What’s been the biggest (or one of the biggest) roadblocks to continued advancement/improvement of medical wearables?
One of the biggest roadblocks is that active devices require long, expensive certifications to meet regulatory requirements. Regulations vary by country, but the U.S. tends to be very conservative in giving approvals with devices needing to be approved by the FDA. It’s hard to say how long it takes to get a device approved, but generally, the more revolutionary the device, the longer approval will take.
In addition, design challenges, such as efficacy, quality, size, patient experience, and costs, require specialized solutions when compared to traditional consumer or industrial product developments. When a consumer IoT device, like a smart thermometer, fails, the impact to the end user is fairly small. However, if a medical device fails—and especially an active device—the impact has the potential to be far more serious. To address these challenges, it’s necessary to go to extreme optimizations when designing these devices, such as custom integrated circuits, packaging, and architectures, in order to provide the best solutions.