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2 weeks, 6 days ago

The Wearable Reckoning: MedTech Slept Through a Revolution

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  • Wearables are no longer lifestyle accessories. They are becoming core infrastructure for modern healthcare
  • Traditional MedTech was too slow to see that continuous data, not just devices, would create the next strategic battleground
  • The boundary between consumer health and clinical utility is dissolving fast, with major consequences for incumbents
  • Future advantage will come from platforms that support entire therapeutic journeys, not products built for isolated interventions
  • This Commentary explores why MedTech drifted, why wearables matter now, and what traditional players must do

The Wearable Reckoning: MedTech Slept Through a Revolution

Wearables were dismissed as gadgets. That was the strategic mistake. For too long, much of traditional MedTech treated wearables as if they were toys for the anxious well. Interesting, perhaps. Fashionable, certainly. But not serious. Not clinical. Not “real” medicine. That judgement is now colliding with reality.

What many incumbents failed to understand is that wearables were never just about counting steps, logging sleep or nudging consumers to stand up more often. They were the first mass-market infrastructure for continuous physiological observation. While traditional MedTech remained focused on devices designed for single interventions, single departments and single moments of contact, the wearable market evolved into something much more consequential: a persistent, data-generating interface between the human body and the healthcare system.

Wearables are no longer a side market orbiting the edge of medicine. They are becoming one of the foundational layers through which modern healthcare will monitor, interpret and manage patients over time. The global wearable medical devices market is growing rapidly, with multiple analysts placing it on a trajectory >$100B by the end of the decade, driven by ageing populations, chronic disease burdens, remote monitoring, and the wider digitisation of care. Estimates vary, but the direction is unmistakable: this is no side market. It is becoming one of the organising layers of healthcare delivery. 

And yet, with a few exceptions such as Masimo, known for developing patient monitoring devices and software platforms used in hospitals and home settings, traditional MedTechs were slow to act. Many incumbants continued to manufacture and market devices for narrow interventions, while underestimating the strategic significance of longitudinal data, patient-facing platforms, and continuous monitoring. They did not collapse. But they drifted and lost value. The significance of that drift is underlined by Danaher’s February 2026 agreement to acquire Masimo for $9.9 billion: one of the few established MedTech companies to invest meaningfully in platform infrastructure and continuous data has proved valuable not despite that strategic shift, but in part because of it.

The lesson is uncomfortable. The wearable market did not grow because incumbents were wiped out. It grew because incumbents largely kept behaving as if the old categories still held. They assumed the market for wearables was mainly personal, not medical. They assumed consumer technology was adjacent to healthcare rather than increasingly entangled with it. They assumed that because wearables did not match invasive gold standards, they were clinically peripheral. All three assumptions now look increasingly untenable.

The line between personal and medical utility is dissolving. That should alarm traditional MedTech, but it should also clarify what comes next.
 
In this Commentary

This Commentary argues that MedTech underestimated the significance of the wearable revolution, allowing consumer technology companies to reshape how health data are generated, interpreted, and used. It examines why incumbents were slow to respond, what this shift means for clinical practice and industry strategy, and why the consequences now extend far beyond the wrist.
 
The Category Error at the Heart of MedTech’s Delay

Traditional MedTech did not just underestimate a device trend. It misunderstood what the wearable market was producing. A significant share of the sector’s leadership was formed in an era where value resided primarily in the physical device: its engineering, reliability, regulatory approval, installed base and integration into specialist workflows. In that worldview, the medical device was the centre of gravity. Software was an accessory. Data was an output. The clinical encounter was the moment that mattered.

Wearables challenged all of that.

Their significance was never only that they could sit on the wrist, chest or finger. Their significance was that they could sit in time. Traditional devices often generate clinically important snapshots. Wearables generate streams. They capture physiology continuously, or at least repeatedly enough to reveal patterns that snapshots cannot. That difference is not cosmetic. It changes the nature of what can be known, when it can be known, and what can be done with that knowledge. Continuous and longitudinal monitoring enables earlier detection of deterioration, richer context for symptoms, better understanding of recovery, and a more realistic account of how physiology behaves in everyday life rather than only in controlled settings.

