MasterControl News Archive

U.S. physicians are losing trust in the FDA and CDC, according to a new survey that identifies a new challenge — and opportunity — for device developers and manufacturers.

Manufacturing quality software provider MasterControl surveyed 250 doctors in the U.S., including family medicine physicians, primary care providers, and device- and medication-oriented specialists.

The online survey was conducted from April 3-7, shortly after the Trump administration started mass layoffs at the FDA and other Department of Health & Human Services agencies, cancelled billions of dollars worth of federal research grants, and tapped controversial figures like Robert F. Kennedy Jr., Dr. Martin Makary and Dr. Mehmet Oz for leadership.

Related: Former CDRH Director Jeff Shuren on what FDA cuts might mean for device developers

While 71% of the physicians said the CDC and FDA bring value to their practice, 53% reported declining confidence in regulatory agencies over the last 12 months, including 46% for the CDC and 44% for the FDA.

“A striking 67% of American physicians believe regulatory decisions are not properly insulated from political influences, and 56% feel there aren’t sufficient opportunities for physician input in regulatory decisions,” MasterControl said in its report. “Over half of doctors (54%) agree there is room for improvement in regulatory institutions. This suggests that while these institutions remain valuable resources for physicians, there are significant opportunities to strengthen their effectiveness and rebuild trust.”

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And 82% of the physicians said they have questioned the quality or safety of medical products they prescribe to patients, including 41% who said they frequently question the quality of cosmetic devices and 26% who frequently question the quality of home medical devices such as glucose monitors and CPAP machines, the latter of which has made headlines for years due to the massive Respironics recall in recent years.

Regarding R&D, 98% said they were concerned about current medical research, with 92% worried about political influence on research priorities, 88% worried about commercial interests affecting research conclusions, 85% concerned about clinical trial funding and 84% worried about basic science research funding.

The challenge — and opportunity — for medtech companies

All of this presents a challenge for medical device developers and manufacturers, as well as an opportunity to set themselves apart from their competitors.

FDA authorization might no longer be enough to to earn the trust of physicians, who may need to see more evidence in the form of expanded clinical trials, post-market registries and other research.

And while medical device designers and engineers are always eager to learn more about user needs when developing new products, medtech companies might need to spend more time understanding and addressing the growing gap between physicians and regulators when designing products and clinical trials.

MasterControl says one potential solution might be artificial-intelligence-powered solutions like the manufacturing quality software it sells, pointing to the 54% of physicians who said they “believe AI should be used to improve quality assurance processes of pharmaceutical and medical device manufacturers.”

“When the vast majority of physicians question the products they prescribe, it signals an urgent need for enhanced quality systems and greater transparency throughout the medical product supply chain, and the manufacturing industry is uniquely positioned to address these concerns,” MasterControl CEO Jon Beckstrand said in a news release.

Related: Philips offers recommendations for building trust in medtech AI