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complex spine surgery

LBP

lower back pain

This is a series of seven Commentaries on Low Back Pain and the global spine industry. They are not meant to provide “answers”, but to stimulate strategic thought and discussion.
Happy reading!

Low back pain, spine surgery and market shifts

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If spine surgery fails to relieve low back pain why is it increasing?

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Minimally invasive spine surgery and computer assisted navigation systems

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Robotic surgical spine systems, China, and machine learning

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Will a rear mirror mindset slow the adoption of technologies poised to influence the spine market?

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Digitalization: the reinvention of spine companies’ supply chains and controlling the inventory-to-revenue ratio

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The spine market and smarter diversity and inclusion policies

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2 years, 8 months ago

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The spine market and smarter diversity and inclusion policies

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The spine market is challenged by the physical and digital worlds converging
Lucrative traditional markets are slowing, and large emerging markets are growing
Environmental, social and governance (ESG) issues are growing in significance
Future clinical and financial success will depend on industry leaders pursuing smart and aggressive diversity and inclusion policies, but it won’t be easy

- Low back pain and the global spine industry -

The spine market and smarter diversity and inclusion policies

Spine companies are predominantly manufactures led by White males who find themselves on the cusp of a transformation driven by the continued convergence of the physical and digital worlds, slowing traditional Western markets and growing emerging markets, and an increasing need to provide patients with the best outcomes at the lowest cost. This raises the bar for spine companies to demonstrate differentiated clinical and economic value. Over the next five years, the spine market is likely to face disruptions and opportunities that impact its core and emerging businesses. Industry leaders are tasked to discover ways to own their disruptions and find solutions to challenges associated with change. Given the projected nature and speed of this transformation, spine leaders’ quest for answers is unlikely to be satisfied by pursuing business as usual. To benefit from the opportunities presented by market challenges, industry leaders will need to recruit new talent with capabilities and competences relevant to an evolving ecosystem. Smarter and more aggressive diversity and inclusion policies, as part of a wider environmental, social and governance (ESG) focus, will be essential to stand a chance of hiring such talent.

Environmental, social and governance issues

Environmental, ‘E’ issues, include the energy a company consumes, the waste it discharges, the resources required to address these matters and the impact ‘E’ questions have on people (e.g., radiation emissions). Social, ‘S’ issues, include a company’s diversity and inclusion policies. ‘S’ emphasises the fact that companies operate within a broader diverse society and addresses an enterprise’s relationships with people, institutions, and the communities where it does business. Governance, ‘G’ issues, represent the internal processes and controls an organization adopts to make effective decisions, comply with the law, and meet the needs of their stakeholders.

In this Commentary

This Commentary focusses on the significance of social, 'S', issues to spine companies and suggests that adopting more aggressive diversity and inclusion policies could help them adapt their business models and strategies to become more clinically relevant and commercially successful in a rapidly changing ecosystem.

Changing emphasis

Historically, ESG issues have been of secondary concern to corporate leaders and investors, but this has changed because ESG matters can provide insights into factors that impact on a company’s financial performance and thereby inform investment decisions. In recent years, institutional investors and pension funds have grown too large to diversify away from systemic risks, which has obliged them to consider the ESG impact of their portfolios. The possibility of commercial enterprises being held accountable by shareholders for their ESG performance puts pressure on managers to prioritize such matters. Already, public companies in the US are being encouraged to: (i) publish statements of purpose, (ii) provide investors with integrated financial and ESG reports, (iii) increase the involvement of middle managers in ESG matters, (iv) invest in robust IT and data management systems, and (v) improve internal practices for measuring and reporting the ESG impact on financial performance.

ESG issues and spine companies

A spine company’s environmental ‘E’ footprint is comprised of instruments and devices, which have a variety of impacts and lifecycles. For example, imaging and guidance equipment eventually becomes electronic waste, surgical instrument sets require sterilisation before reprocessing and infected single-use devices add to recycling challenges.

Spine companies’ play a role in the populations they serve and derive significant revenues from governments: S issues. This is demonstrated in an analysis of Medicare [a US national health insurance programme] data by researchers from the University of Michigan and Harvard University Medical School and published in the July 2014 edition of the Spine Journal. Findings show that between 2000 and 2010, the US government spent >US$287bn on fusion-based spine surgeries.

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The research also suggests that for patients covered by Medicare, the rate of complex spine surgeries increased 15-fold between 2002 and 2014, and concludes that, “despite these large expenses, there is no consensus on the accepted indications for which spinal fusions are performed”: an issue discussed in a previous Commentary.

Governance, ‘G’ issues, for spine companies are dealt with at the sector level, and involve safety testing of their implants and devices, monitoring outcomes and manufacturing quality, safeguarding patient information, and ensuring marketing compliance. However, the future focus of governance ‘G’ issues will likely be company specific, and more attention is expected to be paid to companies’ cultures and ownership structures.

Short supply of relevant talent

As spine enterprises adapt and change their business models and strategies to remain competitive, and as ESG issues increase in significance, corporations will need new expertise, new roles, and new employees to assist them to take a fresh look at legacy issues and turn disruptions into opportunities. The skills required to create and develop future clinical and commercial success include digital expertise, and data management abilities or STEM subjects; [science, technology, engineering, and mathematics] and a knowledge of international markets. However, such capabilities are in short supply, and millennials [people born between 1981 and 1994/6] and older generation Z’s [people born between 1997 and 2015], who tend to possess such skills, prefer to work for giant tech companies, which have untraditional work environments.

A 2018 Forbes study describes the US as having, “a significant high tech STEM crisis”. Another recent study suggests that the greatest demand for STEM workers is from the healthcare industry, which is among the fastest growing sectors, and therefore is expected to face the greatest shortage of STEM talent. Thus, it seems reasonable to assume that, over the next decade, MedTech’s will be challenged to recruit and retain an adequate supply of appropriate talent to help them transform their businesses and this will oblige them to increase their search for capabilities among women and minorities.

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Diversity and inclusion as investment criteria

Currently, MedTechs have a predominance of White males in their workforces. 2020 data from the US Bureau of Labor Statistics show that US MedTech’s employ ~660,000 people, of which ~40% are women; ~77% are White, ~8.4% Black/African American, ~11.5% Asian and ~13% Hispanic or Latino, with women and minorities significantly underrepresented in leadership positions.

Company initiatives to promote diversity have recently gained impetus following the death of George Floyd. On 25 May 2020, Minneapolis police officers arrested George Floyd, a 46-year-old Black man, after a convenience store employee called the police and told them that Floyd had bought cigarettes with a counterfeit US$20 bill. Seventeen minutes after the first police car arrived at the scene, George Floyd was pinned beneath three police officers and was dead. This triggered condemnations from the CEOs of the biggest US banks and the world’s largest asset managers, and turbocharged their intention to make ESG assessments critical to investment decisions.

Reflecting on racial injustices in the US, Larry Fink, chairman and CEO of BlackRock, the world’s largest asset management firm, said that protests following George Floyd’s death, “are symptoms of a deep and longstanding problem in our society and must be addressed on both a personal and systemic level. . . . This situation also underscores the critical importance of diversity and inclusion within companies and society at large”. A similar reaction came from Jamie Dimon, chairman and CEO of JPMorgan Chase, the largest bank in the US and the forth largest bank in the world, who said, “we are watching, listening and want every single one of you to know we are committed to fighting against racism and discrimination wherever and however it exists”. This signalled a corporate shift to a more proactive stance, leading to policy initiatives focused on board refreshment, board gender diversity, and holding boards accountable to a higher standard of ESG practices.

