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Study: Europe medtech as safe as U.S.

1/28/2011 04:27 PM EST
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Mark Wehrmeister
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re: Study: Europe medtech as safe as U.S.
Mark Wehrmeister   1/31/2011 7:01:32 PM
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If the study is accurate (and not skewed by who conducted it) then medical device manufacturers would be wise to release new products in Europe first while waiting for approval in the U.S. The Europeans are apparently more willing to take risks than the U.S. regulators are and where there is more risk there can be a higher return, especially for those that really need the new medical devices. Hopefully device manufacturers will not abandon the U.S. entirely.

rick merritt
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re: Study: Europe medtech as safe as U.S.
rick merritt   1/31/2011 1:15:34 AM
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What I hear is we need an objective analysis that includes--how US and Euro processes differ, how approval times differ and recommendations based on the analysis on what to do next. Sounds great to me--anyone working on this??? Sounds like something that could have value for any global regulatory body.

kdboyce
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re: Study: Europe medtech as safe as U.S.
kdboyce   1/30/2011 6:21:40 AM
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In studies of this kind it is always useful to look at who commissioned and paid for the study. In this case it was the Advanced Medical Technology Association (AdvaMed), an industry trade group. AdvaMed have a "vested" interest in getting quicker approvals for medical devices and have pointed to the European process as well as lack of any definitive recall differences between the two systems to "explain" (read - justify) why device makers go for European approval first. The same thing can be said of the second survey cited in the article by Medical Device Manufacturers Association and the National Venture Capital Association. I am NOT saying the studies are inaccurate, but like any survey, the answers often depend upon the questions asked and in what context. It would have been better if a group not related to a trade group had done an independent study, then the results would hold more validity (at least for me). Not having any recommendations to improve the US process in my mind confirms what H.Gupta said about it in his comment.

wilber_xbox
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re: Study: Europe medtech as safe as U.S.
wilber_xbox   1/29/2011 5:05:24 PM
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If i believe that BCG took enough measures, as i expect them to take to finalize their study, and conclude that the European medtech is as safe as in USA then i am very surprised to read that the group did not make any specific recommendations to fasten the US approval procedures. From the tone of this article, BCG seems to believe that hard US regulations are not necessary and can be relaxed to the level of that in Europe.

Warren3
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re: Study: Europe medtech as safe as U.S.
Warren3   1/28/2011 5:43:45 PM
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Objective methods of comparison such as what BCG has attempted with this report ought to be a good tool for the FDA to develop confidence that loosening their grip won't lead to disaster. Now, not having actually seen the report, it will be interesting to hear if BCG took enough elements into account given that the US and European medical industries are different (things like the rate of introduction of new medical technology, rate of uptake once available for use, breadth of use by professional caregivers, etc.).

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