surgeries. During its establishment in 2014 in Cambridge, UK, the company’s founders asked, “why are so many people not receiving minimal access surgery and how can we change this?”. CMR’s main product is “Versius”, an EUMDR compliant device developed for high precision operations. During surgical procedures it can continuously collect data, which are stored and analysed to support surgeon training, and enhance the performance of future surgeries.
 
Healthy.io
Healthy.io is an Israeli start-up established in 2013. Its founders saw an opportunity to increase access to healthcare by leveraging the continuous improvement in smartphone cameras, which they transformed into at-home medical devices. As smartphone camera capabilities grew, Healthy.io’s range of clinical grade services expanded. With the company’s app and kits, users can undertake unitary tract infection (UTI) testing, prenatal monitoring, open wound assessments, and more, all in their homes. Health.io has partnered with healthcare systems throughout the world to provide clinical results at critical moments.
 
Proov
Proov, a US femtech start-up based in Boulder, Colorado, whose flagship offering is a rapid response progesterone test strip invented by Amy Beckley, a pharmacologist, with expertise in hormone signaling. It is the only FDA-cleared (March 2020) urine progesterone (PdG) test to confirm successful ovulation at home. Lack of, or insufficient ovulatory events, is the primary cause of infertility worldwide. In the US, ~12% of couples are diagnosed with infertility each year.  Thus, being able to confirm ovulation is an essential component of infertility evaluations in women.  Gold standards for confirming ovulation include transvaginal ultrasounds and serum progesterone blood draws. Both techniques are invasive, expensive, and/or inaccessible to most women. Proov’s offering is a non-invasive, inexpensive, home-based testing system.
 
A new era for AI in healthcare
 
Such start-ups with AI driven offerings suggest a new era for healthcare, which also is signalled in the introduction to a 2021, FDA action plan for AI/ML-based software medical devices. The plan describes how traditional B2B MedTech strategies are being complemented with B2C digital solutions and services that support entire patient journeys. According to the FDA’s action plan, “Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day. Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care. One of the greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance. FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive”. The agency currently has several ongoing projects designed to develop and update regulatory frameworks specific to AI. As of early 2023, there have been >500 FDA approved AI/ML-algorithms as medical devices.
 
Al and healthcare systems

Although AI is in its infancy and has only relatively recently begun to be used in healthcare systems, it has already taken root in many healthcare applications, including data analysis, diagnoses, monitoring, personalized apps, robotics, wearables, and virtual health assistance. This suggests a new era and the re-imagination of healthcare. Ambulances have become smart platforms, equipped with AI-based systems connected to hospitals, which can be used to diagnose medical conditions and provide real-time treatment recommendations. A&E departments use AI driven automated triage and diagnosis systems to assess incoming patients and prioritize those with the most serious conditions quickly and accurately. AI is also used to automate the dispensing of medications. Hospitals employ AI-based systems to analyze medical images such as X-rays and CT scans, which help medical personnel to quickly identify any abnormalities and make more accurate diagnoses. Surgery employs AI-enabled systems to assist with planning procedures, automating the delivery of anesthesia, and performing complex and delicate surgical interventions. Virtual recovery coaches use AI technology to create personalized plans for individuals recovering. Smart systems collect real time patient data and provide advice and support to help patients stay on track from their homes. AI-powered medication management systems help patients to track and manage their medications and send alerts to healthcare providers if there are any issues.
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Have diversified medical technology companies blown their competitive advantage?
 
The cusp of a new era

According to Huang, a new era of AI has been triggered by a technology most people have become familiar with over the past few months: ChatGPT. Developed by OpenAI and built on top of its family of generative, large language processing models, which have been fine-tuned using both supervised and reinforcement learning techniques.
Huang views ChatGPT, as “one of the greatest things that have been done in computing”. Generative AI models [algorithms that generate new outputs based on the data they have been trained on] have >100bn parameters and are the most advanced neural networks in today's world.  In no computing era has one computing platform (ChatCPT) reached ~150m people in ~60 days. In commercial terms this means, “a torrent of new companies and new applications . . . Nvidia is working with ~10,000 AI start-ups throughout the world in almost every industry”, says Huang. In a February 2023 earnings call to analysts Huang said that ChatGPT has incentivized businesses of all sizes to purchase Nvidia’s chips to develop ML software. Following the call, Nvidia’s market cap rose by US$79bn.
 
