By overpromising and underdelivering, wearable medical devices have failed to meet expectations. But are things about to change? Paul Quigley investigates
It’s often said that necessity is the mother of invention. But when it comes to medtech for healthcare, imagination is clearly the mother of innovation. This has never been more true than today, as innovation in all forms of technology is tethered with rapid advances in computing power, Big Data, wireless networks and the Cloud. Low-cost manufacturing, and shorter software development cycles have also reduced the time it takes for new tech products to move from drawing board to inventory. So the possibilities for medtech applications seem endless.
Yet there have been teething problems and stumbling blocks in recent times. Despite media-driven fads for high-tech health wearables and business’ love affair with concepts such as Bring Your Own Device (BYOD), medical professionals are increasingly frustrated by clinical standards that seem insurmountable in the race to get new, cheaper innovative medtech systems and processes robust and fit for purpose.
To date, one key issue hindering health wearables’ prospects for type approval and favourable user experiences is the reliability and duration of energy cells and batteries. Rob Phillips, MD of battery specialists Accutronics explains: ‘Many devices are fitted with consumer-grade batteries that don’t currently meet health professionals’ needs. The battery lifecycle is unreliable, and devices often lack vital features such as accurate fuel gauging and rapid charging, not to mention their contribution to increased levels of electromagnetic interference which can detrimentally affect surrounding devices,’ adds Phillips. ‘Medical device manufacturers should always specify reliable and efficient battery technology specifically designed for the rigorous demands of the industry.’
Collette Johnson, Medical Director at Plextek Consulting, concurs and goes further in her frank critique of the wearable wannabes. ‘Wearable medical devices have had their day in the medtech space,’ she asserts. ‘They haven’t caused the health revolution anticipated, not least because people quickly lose interest in them. The problem with health wearables, at present, is the design. Most tend to be bands or watches created for sporty, younger demographics and not for people with medical conditions of varying demographics.’ Moreover, some of the health wearables’ shortcomings seem insurmountable, as Johnson explains. ‘Wearable fabric needs to be in full contact with the skin and, therefore, doesn’t offer an everyday solution for the average person,’ she says. ‘If wearables are to reach their full potential, indication-specific innovative thinking on design and monitoring signs needs to happen. The market is becoming flooded with too many “me too” products with little game-changing innovation,’ she adds. However, she does recognise that there is some positive movement among health providers towards wearable technology. ‘Market penetration is slow due to the consumer approach of these systems. For real market penetration, we need healthcare-specific systems, like the concussion monitors that have already proved to be a great success,’ says Johnson.
With not just Apple and Google leading the charge, many IT vendors are piling in with offerings that may – or may not – gain traction with healthcare professionals. Examples are now many and varied; such as the recent venture between IOT Cloud pioneer Kii and Kyocera to develop Daily Support, a Cloud-based monitoring system and smart device, featuring a wearable that measures steps, calories, activity, sleep, fat levels and beyond. The service is aimed at healthcare providers, and companies and their employees. South Korean tech giant Samsung is also driving hard into the medtech space with its BioLogics division, which targets the healthcare industry around the world, taking a completely different tack to that of either Apple or Google.
For health providers, being somewhat more realistic rather than idealistic seems to be their priority. One firm, British startup InHealthcare, is focused on making existing clinical pathways go digital. It claims to be ‘technology agnostic’ as it doesn’t push any specific brand of device. ‘Wearables will not create a healthcare revolution,’ says Richard Quine, Product Director for InHealthcare. ‘For technology to have real impact on the population, there are a few things wearables must do. They must be clinically led, not technology led. As much as we may love Apple, they are not the best people to work out how to make us healthier,’ he says. ‘And we all know about Dr Google’s dodgy record of health diagnosis. Put the healthcare professionals in the driving seat of digital health, not the engineers.’ According to Quine, a cash-strapped NHS – under major political and budgetary pressures – will rightly only pay for things that are evidence-based. ‘There’s very little evidence that health wearables make a difference,’ says Quine. ‘You need proof that they work – being shiny is not enough. A revolution is about the people, and wearables are not yet “of the masses”. Digital health must embrace a whole range of low-tech and high-tech so that the largest proportion of the population can access it.’