Striking a different note, Omar Ishrak, a Bangladeshi American business executive, Chairman of Intel, and former CEO of Medtronic, stressed the importance of diversity of thought. According to Ishrak, it is not just important to have different people in your organization, but more significant is what you do with the difference. “What happens when you leave the room? How does diversity challenge your thinking and impact your customers?”, asks Ishrak. Such pressure from investors and key opinion leaders serves as a catalyst for change and a greater emphasis on ESG issues, which will become the new normal.

White men rule

Outwardly, all companies, generally agree on the importance of diversity across organizations, and executives promise to rebalance their workforces. However, it is not altogether clear whether such promises lead to tangible outcomes. For example, as of 2021, only ~7% of Fortune 500 company CEOs were women, despite the fact that there were ~77m women in the US labour force, representing close to half (47%) of the total labour force. Similarly in Britain where the 100 largest companies (the FTSE 100) have only six female CEOs, which is the same number as between 2017 and 2019. Also, Black individuals are particularly under-represented in the higher echelons of corporations. According to Equilar, a clearinghouse for corporate leadership data, ~30% of companies on the S&P 500 do not have at least one Black board member, and currently, there are only five Black CEOs in the Fortune 500.

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Available data suggest that women and minorities are significantly underrepresented when moving up the corporate ranks. Tracking such progress is difficult since corporations are not required to disclose information on the composition of their workforces. However, a 2020 report from Mercer, a human resources consulting firm, suggests that the problem of diversity in companies begins early, with minorities not advancing at the same rate as their White colleagues. ~64% of workers in entry level positions in large US corporations are White, ~12% are Black, ~10% are Hispanic, ~8% are Asian or Pacific Islander and ~6% are other races. The share of positions held by White employees increases with seniority. At the executive level, ~85% of positions are held by White employees, while Black and Hispanic employees make only ~2% and ~3% of these positions, respectively. This suggests that minorities face a significant promotion gap in US corporations.

Economic consequences

According to Haim Israel, a Bank of America (BofA) analyst, increasing diversity has significant commercial benefits. According to studies undertaken by Israel, diversity means higher sales and lower earnings volatility risk. “Companies focused on gender diversity at a board, C-suite and firm level consistently achieve higher ROE [return on equity] and lower earnings risk,” says Israel; while highlighting the fact that corporate executives, “don't forcefully step-up their diversity efforts”. S&P 500 companies with above-median gender diversity on their boards see ~15% higher ROE, and the ROE in companies with ethnic and racially diversified workforces is ~8% higher. Israel suggests that the continued lack of diversity inside corporate America, “could cost the US economy ~US$1.5tn in lost consumption and investment over the next decade". If US business and government leaders had decided more than 30 years ago to act on diversity and inclusion, about US$70tn would have been added to the nation’s economic output, says Israel.

Diversity and company performance

The BoA’s findings on diversity are supported by research from several global consulting firms. For instance, a 2018 McKinsey study suggests that there is a significant correlation between diversity in the leadership of large corporations and financial outperformance. More diverse companies outperform their more homogeneous counterparts. This is supported by findings of a 2020 report from the same consulting firm. The research shows that, “companies in the top quartile for gender diversity on executive teams were 25% more likely to have above-average profitability than companies in the fourth quartile - up from 21% in 2017 and 15% in 2014”. Findings were more compelling for ethnic and cultural diversity, where companies in the top 25% outperformed those in the bottom quartile by ~36% in terms of profitability. These conclusions support a 2018 study by the Boston Consulting Group, which found that companies with more diverse management teams had ~19% higher revenues.

Diversity and spine companies

It seems reasonable to suggest that spine companies have been behind the curve when it comes to attracting and promoting women, Black, Asian, ethnic minorities, and people with disabilities. Over the next decade, this could change; not because of imposed quotas, guilt, or shame, but because within these groups, there is a wealth of diverse experience, talent and thought, which could help companies adapt and change. Not only is greater diversity and inclusion expected to help spine companies develop optimum solutions to such issues as the convergence of the physical and digital worlds, but also help them to take advantage of the growing spine market opportunities in emerging economies.

Emerging market opportunities

For the past three decades US corporations have dominated the spine market, but this is beginning to change. American market rule can be attributed to suppliers’ ability to manufacture sophisticated surgical implants and devices relatively cheaply and market them expensively, predominantly in the US, EU-27, and a few other wealthy regions of the world, with highly developed healthcare infrastructures, generous reimbursement policies and well-trained physicians.

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Low back pain, spine surgery and market shifts

However, over the next decade, the US spine market is expected to slow, and the Asia Pacific (APAC) market is projected to grow at a much higher compound annual growth rate (CAGR). This is partly because the US has a shrinking working-age population to provide for the vast and escalating spine surgery costs required by the large and rapidly growing cohort of >65-year-olds with age related spine disorders. This has led to the tightening of previously benign reimbursement policies and more stringent regulations, which has squeezed spine companies’ revenues. APAC countries, on the other hand, have ageing populations and a consequent increase in the incidence rates of low back pain (LBP) and degenerative disc disorders, but they also have improving healthcare infrastructures and reimbursement scenarios, increasing numbers of trained clinicians, and increased affordability due to rising per-capita GDP.

Recent policies enacted by several Asian governments are positioned to support the growth of healthcare spending. China represents the largest and fastest-growing market in Asia-Pacific, having already surpassed the combined market value of most nations that make up the EU-27. China is seeing some of the fastest growth in healthcare spending, which support sales of spinal implants and devices, which are growing at a CAGR of 9%.

China has broadened its healthcare insurance coverage and is working on an ambitious programme of reforms, which include the government raising medical subsidies, and improving the quality and range of services of its ~9,000 tier 1, and ~11,000 tier 2 hospitals, which serve townships in rural areas and medium size cities throughout the country. Health expenditure in China has soared from <US$72bn in 2000 to >US$690bn in 2019. According to OECD data, in 2016 China surpassed Japan in total healthcare spending with US$574bn compared to Japan's US$469bn; and surpassed the US in hospital beds per 1,000 persons, with 3.8 for China and 2.9 in the US.

While such changing market dynamics are expected to exert further downward commercial pressure on US spine companies, they also present opportunities for American corporations with the capabilities to fully leverage the fact that by 2022, >30% of the global healthcare expenditure is expected to arise from emerging economies. To put it into a spine perspective; the global spinal surgery market’s competitive landscape is maturing and consolidating while serving an increasingly demanding healthcare sector. Spinal implants and devices represent ~US$14bn global industry projected to approach US$18bn by 2023. Industry leaders are tasked to achieve growth in developed markets and to capture market share in emerging countries. This will require a more diverse employee base with capabilities to develop cost-efficient products, with improved medical outcomes, tailored to local needs. To increase share of emerging markets over the next decade, it will not be sufficient for MedTech companies to simply duplicate what is already being sold in traditional developed markets, both due to cost, resource, and competence reasons in diverse market segments. The spine industry will therefore increasingly need to be agile enough to adapt solutions to local needs.

Takeaways

The bar for spine companies to demonstrate differentiated clinical and economic value has risen over the past decade and is likely to continue rising over the next decade. This new “value bar” increases the pressure on enterprises to rethink their legacy strategies and business models. ESG policies that increase diversity and talent pools could help them do this. The economic consequences for companies that are slow to adopt and pursue ESG policies and promote diversity could be significant.

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2 years, 8 months ago

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Digitalization: the reinvention of spine companies’ supply chains and controlling the inventory-to-revenue ratio

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Traditional spine companies’ supply chains are linear, labour intensive and siloed and their inventory-to-revenue ratios tend to be high
To remain relevant in an environment where the physical and digital worlds are converging company leaders will need to improve their supply chains
Digitalization can help achieve this but requires embracing data management techniques
As a response to the COVID-19 crisis some MedTech’s introduced and extended their digital strategies
Have they done enough to remain relevant in a rapidly evolving ecosystem?