This is the strategic point many incumbents missed. The opportunity was not simply to sell a new class of sensor. It was to build a layer of persistent clinical visibility. Once viewed that way, the mistake becomes obvious. Traditional MedTech remained largely organised around interventions. Wearables were building toward journeys.

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From Episodic Medicine to Continuous Medicine

The classic MedTech model is built around episodic contact. A patient appears at a site of care. A device is used. A measurement is taken. An intervention happens. Data are captured within a bounded event. Reimbursement, workflow and commercial logic all follow that structure.

But many of the most important health problems do not behave episodically. Heart failure worsens between visits. Arrhythmias appear intermittently. Respiratory decline may start subtly. Recovery after surgery unfolds unevenly. Cancer treatment produces changes in fatigue, activity, temperature and physiology that do not neatly coincide with appointments. And as populations in advanced, wealthy economies age, the disease burden itself is changing; chronic lifetime conditions and multi-morbidity are becoming more prevalent, while healthcare systems were largely built for a different disease profile and patient cohort. Chronic disease is lived continuously, even if healthcare has historically observed it intermittently.

Wearables matter because they are one of the first scalable infrastructures capable of narrowing that observational gap. They provide the possibility of following patients across time, across setting and, increasingly, across the full therapeutic journey. In practical terms, that means moving from isolated readings to contextualised trends; from reactive discovery to earlier warning; from hospital-only visibility to distributed monitoring.

That is why today’s wearables are increasingly expected to do far more than track heart rate. The market has moved toward continuous ECG, respiratory metrics, heart rate variability, temperature, oxygen saturation, sleep, posture and activity context, while continuous glucose monitoring has become especially important for many people living with diabetes. In some cases, devices also offer inferred measures such as blood pressure, stress, hydration status, or recovery. The important shift is not simply the growing number of metrics. It is the emergence of wearables as multi-physiologic platforms: sensing systems rather than single-purpose trackers.

For MedTech incumbents, this should be a strategic shock. The company that owns the most valuable part of the patient journey may no longer be the company with the strongest device at a single intervention point. It may be the company that can monitor, interpret and support the patient most effectively across time.
 
The Consumer-Health Boundary is Breaking Down

Perhaps the most damaging assumption inside traditional MedTech was the idea that the wearable market belonged to lifestyle rather than medicine. That distinction once appeared neat. Consumer devices were for fitness, wellness and self-optimisation. Medical devices were for diagnosis, treatment and clinical care. But that boundary has been eroding for years, and now it is dissolving fast.

Apple is the obvious case, even if earlier consumer wearables such as Fitbit helped familiarise users with the idea of continuous personal health tracking. The Apple Watch did not begin by trying to resemble a traditional medical device. It entered through habit, design, convenience and ecosystem integration. Yet over time it gained FDA-cleared ECG capabilities and established itself as a serious participant in arrhythmia screening and atrial fibrillation awareness. Its importance is not that it replaced cardiology. It is that it normalised the idea that clinically relevant health monitoring could exist in an everyday consumer device worn by millions.

That changes expectations everywhere else.

Patients begin to wonder why their smartwatch can surface trends their formal care pathway ignores. Clinicians begin to ask which parts of consumer-generated data may be useful for triage, follow-up or escalation. Health systems begin to explore whether lower-cost continuous monitoring can reduce unnecessary admissions or detect deterioration earlier. Payers begin to look for evidence that remote monitoring can lower downstream costs.
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The key point is not that every consumer wearable is clinically robust. Many are not. The point is that the market has changed the cultural expectation of what monitoring can be. Once the public becomes accustomed to passive, continuous, always-on physiological insight, the old model of healthcare waiting for the patient to arrive before observing them starts to look increasingly archaic.
Traditional MedTech underestimated this because it focused too heavily on what wearables were not. They were not invasive. They were not always gold-standard. They were not confined to clinical settings. They were not sold through the familiar institutional channels. But that scepticism obscured what they were becoming: the everyday interface through which health data enters routine life.
 
Accuracy is Not the Whole Argument. Clinical Relevance Is

One reason incumbents were able to dismiss wearables for so long is that many wearable measurements did not match the precision of invasive or hospital-grade reference systems. This criticism was never entirely wrong. Signal quality matters. Motion artefact matters. Validation matters. Gold standards exist for good reasons.

