Regulating Our Complaining

Although it’s too early to assess the impact of an Institute of Medicine report on possible changes to the FDA’s process of reviewing medical devices, it’s not too early to gauge public sentiment to efforts by the medical device industry to resist additional regulation. Device manufacturers have been concerned about that forthcoming report since Jeffrey Shuren, director of the Center for Devices and Radiological Health, announced over a year ago that CDRH would be conducting an external review of the 510(k) process [NBR Jun10 p7]. A good preview of the public and media reaction to that resistance is an article in the July 27 New York Times about an “extraordinary campaign” by the device industry to discredit the IOM report even before it was released.

In case the article itself does not cast the medical device industry in a sufficiently negative light—citing, for example, criticism about industry efforts to resist additional regulation from editors of journals such as New England Journal of Medicine and the Journal of the American Medical Association—on-line comments from readers indicated the public perception problem the industry faces. Nearly all of the 100 or so comments posted to the NYT website—including several from medical professionals—castigated the device industry for putting profiteering above patient safety and for attacking the IOM report before it was released. The current political climate in the U.S. has created a perfect storm: conservatives are eager to find ways to reduce Medicare expenditures—including device reimbursement—and liberals are increasingly suspicious of corporate efforts to influence public policy.

Part of the problem confronting the neurotechnology device industry is being lumped in with manufacturers of metal-on-metal hip implants, cardiac stents, and other products that have experienced public relations disasters. With the possible exception of Medtronic’s recent problems with its SynchroMed II implantable pumps [see p4] and an earlier issue with cochlear implants, neurotech devices have been largely free of serious safety issues. Another problem is the IOM report’s focus on the 510(k) process, as opposed to the PMA process, which is replete with problems and a particular thorn in the side of neurotech devices.

Perhaps the best course of action at this point for neurotech device manufacturers is to conduct a public relations campaign that educates consumers and the media to the problems with the PMA process and divorces itself from the orthopedic and cardiac device vendors currently whining about impending changes to the 510(k) process. Like it or not, changes are coming, possibly including post-market monitoring, patient registries, and stricter definitions of predicate devices. We would be better to focus our attention on the excruciating PMA process that is costing the neurotech industry decades of delay and frustration.

James Cavuoto
Editor and Publisher



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