- Low back pain and the global spine industry -

Digitalization: the reinvention of spine companies’ supply chains and controlling the inventory-to-revenue ratio

In 2020, spine companies, like most MedTechs, absorbed shocks of the COVID-19 crisis by digitizing aspects of their supply chains, which consists of a wide range of transactions and constitute a significant part of a company’s’ total value creation. Industry observers are asking: Will enterprises extend their digitalization strategies and emerge stronger after the impact of the pandemic, or will they reduce their digital activities and emerge weaker?

Market changes

Even before the COVID-19 pandemic, the days of business-as-usual for spine companies were numbered as technologies advanced, regulations became more stringent, populations aged, healthcare systems struggled with unsustainable costs of surgeries for common age-related degenerative disc disorders, and payors tightened their reimbursement policies. In the US, which is the biggest market for spinal implants and devices, an increasing percentage of people have become covered by Medicare and Medicaid [state and federal government healthcare programmes], which reimburse providers at a fraction of private healthcare insurance levels. These changes encouraged independent hospitals in the US to join purchasing syndicates, clinicians to give up private practice and become salaried employees of hospitals, and private payors to shift away from a fee-for-service provision towards a value-based reimbursement approach focussed on improving patient outcomes and lowering costs. This shift encouraged policies to keep patients out of hospitals and increased the utilization of outpatient settings and other measures expected to improve outcomes and generate shared savings.

The structural headwinds described here have not abated and are likely to intensify over the next five years. To prosper in this evolving ecosystem, companies will need to devise and enhance solutions that bring enhanced clinical benefits to patients and economic rewards to the system. Tried and tested and widely used digital strategies can help to improve supply chains. However, while these structural changes have been progressing, spine market supply chains have tended to remain linear and labour-intensive and are now becoming significant obstacles to change, while producing infrastructures with unsustainable costs.

In the Commentary

This Commentary suggests that, over the next five years, market forces will oblige spine companies to pivot away from their inefficient supply chains and start developing supply networks, predicated upon digital strategies that add value to patients and reduce costs. Such systems, employ common digital applications that are used extensively in other industries to ensure the right products and services are delivered to the right place, at the right time, at the lowest cost. This would constitute a “first step” in a bigger digital transformation of the spine market, which will be necessary to create new levels of productivity, growth, and sustainability. We suggest that the reluctance of some MedTech’s to transition from inefficient supply chains to efficient ones could be explained by a significant proportion of their C suite members not acquiring a familiarity with digital systems until much later in their careers when they were adults. The Commentary uses two concepts: ‘digitization’ and ‘digitalization’. The former is a process to convert various physical signals into digital formats and the latter leverages digitized information to improve business processes.

Digitizing supply chains

Over the past two decades the cost of digital technologies has plummeted while their power and capabilities have substantially increased. This has enabled business leaders to combine technologies associated with information and operations and empowered them to create value in new and different ways. Improved processing capabilities now augment human thinking to analyse more data more quickly, and then act upon the outcomes. Such changes have ushered in the new digital era for MedTech’s.

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However, the spine market has been slow, compared to other industries, to adopt digital supply networks. The process of developing such strategies to drive productivity, while absorbing the shock of a pandemic has not been easy as it meant installing new technologies under pressure. However, the COVID-19 crisis created an incentive to reconfigure operations. The companies that did this have an opportunity to develop an omnichannel [multichannel approach to sales and marketing] dedicated to enhancing engagements with healthcare professionals and improving the overall quality of care, patient outcomes, revenues, productivity, employee satisfaction, and talent attraction and retention. But this will mean companies establishing virtual options as a core competence and reinventing the way they engage with stakeholders to provide a seamless experience across digital, remote, and in-person channels.

Neo Medical and value-based spine care

A firm that has employed digital strategies to streamline part of its supply chain to enhance value and gain a competitive edge is Neo Medical, a privately held Swiss company founded in 2013 by two former Stryker employees. The company has developed a universal value-based surgical spine platform to provide patients with high quality outcomes at relatively low costs. Neo’s approach is predicated upon its ability to reduce an instrument set, comprised of >200 screw sizes to 14, and use it in a novel approach to thoracolumbar fusion. [The thoracolumbar spine is the area between your stiff thoracic cage and your mobile lumbar spine].

Neo refers to its solution as a ‘controlled fixation’, which is beginning to have an impact in markets across the EU-27, Asia-Pacific (APAC) and more recently, the US. The approach is designed to facilitate an anatomically neutral, balanced, and stable spine load bearing to achieve a more functional fusion. It is reported that the platform: (i) enables clinicians to limit stress overload on a patient’s spine and thereby reduces the risk of screws loosening and hardware failing, (ii) limits infections, (iii) removes the need for re-sterilization, (iv) declutters the operating room, (v) reduces revision rates and (vi) cuts costs.Equally important are Neo’s digital strategies to provide an easier and more efficient experience for patients, surgeons, and hospitals.

Findings of a study, published in the December 2020 edition of Interdisciplinary Neurosurgery, suggest that Neo Medical’s value proposition saves costs by: (i) reducing supply chain processing and logistical expenses, (ii) decreasing rates of contaminated instruments, (iii) minimizing operating room delays and (iv) potentially lowering revision and infection rates.

Reconfiguring the supply chain

By contrast, traditional industry supply chains tend to be linear, labour intensive and siloed. As suggested by Neo Medical and others, digitalization can transform these inefficient systems into dynamic, interconnected efficient networks with the capacity to accommodate a range of stakeholders simultaneously. The shift from linear, sequential structures to interconnected, open supply operations could provide a foundation for how spine companies compete in the future.

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Companies in other sectors have already made such transformations and integrated their supply networks into their operations and decision-making processes with the objective of gaining competitive advantages. However, business leaders should be mindful that the more customer focussed enterprises become, the more developed their data and analytical capabilities must be.

Currently, few MedTech’s integrate their supply chains into their long-term strategies, and few actively and fully embrace the potential of data management techniques. This reluctance decreases a company’s ability to optimize inventories and enhance operational efficiencies of product offerings moving across supply chains. Given the increasing number of exogenous forces affecting the spine market, [e.g., ageing populations, vast and escalating healthcare costs, more stringent reimbursement policies, pricing pressures, tightening regulations, increasing competition, advancing technologies and heightened customer expectations], it seems reasonable to suggest that investing in and developing digital supply networks could be a logical step to enhance value agendas.

Appropriate digitalization of supply chain planning and processing could help to: (i) reduce operational siloes, (ii) respond effectively to market disruptions, (iii) minimize the time, costs and risks associated with onboarding and collaborating with suppliers, (iv) deliver products and services that customers need, when they need them, where they need them at the lowest cost and (v) enable end-to-end supply chain visibility and transparency to facilitate gathering and analysing real-time intelligence to enhance efficiencies.

C suites and digital immigrants

Given that there are significant advantages in adopting digital technologies, why is the spine market lagging other industries in adopting such strategies to improve its supply chains to enhance its productivity and sustainability? A preponderance of digital immigrants among C suites could help to explain why some MedTech’s fail to grasp the full potential of digitalization strategies. Let us explain.