But the criticism was strategically incomplete.

Wearables do not need to replace invasive devices to be transformative. They need to produce signals that are clinically relevant enough to change decisions, allocate attention more intelligently or flag deterioration early enough to matter. For many use cases, the comparator is not the best possible measurement under ideal conditions. It is the absence of continuous information.

That distinction matters. A wearable ECG does not have to replace a full cardiology work-up to be valuable. A respiratory trend monitor does not have to replace spirometry to signal that a patient is worsening. A multi-parameter patch does not need to achieve the perfection of ICU monitoring to reduce blind spots in recovery or step-down care. In many settings, an early directional signal with appropriate workflow integration can be more valuable than a pristine reading that arrives too late.

This is where the phrase “actionable trends” becomes more important than “raw accuracy”. The frontier for health wearables is not whether they produce elegant streams of data for their own sake. It is whether they can meaningfully signal risk before a crisis, inform escalation, support monitoring and improve allocation of clinical attention.

Traditional MedTech should understand this better than most. Yet too often it has remained trapped in an all-or-nothing mindset: either a device is diagnostic-grade, or it is strategically secondary. That is the wrong frame for a healthcare environment increasingly defined by prevention, surveillance, stratification and remote care.

MedTech Built Products. Wearables are Building Platforms.

This is the deeper challenge. Traditional MedTech companies are typically organised around products, categories and sales channels: a cardiac product line sits here, a respiratory line sits there, a monitoring business sells into one part of the hospital, and a surgical business into another. Success is measured through familiar commercial metrics such as unit sales, account penetration, consumables and service contracts - indicators that feed neatly into quarterly reporting, revenue visibility and earnings calls, and which, over time, have come to shape much of the executive mindset in the sector.

Wearables destabilise that logic because their value does not end at the sensor. It begins there.

The strategic asset is the platform that sits above the sensor: the data architecture, the analytics layer, the workflow integration, the alerting logic, the patient interface, the clinician dashboard, the interpretation models, the interoperability with broader health IT systems. In other words, the device is still important, but it is no longer sufficient.

This is where traditional MedTech’s legacy strengths can become constraints. Their commercial models are often transactional. Their organisational structures are often departmental. Their software capabilities may be fragmented. Their digital investments may still be treated as support functions rather than core strategy. They know how to sell a device. They are less practiced at managing an ongoing data relationship with patients across months or years.

The wearable era rewards different kinds of strength. It rewards firms that can accumulate longitudinal datasets, translate physiological streams into useful risk signals, integrate monitoring into care workflows, and maintain engagement outside the clinic. It rewards interoperability rather than siloed device logic. It rewards persistence rather than event-based contact.

The winners will look less like catalogue companies and more like platform companies. That does not mean every MedTech firm must become Apple. However, it does mean they must stop pretending that hardware alone will remain the centre of defensibility.
 
Why Consumer Technology Learned Faster

There is also a cultural lesson in all this. Consumer technology companies often moved faster not because they understood medicine better, but because they understood adoption better.

Healthcare has long excelled at seriousness, engineering and clinical validation. Consumer technology excels at usability, behaviour and habit formation. In a world of continuous monitoring, that difference matters. The best wearable in the world is useless if patients do not wear it, charge it, trust it or understand it. Longitudinal value depends not only on signal quality, but on sustained human use.

This is where many incumbents were weakest. They judged performance mainly in technical terms, not behavioural ones. Yet what matters in the real world is not simply whether a device performs well in principle, but whether patients will use it consistently. A device that is slightly less sophisticated but fits easily into everyday life can therefore be more valuable than a technically superior one that patients stop using.

This is another reason the “lifestyle” dismissal is strategically foolish. Consumer markets solved adherence, comfort, interface and routine interaction earlier than MedTech did. And those capabilities are not superficial. They are central to the success of remote and continuous monitoring.

The phrase “digital immigrants” may sound harsh, but it captures something real about leadership mindset. Many executives trained in a pre-platform era interpret digital as a wrapper around the product: an app, a dashboard, a software add-on. But in platform markets, digital is not the wrapper. It is the business logic. Wearables exposed that difference.
 
