FDA Accelerates Approval of Medical Devices

Left to right: Kwalme Ulmer, Jennifer McCaney, and DeviceTalks West moderator Tom Salemi discuss innovations in medical technology.

A decade ago, medical device companies often turned to Europe for the first regulatory approval of new products. The United States is a larger market, but many companies have turned to Europe for regulatory approval for their medical technology innovation efforts. As a result, according to his 2010 study by Dr. Josh Makower, patients in Europe had access to new treatments, on average, two years earlier than those in the United States.

Now, however, the tables have turned and the FDA is more likely to approve or approve new medical devices before their European counterparts. UCLA Biodesign Executive Her Director Jennifer McCaney said: DeviceTalks West.

McCaney worked with Medtech Impact Partners and BCG Managing Partner Kwalme Ulmer to explore how medical technology innovation has evolved over the past decade and how the FDA has adapted . The study is a “combination of quantitative and qualitative research,” Ulmer said. “That’s the exciting part.”

This survey shows a significantly different regulatory environment than 12 years ago. Makower’s report concluded that the U.S. regulatory environment is unpredictable, inefficient and costly, but companies are now more likely to seek regulatory approval in the U.S. before doing so elsewhere. I’m here. “I think it shows how far we’ve come in the last 12 years,” he said.

The FDA’s de novo classification process has evolved significantly. For example, “Ten years ago, de novo programs were ugly stepchildren,” he says Ulmer. “It was a very slow process.” But thanks to user fees, increased headcount and more precise guidelines, the agency has made de novo a “valid path,” Ulmer said. “If you had asked regulators 10 years ago if they wanted you to use de novo routes, they probably would have advised you not to use them. rice field. Regulatory timelines related to pathways are now faster and more predictable.

FDA’s progress in reviewing breakthrough medical devices has evolved broadly with more than a decade of policy innovation.

McCaney and Ulmer’s work with BCG highlights that a majority of 100 senior executives at medical technology companies now support the United States for initial regulatory approval.

Of course, there are still anecdotes of companies running into trouble trying to get regulatory approval for medical technology innovations. “There are some survey data that people are still complaining about. [the agency] We’ve changed lead reviewers, but at least we have public and research data that we can mine,” Ulmer said.