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Michael Causey

FDA Compliance

Medical Device Makers Urged to Play Nicer by Sharing Data

Speak up now, or don’t complain later

Published: Wednesday, February 19, 2014 - 11:46

You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes.

The Institute of Medicine (IOM), already working with more than a dozen drug makers, the FDA and the National Institutes of Health (NIH), wants to see a little more enthusiasm from the medical device community when it comes to data sharing in device clinical trials. To be fair, this requires a delicate balance: Everyone wants to advance the public health, but it’s not fair to expect a drug or device company to just give away all of its hard-earned, costly proprietary data, either.

IOM understands that, it appears. Yet the medical device industry won’t be doing itself any favors by trying to ignore this issue. Beside the bad PR hit the industry could take, what happens if the FDA decides to just swoop in and impose something on industry? The drug folks have had their input, and the medical device industry would be well advised to speak up, too.

Industry and anyone else with interest in the issue has a few ways to get involved. Comments on IOM’s proposed framework for getting this right can be sent here until March 24, 2014.

For those in the area or looking for a nice trip, there is an open workshop in Washington D.C. on May 5, 2014.

Seems like the medical device industry has a clear choice here: Speak up now, or don’t complain later.

Reminds me of another useful slogan: Silence is consent.

IOM’s proposed framework can be found here.

Information on the public workshops is here.

First published Feb. 6, 2014, on the AssurX blog.

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About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.