The Therapeutic Journey is now the Real Battleground

The most important strategic lesson for traditional MedTech is that healthcare value is shifting from isolated interventions toward the orchestration of whole patient journeys.
A heart failure patient does not care that one company owns a monitor, another owns a diagnostic device and a third owns a post-discharge patch. They experience a single journey: symptoms, observation, deterioration risk, hospital contact, discharge, recovery, relapse prevention. Likewise, an oncology patient, a respiratory patient or a post-operative patient does not live inside neat device categories. They live inside uncertain therapeutic trajectories.
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The company that matters most in that environment is not necessarily the one with the single most impressive piece of hardware. It is the one that can generate meaningful visibility across the journey and turn that visibility into support, interpretation and action.

This is why journey-centric design should replace intervention-centric design as MedTech’s organising principle.

For each therapeutic area, incumbents should be asking harder questions. Where are the blind spots between visits? Which signals change before symptoms become severe? Which data can be collected passively rather than requiring effort from the patient? Which alerts are clinically actionable rather than just noisy? How should information move between patient, clinician, caregiver and system? Which parts of the pathway demand medical-grade certainty, and which are well served by reliable early-warning systems?

These are not just product questions. They are strategic questions about where value is created.
 
Traditional MedTech Still Has Advantages. But only if it Changes the Frame

This is not a story in which incumbent MedTech is doomed and consumer technology wins by default. Traditional MedTech still possesses formidable assets: regulatory experience, clinical credibility, provider relationships, knowledge of pathways and the ability to operate in high-stakes settings where trust matters.

But those strengths only matter if they are reassembled around the realities of continuous, connected care.

A useful example comes from enterprise and hospital monitoring, where firms such as Philips are beginning to frame wearables not as standalone gadgets but as interoperable elements within wider patient-monitoring architectures. Philips, for instance, describes an “end-to-end” monitoring solution built around live device data and, in its smartQare partnership, explicitly positions wearable sensing as part of continuous monitoring “in and out of the hospital,” linking observation across bedside, ward and home settings. That is much closer to the right strategic frame. The product is no longer the device in isolation, but the monitored patient journey it helps make visible.

This is where incumbents can still win. They can build clinically robust wearables for high-value pathways such as cardiac monitoring, respiratory deterioration, post-operative recovery, oncology support or chronic disease management. They can become workflow integrators, using third-party sensors where necessary but owning the orchestration layer. They can focus on analytics, translating streams of noisy physiology into useful risk models and escalation pathways. They can build trusted bridges between consumer-generated data and formal clinical systems.

But they will not win by bolting generic software onto legacy hardware and calling it transformation.
 
The Risks are Real. Denial is Worse

None of this means the wearable future is frictionless. Signal quality remains uneven. Many devices are over-marketed and under-validated. False positives can create anxiety. False negatives can create false reassurance. Remote monitoring can swamp clinicians with noise if not carefully designed. Interoperability remains poor. Reimbursement is still inconsistent across markets. Data privacy and governance are concerns. Health systems are not yet built to metabolise continuous data gracefully.

But these are not arguments for treating wearables as marginal. They are arguments for building better systems around them. Healthcare has always advanced through the combination of new capability and institutional adaptation. The strategic failure would be to wait for the market to become perfect before taking it seriously.

In fact, incumbents should recognise that these frictions are where their capabilities ought to matter most. Clinical governance, validation, regulatory navigation and pathway design are not side issues. They are how wearables move from promising consumer technologies to trusted components of care.

The mistake is not caution but mistaking caution for strategy.
 
The Real Danger is Strategic Drift, Not Collapse

The most important warning for traditional MedTech is that disruption in healthcare rarely looks dramatic at first. Incumbents often do not fail overnight. They continue generating revenue, servicing installed bases and selling into established channels. The balance sheet looks stable. The products still work. The clinician relationships remain intact. Nothing appears to be collapsing.

But underneath, value migrates.

It migrates into data assets, patient interfaces, workflow platforms, predictive models and continuous relationships. It migrates toward firms that understand how to live with the patient beyond the clinical encounter. It migrates toward systems that make deterioration visible earlier, care more distributed and intervention more targeted.

