Austen BioInnovation Institute, FDA to partner on medical device regulation

The Austen BioInnovation Institute in Akron is collaborating with the U.S. Food and Drug Administration to share its expertise in the use of biomaterials and polymers in medical devices.

The goal of the partnership is to help the FDA more effectively regulate the safety and performance of the materials when they’re used in the manufacture of medical devices, according to a statement from the Austen BioInnovation Institute in Akron (ABIA).

For example, the partnership will allow the FDA to draw on the ABIA’s resources — such as a library of test methods for crystalline polymers — to develop research methods and protocols to standardize ways of evaluating devices that utilize biomaterials and polymers.

“Our partnership with ABIA will advance regulatory science by augmenting our capacity to examine and better understand engineered tissues, polymers and coatings, and to detect nanoparticle surface defects,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

The FDA establishes these sorts of external partnerships to leverage the expertise of academic and research institutions to help the agency stay up-to-date with the latest scientific and medical advances.

The ABIA is also engaging with the federal government on the group’s “value-driven engineering” initiative. The concept refers to developing low-cost, high-value medical devices with an emphasis on quality to benefit patients. ABIA leaders presented the concept to Obama administration officials earlier this year.