When do fitness apps or health devices turn into wearable medical devices for patients, and how will it impact your office?
Wearable electronic health devices are an excellent option for detecting the physiological parameters of the wearer and are quickly moving into the health space for chiropractors, MDs and other health care providers.
Of the $70 billion wearable technology market in 2019, $20 billion in revenue came from wearable medical health devices. On top of this, an additional $28 billion came from non-medical product categories such as fitness and “infotainment” product categories that also integrate physiological monitoring to some degree. Traditionally, these two sectors have been clearly separated along dividing lines in the form of regulatory barriers. However, the introduction of increasingly sophisticated physiological monitoring techniques into products such as smart watches indicates increasing encroachment toward and over this line, bringing traditional consumer product companies toward the realm of medical devices.
Rhymes with ‘grapple’
In June the largest smart watch seller in the U.S. introduced a slew of new features, including a series of new health app features with “mobility metrics,” such as low-range cardio fitness, walking speed, stair-descent speed, stair-ascent speed, six-minute walk distance, double support time, step length and asymmetry. These new features are based on motion-sensing hardware that has been present in each edition of the product, illustrating the advancement in the algorithms used to characterize motion. Previously, watch motion analysis was prominently used in a variety of other features such as step counting, activity characterization and fall-detection alerts (one of the first medical-related functions on the product).
The most prominent medical feature on the market-leading smart watch was the ECG monitoring — after the company gained FDA Class II clearance for the ability to detect and notify the user of irregular heart rhythm, and an ECG app which could be used to identify potential signs of atrial fibrillation. These were deployed by using the watch crown or features in a strap as an electrode, with biopotential measured at the finger. This functionality was very similar to another cardio-band-type product already on the market.
Health devices and intense smart watch competition
The leading smart watch maker is certainly not the only player to introduce more medical metrics into health devices. Another relatively common example is the introduction of wearable pulse oximetry. The technique involves measuring oxygen saturation (known as spO2), usually via a photonic sensing system involving red and infrared light. Traditionally, pulse oximetry would be done via a transmissive approach (e.g. measured on the finger using a finger clip device), but recent advances have also demonstrated a reflective version that can be deployed in a smart watch.
This has been announced in both non-medical products from companies, and also in regulated medical devices. The fundamentals of the technique deployed in the different devices are similar. However, without the formal regulatory approval, the non-medical devices can display rough indications of spO2 over time or build it into rough aggregate health metrics, but cannot link this to any formal medical claims such as detection of sleep apnea.
Blood pressure monitoring advances
Another medical metric with growing popularity in wearable products is blood pressure monitoring. Industry players have taken the principles of a blood pressure cuff and deployed this within FDA Class II cleared smart watches, and other players have produced similar devices based on this “occlusive” method.
There is also a move around “cuffless” optical blood pressure detection. While the earlier patents for this go back over a decade, there has been a more recent move to deploy optical blood pressure in wearable health devices.
All of these applications sit within a section of overlap, where similar device functions can be either recognized as fitness/wellness or medical/health care depending on the level of claims made and the regulatory clearance. Products on the fitness/wellness side can use any of the metrics mentioned as part of general health assessment algorithms but cannot provide specific medical metrics or diagnoses. Regulatory clearance means they have been specifically benchmarked against previously approved medical products and produce equivalent performance in the specific area of assessment. This enables more claims to be made by the device maker, as well as use of the product in specific environments related to the area of approval. The regulatory boundary is clear but sits atop a product and application ecosystem which is a continuum from fitness/wellness through to health care/medical.
The regulatory approval ceiling
For the majority of medical devices, regulatory approval or clearance is an essential prerequisite to commercial sales. However, smart watches now join groups of other products which exist on the boundary where choosing whether or not to seek formal medical device approvals is a more complicated strategic decision.
Other devices, such as electronic skin patches, can be used in a variety of applications such as muscular training and pain management, but are sold across a spectrum of both “wellness” devices or “medical” devices depending on the level of approval.
Medical approval does open up some new application areas (e.g. EMS rehabilitation for road accident recovery), adds to what can be claimed in product marketing, and often results in higher sales prices for the products. On the other hand, it costs a significant investment of time and money to get the approval in the first place, and performance can often be largely equivalent between the medical and non-medical versions (according to sources from companies with products in both areas).
The situation is similar with smart watches. The FDA clearance for ECG and atrial fibrillation alerts plus future options such as some of those mentioned previously does open up new application possibilities for these health devices. However, these remain relatively minor when compared to the broad adoption of the smart watch space as a whole. The approval does give an interesting edge in marketing, in terms of the specific products but also in the higher-level narrative around the technology positioning and reputation of the parent company. However, this again is a subtle advantage and typically still just a side note in the general product marketing narrative.
For example, the new mobility metrics announced by the leading smart watch maker were not directly mentioned in their biggest conference keynote presentations, with details only appearing on a supporting press release. In general, the favored approach seems to focus on under-promising and over-delivering, managing customer expectation in the short term while developing partnerships, know-how, product capabilities and strategies for expanding medical relevance over time.
Natalie Moreton is a digital marketing manager for IDTechEx, which since 1999 has provided independent market research, business intelligence and events on emerging technology to clients in over 80 countries. They work with business leaders, technology scouts, sales and marketing, and research and development teams in organizations large and small. She can be contacted at press@IDTechEx.com; or for more information go to idtechex.com.