That is the kind of strategic drift the wearable market has exposed. Traditional MedTech did not implode. It simply underestimated where the future centre of gravity was moving. That is often how industries lose their strategic position: not through spectacular failure, but through outdated categories.
 
Takeaways

The wearable market is not just another adjacent segment for MedTech to notice late and enter cautiously. It is a warning about the future structure of healthcare technology. The next generation of winners will not think of themselves only as device manufacturers. They will think of themselves as managers of physiological intelligence across the therapeutic journey. They will combine sensing, software, analytics, patient engagement, workflow integration and services. They will understand the difference between diagnostic perfection and decision-grade usefulness. They will know when clinical-grade precision is necessary and when timely directional insight is what changes outcomes. Most importantly, they will stop treating data as a by-product of the device and start treating it as the basis of the business.

That is the sharper strategic lesson for traditional MedTech. The future will not be won solely in the procedure room, the procurement contract or the single device category. It will also be won on the wrist, on the chest, in the home, across the patient pathway and within the data streams that reveal risk before crisis.

Wearables began at the margins of medicine because incumbents were too comfortable calling them lifestyle devices. They are moving toward the centre because healthcare increasingly needs what they provide: continuity, context, earlier warning and a more patient-centred model of observation.

Traditional MedTech can still respond. But it must do so by abandoning one of its most persistent illusions: that the serious business of medicine begins only when the patient reaches the clinic. Increasingly, it begins long before that. And the companies that understand this will not just build better devices. They will redefine what a medical technology company is.
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5 years, 6 months ago

E-skin set to disrupt healthcare

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artificial skin
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e-skin
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  • The ‘needle’ has moved significantly since the FDA approved the first artificial human skin in 1996
  • Researchers in Australia have developed an electronic artificial skin (e-skin) that reacts to pain just like real skin 
  • Researchers in the US have developed an e-skin that mimics the functions and properties of human skin
  • These are just 2 examples of 100s of e-skin developments currently taking place around the world
  • Research findings on the functions and properties of e-skin pave the way for enhancing non-invasive alternatives to skin grafts, improving consumer healthcare, developing smarter prosthetics and advancing intelligent robotics
  • Such improvements are likely to take place over the next decade
  • One possible near-term application for e-skin is to enhance the Apple Watch
  • The commercial beneficiaries of e-skin are more likely to be giant tech companies rather than traditional manufacturers of medical devices
  
E-skin set to disrupt healthcare
 
 
In September 2020 researchers from Australia’s Royal Melbourne Institute of Technology (RMIT) published findings of a study entitled, “Artificial Somatosensors: Feedback Receptors for Electronic Skins” in Advanced Intelligent Systems. The study’s focus was an electronic artificial skin (e-skin) made of silicone rubber with integrated electronics with the capacity to mimic the functionality of real skin and almost instantaneously distinguish between less and more severe forms of pain. Just as nerve signals instantaneously travel to your brain to inform you that you have encountered something sharp or hot, the e-skin reported in this study triggers similar mechanisms to achieve comparable results. This represents a significant advance towards the next generation of biomedical technologies, non-invasive skin grafts, smart prosthetics and intelligent robotics: all large, underserved fast growing global markets.
 
A significant advance in bioengineering

According to Madhu Bhaskaran, the study’s lead author, a professor at RMIT and the co-leader of the University’s Functional Materials and Microsystems Research Group, the research is the first time that electronic technologies have been shown to mimic the human feeling of pain. “No electronic technologies have been able to realistically mimic that very human feeling of pain - until now. It’s a critical step forward in the future development of the sophisticated feedback systems that we need to deliver truly smart prosthetics and intelligent robotics,” said Bhakaran.
 
Her remarks were emphasised by Md Ataur Rahman, a researcher at RMIT who said, “We’ve essentially created the first electronic somatosensors - replicating the key features of the body’s complex system of neurons, neural pathways and receptors that drive our perception of sensory stimuli . . . . While some existing technologies have used electrical signals to mimic different levels of pain, our new devices can react to real mechanical pressure, temperature and pain and deliver the right electronic response . . . .  It means our artificial skin knows the difference between gently touching a pin with your finger or accidentally stabbing yourself with it - a critical distinction that has never been achieved before electronically.”
 
