The Next Generation of Hardware for Health

People from around the world are paying closer attention to their health. More people today select food based on the nutrition facts panel. Exercise and calorie tracking apps like MyFitnessPal have attracted tens of millions of users. And of course there’s the exploding interest in wearables: the worldwide market grew 223.2% in the second quarter of 2015 driven by consumer demand for more personal engagement in their health.

Advances in sensors and hardware are in part responsible for this revolution in proactive self-care. People want to understand more about their own body, and they now have access to certain forms of data previously available to them only through hospitals or research centers. But to keep up with consumer expectations, companies developing hardware for health need to evolve and think smarter about design and execution.

What will that next generation of consumer health products look like? From what we’ve seen so far, the products must have a strong value proposition to consumers. This could come in the form of a medically directed or condition-specific opportunity to track their health, such as non-invasive solutions for type 2 diabetes or asthma that offer an intervening therapeutic benefit. Of course, “non-invasive” also extends to the look and feel. Luckily, more companies today realize the value of fitting seamlessly into a consumer’s life. The trend of wearables turning into more of a fashion accessory is an encouraging example, and vital if hardware companies want their technology to work on someone’s wrist, or displayed on a bathroom counter or a nightstand. Next gen products must not only work, but be comfortable and aesthetically pleasing.

The next generation of hardware health products will also have a clearer strategic path to FDA approval, which we’re already seeing in practice. The time to market for a diagnostic hardware needing FDA approval is considerably longer than an informative health product such as a fitness tracker. A few companies have validated the strategy of introducing a product into the consumer market without specific health claims in order to collect consumer data and learn about their product in the market before they consider pursuing an FDA regulated path with a higher value proposition and more defined intended use. Such products are also being used to improve reporting in current clinical trials: the National Institutes of Health reports that at least 299 clinical trials have used wearable technology to track the effects of drugs on participants. And the Department of Veteran Affairs will soon run a clinical trial to monitor veterans with back pain, possibly using Fitbits.

Our prediction: To get to market more quickly and to attract investment earlier in their lifecycle, startups interested in creating medical products needing FDA approval will first launch informative health sensors. This strategy will allow them to 1) get initial consumer interest in their product roadmap and 2) collect data that can build up to clinical trials necessary for FDA approval. This will be helped in part by the FDA itself, which has started to give better instructions on its regulatory process.

Despite the positive trends supporting their growth, hardware startups interested in developing consumer health products still have a difficult path ahead of them. Where can a smaller team access expertise in product design, engineering, manufacturing, and execution?

To help answer these questions, PCH and our partner Johnson and Johnson Innovation will host our first Hardware for Health workshop and cocktail reception on February 3. The session features a conversation with Casper de Clercq, Daniel Kraft and Yves Béhar, three powerhouses in hardware for health innovation. If you’re interested in learning how to capitalize on today’s opportunities to develop smart hardware for life enhancing and potentially life saving solutions, RSVP now.

And if you’re an entrepreneur from a transformative health hardware company either in the prototype or later development stage, check out PCH and Johnson & Johnson Innovation’s Hardware for Health initiative, which is a custom-fit program to bring hardware health companies to market. Apply here.