The Burrill Report

The Burrill Report (June 6, 2011): Industry Says FDA is Forcing MedTech Innovation Overseas (.MP3,12.18 Mb)

The threat posed by the high cost and lack of predictability of FDA regulation of medical devices was the subject of a Congressional hearing June 2. The hearing came as the Medical Device User Fee Act faces renewal in 2012. David Gollaher, president and CEO of the California Healthcare Institute, testified on the issues of concern to the medtech industry over the FDA process of reviewing new devices and its impact on competitiveness. We spoke to Gollaher about his testimony, the growing frustration medtech companies have with the agency, and why these companies are increasingly looking overseas to bring their products to market first.

June 02, 2011
http://www.burrillreport.com/article-industry_says_fda_is_forcing_medtech_innovation_overseas_.html