Combination of three smart technologies

The RMIT device combines three ”game-changing” technologies to deliver its superior sensing capabilities, all previously designed and patented by Bhakaran’s team. The first is a stretchable, transparent and unbreakable electronic device made of oxide materials and biocompatible silicone, which allows it to be as thin as a piece of paper. The second is a temperature-reactive coating that is, “1,000 times thinner than a human hair”, which can transform when it comes into contact with heat. The third is a “brain-mimicking memory”, which facilitates electronic cells to simulate your brain’s ability to remember temperature and pain thresholds and store these in its own long-term memory bank. Further development is required to integrate these technologies into biomedical applications and demonstrate their stability over time, but crucially says Bhaskaran, “the fundamentals - biocompatibility, skin-like stretchability - are already there."
 
E-skin research has been progressing for decades

E-skin research is not new and has been developing for at least the past three decades. Here we cannot do justice to the breadth and depth of such research, but we can give a flavour of its history and briefly describe another e-skin that mimics human skin, which was reported in the February 2018 edition of Science Advances.
 
As early as the 1970s, researchers were exploring the potential application of tactile‐sensing simulation and had demonstrated certain touch sensors, but with low resolution and rigid materials. Notwithstanding, over the ensuing two decades significant breakthroughs were achieved in malleable and stretchable electronic devices for various applications. More recently, tactile sensors with enhanced performance have been developed based on different physical transduction mechanisms, including those affecting: (i) the change in the electrical resistivity of a semiconductor or metal when mechanical strain is applied (piezoresistivity), (ii) the ratio of the change in electric charge of a system to the corresponding change in its electric potential (capacitance), and (iii) the electric charge that accumulates in certain solid materials in response to applied mechanical stress (piezoelectricity). Parallel to these advances, significant progress also has been made in design, manufacturing, electronics, materials, computing, communication and systems integration. Together, these developments and technologies open new areas for applications of bioengineered systems.
 
Breakthrough e-skin by a US group

The 2018 e-skin research study reported in Science Advances was led by Jianliang Xiao, a Professor of Mechanics of Materials and Wei Zhang, a Professor of Chemistry, both from the University of Colorado Boulder. They describe the characteristics of their e-skin, as “thin, translucent, malleable and self-healing and mimics the functions and properties of human skin.” Reportedly the e-skin has several distinctive properties, including a novel type of molecular bond, known as polyamine, that involves the sharing of electron pairs between atoms, which the researchers have embedded with silver nanoparticles to provide enhanced mechanical strength, chemical stability and electrical conductivity. “What is unique here is that the chemical bonding of polyamine we use allows the e-skin to be both self-healing and fully recyclable at room temperature,” said Xiao. Further, the e-skin’s malleability enables it to permanently conform to complex, curved surfaces without introducing excessive interfacial stresses, which could be significant for its development. The Boulder group has created a number of different types and sizes of their wearable e-skin, which are now being tested in laboratories around the world.
 
In the Commentary

In this Commentary we not only report the research findings of the two e-skin studies mentioned above, but we also describe, in simple terms, how you experience pain to illustrate the achievement of the Australian researchers from RMIT. We then describe human skin, its capacity to be wounded and traditional skin graft therapies to deal with such wounds. We briefly reference the invention of the first artificial human skin to receive FDA approval and highlight some of the massive and significant technological and market changes that have taken place since then. We conclude by suggesting that, over the next decade as e-skin technologies are enhanced, their potential healthcare applications are more likely to be owned and controlled by giant tech companies than traditional manufacturers of medical devices. More about this later. In the meantime, let us return to Bhakaran’s new pain-sensing e-skin and briefly describe the devilishly complex functionality of how you experience pain.
The function of pain and how you experience it
 
Your skin constantly senses things and your sensitivity to pain helps in both your survival and your protection. Pain prompts reflex reactions that prevent damage to tissue, such as quickly pulling your hand away from something when you feel pain. Notwithstanding, your pain response only begins when a certain threshold is breached. For example, you do not notice pain when you pick up something at a comfortable temperature, but you do when you prick your finger or touch something too hot. Consider this brief, over-simplified, description of how you experience pain.