The democratization of AI programming

Huang’s enthusiasm for ChatGPT is partly because he perceives it as “democratising programming” by making human language a perfectly good computer programming language. The platform has the capacity to understand human-explained requests, generate coherent answers, translate texts, write code, and more. It has excited enterprises throughout the world and can be used for copywriting, translation, search, customer support, and other applications. While ChatGPT has many advantages, PyTorch and TensorFlow, two free and open-source software libraries have arguably done more to democratise programming by making it relatively easy to develop sophisticated ML applications without extensive programming skills. Notwithstanding, Huang is right to stress the significant leaps forward made by AI in the recent past and right to suggest that “AI is at a watershed moment for the world”.
 
Edge computing

Over the next decade, Huang predicts there will be a proliferation of edge-computing made possible by the spread of the Internet of Things (IoT). Edge computing is a connectivity paradigm that focusses on placing processing near to the source of data. This suggests that fewer activities will be executed using cloud computing. Instead tasks will be relocated to a user’s PC, cell phone or IoT devices. Huang refers to these as ‘AI factories’, which are positioned to have a significant impact on healthcare. By 2025, the global market for Internet of Medical Things (IoMT) is estimated to reach >US$500bn. This signals a significant change because currently most healthcare computing takes place in on-premises networks or, in the cloud. However, processing healthcare data from afar can be limited by infrastructures that cannot manage them quickly, securely, or cost-effectively. To address these issues, healthcare companies are implementing edge computing, which facilitates data being analysed and acted upon at the site of collection. This reduces end-to-end congestion and the constraints of limited connectivity and data broadband connections across vast distances by lowering transmission time, while also reducing risks to privacy and data protection. 

According to Huang, “AI processing performance has been boosted by a factor of no less than one million in the last 10 years”. Over the course of the next decade Huang predicts there will be, “new chips, new interconnections, new systems, new operating systems, new distributed computing algorithms and new AI algorithms (which will) accelerate AI by another million times."
 
Takeaways

Our discussion suggests that Peter Arduini, CEO of GE Healthcare, is right: software development is central to the growth potential of medical technology companies. Over the past two decades AI, ML and big-data strategies have substantially extended the horizons of industry players by giving them the means to provide software solutions and services to support entire patient journeys. This has introduced B2C MedTech business models, which complement conventional B2B models, and have the potential to provide access to new revenue streams while improving patient outcomes and reducing healthcare costs. If software initiatives like Arduini’s and others spread, healthcare systems are likely to be re-imagined. The fundamental technology of MedTech leaders is intelligence. But as Huang suggests, “We’re in the process of automating intelligence”, which can only empower industry executives. “The thing that’s really cool”, says Huang, “is that AI is software that writes itself, and it writes software that no humans can. It’s incredibly complex. And we can automate intelligence to operate at the speed of light, and because of computers, we can automate intelligence and scale it out globally instantaneously”. If Huang is right, over the next decade, AI is well positioned to play a significant role in re-imagining healthcare.
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1 year, 2 months ago

Out of the hospital into the home

HealthPad
Directory:
Medical Technology
Tags:
commentary
digital healthcare
MedTech
virtual healthcare
  • For the past three decades care has been moving out of hospitals into peoples’ homes
  • This is a significant and rapidly growing shift positioned to accelerate over the next decade
  • Driving this change are significant structural, organizational, and social factors
  • An early wave of new entrant digital ‘pure plays’ started to take advantage of this move ~3 decades ago and developed innovative software health solutions and services for people to consume in their homes
  • Later, there followed a second wave, comprised of several giant diversified healthcare companies that created and marketed digital home health offerings
  • The majority of traditional MedTechs have not responded to this shift and continue to produce physical devices for episodic surgical interventions in hospital operating rooms
  • Could their failure to develop software solutions for care in the home be an obstacle to their future growth and competitive advantage?
  
Out of the hospital into the home
A bridge too far or one that traditional MedTechs must cross?
 
