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Compliance In Focus
Posted by John Lehmann on Wed, Jul 25, 2012

A Call for Change at the FDA

The drumbeat for change at the FDA continues.  According to an article in MD+DI, leaders ofA Call for Change Minnesota companies and venture capitalists believe the industry faces a dire future unless the FDA changes its policies and procedures.

There seems to a growing chorus of concern that dramatic change is needed at the FDA. In addition survey by Introworks found there is a growing level of concern by CEOs and VC’s to invest in medical technology in Minnesota.  Here are some highlights of the survey results:

  • 64% have a negative view of the industry, in large part because of the regulatory difficulty imposed by the FDA.
  • 36% of the leaders indicated they would not invest in the medical device industry in the U.S.  A majority of the respondents indicated there strategy would be to invest outside of the U.S. in Europe or developing markets.
  • 85% of respondents indicate that the current regulatory environment is impacting their ability to create jobs.  Many indicate that future job growth at their companies will happen outside the U.S.

The major theme that seems to emanate from the survey’s findings is that Minnesota med-tech industry leaders do not feel that the change promised by the FDA has come to reality.  They hold Europe in very high esteem, specifically when it comes to timeliness, fairness and consistency.  They believe these aspects of the EU environment promote innovation and excellence.

There is no doubt the industry faces many challenges and many are concerned over the lack of goodwill between the industry and the FDA.  What is your reaction to this survey?  Can the med-tech industry and the FDA work together to help keep jobs from migrating overseas?  Let us know what you think.

Photo Credit:  Pete Prodoehl’s Photostream

Topics: A Call for Change, Medtech Industry, FDA, MD+DI


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