FDA 510(k) reaction: The entrepreneur

Bob Schmidt is a medical device entrepreneur who has started several companies, including Cleveland Medical Devices (CleveMed), Orbital Research, Neurowave Systems and Flocel. Neurowave, in particular, has recently had an up-close view of the regulatory process for medical devices, having last month received clearance to begin selling a brain-activity monitoring system. Schmidt, Neurowave’s chairman, has years of experience navigating the regulatory process and rarely hesitates to share his opinions on it.

Schmidt said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

“While small companies will need time to understand all of the effects of the new FDA rule changes, all taxpayers and healthcare consumers need to understand that new regulations that add expense or cause delays in getting new cost-saving medical devices to market will increase healthcare costs while denying Americans better technology that is available in the rest of the world, making the U.S. less competitive.”