When do fitness apps or health devices turn into wearable medical devices for patients, and how will that impact your practice?
Wearable electronic health devices are an excellent option for sensing physiological parameters of the wearer and moving quickly through the health space for chiropractors, physicians, and other health care providers.
In the $70 billion wearable technology market in 2019, $20 billion in revenue came from wearable medical health devices. On top of that, another $28 billion came from non-medical product categories such as fitness and “infotainment” product categories that also incorporate physiological monitoring to some degree. Traditionally, these two sectors have been clearly separated by dividing lines in the form of regulatory barriers. However, the introduction of increasingly sophisticated physiological monitoring techniques into products such as smartwatches indicates a growing encroachment to and beyond this line, bringing traditional consumer product companies into the medical device arena. .
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In June, the largest smartwatch seller in the United States introduced a slew of new features, including a slew of new health app features with “mobility metrics,” such as low-range cardio fitness , walking speed, stair descent speed, stair climbing speed, six-minute walk distance, double-tap time, step length, and asymmetry. These new features are based on the motion detection hardware that has been present in each edition of the product, illustrating the advancement of the algorithms used to characterize motion. Previously, watch motion analysis was used extensively in a variety of other features such as step counting, activity characterization, and fall detection alerts (one of the product’s first medical features ).
The market-leading smartwatch’s most important medical function was ECG monitoring – after the company won Class II clearance from the FDA for the ability to detect and notify the user of a heartbeat irregular, and an ECG app that could be used to identify potential signs of atrial fibrillation. These were deployed using the watch crown or features of a bracelet as an electrode, with biopotential measured on the finger. This feature was very similar to another cardio-band type product already on the market.
Health Devices and Intense Smartwatch Competition
The leading smartwatch maker is certainly not the only player introducing 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 photon detection 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 was advertised in both companies’ non-medical products and regulated medical devices. The fundamentals of the technique deployed in the different devices are similar. However, without formal regulatory approval, non-medical devices may show approximate indications of spO2 over time or incorporate it into approximate overall health metrics, but cannot link this to formal medical claims such as detection of sleep apnea.
Blood pressure monitoring progresses
Another increasingly popular medical measurement in wearable products is blood pressure monitoring. Industry players have taken the principles of a blood pressure cuff and deployed it into Class II FDA-approved smartwatches, and other players have produced similar devices based on this “occlusive” method. .
There’s also movement around “cuffless” optical blood pressure detection. While the first patents for this date back more than a decade, there has been a more recent trend to deploy optical blood pressure in wearable health devices.
All of these apps are in an overlapping section, where similar device functions may be recognized as fitness/wellness or medical/healthcare depending on the level of claims made and regulatory clearance. Products on the fitness/wellness side may use any of the metrics mentioned as part of general health assessment algorithms, but may not provide specific medical metrics or diagnoses. Regulatory clearance means that they have been specifically compared to previously approved medical products and produce equivalent performance in the specific area of evaluation. This allows the device manufacturer to make more claims, as well as to use the product in specific environments related to the trust domain. The regulatory boundary is clear but sits at the top of an ecosystem of products and applications that is a continuum from fitness/wellness to healthcare/medical.
The regulatory approval cap
For the majority of medical devices, regulatory approval or clearance is an essential prerequisite for commercial sales. However, smartwatches are now joining groups of other products that exist on the frontier 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 muscle training and pain management, but are sold in an array of “wellness” devices or of “medical” devices depending on the level of approval.
Medical approval opens up new areas of application (e.g. EMS rehabilitation for road accident recovery), adds to product marketing claims, and often results in higher selling prices for the products. On the other hand, it costs a significant investment of time and money to gain approval in the first place, and performance can often be broadly equivalent between medical and non-medical versions (according to company sources with products in both areas).
The situation is similar with smartwatches. FDA clearance for ECG and atrial fibrillation alerts as well as future options such as some of those mentioned above open up new application possibilities for these health devices. However, these remain relatively minor compared to the widespread adoption of the smartwatch space as a whole. The endorsement gives an interesting marketing edge, in terms of specific products, but also in the higher-level narrative around the technology positioning and reputation of the parent company. However, this is again a subtle benefit and usually still a side note in the overall product marketing narrative.
For example, new mobility measures announced by the leading smartwatch maker were not directly mentioned in their biggest conference presentations, with details only appearing on a supporting press release. In general, the preferred approach seems to focus on under-promising and over-delivering, managing short-term customer expectations while developing partnerships, know-how, product capabilities and strategies to expand relevance. medicine over time.
Nathalie Moreton is Head of Digital Marketing for IDTechEx, which since 1999 has provided independent market research, business information and events on emerging technologies 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 [email protected]; or for more information, visit idtechex.com.