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When you prick your finger on something sharp it causes tissue damage, which is registered by microscopic pain receptors in your skin. These send electrical signals through your nerve fibres that are bundled together with others to form a peripheral nerve. These electrical signals pass up your peripheral nerve and spinal cord to your neck area. Here they are transferred from one nerve cell to another by means of chemical messengers. The signals are then passed to three areas of your brain: one, the somatosensory cortex, that deals with physical sensation, another, the frontal cortex, which is linked with your thinking and a third area, your limbic system, which is associated with your emotions. All this occurs in nano seconds and results in you instantaneously feeling pain, wincing and becoming irritated when a pin pricks your finger.
 
Human skin and traditional skin grafts

Skin is your body’s largest and most versatile organ, which is unlike any other, not least because you wear it on the outside of your body. Not only is your skin a huge sensor packed with nerves for keeping your brain in touch with the outside world, it provides you with free movement. Adults carry  between 1.5 and 2.0 square metres of skin on their bodies, which weighs about 3.5kgs (≈16% of your body weight). Your skin is a “smart”, multifunctional organ that not only serves as a protective shield against heat, light, injury and infection, but also it is a sensory organ that regulates body temperature, stores water and fat, prevents water loss and helps to produce vitamin D when exposed to the sun. Skin wounds are relatively common and can be caused by trauma, skin diseases, burns or removal of skin during surgery. In the US alone, each year some 35m cases require clinical intervention for major skin loss.Your skin has three layers. The thin, outer layer that is visible to the eye is called the epidermis and the deeper two layers are called the dermis and hypodermis. Due to the presence of stem cells, a wound to your epidermis is able to stimulate self-regeneration. However, in cases of deeper injuries and burns, the process of healing is less efficacious and leads to chronic wounds. Any loss of full-thickness skin more than 4cm diameter needs to be treated immediately. Traditional ways of dealing with significant losses of skin have been skin grafts. The most common is to use either your own shin (autograft) or the skin from another person (allograft). Skin  grafts can also be obtained from a non-human source, usually a pig (xenograft). Autographs suffer from the fact that you may not have enough undamaged skin to treat the severity of your injury. Allografts and xenografts suffer from the possibility of rejection or infection. These challenges drove a need to develop an artificial skin.
 
The first FDA approved artificial human skin

The first artificial human skin to receive FDA approval was invented in the late-1970s by John Burke, a Professor of Surgery at the Harvard University Medical School and Chief of Trauma Services at Massachusetts General Hospital and Ioannis Yannas, a Professor of Polymer Science and Engineering at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. Burke had treated many burn victims and realized the need for a human skin replacement. Yannas had been studying collagen, a protein found in human skin. In the mid-1970s the two professors teamed-up to develop a material - an amalgam of plastics, cow tissue and shark cartilage - that became the first commercially reproducible, artificial human skin with properties to resist infection and rejection, protect against dehydration and significantly reduce scarring. In 1979 Burke and Yannas used their artificial skin on a woman patient, whose burns covered over half her body. In the early 1990s the Burke-Yannas skin was acquired by Integra LifeSciences Corporation. In March 1996 the company received FDA approval for it to be used on seriously burned patients, and Integra Artificial Skin became the first tissue regeneration product to reach the market. Since then, it has been used in therapies throughout the world and has saved and enhanced the lives of innumerable severely burned people. More recently, the Integra Artificial Skin has also been used in a number of other indications.
 
Technological advances and market changes since the first artificial skin

Since Integra’s launch of the first FDA approved artificial human skin, healthcare markets and technolgies have changed radically. In the mid-1970s when Professors Burke and Yannas came together to develop their artificial skin, Apple and Microsoft, two giant tech companies with interests in healthcare, were relatively small start-ups, respectively founded in 1976 and 1975.  it would be more than another  decade before Tim Berners-Lee invented the World Wide Web (1989), and then another decade before the internet became mainstream. The tech giants, Amazon and Google, also with interests in healthcare, were not founded until some years after that: 1994 and 1998 respectively. Over the past four decades substantial progress has been made in tissue engineered skin substitutes made from both artificial and natural materials by employing advances in various fields such as polymer engineering, bioengineering, stem cell research, nanomedicine and 3D bioprinting. Notwithstanding, a full thickness bioengineered skin substitute with hair follicles and sweat glands, which can vascularize rapidly is still not available. 
 
