Sophisticated FDA approved wearable sensors and devices will be introduced that will allow for medically accurate 24x7 monitoring, data gathering and sharing with healthcare providers. These devices will leverage ubiquitous smartphones as the connection hub required to capture data, store it in the cloud, while providing powerful analysis, and useful feedback to its end users.
The dilemma however is: Can wearables truly generate medical-grade data that can be useful in monitoring, diagnosing and potentially preventing a host of health conditions? The answer is a resounding YES as the FDA prepared for the onslaught by recently hiring three new senior health scientists focused entirely on digital health.
Long criticized by some health-tech entrepreneurs as a barrier to innovation, the FDA is now seen as an important ally by companies eager to show that their devices can improve peoples' health - and eager to get heath insurers to cover them.
One of these companies is US based LifeQ, a health informatics company that has recently released a cloud based bio-mathematical engine and API. LifeQ’s bio-mathematical engine can ingest various data streams (continuous, periodic, episodic and/or static physiological data streams) to construct a highly personalized and accurate digital representation of an individual’s unique physiology. LifeQ’s cloud based software platform seeks to become the hub for collecting highly accurate physiological data that is currently only available through the use of expensive, invasive and hard-to-access equipment. On the hardware side of body-data acquisition, LifeQ partnered with Massachusetts based Analog Devices, Inc (ADI) which already has comprehensive portfolio of linear, mixed-signal, MEMS (microelectromechanical systems) and digital processing technologies are used in healthcare diagnostics, clinical monitoring equipment, life science and medical instrumentation, and health and wellness device designs.
ADI’s mission is “The development of smart wearable sensors essential to supercharge the next generation of non-invasive body monitoring solutions,” that can track heart rate, sleep phases, sleep quality, blood lactate, 24-hour calorie intake as well as stress markers such as salivary cortisol. Monitoring this type of data can increase early detection of emergency conditions and diseases in at-risk patients.
Not to be outdone, Europe continues to lead the charge in medical devices innovation.
A startup that caught our attention is Amiko.io – Founded in 2014 in Milan, Italy Amiko.io set its sights on transforming healthcare by improving medication taking habits. In the following two years, it has embarked in creating an impressive portfolio of connected devices that support patients in diabetes and respiratory care with products such as Metered-dose inhalers, Dry-powder inhalers, Auto Injectors, Insulin pens and Pill bottles. To help both patients and healthcare professionals, Amiko.io has also developed a platform called Quantified Medicine which allows for the true value of their connected devices to be realized. Quantified Medicine is a cloud based service which uses the medical devices’ collected data to closely track patient adherence to medication in real time, and delivers top class analytics of the patient’s health data to providers so that earlier intervention, and better outcomes can be possible. The same analytics can generate reports to assess real world treatment value so that payers can also make better decisions in the long run meant to improve the standard of care while also lowering its costs.
While a lot of the buzz is around startups, big players who already have significant know how in the medical electronics arena are also quietly jumping onboard the wearable bandwagon, with Philips leading the charge with a wearable device it intends to market to hospitals. Philips officials say the yet to be named medical-grade biosensor will gather vital signs – including temperature and heart and respiratory rate – of at-risk patients in low-acuity hospital settings. The continuous, real-time data is transmitted to a clinical decision support platform that will enable caregivers to better chart a patient’s process and improve the transition from hospital to home.
One set of players to keep a close eye on are the leading consumer-focused companies, including Apple, Google and Samsung, which have all made significant investments to develop ways to bring consumer activity data into patient management platforms, and are jockeying first to market advantage with their respective devices and health platforms.
Wearables’ potential in healthcare has also caught the eye of the American Medical Association which is a founding partner of Health2047, a San Francisco-based innovation studio whose mission is Nothing less than rethinking the role of physicians, business models, distribution, and even financing and transforming health care in the U.S. over the next three decades.
With both the FDA and the AMA fully involved in digital innovation, the vision of medical grade biometrics for everyday consumer use is a step closer to becoming a reality.
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