When the Institute of Medicine (IOM) released its report on the 510(k) process in July, many industry insiders reacted with skepticism, if not outright scorn. However, based on the picture painted in some conventional media accounts, some members of the public likely took the report seriously. Such a divide could put industry in an awkward place, public-relations-wise.

Media outlets such as The New York Times and the Washington Post depicted the IOM’s assessment as controversial but not illegitimate. The Times also preceded its reporting with an article about industry’s efforts to discredit the report before it was released and ran an editorial questioning whether the current approval process is safe. An uninformed reader might see an industry bent on maintaining dangerously lax regulations for the sake of profits.

But Kurt Wise, a professor who chairs the public relations department at Quinnipiac University, says industry should not be overly concerned. Wise, who has worked in medical device public relations, says companies should determine whether the issue is resonating with the sectors of the population that matter to them. While the Times articles may seem to cast industry in a negative light, Wise says, it’s important to gauge true public reaction before launching any counter-measures.

“How many people actually read the article?” Wise says, referring to the Times piece. “How many people actually remember what they read in the article, and are they likely to form any opinions that might sway whether they get a medical device once they’re speaking to their physician?” Wise says that in addition to traditional research tools, a good way to measure public concern about an issue is to go into the community and listen. In the days after the IOM report was released, Wise says, he had “not heard one single member of the lay public mention this issue, period.”

Wise says if the research were to confirm his hunch that device regulation is not resonating as an issue generally, he would advise industry to keep relatively quiet. It should engage FDA behind the scenes, he says, and avoid the public sphere, where the chance that it could be “painted as the heavy” is higher.

Jim Weinrebe, executive vice president of healthcare practices at Schwartz Communications, says industry should generally be doing more to further its reputation. “I don’t think you just wait until you think your interests are being affected in some adverse way economically and use that as the time to sort of step up and educate,” Weinrebe says. “I think you have to recognize the responsibility you have, the obligation you have, as a lifesaving, life-sustaining force in our society that is affecting more and more people, and I think they should communicate accordingly.”

Weinrebe agrees with Wise that industry should not loudly challenge the IOM. “Publicly questioning the integrity of a body deemed scientifically objective and dedicated to the public interest does not seem like a wise public stance for an industry entity,” he writes in a follow-up e-mail.

—Thomas Blair