According to research undertaken by Korn Ferry, a consulting firm, the average age of a C suite executive of the top 1,000 US organizations is ~57. Statista confirms this and reports that in 2018, the average age of CEOs in US at the time they were hired stood at 54 years, while the average age of CFOs when they were hired was 50. Since 2005 the average age for CEOs and CFOs has been trending upwards. To the extent that these data are indicative of MedTech’s, it seems reasonable to suggest that their C suite members: (i) would have completed their formative schooling before the digital era, and (ii) when they started their professional careers the digital age was just beginning. For example, in 1989 only 15% of US households owned a personal computer, <1% of the world's technologically stored information was in a digital format, and the World Wide Web did not become publicly available until 1991. In 1990, when the average C suite member would have been ~31, there were only ~12.5m cell phone subscribers worldwide; ~0.25% of the world’s population, and Internet users only amounted to ~2.5m; 0.05% of the world’s population. In 2002, when the average US C suite executive would have: (i) been ~37, (ii) completed their professional training and (iii) well into their careers, digital technologies were still relatively underdeveloped. For example, cell phone subscribers were only ~1.5bn; 19% of the world’s population, and Internet users were only ~631m; 11% of the world’s population.

This suggests that during C suite executive’s formative education and professional training, digital technologies were embryonic, and the Internet, mobile devices, social networking, big data, and computing clouds, had not yet transformed work practices and healthcare. Thus, a significant proportion of current executives of US MedTech’s could be digital Immigrants: people whose professional careers were influenced by analogue technologies, paper, and television, and they only acquired a familiarity with digital systems later in their careers when they were adults. This could affect their ability to appreciate the full potential of digital technologies and help to explain the relative reluctance of MedTech’s to digitize labour intensive, inefficient, linear supply chains.

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Stringent regulation and digitization

This reluctance becomes more significant as regulators demand that MedTech’s employ more sophisticated digital strategies. Increasingly, people are being given spinal implants and devices, which cannot be subsequently removed. Patients rely on these to be safe and to perform as intended for their lifetime, and regulators are devising more stringent rules to ensure that this is the case. For example, the European Medical Device Regulation (MDR), which entered into force in May 2017, requires all medical devices sold in the EU-27 and Switzerland to be MDR approved. The EU-27 represents ~33% of the spine market’s global revenues. MDR governs the production and distribution of medical devices and their compliance. The regulation states that, “Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording, and analysing data on safety and performance”. MDR expects all MedTech’s to have robust supply chains and the ability to conduct data-driven audits to trace manufacturing modifications to specific implants and devices and to prove the resolution of any problem that might arise. While tightening regulations increase approval costs and prolongs product development time, they also provide incentives for companies to enhance their digital supply networks.

Controlling the inventory-to-revenue ratio

A digital supply network can enhance an organization’s ability to manufacture products in optimum volumes and deliver them to the right customers at the right time. This could help to improve patient outcomes and lower costs. Also, digitalization assists enterprises to enhance the control of their inventory by improving planning, forecasting and management, which is critical given their relatively high inventory-to-revenue ratios.

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Spine surgeons in hospitals need to have relevant implants and devices available in the operating room at the right time. Hospitals need to be able to locate products in their cabinets. Without appropriate digitalization strategies health professionals would need to spend time searching for devices that may or may not be used during an operation. This means increased costs, as high value surgical trays would flow through inefficient supply chains.

To reduce costs, hospitals and healthcare systems push the responsibility for inventory management onto their suppliers. This results in a range of different models, which tends to increase the risks to manufacturers. Currently, spine companies manage a range of different types of inventories, with a significant proportion of their product offerings being held either on consignment or by sales reps, who often spend time managing offerings on behalf of their customers. This increases the difficulty to accurately account for supply levels, location, ownership, and usage, which further complicates billing and replenishment and often leads to excess inventory and unnecessary costs.

A digital supply network can help to reduce these inefficiencies by eliminating waste and saving costs for all stakeholders. Typically, spine surgical sets contain several types of devices, plates, and screws, and usually are sold on consignment. Hospitals return these for re-provisioning often after only having used some of the items in the trays. To guarantee that sales-reps and hospitals have sufficient supplies, manufacturers maintain relatively large, consigned inventories, at significant costs, which impact on the rate of excess and obsolete inventories.

A digital supply network effectively connects manufactures with their sales-reps and hospitals to reduce inefficiencies. Surgical trays are tagged with radio-frequency identification (RFID), so they can be effortlessly tracked by hospitals’ smart cabinets and by all other stakeholders. This allows: (i) hospitals to be billed as soon as a surgical tray, or a part of it, is removed, and the replenishment process started, and (ii) suppliers to reduce their consigned inventory, reduce their excess and obsolete inventory, and reduce their costs.

Ethical issues

We have broached some of the functional benefits and challenges of digitizing supply chains. Before closing, let us briefly draw attention to some ethical issues associated with digitization, which include increasing the challenges associated with data privacy, cybercrime, and the need to keep pace with new and rapidly developing technologies. This gives weight to environmental, social and governance (ESG) agendas, which are positioned to play an increasingly prominent role over the next five years and shall be discussed in a future Commentary.

Takeaways

We have made some suggestions about how common digitalization strategies could improve spine market supply chains and create added value for patients while delivering the highest sustainable returns for manufactures. We have also suggested reasons for the reluctance of some companies to employ digital strategies to transition from linear labour-intensive supply chains to supply networks. In response to the COVID-19 crisis, many organizations partially digitized their supply chains to sustain trading during what became a “new normal” of remote engagements. This suggested that digital enhancements could help spine companies improve their way of working, expand access to services, and deliver more valuable patient-clinician experiences. Dynamics within sectors usually change after a crisis. For example, following the 2008 economic crash, strong companies emerged stronger while weak companies emerged weaker. A defining difference between the strong and the weak was resilience: the ability not only to absorb shocks, but to use them to transform supply chains and enhance competitive advantage. Will spine companies emerge from the COVID-19 crisis stronger and extend their digitized supply networks or will they revert to their costly and inefficient labour-intensive linear supply chains? Keep an eye on the inventory-to-revenue ratio.

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Will a rear mirror mindset slow the adoption of technologies poised to influence the spine market?

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Internet of Medical Things

orthobiologics

Artificial discs, 3D printing, orthobiologics, and the Internet of Medical Things (IoMT) are technologies positioned to increase their impact on the spine market
The speed of their adoption should not be overestimated given the nature and structure of the industry
The challenge for spine companies is not too few employees who understand the traditional spine market but too many

-Low back pain and the global spine industry-

Will a rear mirror mindset slow the adoption of technologies poised to influence the spine market?

This Commentary describes four evolving medical technologies: motion preserving spinal techniques, 3D printing, orthobiologics, and the Internet of Medical Things (IoMT). All are poised to contribute to improving the therapeutic pathways of people with low back pain (LBP) and age-related spine disorders, which cause significant disability and are common reasons for people to visit primary care doctors and A&E departments. At what speed will these technologies be adopted by the spine market?

An optimistic view suggests that by 2025, all four technologies will be commonly used in spine care. More people will be focussed on aging well, they will be better informed about their health and taking proactive rather than reactive approaches to common spine disorders and treatments. Developed nations and some emerging economies will have extended their public healthcare systems and larger percentages of their populations will have access to quality spine care. Digital inclusion will have spread, and the acceptance of scientific and technological advances will have accelerated. The spine market will have increased its use of AI, behavioural sciences, genomics, and screening and healthcare risks will have been substantially reduced. Spine companies would have shifted from being predominantly manufacturers of hardware to more solutions orientated patient-centric enterprises focused on maintaining the health and wellbeing of an ageing population in an healthcare ecosystem designed around people rather than places.

