FDA turns to Akron partnership to help bring safer medical devices to patients

From joint replacement implants and cancer drug delivery systems to pacemakers and stents used in blood vessels, many medical devices aimed at healing the body have one thing in common: polymers. Now, as the number of patients needing such devices to get them back on the road to recovery grows, so does the need for biomedical implants to be safe, effective and compatible with the body's own tissue.

That's why the Food and Drug Administration is turning to Akron – specifically, the Austen BioInnovation Institute in Akron (ABIA), a partnership of The University of Akron, Northeast Ohio Medical University (NEOMED), Summa Health System, Akron Children's Hospital, the Akron General Health System and The John S. and James L. Knight Foundation – to help it determine the safety and reliability of medical devices made with biomaterials.

The Memorandum of Understanding between the FDA and the ABIA is designed to speed the development and approval of safer medical devices. Researchers will help device manufacturers develop and test more reliable coatings so that medical devices are less likely to corrode inside the body. They also will develop new ways to predict the possibility of device failure. As devices get smaller, the surface coatings become thinner, so it is more difficult to detect weaknesses and defects.

Working to increase effectiveness

"In fact, as the devices have gotten smaller, failure rates have increased," said Matthew Becker, Ph.D., associate professor of polymer science at UA. "So there's tremendous incentive for device manufacturers to detect defects that occur during the manufacturing process so implants will not fail after they are placed inside the body."

Research will be conducted at the Akron Functional Materials Center (AFMC) in the National Polymer Innovation Center on the UA campus. AFMC assists industry, researchers and innovators with the design, fabrication and optimization of polymers and advanced materials. Launched with $1.6 million funding over two years from the ABIA, the center, which employs 40 faculty and 300 graduate students engaged in all areas of polymer research, provides industry and other organizations with open-source access to experts and technological developments across areas of research covering six technical working groups: nanomaterials, complex fluids, biomaterials, adhesion, membranes and automation.

The center, which is led by Becker and Alamgir Karim, Ph.D., The Goodyear Tire and Rubber Company Professor of Polymer Engineering at UA, has established partnerships with 16 companies to date, including Dow-Corning, PolyONE Corp., Lubrizol and United Technologies Research Center. It is anticipated that this list will grow significantly as more device manufacturers seek the expertise available in Akron labs.

Partnership could improve quality of life

Becker, whose specialty is tissue engineering and imaging, said he and other researchers associated with ABIA will work closely with the FDA's scientific staff to determine how the materials are going to react in the body, and also help determine a way to accelerate approval of the devices.

"It's easy to make a material but difficult to prove you have what you think you have,” Becker said. "The FDA also is relying on our researchers to determine the specific performance – a reliable and predictable performance – of the material that has been created."

Media contact: Laura Massie, 330-972-6476 or massie1@uakron.edu.