Medtech veterans have come to expect the path to regulatory approval to be arduous or even painful one. As the pace of development accelerated, it seemed that the FDA couldn’t – or wouldn’t – keep up.
But in recent years, the federal safety watchdog adapted, becoming more responsive and transparent, according to Mac McKeen, a seasoned industry professional and adjunct professor at the University of Minnesota.
“I’ve been working with FDA for over 20 years and they’re really leaning forward,” he told MassDevice. “Twenty years ago, you’d call FDA and they wouldn’t answer and then they’d never call you. Now, they’re very interactive, with pre-submission meetings and interactive reviews.”
The agency has been busy, issuing more than 75 releases in the first few months of 2018. McKeen noted that the FDA is making an effort to keep companies in the loop and appear transparent. To keep up with the slew of guidance documents and statements from FDA chief Dr. Scott Gottlieb, regulatory professionals should keep an eye out for summaries produced by daily journals and publications – they don’t have always have the time to comb through a 57-page guidance document, he said.
Gottlieb and the FDA have signaled a number of priorities for the medical device industry. Among them is a move to incorporate the use of real-world evidence into the product approval process.
“They’re not being reckless. They’re not lowering the bar or the rigor of data needed to get a product approved,” McKeen explained. “They’re open [to considering real-world data] because there’s such valid scientific evidence in peer-reviewed literature. Why ignore it? Why do another $30 million clinical trial to tell you the same thing you already know about a device.”
The FDA is working to identify how it can best use real-world evidence to make the regulatory pathway less costly and time-consuming, while boosting the quality of evidence generated for a particular device, according to the head of the FDA’s device group, Dr. Jeffrey Shuren, who spoke at this month’s meeting of the Mass. Medical Device Industry Council.
He noted that one challenge the industry has to help solve is how to generate consistent data in a real-world setting. If companies can figure out how to address that challenge, “then we could leverage real-world data much more in both making pre-market decisions and for post-market and it would allow us to better reflect the shifts from pre- to post-market that we could tolerate if we knew we were getting the data,” he said.
“We’re not sacrificing anything on data,” he added. “We’re getting a richer understanding of the technology than if all we were relying on was the more traditional pre-market clinical trials.”