A less optimistic view is that by 2025, the spinal implant and devices market will continue to be conflicted between increasing patient demands and the level of evidence for various spine care options. This will perpetuate the current system, which leaves clinicians obligated to provide treatments based on insufficient information. Entering this environment will be an increasing supply of spine surgeons trained to deliver interventional care, and economic incentives for them to perform surgical procedures with increasing frequency. Due to decreasing fertility rates and increasing life expectancy, there will be >0.8bn people ≥65 years: ~11% of the global population, (~19% and ~21% respectively of the populations of the US and Europe). The result will be a spine care ecosystem that: (i) continues to emphasize the performance of narrowly focused and insufficiently studied procedures to address what are complex biopsychosocial pain problems and (ii) eschews technologies outside a relatively narrow surgical bandwidth. This will support a business-as-usual mindset among spine companies, and in turn, slow the adoption rates of technologies described in this Commentary.

Motion preserving spinal techniques

Spinal fusion, which permanently connects two or more vertebrae in your spine and eliminates motion between them, is one of the most performed spinal procedures indicated for a wide range of spinal conditions. Given that people are ageing and living longer after spinal surgery, there is the beginnings of a movement away from the gold standard spinal fusion-based solutions towards motion preserving surgery. This aims to maintain normal, or near normal, motion to prevent adverse outcomes commonly seen with conventional spinal fusion, most notably the development of adjacent-level degenerative disc disorders.

Several different surgical approaches have been developed to preserve motion in the lumbar spine, including total disc replacement (spinal arthroplasty), partial disc (nucleus) replacement, interspinous spacers, dynamic stabilization devices, and total facet replacement devices. The design of artificial (manufactured) discs varies, but all aim to stabilize the spine and eliminate pain while conserving natural motion of the functional spinal unit, which is essential for mobility, walking, reaching, and having the stamina to participate in activities for periods of time.

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Motion preserving technologies were introduced ~2 decades ago. In 2004, DePuy’s Charité Artificial Disc received FDA approval for the treatment of LBP due to a damaged or worn out lumbar intervertebral disc. Since then, more than a decade passed before AESCULAP’s activL^® Artificial Disc received FDA approval in 2015. Findings of a 2016 clinical study suggest that, “the activL^® Artificial Disc results in improved mechanical and clinical outcomes versus an earlier-generation of artificial discs and compares favorably to lumbar fusion”. In 2019, RTI Surgical, an implant company, acquired Paradigm Spine, a privately held company, for US$300m. Paradigm manufactures Coflex, an FDA approved spine motion preserving solution.

Some artificial discs adapt traditional titanium implants with specialized coatings and advanced surfacing to allow for a smoother press-fit fixation and future bone ingrowth, which is expected to keep the new discs more securely located. Despite growing enthusiasm for motion preserving spinal techniques, their utilization rates have remained relatively low. This may be attributable to size constraints of available total disc replacements (TDR), stringent regulatory indications for their use, difficult instrumentation, mixed clinical outcomes, and reimbursement challenges. Despite these headwinds, the artificial disc market surpassed US$1.6bn in 2019, and its compound annual growth rate (CAGR) is expected to be >18% for the next five years. The US represents >50% share of this market.

The wider adoption and growth of motion preserving techniques for the treatment of low back pain (LBP) and degenerative disc disorders will depend on the long-term outcomes assessed by controlled randomized clinical studies of spinal arthroplasties. As studies demonstrating the efficacy for TDRs increase and the procedures become more established, incidence rates of traditional spinal fusions are likely to slow.

3D printing

3D printing, also known as “additive manufacturing”, facilitates the conversion of computer-added anatomical images into physical components using special printers, which add successive layers of material. The technology is believed to be particularly suited to the complex anatomy and the delicate nature of spine surgery and is used for spinal implants, pre-operative surgical planning, intra-operative guidance, customised and off-the-shelf devices as well as patient–clinician communications, and medical education. Reports suggest that 3D printing enhances procedural accuracy, decreases surgical time and improves patient outcomes.

Over the past decade, 3D printed spinal implants have developed and grown as access to the technology improved. Today, 3D printed spinal implants are being created from materials such as porous titanium, which has the benefit of being strong and durable as well as achieving faster bone growth and osseointegration than conventional PEEK (polyetheretherketone) implants. Increasingly, 3D printing is being used in the pre-operative planning stage for spine surgery by providing a full-scale, stereoscopic understanding of the pathology, which allows for more detailed planning and simulation of a procedure. It is also used to create intra-operative guides for placing pedicle screws using patient-specific data, which lowers risks. [Pedicle screws are fixations routinely used in spinal surgery to stabilize vertebrae. The placing of the screws is dependent on the experience of the surgeon and can result in a breach of the pedicle and cause complications and injury].

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Another advantage of 3D printing for spinal surgery is its ability to manufacture customised, patient-specific devices for difficult to treat cases. With traditional off-the-shelf implants, patients run an increased risk of a suboptimal fit into the reconstructive site. Although research on 3D patient specific implants is limited, they are expected to have enhanced durability due to a more even load distribution and superior osseointegration. The cases of 3D printed customised implants performed to-date have been limited to anatomically challenging pathologies where an individualized solution to restore patient-specific anatomy is a key prognostic factor.

3D printing is also used to manufacture off-the-shelf implants. Spine companies, such as 4Web Medical, and Stryker, are beginning to extend their use of 3D printing techniques to optimise the properties of implants, including the ability to mimic the interconnected structure of cancellous bone [a meshwork of spongy tissue of mature adult bone typically found at the core of vertebral bones in the spine]. In the future, it is expected that 3D printing techniques will be used to incorporate more innovative features into spinal implants, such as porous matrices where density, pore diameter and mechanical properties can differ in different regions of the implant.

As 3D printing evolves and becomes cheaper, faster, and more accurate, its use in spine surgery is likely to become routine in a range of procedures. The production of 3D orthopaedic and medical implants is estimated to grow at a CAGR of 29% between now and 2026, of which spinal fusion devices are expected to be one of the fastest-growing segments. Stryker, which has novel spinal implants comprised of highly porous titanium, has invested €200m (~US$226m) in its Instrument Innovation Centre and the Amagine Institute, in Cork, Ireland, which are focussed on the development of 3D printed spine products.

However, currently, there are only a handful of vendors that design and manufacture medical grade 3D printers. Spine companies are constrained by the limited availability of such machines and typically are not privy to certain proprietary aspects of the manufacturing process. In addition, 3D printing is more costly and time consuming than conventional manufacturing processes. The FDA has issued guidance for “patient specific” 3D implants, but as of July 2021, it has not issued a standardized framework for 3D spinal implants to be approved. This regulatory challenge can make surgeons and hospitals hesitant to use the technology. A study of 3D printed surgical implants published in the July 2019 edition of The Lancet suggests that, “Comprehensive and efficient interactions between medical engineers and physicians are essential to establish well designed frameworks to navigate the logistical and regulatory aspects of 3D printing to ensure the safety and legal validity of patient-specific treatments”. As the body of research continues to grow, larger scale studies and longer-term follow ups will enhance our knowledge of the effect 3D printing has in spinal surgery.

Orthobiologics

Compared to the introduction of innovative spine surgical techniques such as computer assisted navigation (CAN), minimally invasive spine surgery (MISS) and surgical robotic systems, the cadence for new spinal implant materials has been relatively slow to impact the market: titanium and cobalt chromium remain common choices for spinal implants.

One reason for this is because the biology of spinal fusion is a complex process that mimics bone healing after a fracture. Techniques used to enhance spinal fusion include stabilization with metallic or polymeric implants, grafting with bone products and more recently augmenting grafts with a variety of biologic agents. With autologous [patient’s own tissue], and allogenic [donor tissue] bone grafts, tissue is often manipulated to remove mineral content and/or maintain a cell population to enhance fusion.