On 30th January 2023, England's state funded National Health Service (NHS) announced a two-year recovery plan to help restore emergency care and frontline services. The plan, backed by a £1bn (US$1.2bn) fund, will increase virtual hospitals where patients receive high-tech care in their homes. It also includes 5,000 new hospital beds that will boost capacity by 5%, and 800 new ambulances, which will increase the fleet by 10%. Currently, England has ~7,000 virtual ward beds in the community. By 2024, ~50,000 patients a month are expected to benefit from these, which shall provide care mostly for elderly patients with chronic lifetime conditions. NHS virtual hospitals will be supported by a range of wearables and medical devices to diagnose and monitor patients’ conditions and share the data with their physicians in real time. This is not a new phenomenon; in 2006, China responded to its shortage of health professionals by developing virtual (internet) hospitals, and by mid-2021 there were >1,600 of them providing convenient and efficient medical services to millions of patients in their homes.

The UK government’s NHS recovery plan is a response to a series of strikes by health workers, protesting about staff shortages and deteriorating hospital conditions. Currently, there are >130,000 vacancies in the NHS; a vacancy rate of ~10%. Last December (2022), 54,000 people in England waited >12 hours for an emergency hospital admission. The figure was virtually zero before the pandemic. The average wait time for an ambulance to attend a stroke or heart attack in December 2022 was >1.5hrs, while the target is 18 minutes. In September 2022, >7m people in England were waiting to start NHS hospital treatments, which is the highest number since records began in August 2007. Surgeons were reported to being frustrated because operating rooms were not being used due to a lack of beds and staff.

This is not simply a UK problem. Since December 2022, health workers in the US, and France have engaged in similar strikes to protest about deteriorating hospital conditions. According to the World Health Organization (WHO), such protests are manifestations of a global shortage of medical staff. “All countries face challenges in training, recruitment, and the distribution of health professionals”, says the WHO, and suggests that by 2030, the global shortage of medical staff will mount to ~15m.  To the extent that a significant element of the challenges facing healthcare systems is staff shortages, it is not altogether clear how the British government’s recovery plan to increase NHS hospital beds and services will work if there is a dearth of health professionals.
 
In this Commentary

This Commentary suggests that the movement of care out of hospitals to peoples’ homes is not just a passing political response to a temporary crisis. The shift is driven by significant structural, organizational, and social factors, which we describe.  Since the late 1980s these factors have been gaining momentum and are positioned to have a defining influence over the next decade. Two distinct ‘waves’ of medical technology companies have taken advantage of this shift. The first wave started ~3 decades ago with several digital ‘pure play’ new entrants, which included ResMed, Propeller Health, Teladoc Health, Livongo Health, and Masimo. These companies all developed and marketed software health solutions to be consumed by patients in their homes. Later, there followed a second wave, comprised of a few giant diversified healthcare companies that included Philips,Medtronic, and Johnson & Johnson, which successfully entered the digital home care market. Notwithstanding, the overwhelming majority of traditional MedTechs have not developed digital solutions and services for patients to consume in their homes. Is this “a bridge too far” for them, or a bridge they must cross if they want to increase their growth rates and competitiveness?
1st wave: digital pure plays
 
ResMed
An early pure play that developed digital health solutions and services to be consumed by patients in their homes is ResMed, (an abbreviation of ‘respiratory medicine’), which started life in the late 1980s in Australia. In 1981, Colin Sullivan, a Professor of Medicine at the University of Sydney, developed and patented a continuous positive airway pressure (CPAP) device, which was the first successful non-invasive treatment for obstructive sleep apnea (OSA). Before Sullivan’s invention, the treatment for chronic OSA was a tracheostomy, where a hole is made through the neck into the trachea so breathing can bypass the nose and mouth. Initially, Sullivan partnered with Baxter, a US multinational medical technology company, to help commercialize his technology. In 1989, Baxter decided not to enter the sleep apnea market, and Peter Farrell, a Baxter executive, led a management buyout to acquire the technology and established ResMed in Australia. In 1990, the company relocated to San Diego, USA, and today, is a world leading software-driven, medical device enterprise, traded on the New York Stock Exchange (NYSE), with a market cap ~US$32.5bn, annual revenues ~US$3.6bn, >8,000 employees and a presence in >140 countries. Its main product offering, the AirView™ telehealth platform, is a secure, cloud-based system, which enables patients with sleep-disordered breathing and respiratory insufficiencies to be treated in the comfort of their own homes. The device provides real-time patient data, personalized insights, and proactive alerts that allow physicians to remotely monitor and connect to their patients. ResMed has >10m, cloud enabled, home care devices in the market and has accrued ~5bn nights of medical sleep and respiratory care data.
 
