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For a Brighter Future, FDA and Industry Must Focus on Solutions

You would expect there to be finger pointing and an undertone of hostility at a panel titled “CEOs Unplugged”—especially on the topic of technology and regulation.   But instead of talking about what’s not working and what’s not happening, the CEO panelists participating in the discussion at AdvaMed 2011 toned down the rhetoric and acknowledged what is working.  

By Tricia Rodewald 

The key to improving relations between FDA and industry is to focus on pragmatism rather than mutual criticism.
These industry leaders said that both sides (FDA and industry) have come to the conclusion that beating each other up isn’t productive. At least for now, the CEOs are ready to play nice—or at least nice-er.
 
For example, the CEO panelists credited FDA and voiced overall appreciation for the role the Administration has to play in the midst of all the limitations and bureaucracy it too must deal with.
 
The goal, it seems, is to focus on actionable, productive items and come together to improve the medical device innovation and regulatory challenges in the United States.
 
It was made clear that, at the end of the day, if both industry and FDA agree that the goal is to attain the best and safest possible outcomes for patients, positive change can be fostered.
 
While both sides may have different approaches to getting there, keeping that as the destination will, hopefully, allow for more predictability and consistency from FDA and more quality innovation from the medtech industry.
 
Otherwise, the United States will continue to see innovation flourish… outside of its borders.
 
Tricia Rodewald is director of marketing and strategic alliances at Pro-Dex Inc.
 
Image courtesy of ?Μø?α?_B?ε??? on Flickr.

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