Although autologous bone grafts remain the gold standard, concerns about their failure to achieve fusion has prompted the evaluation of an increasing range of new biologic materials. These new materials are synthetic, and are generally composed of ceramic or bioactive glass. Recombinant growth factors [proteins derived from a combination of materials that stimulate cell growth], most commonly bone morphogenic protein 2, are sometimes added because they are potent stimulators of bone formation. However, morphogenic protein 2 can be associated with enhanced risks.

A growing number of mid-size and smaller biotech companies engage in the production of orthobiologics. Thus, there is a growing number of new biologic agents specifically developed for spinal implants coming onto the market. These tend to be more durable and bio-friendly than traditional implants and have the potential to improve recovery times for patients and minimize soft tissue disruption.

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Two examples of new biologic materials used in spine surgery for improving bone growth and fighting infection are Xiphos™-ZFUZE™, and molybdenum rhenium (MoRe).

The former is a new interbody fusion system designed to provide an alternative to the more commonly used titanium and PEEK spinal implants. It’s developed by Difusion Technologies, a biotech company based in Austin, Texas, and received a 510(K) FDA clearance in November 2019. Xiphos™ is the first spinal implant created from ZFUZE™; which is a new biomaterial specifically engineered to interact with the human immune system so that it does not attack the spinal implant as a foreign body. Such foreign body responses can lead to long-term chronic inflammation and a significant number of patient complications. Studies suggest that ZFUZE™ is superior to nano-surfaced titanium and conventional PEEK materials.

The latter, MoRe, is a new biomaterial for spine surgery, which received FDA approval in 2019, and is produced by MiRus Bio, a US biotech company founded in 2016. MoRe is compatible with MRI and CT scans, and is also corrosion resistant. The material is reported to be two to three times stronger, and more fatigue resistant, than either titanium or cobalt chromium. This is significant for the spine market where rods used in surgical constructs can break. It is also reported that MoRe is >2X more hydrophilic [a strong affinity to water and mixes well] than titanium. Spinal implants that contain MoRe have double the osseointegrative characteristics of 3D printed titanium spinal implants. MiRus has ~14, 510(K) clearances from the FDA and >150 patents in its portfolio and is well positioned to address increasing unmet needs in this segment of the spinal implant market.

With an increasing array of biologic interbody graft materials available for use in spine surgery, maintaining a comprehensive understanding of their characteristics, benefits and drawbacks is becoming increasingly important. As these new materials enter the market, traditional titanium or cobalt chromium implants are likely to be surpassed, and as they become more diverse and more widely used, their characteristics, cost effectiveness and efficacy in specific patient populations will need to be better understood and communicated to assist hospitals and surgeons to select materials that are optimal for their patients.

Despite the desirability of such a register, it is unlikely that it will materialise in the medium term given security issues, the large and escalating number of producers, patients, hospitals, and surgeons, which are dispersed and have little or no incentive to provide implant information to a central register. Further, independent studies on orthobiologics tend to be relatively weak and patchy. Thus, it seems reasonable to suggest that, in the near to medium term, purchasing parties will continue to be influenced by producers’ marketing endeavours.

Internet of Medical Things

Most spine companies are manufacturers, which are focussed on hospitals, surgeons, and operating rooms. However, hospitals, looking to reduce their expenditures on implants and devices, have formed purchasing syndicates, concentrated purchasing to a narrow range of trusted offerings and changed their reimbursement policies.

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Low back pain, spine surgery and market shifts

Vast and escalating healthcare costs, ageing populations, advancing medical science and technologies, more stringent reimbursement policies, and stricter regulations conspire to nudge conventional spine companies to shift away from their traditional production processes and move towards solutions-based, patient-centric endeavours. The Internet of Medical Things (IoMT) can help to facilitate this. Some spine companies have reinvented themselves to become more solutions-orientated and patient-centric. However, for such new business models to be sustainable, companies will need to make data management a core, rather than a peripheral, capability.

A typical treatment journey for a patient with LBP and degenerative disc disorders includes: the presentation of symptoms, diagnostic tests, treatments, monitoring and rehabilitation. This usually involves interacting with several healthcare functions and a range of equipment and devices, including MRI and CT scanners, blood pressure and heart monitors, surgical instruments, implants, and software applications as well as a range of healthcare professionals, systems, and services. Advances in wireless technology, the miniaturization of medical electronics, and the increased power of computing create opportunities for the IoMT to connect all these disaggregated entities and retrieve from them a range of relevant clinical and scientific data, which can be used to improve a patient’s therapeutic pathway.

The IoMT is an amalgamation of sensors, software, data management, and networking technologies and is driven by: (i) the general availability of affordable broadband Internet, (ii) almost ubiquitous smartphone penetration, (iii) increases in computer processing power, (iv) enhanced networking capabilities, (v) miniaturization, especially of computer chips and cameras, (vi) the digitization of data, (vii) growth of big data, Cloud-based repositories, and (viii) advances in AI, machine learning (ML), and data mining. This provides the potential for common spinal implants and devices to become ‘intelligent’ by having the added capability to retrieve, analyse and communicate clinical and scientific information. The IoMT can assist spine companies to streamline their clinical operations and workflow management, enhance patient outcomes, lower costs and transform their role and relationship within the evolving value-based healthcare ecosystem.

Indicative of this is Canary Medical, a privately held Canadian company founded in 2013, which uses IoMT to enable remote monitoring of patients’ implants. Starting with artificial knees, Canary’s technologies provide real-time feedback on how surgical implants and devices are working by generating self-reports on patient activity, recovery, and treatment failures, without the need for physician intervention and dependence upon patient compliance. Canary applies machine learning algorithms to the data it collects to identify patterns that could help clincians catch problems, such as infections or loosening of the joints before they worsen.

The COVID-19 crisis forced physicians to use more remote services. It seems reasonable to assume that over the next five years this will increase, remote monitoring will become the norm, and the value of data generated by spinal implants and devices will be significantly enhanced. The growing importance of data, which are derived from implants and medical devices, is evidenced by the fact that the FDA has embraced AI and has several ongoing projects designed to develop and update regulatory frameworks specific to it. A research paper published in the January 2021 edition of The Lancet Digital Health demonstrates the increasing significance of data and algorithms for MedTech’s. In 2015, the FDA approved nine AI-machine learning (ML) based medical devices and algorithms. The number increased to 12 in 2016, 32 in 2017, 67 in 2018, and a further 77 in 2019. In Q1,2020, 24 AI/ML-based medical devices were approved by the FDA.

Canary is unusual as the spine industry generally has been relatively slow to embrace the IoMT. This partly could be associated with security and privacy issues. However, according to a July 2018 report from Deloitte, a consulting firm, there are, “more than 500,000 medical technologies currently available, which all share a common purpose: having a beneficial impact on people’s health and quality of life” and all are currently accessible to collect, analyse and transmit healthcare data. The increasing significance of data also is stressed in another research report by Deloitte on the European MedTech industry. Findings suggest that AI technologies, which, “can be used across the entire patient journey”, save European healthcare systems “~€200bn (~US$238bn) each year” and “have the potential to assist European health systems in responding to major challenges they face”.

A February 2020 Fortune Insights Report, valued the global IoMT market at ~US$19bn, and projected it to reach ~US$142bn by 2026, exhibiting a CAGR of ~29%. Given the growing significance of the IoMT to the spine market, in the medium term, data could become more valuable than actual spinal implants and devices. Spine companies need to consider developing new business models to take advantage of this and develop a deeper understanding of the needs of patients and demonstrate how their offerings improve patients’ therapeutic journeys.