Despite the naysayers and sceptics, Apple is trudging on regardless, with its HealthKit software development apps framework at the forefront of its relentless push to wearable world domination. It has also recently filed an intriguing new patent for a wearable wireless biometric sensor device that would be worn on the index finger, tentatively dubbed an ‘iRing’ by pundits. Believed to form the hub of Apple’s plans to reinvigorate its flagging foray into wearables to date, alongside major new drives into medtech and biometric health devices, methods and apps, Apple’s recent mass recruitment of health professionals has stunned the industry and, along with arch-nemesis Google, is being attributed to its determination to make a bigger splash in the multibillion dollar, but as yet nascent, untapped medtech space. Though nothing official has been announced as yet, the ring device patent gives substantial clues to where the company is headed next in its life sciences aspiration. Interestingly, both Apple and Google declined to comment on their plans for medtech. However, the Apple patent was filed on April Fool’s Day, and Apple’s iWatch, while sharing many of the product features, has received a lukewarm market response.
According to Apple’s patent filing, the ring device would comprise a multisensory array mounted inside the computing ring, which will collect biometric data such as heart rate, body temperature, gyroscopic motion, as well as cardiac rhythm, body perspiration and so-called ‘galvanic skin response’. The biometric data is then collated and displayed by the ring computing device and/or a paired electronic device – near-field communications-based – so that a user can monitor their own health, fitness, activity or caloric energy expended. However, as far as Apple’s corporate bottom line is concerned, the medtech aspect of iRing may become subordinated over time to a more ‘Trojan horse’ aspect – that of surveillance and ‘security’ rather than the altruistic uses associated with healthcare. According to the patent application, the ring’s ‘biometric data is used to authenticate the user by comparing the collected data against a database of data signatures known for the user’. What Apple does state about data protection remains rather cryptic and uncertain. The company patent says: ‘Some, or all, or the collected data may be shared with… health professionals, or other parties.’ Going further, Apple continues, ‘the computing ring transmits the pulse of the user to another user also wearing a ring computing device, which informs the other user of the first user’s pulse via visual (for example, animation of a heart pumping) or haptic feedback’. Haptic – or kinaesthetic – communication is commonly familiar in current devices such as vibrating phones, pagers or anything that can be felt by touch. Apple states that the ring’s collected data could also be used to access laptops or even cars. All of which is fascinating, given that many of these applications were also cited in Apple’s earlier ‘iWatch’ feature remit.
Not to be outdone by its arch-rival, Google is now also focusing its life sciences aspirations on its wristband-based device as a vanguard move into the wearable medtech space. After a somewhat disastrous foray into wearables with its ill-fated Google Glass eyewear project in 2014, it seems to be back to the drawing board for the clunky sunglasses gizmo, while a major rethink of its commercial feasibility is undertaken. Instead, its wristband device will seemingly go head to head with the Apple Watch and the promised ring device. But for now, Google remains extremely tight-lipped. When asked to comment for this article, the company declined, apologising. Nevertheless, having established its own life sciences business several years ago, Google is ramping up recruitment as well as seemingly infinite R&D investment into the biosciences and biometric medtech space. Sharing a striking resemblance to prison wrist shackles, the Google tracking wristlet currently measures the subject’s pulse, skin temperature and heart rate as well as monitoring external variables such as photosensitivity, noise levels and sound waves. Google already developed some of these medtech capabilities into its existing wearable Android Wear devices, but the mass-market take-up didn’t happen as the company had hoped. So, the new drive into the medtech space has become more important for Google’s human intelligence operations.
Clearly, the prospect of Apple and its ilk charging like some white knight to sweep away all the ills of state healthcare provision is an unlikely outcome, though doubtless the corporate chiefs are working on other means to achieve it. The recent fears over the Transatlantic trade and Investment Partnership (TTIP) supranational issue has thrown the entire privatisation of parts of the NHS into confusion, making NHS fundholders even more risk averse than ever before. Ultimately, the successful medtech apps and devices will be those that offer liberation and health benefits rather than control and clinical clunkiness. Shoehorning handheld apps into a highly regulated medtech health sector will be all but impossible given strict regulations, legislation such as the Health Insurance Portability and Accountability Act (HIPAA) and fear of medical negligence lawsuits for corporate malfeasance. Casual forays by consumer electronics firms into the healthcare space will receive short shrift from its meticulous professionals.
So, for the time being at least, health wearables are in limbo. Whether the bright spark of innovation can light the touchpaper of real-world healthcare sustainability remains uncertain. If a breakthrough can be made to meet rigorous expectations and regulatory compliance, and the wider medtech community can be convinced that mHealth does indeed have clinical legs and substance, then there is everything still to play for.
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