At the close of his two-day visit to Minnesota, Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health, announced that a new public-private partnership will be formed with trade group LifeScience Alley in efforts toward developing regulatory science, a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.
"As a country we don’t invest in regulatory science as opposed to basic science or translational science," Shuren said.
Details of the partnership, which is still in nascent stage, were not available. But Dale Wahlstrom, president & CEO of LifeScience Alley, said that creating a structure is the group’s no. 1 priority.
The hope is that if the tools for regulatory science are identified and new devices developed using those tools, the path to regulatory clearance will be smoother. If the pilot works in Minnesota, it may serve as a national model for medical devices safety and clearance.
Shuren told the audience gathered in St. Paul that such a broad public-private partnership involving the FDA is a first for the medical devices industry. However, such collaborative models do exist with drug makers. Shuren’s deputy echoed his comments.
“Regulatory science has helped lay the foundation for new drug development,” said Dr.William Maisel, deputy director for science at CDRH.
One such regulatory science tool is computer modeling, Shuren said, which can take the place of very expensive testing. Further, having such a partnership may help to clarify what tools are required to assess new technology like nanotech, Wahlstrom added.
Wahlstrom explained that the public-private partnership, whatever form it takes, is meant to engage small, medium and large medical device companies with varying levels of involvement depending on their needs.
“It is meant to advance the entire industry,” Wahlstrom said.
Maisel also hastened to remove any notion that the FDA will be the 800-pound gorilla in the collaboration and sought to manage expectations.
“It’s not a partnership with FDA steering the ship,” he said. “Building science takes time. This is not going to be an immediate solution to problems of industry.”