For medical device companies, the consumerization of Medtech represents a new paradigm. In the past, medical devices were more targeted toward healthcare providers and payers – now there is a demand for direct-to-consumer products. People are demanding to have more control over their healthcare and they want the ability to proactively manage it. The connected health and wellness devices market is expected to reach $612 billion by 2024, according to a report by Grand View Research Inc. and the wearable medical device market alone is projected to reach $14.41 billion by 2022, according to Markets&Markets Inc. As Medtech explores opportunities within this business model, this consumerization will forever change how healthcare is delivered and medical device evolve. In this episode of DeviceAlliance’s Medtech Radio, we speak with the FDA Consultant and President of Vascular Sciences, Dr. Michael Drues. Join us as we discuss the consumerization of Medtech, defining what is a medical device vs. wellness device with respect to regulation, the "essence" of these distinctions, interpretation of words, and one's ability to defend them in regulation, "Class 0" devices, and wellness devices impact on the evolution of medical devices.