Propeller Health
In 2019, ResMed acquired Propeller Health for US$225m, but the company continued to operate as a standalone business. Founded in 2007, Propeller developed a mobile platform that offers sensors, mobile apps, analytics, and services to support respiratory health management. It is now a world leader in providing digital health solutions that keep patients with chronic obstructive pulmonary disease (COPD) and asthma out of hospital. The company’s sensors attach to patients’ inhalers and through its app, users can track their medication use, record their symptoms, receive environmental forecasts, which could affect their conditions, and download progress reports to share with their physicians. The app allows health providers to monitor their patients’ progress remotely, adjust treatment plans based on objective data and intervene when necessary. Propeller’s clinically validated solutions have found favour with US health insurers because they have demonstrated ~58% improvement in medication adherence, ~48% increase in symptom-free days, ~53% reduction in hospital visits and lowered costs of treating COPD, a condition that affects ~24m American adults and costs ~US$50bn to treat each year. In 2017, Fast Company named Propeller as one of the “most innovative companies”. In January 2019, the company launched ‘My Pharmacy’ with Walgreens as an in-app feature that allows users to manage their prescription refills for COPD and asthma and to locate a nearby pharmacy. The company quickly expanded this feature to CVS, Kroger, Rite-Aid and Walmart;  five of the seven largest pharmaceutical providers in the US.
 
Teladoc Health
Another early digital pure play is Teladoc Health, an American enterprise founded 21 years ago to provide convenient home healthcare for those who have difficulty accessing traditional healthcare services. Initially, it provided telephone-based physician consultations and medical advice. In 2006, the company added a proprietary digital platform, which enabled patients to securely upload medical records, images, and notes and share them with their doctors. This allowed physicians to assess a patient’s medical information and provide appropriate treatment plans quickly and easily. Teladoc continued to expand its services, including the introduction of remote medical consultations and a suite of digital health tools. Today, the company is a multinational telemedicine and virtual healthcare corporation. Its offerings include virtual care services and digital health solutions, medical opinions, artificial intelligence (AI) and machine learning (ML) driven analytics, telehealth devices and licensable platform services. Its primary services, which have expansive clinical depth and breadth across >450 medical subspecialties, are available in 40 languages and 175 countries.
 
Livongo Health
In 2020, Teladoc acquired Livongo Health, another pure play, in a deal valued at US$18.5bn, which is the largest digital health transaction in history, and created a combined entity valued at ~US$38bn. Livongo was founded in 2008, with a mission “to make virtual care the first step on any healthcare journey”. In July 2019, the company successfully IPO’d and raised US$335m. Until its merger with Teladoc, Livongo traded on Nasdaq and reached a market cap of ~US$14bn. The company’s principal offering is a digital platform that collects data from connected devices, wearables, and mobile apps to provide users with personalized care plans, coaching, and support to help them accomplish their medical goals from the comfort of their homes. A joint statement from the two companies at the time of the merger said that the combination is expected, “to create substantial value across the healthcare ecosystem, enabling clients everywhere to offer high quality, personalized, technology-enabled longitudinal care that improves outcomes and lowers costs across the full spectrum of health".
Masimo
Masimo is a digital pure play founded in 1989 by Joe Kiani, an Iranian American with the mission to create innovative digital patient centric medical solutions that improve outcomes and lower health costs. Over the past three decades Masimo has helped to make in-home medical care more accessible and affordable. Its digital offerings help to automate processes, reduce costs, and streamline communications between providers and patients. The company’s first product was a digital stethoscope, a device, which enables doctors to monitor a patient’s heart sounds remotely.
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Kaini, an electrical engineer by training, has >500 patents or patent applications for advanced signal processing, optical sensors, and wearable technologies, and is the company’s current chair and CEO. Masimo became a Nasdaq traded company in 2007, and today is a global player with a market cap of ~US$9bn, annual revenues ~US$1.25bn and >5,300 employees. The company has grown to become a leader in the digital healthcare space by developing and marketing a range of offerings, including a clinical decision support and monitoring platform, which helps to provide convenient and cost-effective care in patients’ homes.  Its core offering, a pulse oximeter, is a non-invasive, medical device that can easily be clipped onto a finger or toe to provide accurate readings in just seconds and is used to diagnose and monitor the amount of oxygen in the blood of people with respiratory conditions, such as COPD and asthma. Previously, blood oxygen levels could only be determined in a laboratory on a drawn blood sample. The pulse oximeter is also used for monitoring newborns, the elderly, and athletes, and each year monitors >200m patients.
 
