In September, medical professionals and designers gathered in Chicago for the American Medical Device Summit, covering the newest developments in medical technology. Medical Design Technology editorial director David Mantey sat down with professionals in the field to talk about the science and business of medical design.
The evolution of wearables is a particularly hot topic in the medical device field. Norman Rabin is the quality solutions leader with consulting firm Maetrics, which looks at compliance and quality issues within mergers and other business management concerns. He talked about how existing types of wearables might “evolve” into medical devices, used, for example, to monitor the health of the elderly. These home health care devices might run without the owner having to touch them, but the laws governing whether something is a medical device are still in discussion among regulatory bodies. Regulation is a big challenge to developing these kind of devices, Rabin said, and it continues to be so as the FDA launches new initiatives like their Quality by Design regulations and Pharmaceutical Quality for the 21st Century.