Sep ‘12
6
Questions about Medical Device Effectiveness
Have you noticed the increasing frequency with which reputable surgeons are questioning the effectiveness (not cost effectiveness) of new medical devices? I read about it every week in the Journal or the Times. The themes are the same: FDA has approved the safety and efficacy of a new product (meaning it does what it’s makers claim it does), but there are no clinical studies proving for how long it works nor whether it is more effective than other therapies – long term.
The manufacturer wants to move as much product as quickly as possible. Sometimes just to satisfy pressure from its investors to sell the product or the company to a larger device marketing company. A knowledgeable surgeon raises questions as did Dr Daryl Fourney in this case. And the device industry complains. What is somewhat different here is that the company is fighting back. This represents a deeper problem for device companies in the U.S. With payment policy focused on value-added and medical necessity and comparative effectiveness, the industry is having to change. This is hard news. Blaming it on Obamacare taxes won’t work.
Read Barry Meier’s medical device article in the NYT here.
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