In 2020, in response to the COVID-19 pandemic, the company introduced the Masimo SafetyNet for smartphones. In addition to helping combat COVID-19, the device can also be configured to help physicians create, relay, and manage treatment plans for >150 other health needs. In 2022, the company launched its W1 Health Watch, which is a water-resistant and dust-proof consumer-oriented health monitoring device equipped with a range of sensors and sensor-based algorithms that are designed to give users a comprehensive overview of their health. The watch also has an emergency feature that can detect and alert specified contacts if the wearer is in distress.
 
Factors driving care out of hospitals into homes
 
Since this first wave of digital health pure plays, there have been several significant structural, organizational, and social factors that have gained momentum and together helped to drive care out of hospitals into homes. We briefly describe these.

(i) Demographics: aging populations and escalating chronic lifetime disorders
United Nation’s data on global population trends suggest that by 2050, one in six people will be ≥65, (16%), up from one in 11 in 2019 (9%). According to the US Census Bureau, in 2022, there were ~56m Americans ≥65, which is ~17% of the population. This figure is projected to reach >73m by 2030 and ~86m by 2050: ~22% of the population. In the US, ~60% of adults have chronic diseases. According to the Centers for Disease Control and Prevention (CDCP), 90% of America’s ~US$4trn annual healthcare costs is attributed to people with chronic lifetime diseases and mental health conditions.

Since 2000, in the US, 18% of healthcare professionals have quit their jobs. According to data published in June 2021 by the Association of American Medical Colleges (AAMC), the US could see a shortfall between ~37,800 and ~124,000 physicians by 2034, with the largest disparities being in specialty doctors. These data suggest that, over the next decade, there will be fewer hospital resources available to care for a growing aging population with complex healthcare needs.

(ii) Technological advances
Technological advances are changing how clinicians practice medicine, how consumers manage their own health, and how patients and providers interact.

Remote patient monitoring, video conferencing, telemedicine, and mobile health applications have enabled care to move out of hospitals and into peoples' homes. Remote patient monitoring allows healthcare professionals to monitor a patient's vital signs and other health data remotely. Video conferencing provides patients with the ability to have real-time consultations with their physicians. Telemedicine allows a patient’s medical information to be securely shared with a range of healthcare providers, which increases access to care, and enhances its coordination. Mobile health applications allow patients to track their health data and receive reminders for taking medications, scheduling appointments, and other health-related tasks. These technological advances have enabled healthcare workers to deliver care to patients in their own homes, reducing the need for in-person visits to a hospital. AI and ML big data advances have facilitated remote diagnosis and monitoring and improved communications between healthcare providers and patients. Further, AI-powered chatbots help patients navigate healthcare systems, make appointments, and answer medical questions more quickly and accurately than traditional methods.
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(iii) Regulations
The US Food and Drug Administration (FDA) has revised its healthcare regulations to include the acceptance of algorithms for use in the healthcare industry. Since 1995, the FDA has authorized >500 AI-enabled medical devices. By providing for the use of algorithms, the FDA is helping to move care out of hospitals into homes. Recently, the agency set up the Digital Health Center of Excellence (DHCoE) to “empower stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation”.
(iv) Payors’ policies
In most nations, governments increasingly offer coverage for in-home health care services. We have mentioned government backed virtual hospitals in the UK and China. In the US, Medicare, and Medicaid [federal and state healthcare insurance programmes] have expanded their benefits to support home health care. The agencies' reimbursement policies are becoming more favourable in providing value-based healthcare for improved patient outcomes at lower costs. As a consequence, in-home care has become a modality of choice for treatment. Medicare now covers a variety of telehealth services, including remote patient monitoring, and the Medicare Advantage plans [Medicare-approved plans from private insurance companies] are now required to cover certain home health services, including skilled nursing, as well as medical equipment and supplies. Additionally, Medicaid programmes have implemented waivers that allow for some long-term health services to be provided in peoples’ homes. According to the US Centers for Medicare & Medicaid Services, spending on home healthcare services in America rose from ~$37bn in 2000 to >$97bn in 2018; an overall increase of ~161%.
 
