Wearable tech includes everything from wearable thermometers to robotic exoskeletons. It’s a hot investment area for Silicon Valley venture capital funds. But most startups in the wearable industry are very careful to avoid claiming that they are producing “medical devices.” Yet the divide between these wearables and medical devices seems incredibly arbitrary. After all, how is a traditional thermometer that you place under your tongue a medical device, yet a patch that you place on your skin to monitor your PH levels not one?
As this episode explores, that arbitrary distinction is made to avoid regulatory scrutiny from the Food and Drug Administration, which is responsible for medical devices. That regulation has perversely encouraged stagnation in the medical device industry, especially when compared to the bewildering array of new products and innovations coming out of the unregulated wearable industry.
Where is wearable tech heading? What counts as essential and non‐essential medical care? Why are health tracking wearables claiming to not be medical devices? How does the FDA regulate medical devices? How can you circumvent having to do a full review of a new medical device? How do FDA processes stifle innovation?