By PAUL QUIGLEY
It is often said that necessity is the mother of invention. when it comes to med tech 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 and the cloud. Low-cost manufacturing and shorter product leadtimes and software development cycles has also shrunk the time it takes for new tech products to move from drawing board to inventory. So the possibilities for medtech applications seem endless.
But this does not mean that there have not been teething problems and stumbling blocks over recent times. There is a real concern that despite the media-driven fads over high tech gadgets and business love affair with concepts such as BYOD – ‘Bring Your Own Device’ – medical and healthcare professionals are increasingly frustrated with some systemic hurdles regarding clinical standards that seem insurmountable in the race to get new, cheaper, innovative medtech systems and processes robust and fit-for-purpose. Whilst the idea of utilising ‘off-the-shelf’ or customised wearable tech devices and smartphone apps appeals, in principle, to be a way of advancing the efficacy of medical technology,
ASSAULT ON BATTERY
To date, part of the problem with wearable tech’s lacklustre success in the medtech space is the reliability and duration of energy cells and battery power supply, which has failed to meet the rigorous needs of healthcare and medical professionals. This is one key area holding back wearable tech’s prospects for type approval and favourable user experiences. Rob Phillips, managing director of battery experts Accutronics explains. “Many devices used by professionals are fitted with consumer grade battery technology, which cannot currently meet the needs of medical practitioners. The battery life-cycle is unreliable and these types of devices lack key vital features, such as accurate fuel gauging and rapid charging, not to mention their contribution to increased levels of electromagnetic interference (EMI) which can detrimentally affect surrounding devices” says Phillips. “Medical device OEMs should always specify reliable and efficient battery technology that is specifically designed for the rigorous demands of the industry:” he adds.
Collette Johnson, business manager of medical at Plextek Consulting concurs, and going further in her frank critique of the wearable wannabe’s. s“Wearables have had their day in the medtech space” she asserts. “They have not caused the health revolution anticipated, not least because people lose interest in them” she says. “The problem with wearables, at present. is the design. The majority tend to be in bands or watches that are created for sporty and younger demographics and not for people with medical conditions of varying demographics.” Moreover, some of the wearables’ shortcomings seem insurmountable, as Johnson explains. “Wearable fabric needs to be worn with full contact on the skin and, therefore, do not offer an everyday solution for the average person” she says. “If the potential of wearables is to be fully reached, innovative thinking regarding design and innovative monitoring signs need to be gathered that are indication specific.”
However, according to Plextek’s Johnson, there is some positive movement with health providers towards wearable technology. “Penetration in the market is slow due to the consumer approach of systems. For real market penetration, we need healthcare specific systems, such as concussion monitors, that have already proven 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 the healthcare professionals. Examples are now many and varied; such as, a recent venture between ‘Internet-of-Things’ cloud pioneer Kii teaming up with Kyocera to develop a cloud-based healthcare monitoring system and smart device, featuring a wearable device that measures steps, calories, activity, sleep, fat levels and beyond. The service is aimed at healthcare providers, companies and company employees. South Korean tech giant Samsung is also driving hard into the medical and healthcare tech space with its BioLogics division that the company is targeting squarely at the healthcare and medical care 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 start-up InHealthcare, is focussed on making existing clinical pathways go digital. It claims to be ‘technology agnostic’ as it does not push any specific brand of mobile or wearable 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 they 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 health care 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 is very little evidence that 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.”
ONE RING TO RULE THEM ALL
Nevertheless, despite the naysayers and sceptics, Apple is trudging on regardless, with its currently available HealthKit software development apps framework forming the tip of the spear on its relentless push to wearable world domination. The Cupertino-based tech behemoth 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 what Apple is planning to reinvigorate its flagging foray to date into wearables, with major new drives into medtech and biometric health devices, methods and apps, Apple’s recent mass recruitment of medial and health professionals has stunned the industry, and, along with arch-nemesis Google, is being put down to its determination to make a bigger splash next time into the multi-billion dollar but as yet nascent untapped medtech space. Though nothing official has been announced as yet, the ring device patent gives substantial clues are to where the company is headed next in its life sciences aspiration. Interestingly, both it and Google declined to comment on plans for medtech. However, the Apple patent was filed on April Fool’s Day. Apple’s iWatch product, whilst sharing many of the product features, has received a lukewarm market response.
