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The Implications of Digital Health

Digital health, the healthcare sector that is enabled and provisioned by wireless data and the Internet – which together have become known as the Internet of Things (IoT), is the the most significant force influencing the practice and future course of patient care. Digital health is already impacting such diverse areas as drug delivery, medical imaging, and patient/caregiver relationships.

Examples of connected health include drug injectors and inhalers that communicate with patients about when and how to self-administer therapeutic drugs, and which then collect data on dosing events and pass the information to a Cloud-based repository for caregiver review and response. A well-known example of connected health is the rapid spread and adoption of patient portals that allow patients to log on to their account, request appointments, prescription refills, and report health concerns.

One of the most dynamic areas of digital health is medical imaging. Software-based image processing and analysis – referred to as SaMD (Software as a Medical Device) have been proliferating rapidly. Many of these products employ artificial intelligence, machine learning, and neural networks in their algorithms, endowing them with the ability to evolve over time. There are now more than sixty such products approved by the FDA. Regulators are attempting to adjust approval parameters to reflect this capability. For now, a requirement for approval is that the algorithms be locked. Ultimately, the goal of product developers is to move to unlocked versions that will allow the software to adapt over time to become capable of keeping up with the growth in the imaging market.

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Smart Fabrics as FDA 510(k) Devices – Moving Beyond Consumer Gadgets

Interest in fabrics and textiles that incorporate sensors into the fabric and can detect and measure parameters such as body temperate and heart rate have become the new generation of adult toys, joining ‘smart’ watches and similar gadgets. This generation of smart clothing allows users to view data from the sensors on their smart phones and/or Apple/Fitbit devices. But a separate group of companies is emerging, those who are marketing smart fabrics as FDA 510(k) devices.

There are close to one hundred companies active in this market, a testimonial to the low barrier to entry. As a result, competition for sales can be fierce. A secondary business concern is the inevitable drop off in interest as the novelty factor wears off.

smart fabrics as FDA 510(k) devicesThere is, however, another tier of competition – smart fabrics as FDA 510(k) devices – those that have pursued the medical device track, designing and testing their products through the clinical trial process. Market participants that successfully navigate this path can receive marketing authorization – approval to market their products as medical devices for specific indications – under the FDA’s 510(k) authorization.

While the FDA approval process incurs more expense, risk and effort, success represents membership into a rather exclusive club. Of the companies competing for Smart Fabric market share, less than ten percent have at least one FDA approved medical device among their product portfolio.

As the competition continues to intensify for the average consumer/user, we expect the number of players developing and marketing wearables to examine the benefits of FDA approval.


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