Market changes, e-skin, the Apple Watch and giant tech companies

In closing, we briefly focus on one potential near-term application for e-skin - to enhance the capabilities of the Apple Watch.  We do this to emphasise the significant market shifts, which are occurring in healthcare and the large and growing impact that giant tech companies are having on the sector.

The Apple Watch was first released in April 2015 by Tim Cook, Apple’s CEO, as a fashion accessory. Notwithstanding, its focus quickly shifted and within three years it had become a FDA approved medical device. The watch, not only can detect falls, but it also has 3 heart monitoring capabilities: one recognises and sounds an alarm when your heart rate is low, a second detects irregular heart rhythms and a third is a personal electrocardiogram (ECG), which is a medical test that detects heart problems by measuring the electrical activity generated by your heart as it contracts. According to Strategy Analytics, a consumer research firm, in 2019, an estimated 30.7m Apple Watches were sold worldwide; 36% higher than the 22.5m watches Apple sold in 2018.

In 2020, during the coronavirus public health emergency, the FDA expanded its guidance for non-invasive patient-monitoring technologies, including the Apple Watch’s ECG function. This expanded use is intended to help facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to CoVID-19.
 
Currently, the Apple Watch is worn like any other watch and if it is loose, its data harvesting capacity could be compromised. In the form of a watch, e-skin would conformally adhere to irregularly shaped surfaces like your wrist. The two e-skins described in this Commentary; both with intrinsic stretchability could potentially facilitate the Apple Watch to be more integrated with the wearers own skin.

The unstoppable march of giant tech companies into healthcare
 
Today, not only do giant tech companies such as Apple, Amazon, Google and Microsoft have their global market presence as a significant comparative advantage to enter and expand into healthcare, but they also have unparalleled data management capabilities. Since the invention of artificial skin by Burke and Yannas healthcare has become digital and global. Because giant tech companies’ have superior access to individuals’ data and state-of-the-art data handling capabilities; they know customers/patients significantly better than any healthcare provider. This, together with their global reach, positions giant tech companies to provide discerning patients with the healthcare solutions they need and increasingly demand.
 
IBM Watson Health estimates that by the end of 2020, the amount of medical data we generate will double every 73 days. According to Statistica, an analytical software platform, new healthcare data generated in 2020 are projected to be 2,314 exabytes. Traditional healthcare providers cannot keep up with this vast and rapidly growing amount of health information, despite the fact that such information is increasingly significant as healthcare shifts away from its traditional focus on activity and becomes more outcomes/solutions orientated. Giant tech companies are on the cusp of meeting a large and growing need to understand, structure and manage health data to build a new infrastructure for the future of healthcare.
 
Takeaways

The potential impact of e-skin is significantly broader than enhancing the Apple Watch. The research findings reported in this Commentary suggest that e-skin is well positioned to disrupt substantial segments of healthcare over the next decade. Findings published in Advanced Intelligent Systems and Science Advances suggest that one potential application is for e-skin to be seamlessly integrated with human skin. This not only positions it to become the next generation for a number of traditional MedTech applications, such as non-invasive skin grafts, but also to deliver a step change in the consumer health market by producing breakthroughs in human-machine interfaces, health monitoring, transdermal drug delivery, soft robotics, prosthetics and health monitoring. If traditional manufacturers are to benefit from e-skin they will need to adapt and transform their processes because the natural fit for e-skin technologies is industry 4.0, [also referred to as smart manufacturing and the Internet of Things (IoT)], which is expected to become more pervasive over the next decade as developments of e-skin unfold. Industry 4.0 combines physical production and operations with smart digital technology, machine learning and big data to create more solution orientated healthcare ecosystems and thereby tends to favour the giant tech companies and their growing healthcare interests.
 
#e-skin #artificialskin #AppleWatch 
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