Takeaways

Because the risks associated with spine surgery are non-trivial and reducing complications is critical, over the next decade we are likely to see the introduction and adoption of technologies, which have the potential to improve precision, enhance patient outcomes and reduce costs. These, together with technologies described in previous Commentaries, provide companies with an opportunity to influence how the spine market will play out over the next decade. However, the speed that the technologies described in this Commentary will be adopted by the spine market should not be overestimated given the deep-rooted interests and established practices of the industry. To take advantage of these developing technologies spine companies will need to stay ahead of consumer-focussed tech-savvy companies, like Canary, which are entering the market and: (i) increase their digital expertise, (ii) improve their patient-centric interactions, (iii) enhance their data management capabilities, and (iv) extend their digital infrastructures. Over the next 5 years, a challenge for spine companies will not be a lack of executives who understand traditional spine markets, but an excess of them. Executives who know the traditional spinal implant and devices industry well, are likely to keep looking in their rear-view mirrors and assuming that what made money in the past will make money in the future.

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Minimally invasive spine surgery and computer assisted navigation systems

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MISS

Over the past 2 decades minimally invasive surgery and computer assisted navigation (CAN) systems have significantly changed spine surgery
Minimally invasive spine surgery (MISS) has become a significant subspeciality accounting for ~50% of all spine surgeries undertaken in the US
Together MISS and CAN systems promise enhanced precision, improved outcomes, and lower costs
CAN systems provide surgeons with improved visibility of the operating site, but emit hazardous radiation that can cause cancer
Spine surgery appears to be winning the challenge to increase the development of minimally invasive surgery while decreasing harmful radiation in the operating room
MISS is positioned to grow and increase its market share but faces some headwinds

- Low back pain and the global spine industry -

Minimally invasive spine surgery and computer assisted navigation systems

Minimally invasive spine surgery (MISS) requires only a small incision and uses specialized instruments and techniques that minimize cutting and results in minimal damage of body tissue. The technique serves the increasing prevalence of degenerative spinal disorders, attributed to sedentary lifestyles of aging populations, which have helped to drive the growth of a global spinal implants and devices market. In addition to the increased availability of biologics and customizable implants and the refinement of operative techniques, the development of MISS has been supported by advances in imaging and navigation technologies that make surgical targets virtual on a monitor to improve the accuracy and precision of surgical interventions. Today, there is a growing body of research demonstrating MISS’s advantages over the traditional open approach. However, computer assisted navigation (CAN) systems tend to emit harmful ionizing radiation that can cause cancer. Reducing radiation in the OR while improving the quality of image guidance is expected to fuel further growth of MISS.

In this Commentary

This Commentary focuses on minimally invasive spine surgery and computer assisted navigation systems. Two technologies, which have changed the landscape of modern spine surgery and offer potential benefits for both patients and surgeons. Has MISS reached its market saturation? If not, what will affect the speed and extent of its further adoption?

Minimally invasive and open spine surgery

Over the past 2 decades, MISS has become a significant subspeciality and currently accounts for ~50% of all spine surgeries undertaken in the US. It is positioned to increase its influence over the next decade but faces some headwinds.

As a general principle, it is preferable to intrude as little as possible when carrying out a surgical procedure to minimise damage to surrounding tissue and to speed up recovery time. Many spine procedures that once required invasive operations (open surgery) have been replaced with MISS techniques.

Open spine surgery typically involves relatively long incisions down the back to give the surgeon the best view of, and access to, the anatomy. During such procedures, it is sometimes necessary to cut through and move aside muscles and tendons to reach the affected area, which can cause damage to these tissues and prolong recovery.

In MISS the surgeon makes a small incision and then inserts a device called a tubular retractor, a stiff, tube-shaped tool that creates a tunnel to the problem area of the spine by gently pushing aside the muscle and soft tissue around the affected area. The surgeon can then put small tools through the tunnel to work on the spine and use a special microscope to view real-time X-ray images of the spine. This approach results in less damage to the muscles and soft tissues that surround the spine, which leads to a more expedited recovery.

MISS has gained popularity both with patients and clinicians and has become increasingly feasible for the management of a range of spinal disorders. Progress has been made in the development of a direct lateral approach [from the side] as well as improvements of tubular retractors. Common spine surgery treatments available through minimally invasive methods include degenerative disc disorders, herniated discs, lumbar spinal stenosis, spinal deformities such as scoliosis, spinal infections, spinal instability including spondylolisthesis, vertebral compression fractures, and spinal tumours. In 2020, MISS procedures accounted for ~50% of all spine surgeries performed in the US, which had increased from ~16% in 2012.

According to David Bell, a consultant neurosurgeon at King’s College Hospital, London, who specialises in complex spine surgery, MISS significantly improves the patient experience by, “reducing the size of the incision and the amount of tissue manipulation . . . It also minimises post-operative discomfort, cuts infection rates, lessens blood loss and reduces a patient’s recuperation time”. See video below.

The evidence

There is a growing body of research to support the benefits of MISS, which include: (i) reduced trauma to muscles and soft tissue, (ii) better cosmetic results from smaller incisions, (iii) less blood loss, (iv) reduced risk of infection, (v) faster recovery time and less rehabilitation, (vi) diminished reliance on pain medications, and (vii) reduced hospital stays. A further perceived benefit is the increasing range of MISS undertaken in outpatient settings. Such benefits are likely to fuel the refinement of surgical techniques based on patient outcomes, and lead to the growth of MISS.

However, not all studies are so positive about the benefits of MISS. A 2017 review of 17 randomized controlled trials, which compared MISS against open procedures for three common disorders, concluded that, “the evidence do not support MISS over open surgery for cervical or lumbar disc herniation”. The study suggests that there were some advantages for transforaminal lumbar interbody fusion (TLIF), [a procedure that melds the front and back sections of the spine through a posterior approach], but “at the cost of higher revision rates, higher readmission rates and more than twice the amount of intraoperative fluoroscopy”. [an imaging technique employed to improve intraoperative visualization of the operating field, which emits hazardous radiation]. The study concludes that, “Regardless of patient indication, MISS exposes the surgeon to significantly more radiation”.

Two papers published in the January 2020 edition of the Journal of Spine Surgery report on a global survey of 430 surgeons to assess the extent of MISS and the training surgeons receive. The response rate was significant at 67%. 33% of respondents were neurosurgeons, 55% orthopaedic surgeons and 12% were surgeons with other postgraduate training. One research paper concludes that, “endoscopic spinal surgery is now the most commonly performed MISS technique”, and the other suggests that, “very few MISS surgeons are fellowship trained but attend workshops and various meetings suggesting that many of them are self-thought. Orthopaedic surgeons were more likely to implement endoscopic spinal surgery into the routine clinical practice”.

A review of the state of MISS reported in the June 2019 edition of the Journal of Spine Surgery confirms MISS as a significant subspeciality, “evidenced by the large and constantly growing body of literature on this topic”, and driven by “significant advancements in imaging and navigation technologies, refinement of operative techniques, availability of biologics and customizable implants, and most importantly, evidence of feasibility, efficacy, safety and value, compared to traditional approaches as demonstrated by the current literature”.

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Unmistakably, over the past two decades, MISS has become increasingly feasible, efficient, and popular. An important question is, how fast is MISS advancing? There is a paucity of research, which addresses this question. However, a global survey of spine surgeons published in the January 2020 edition of the Journal of Spine Surgery provides some insights. Findings suggest there are regional variations in the acceptance and utilization of MISS. The study surveyed 586 spine surgeons in 5 major regions of the world, which yielded 292 usuable responses: a significant response rate of ~50%. 70% of spine surgeons in Asia and South America thought MISS was accepted into mainstream spinal surgery in their practice areas compared to 63% of spine surgeons in North America, 53% in Europe and 50% in Africa & the Middle East. The percentage of spine surgeons that reported using MISS was higher: Asia (97%), Europe and South America (89%), and Africa & the Middle East (88%). Surgeons in North America reported the lowest rate of MISS implementation globally.

