Archive for March, 2011

Is FDA and Innovation like Oil and Water?

March 17, 2011 |  by  |  FDA, Innovation  |  No Comments

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?

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5 steps to starting clinical studies earlier

March 4, 2011 |  by  |  Clinical Studies, Development  |  1 Comment

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