If you haven’t heard, the FDA has been publicizing their newly launched Medical Device Innovation Pathway. Besides the standard press releases, FDA’s Center for Devices and Radiological Health (CDRH) has created a 53-minute video starring Dr. Jeffrey Shuren, director of CDRH (see below) to spread the word. But, is the FDA really capable of fostering innovation outside a token project each year?
Incorporating clinical studies prior to design “freeze” into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-defined goals, proactive collaboration between functional areas and discipline. Read More