Although innovations and techniques in MISS have continued to develop over the past decade, a significant percentage (~50% in the US) of surgeons are understood to use open surgical techniques. Reasons for this include: (i) lack of adequate surgeon training and experience, (ii) the steep learning curve needed for MISS, (iii) inadequate hospital resources and (iv) the patchiness of research on the benefits of MISS. It seems reasonable to suggest that such factors affect the adoption rate of MISS. But perhaps the most significant factor influencing the speed of its adoption will be the rate of development of robotic surgical systems. An understanding of the impact of these factors will help producers hone their strategies and business models.

Computer assisted navigation systems

A common therapy to correct spinal disorders is fusion, which melds together two or more vertebrae so that they heal into a single, solid bone. Spinal fusion surgeries use implants of biocompatible materials, such as titanium, as well as rods, plates, screws, and interbody cages and account for the largest segment of the global spine market.

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During spinal fusion procedures, pedicle screws are used for spinal fixation, stability, and fusion. The incorporation of such screws into spine surgery in the early 1960s was a significant advance because it offered stability and decreased rates of pseudarthrosis [failure of a fractured bone to heal] compared to previous methods. However, subsequent studies suggested that there was a percentage of pedicle screws inaccurately placed, which could harm adjacent structures and potentially have mechanical, neurological, and vascular consequences for patients.

Image guidance systems were a noteworthy development in spine surgery to reduce the morbidity associated with the mispositioning of pedicle screws and today such systems are used widely. Fluoroscopy, an early guidance method, provided real-time X-ray imaging for guiding interventional procedures, which resulted in more accurate placement of screws, but such systems emitted hazardous ionizing radiation that surgeons, patients, and OR staff were subjected to. Any spine surgery that is visualized with fluoroscopy can involve 10 to 12X higher amounts of radiation from the use of X-rays compared to non-surgical procedures. Compared to a hip surgeon, a spine surgeon can experience 50X more harmful emissions over the course of a professional career and this has been linked to the development of cancers. Reducing radiation exposure is an important challenge.

Guided systems and reduced radiation

Newer intraoperative navigation modalities have been found to reduce radiation exposure significantly compared to traditional fluoroscopic guided percutaneous surgical techniques, and have become an important addition in spine surgery. Real-time image guidance, along with continuous computation and scan integration by the navigation system, allows a surgeon to visualize a comprehensive 3D picture of the operating site. Intraoperative computerized tomography (CT) scans [the use of X-rays and a computer to create detailed images of the operating site], together with infrared and other optical guidance technologies have substantially increased the accuracy and precision of spine surgeons to place pedicle screws.

One such enhanced guidance system is ultralow radiation imaging (ULRI) coupled with image enhancement and instrument tracking (IE/IT). This is a new image modifier that allows a computer to show real-time movement of an instrument as it is adjusted, mimicking live fluoroscopy, but without continuous radiation production. Recent research suggests that ULRI-IE/IT systems, “can dramatically reduce radiation output and the number of images acquired and time needed to perform fluoroscopic procedures”.

There are numerous FDA approved advanced CAN systems but let us briefly describe some popular ones. The Airo Mobile Intraoperative CT-based Spinal Navigation system was approved by the FDA in 2013, and developed by Brainlab, a privately held German MedTech company headquartered in Munich. The technology is one of the pioneers of advanced surgical navigation platforms and has many similarities to other CAN systems. It uses a mobile circular scanner attached to the operating table for 360° imaging, and a scanning stereotactic camera, which uses a set of three coordinates for instrument registration. Research published in the July 2018 edition of the Journal of Neurosurgery suggests that the Airo “mobile CT scanner reduced the rate of screw repositioning, which enhanced patient safety and diminished radiation exposure for patients, but it did not improve overall accuracy compared to that of a mobile 3D platform”.

Another popular system is Medtronic’s Stealth Station Spine Surgery Imaging and Surgical Navigation with O-arm, a portable imaging device that fits over the surgical table to take images of the operating field. This uses similar technology to Brainlab’s Airo, but opens at 90° to allow for mobilization around the patient. A third system is produced by Ziehm Imaging, another German company, which specializes in the development and manufacture of mobile C-arms [imaging devices that can be used flexibly in operating rooms]. In 2015, the company received FDA approval for the Ziehm Vision FD Vario 3D with NaviPort Integration. This is an intuitive technology, which obtains images via a 190° rotation with a C-arm around the patient and provides surgeons with, “crystal-clear and distortion-free 3D images for maximum intraoperative visualization of anatomical structures”. However, if its reference clamps are moved after the initial registration process, repeat CT scanning is required to re-register the clamps. Stryker’s SpineMask Tracker and SpineMap Software system overcome this problem by gluing its reference trackers to patients.

With the widespread use of CAN systems in spine surgery there is an increasing number of studies, which demonstrate the advantages of such technologies. For example, two large meta-analyses suggest that CAN systems significantly increase the accuracy of pedicle screw placement compared to freehand placement. Research also suggests that patients who undergo CAN pedicle screw placement have lower complication rates than those who undergo freehand placement.

Notwithstanding, findings of a global survey conducted in 2013 and reported in the September 2019 edition of The Spine Journal suggest that ~78% of surgeons still use two-dimensional fluoroscopy during spine surgery. Despite the improved accuracy and reduced radiation provided by advanced computer-assisted spine navigation systems. This could be associated with costs, prolonged operative times, and their cumbersome nature.

Machine-vision image guided surgery system

7D Surgical, a Toronto based company that develops advanced optical technologies, has sought to overcome challenges inherent in traditional CAN systems by developing a machine-vision image guided surgery platform, [FLASH™]. The technology employs a satellite-based global positioning system (GPS), to create a 3D image of a patient’s anatomy, and uses visible light coupled with machine-vision algorithms that eliminate exposure to intraoperative radiation. Other benefits of 7D’s system include its rapid set up time and its minimal workflow disturbance. The fact that its navigation camera is integrated into the surgical light, eliminates the need to stop surgery and position supplemental surgical equipment, thereby allowing for continuous access to the surgical field. Further, and unique to FLASH™, is the fact that its reference clamp can be repositioned, and images re-registered within ~20 seconds. This facilitates seamless clinical applicability and reverses many of the drawbacks of preceding navigation systems. In May 2021, SeaSpine, a Nasdaq traded spine company, announced the acquisition of 7D in a deal valued at US$110m. In July 2021 SeaSpine received FDA approval of 7D’s advanced guidance system for MISS.

Takeaways

Over the past two decades, MISS has had a significant impact and established itself as a subspeciality throughout the world. Although it is difficult to calculate, it appears that ~50% of spine surgeries could still be open procedures. This suggests that strategic questions facing producers include whether MISS will expand further, and if so, at what speed. This Commentary suggests some factors, which are likely to impede the adoption rate of MISS. However, perhaps the most significant challenge to MISS is not the prevalence of open surgery, but the rapid rise and adoption of robotic surgical systems. Research published in the January 2020 edition of the Journal of the American Medical Association on the trends in the adoption of robotic surgery concludes, “Hospitals that launched robotic surgery programs had a broad and immediate increase in the use of robotic surgery, which was associated with a decrease in traditional laparoscopic minimally invasive surgery”. Robotic surgical systems in spine surgery is the subject of a forthcoming Commentary.

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Can 3D printing and the use of new alloys reduce the high costs of producing and marketing spinal implants?

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