Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? Pretty exciting news for the medical device industry, which is experiencing a crossover of traditionally consumer goods and technology. For example, health insurance providers and wellness programs are starting to adopt such wellness products. So, expect more technologies to enter the medical device realm in the near future. In this episode, Mike Drues and I discuss this trend and related programs. Some of the highlights of the show include: ● Medical devices being used in a non-traditional clinical setting and by non-clinical professionals, which creates challenges for medical device developers. ● Usability is a concern because more medical devices are being used by untrained users with a lack of expertise. ● What’s the difference between a consumer vs. medical device? Regulations don’t distinguish a difference; what matters - intended use and who uses it. ● Regulations shouldn’t be technology specific, but broad. More regulations aren’t needed, what’s needed is a simpler definition of a medical device. ● FDA is challenged to keep up with the evolution of technology, but most regulations and the way people think tend to be timeless. ● Products need to be reliable and accurate, or more regulations will be implemented to address irresponsible companies. ● Programs are in place, including the Breakthrough Device Designation and Opioid Addiction Initiative, to enable non-traditional medical device technology. ● Does a product do what it claims to do to improve your quality of life? Regulatory risk can include weak medical claims.