Wearables, home testing and e-health trends

Wearables, home testing and e-health trends
Wearable technology is widely expected to revolutionize healthcare, not just fitness. Earlier this year, Forbes reported that investors will commit more than $1 billion in wearable technology startup companies before year end and that the market will gross almost $2 billion in revenues next year. So far, the mainstay of wearable technology has been centered around wearable trackers for consumer fitness. With increased consumer awareness of the dangers of a sedentary lifestyle, a demand has emerged for simple, easy-to-use trackers that help people track and measure their personal health goals. Fewer and fewer people are hitting the tracks without their smart watches, phones or tracking devices. In fact, social running apps (e.g. RunKeeper, Strava, MapMyRun, Motigo, Endomondo, Runtastic) have changed the habits of the common runner so much that some people are even speculating whether the peer pressure from our networks could turn into something counter-productive. However, with legacy brands (e.g. Apple, Samsung, Google) and well-funded startups entering the space, wearable technology is no longer limited to activity tracker wristbands and smart phone apps.

 

From fitness to health monitoring
Interesting examples of innovative wearables in the health space include MC-10 (smart patches that enable remote monitoring and home diagnosis), Oxitone (wristband that monitors blood oxygen wirelessly), Cerora (wearable headband and software platform to identify concussion/mild traumatic brain injury) and VitalConnect (plastic patch with biosensor that monitors vital signs including heart rate, temperature and respiratory rate). Apple’s Health Kit enables developers of apps and hardware to share its data to its Health app. Google and Novartis is collaborating in the diabetes space to track blood sugar levels using smart contact lenses. New wearables are even being developed to monitor the well-being of our pets (e.g. Nuzzle).

 

Regulatory hurdles
When the quantified self movement meets the healthcare industry, it is logical to predict an increased output of advanced health monitoring, disease diagnosis and risk screening tests at home. Already in 2006, one of the most well-known early pioneers in this space (23andMe) started to sell a home test that gave users the opportunity to collect data about personal ancestry and health by simply mailing in a sample of saliva for analysis. However, regulators rarely keep up with new trends in consumer demands and two years ago the FDA issued a letter to co-founder and CEO Anne Wojcicki, saying the home test product was in violation of FDA regulations because it wasn’t approved by the agency and “is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” Last week, the company finally reached an FDA approval and announced that it was launching an entirely new experience that includes carrier status, wellness, trait and ancestry reports. Although it may be argued that regulatory progress thus has been made for consumer genetic tests, this of course means that a lot of consumer-targeting point of care diagnostics companies are left in limbo. Similarily – in Sweden – the Medical Product Agency recently announced that it will require medical apps to undergo CE certification just like any other medical device in the European Union would.

 

Interview with an international panel of experts
Interesting opportunities arise when technologies from biosensors, microfluidics, electronics and software are combined into health tracking devices. Recently, while working for a point of care diagnostics player, Monocl interviewed an international panel of experts in this space to better understand the challenges and opportunities and how these affect the emerging industry trends. Below is a summary of some of the opportunities and challenges the interviewees perceived.

 

Opportunities
Huge opportunities exist in chronic diseases for contextually aware devices where it is important to detect acute or chronic decline. Patients with compromised immune systems may want to monitor body temperature (to detect fevers) and the same would be true for weight gains in heart or kidney failure patients or EEG signals before epileptic seizures. A convenient wearable solution enabling communication with a health professional in such scenarios could definitely become a game changer. Another advantage for the patient that could be implemented is direct feedback, if a certain behavior from the patient is desired. Examples could include physical activity if a patient has been still for too long or more advanced feedback based on brain signals to alleviate stress, anxiety and depression. These are all opportunities for the patient, but the logic could just as well be flipped in order for the health professional to provide better care. Technology for augmented vision (e.g. Google Glass) may help the surgeon spot anomalies during a procedure or may assist remote diagnosis. In the health (but not healthcare) space, obvious applications include biosensors (sampling sweat, blood, etc) on athletes, military personnel, fire squads, paramedics and other work categories where stress levels are high.

 

Challenges
Health focused wearables have evolved mainly from simple tracking of heart rates and x-y-z movements (e.g. sleep, distance, stair climbs). These metrics were geared towards wellness applications, and not intended for clinical decisions. Now, as technology allows us to gather data about blood sugar levels, cortisol levels and other biomarkers – an increasing amount of people would expect that the healthcare system should be able to interpret these levels into meaningful clinical recommendations. However, in order to use these metrics as diagnostic data, it would be unethical for a practitioner to rely upon a test that has not undergone clinical validation (efficacy, safety, accuracy, reproducibility, etc.). Test reliability is key if biomarker levels is used as input  (just look at the commotion right now around the uncertainties surrounding startup unicorn Theranos’ blood tests), and correlation with statistically significant clinical outcomes (in controlled clinical trials) is key to make evidence based clinical decisions. Today, there isn’t enough evidence of impact on health. Clinicians and patients alike need more peer-reviewed and digestible data to be able to discern what wearables to use, when, and for what. Most wearables are stuck in capturing a bunch of data, but much of the data is not actionable – at least not in a clinical setting as this data currently lives in silos outside the healthcare system. Transforming wearables into two-way communication devices with a healthcare professional will be essential in maximizing their utility for those looking to integrate them in the clinical workflow.

 

Are you active in this space? Let us know where you see the biggest opportunities.

CXO and Co-founder of Monocl Software