Over the past decade, an increasing number of American private insurance plans have extended their cover for home health services. Research published in March 2022 by Deloitte, a consulting firm, suggests that over the next decade, as digital pure plays continue to grow and increase their capabilities, major health plans (government and commercial) will increase their partnerships with them. Deloitte suggests that by 2030, “>25% of health plans’ net profits will shift to digital health entrants”. According to a recent market analysis by GrandViewResearch, the global home healthcare market was valued at ~US$336bn in 2021 and is expected to expand at a compound annual growth rate (CAGR) of ~8% from 2022 to 2030.
 
(v) The rise of consumer power in healthcare
The rise of consumerism in healthcare has increased the emphasis on patient empowerment, convenience, cost-effectiveness, and home care. In 2018, Gordon Moore et al provided a compelling rationale of the significant rise of consumerism in healthcare in a book entitled ‘Choice Matters’. Moore, Professor of Population Medicine at Harvard University Medical School, identified the growing influence of patients, which previously had been largely overlooked. Over the past three decades patients have become more knowledgeable about health and this has empowered them to take added charge of their own health and seek out the best possible care for their individual needs. This has helped to drive care out of hospitals and into the home, where patients can receive personalized treatment in a comfortable, familiar setting. Moore argues that patients have more choices than ever before and increasingly demonstrate an ability to make informed decisions about their health. Choice Matters stresses the importance to understand both the medical and financial implications of patients’ decisions and how they help to shape technology, inform public policy, and trigger healthcare initiatives. Moore’s thesis discusses the growing implications of consumer-driven healthcare and explores how the marketplace is evolving in response to the changing needs of patients. The book outlines a variety of arguments that support the idea of healthcare decentralization, such as the need for care to be tailored to an individual's unique needs and preferences, the advantages of providing care in the home, and the potential cost savings associated with these changes. Moore also highlights the value of integrating technology into the home-based care model and the potential of this delivering increased efficiency and improved outcomes for patients. Today, consumerism in healthcare is challenging the traditional medical modality of diagnosis and treatment by putting a greater emphasis on lifestyles and prevention.
 
2nd wave: giant healthcare companies
 
The commercial success of the first wave of digital health pure plays, together with the factors we outlined above, made some giant diversified healthcare companies rethink their business models and employ AI and ML big data strategies to develop and market health solutions and services for people to consume in their homes. These companies include Philips, Medtronic, and Johnson & Johnson; together they represent a second wave of healthcare companies that have successfully gained access to new revenue streams by serving the large and growing home care market. Here we briefly describe some of their digital offerings.
 
The Philips HealthSuite digital platform is designed to help healthcare providers deliver patient-centric  care, reduce costs, and improve outcomes. The platform is powered by the cloud and includes a suite of AI big data analytic tools, which support the monitoring of patients in their homes, and allows physicians to access real-time health information and respond quickly to any changes in a patient’s condition. Similarly, Medtronic’s CareLink™ remote monitoring platform supports home care by facilitating patients to monitor and manage their health information remotely. The device allows healthcare providers to access a variety of patient data, including vital signs, weight, diet, sleep, activity, and medication adherence. It also provides two-way communication between healthcare providers and patients, allowing for more personalized care. Johnson & Johnson has built on its consumer health business that “helps >1.2bn people” and, in August 2019, launched its CarePath Solutions platform to provide patients with personalized health plans and support in their homes. It also helps healthcare providers to make informed clinical decisions, reduce costs, and improve patient outcomes.
 
Takeaways
 
The commercial success that digital pure plays and giant healthcare corporations have gained by providing solutions and services for patients in their homes should raise alarm bells for traditional MedTechs that continue to focus on providing legacy physical devices for episodic surgical interventions in hospitals. Patient centric health, emphasizing convenience and accessibility, shifts the focus of healthcare from the hospital to the home, from physical devices to digital solutions and services. To take advantage of this shift companies will need to invest in developing new digital health innovations. Patient centric healthcare also emphasizes the need for data-driven decision making, which requires the use of more advanced analytics and AI, ML big data strategies. Traditional MedTechs producing physical devices may not be able to keep up with the rapid pace of software developments in healthcare. Pivoting to develop and market software health solutions and services for patients to use in their homes might be a “bridge too far” for these companies. However, can traditional MedTechs afford not to cross this bridge?
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