RINGIN’ IN THE CHANGES
According to Apple’s ring device patent filing, it would comprise of a multi-sensor array mounted inside the computing ring is planned to 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 (NFC) -based, so that a user may 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 and innocent uses in healthcare. According to Apple’s patent application, their ring device is also being developed with a mind to be used, as Apple says, “the 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 remains rather cryptic and uncertain in as regards data protection aspects. 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 (e.g. animation of a heart pumping) or haptic feedback.” Haptic – or kinaesthetic – communication is commonly familiar in current device, such as vibrating phones or pagers or anything that can be felt by touch. Apple also states that the ring device’s collected data could also be used for access – in instances such as where a matching fingerprint or other biometric data could utilised to ‘unlock’ other capabilities of the ring, such as to a laptop or even an automobile, Apple says. All of which is fascinating, given that many of such applications were also cited in Apple’s earlier ‘iWatch’ product feature remit.
GOOGLE: WEAR THERE’S A WILL…
As if not to be outdone by its arch-rival, search engine giant Google is now also focussing its life sciences aspirations on its wristband-based device as a vanguard move into the wearable medtech space. After a somewhat disastrous foray in 2014 into the wearable area with its doomed Google ‘Glass’ eye-wear project, the ill-fated clunky sunglasses gizmo seems to have back on the drawing board whilst a major rethink is made over its commercial feasibility. Instead, their wristband device will seemingly now go head-to-head with Apple’s watch and presumably later – their aforementioned ring device. For now then, Google remains extremely tight-lipped. When asked t to comment for this article, the company declined, apologising. Nevertheless, having established its own life sciences business several years ago, Google is already ramping up recruitment as well as seemingly infinite R&D investment into the biosciences and biometric med tech space. Led by the wristband tracking device move, sharing striking resemblance to wrist shackles as worn by prisoners in custody, the Google tracking wristlet currently measures the subject’s pulse, skin temperature, heart rate as well as monitoring external variables such as being photosensitive and listening in for noise level and sound waves. Google already developed some of these med tech capabilities into its existing wearable Android Wear devices, but the mass market take up did not happen as the company had hoped. So, the new drive into the health and med tech space has become more important for Google’s human intelligence operations. Their recent marketing failure with their ‘Glass’ wearable product, saw Google swiftly withdrew it from shelves, scurrying back to the drawing board with its tech tail between its legs.
Clearly, the prospect of Apple and its ilk waltzing in to state healthcare providers like some white knight waving a magic wand to sweep away all of its ills is an unlikely outcome, though doubtless the corporate chiefs are working on other means to achieve it. The recent fears over the TTIP supranational issue has thrown the entire privatisation of parts of the NHS into confusion, making NHS fund holders even more risk averse than ever before in the Tory government’s austerity programme. Ultimately, the medtech apps and devices that are likely to be successful will be those that are tools of liberation and health benefits rather than tools of control and clinical clunkiness. As is evident from the struggle that medtech has faced embracing wearables to date, holds true even more so. Shoe-horning handheld apps into a highly-regulated medtech health sector will be all but impossible given strict regulation, legislation such as HIPAA and fears of lawsuits for medical negligence for corporate malfeasance. Casual forays by consumer electronics firms into the space will receive short shrift from the meticulous professionals in the healthcare space.
So for the time being at least, wearables are in the tech equivalent of limbo land. Whether the bright spark of innovation can light the touch paper of real-world healthcare sustainability remains somewhere out there in the future. If a breakthrough can be made with the rigorous expectations and regulatory compliance areas, and winning over the confidence of the wider medtech community that it does indeed have clinical legs and substance, and not just back-peddling and PR hot air, then there is everything still to play for.
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First published 2015 on http://www.MedtechEngine.com