Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.
Shuren told MassDevice that a study by researchers at Stanford University titled “FDA Impact on U.S. Medical Technology Innovation,” which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was “highly flawed.”
The Nov. 18th report was based on a survey of 204 public and venture-backed medical device companies out of a possible 1,023 companies in the domestic medical device industry, according to its authors.
“That’s well below the quality level of a good study,” Shuren said, pointing out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. “We want to have good data.”
However, Shuren told us he was most aggrieved by the assertion that the majority of costs to bring a device to market were spent satisfying Food & Drug Administration rules.
The report states that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. Higher risk premarket approval pathway costs averaged $94 million, with $75 million spent on FDA-linked stages, nearly 80 percent of the total cost of bringing devices to market
“The cost issue was based on the first time the company talked to the FDA through the time it went to market,” he said. “But, we talk to companies when the product is under development, which you don’t get in the European Union. We got dinged for talking to companies early.”
Shuren added that there was one surefire way to remedy the situation.
“We could cut costs dramatically by not talking to companies early, but I don’t think anyone wants that,” he said. “It’s a horrible survey.”
Dr. Josh Makower, one of the authors of the study, countered by saying the report’s premise on costs were correct because U.S. regulators influence the process much earlier than their European counterparts, due to a lack of uniformity in the investigational device exemption process. The result, he said, is that costs for the medical device manufacturer go up as they try to build clinical studies and find endpoints that U.S. regulators will accept.
“The issue isn’t that the FDA is being ‘dinged’ for speaking to companies early. It’s that the IDE process has become exceptionally difficult, whereas in Europe the process is exceptionally straightforward,” Makower told us, adding that FDA officials had seen the results of the study prior to its being publicly released and he hoped that the findings would spark collaboration and not acrimony.
“This study really points out for the first time some of the most upsetting and difficult aspects of the FDA process and it’s not a good report,” he said. “Those at the FDA have reason to feel defensive about it but we put real definitive thought into evaluating regulatory processes.”
Shuren was speaking at the annual FDA update at the Mass. Medical Society sponsored by MassMEDIC, the Mass. Medical Device Industry Council, in conjunction with the American Society for Quality/New England Biomedical Discussion Group & the Regulatory Affairs Professional Society/Boston Chapter.