Mobile Health (mHealth) Wearable Fitness Devices: Hipster gadget, or is there potential for more?

n 2011 the wearable fitness devices market was $16.2 Million, and is projected to grow to $93 Million by 2017.  Many people have benefited by being motivated to exercise, taking extra steps to attain their daily goals.  With 35% of the US society qualified by the CDC as obese, these wearable devices are getting people to do that which they know they need to do – exercise. 

The Cloud-based infrastructure brings additional value to these fitness devices by leveraging the social benefits of fitness -  without requiring individuals to align their schedules to exercise at the same time, they can still compete against daily posted goals by using these devices.

Any device that can foster healthier lifestyles is a value to both the user and society, and also holds great potential for secondary use of the data it gathers. By interfacing the data with patients' medical records and other regulated medical devices, such as glucose meters or vitals monitoring systems, there is the potential to have patients and providers improve communications, planning and health care status monitoring.

Yet studies, including Molly Mackinlay's recent publication (Intersect, Vol 6, No 2 (2013)), confirm what many medical device companies with Class II devices already know:  the data from unregulated wearable fitness devices is not accurate.  Users likely do not realize the risks of the lower quality data collection for unregulated devices.  Also, with the lack of consistency in measures like "distances gone" and uncounted StairMaster steps, the rapid market penetration of these unregulated wearable fitness (mHealth) devices risks being self-limiting.

Conversely, medical device companies with Class II devices that measure vitals in professional medical settings have the potential to extend their products to general users by adding lifestyle data collection.  By extending the lifestyle data (e.g.,  steps walked), general users could get similar features as provided by wearable fitness devices, though with significantly higher data quality. Users would also have the ability to transmit data back to the Class II device, for improved communications and care coordination with their provider.

Extending Class II platforms may not be simple.   If a currently unregulated device becomes an extension of a regulated device, and is intended to transmit (display, store or analyze) patient-specific data back to the regulated device, then it will be subject to regulatory oversight.  This means companies would be required to seek FDA and other government regulatory approval, which in turn means that they will be required to meet more stringent data collection standards. 

Once wearable devices with Class II standards begin to obtain approval, we will be able to accurately judge market demand.  Will familiar brand names lacking in regulatory approval continue to lead?  Or will clinically proven products disrupt that market? Or will one or more of the big brand names partner with a Class II manufacturer?

Only time will tell.  But no matter which devices take the lead, there is significant market opportunity here for startups armed with technologies like ClearRoadmap that can guide them through the approval and regulatory processes.   

-- Vizma Carver, Founder and CEO

ClearRoadmap:   a product of Carver Global Health Group