Medical Device Curriculum Explains the FDA Process to Innovators

Kalush

A National Medical Device Curriculum is using fictional case studies to give students and science and technology innovators core information about the medical device regulatory pathway to market.

The curriculum, developed by the FDA-established Medical Device Technology Innovation Partnership, stems from the belief that delivery of new therapies to patients can be accelerated if medical device innovators understand the agency’s regulatory processes, according to CDRH senior science advisor Francis Kalush.

Writing in an FDA Voice blog post, Kalush says the curriculum grew from collaborations with several universities. It includes an understanding of the expertise needed to design, test, and clinically evaluate devices; identify the root causes of adverse events and device malfunctions; develop designs for devices with repetitive functions; and navigate the agency’s regulatory process.

Four learning tools developed so far cover the regulatory pathways for medical devices, safety assurance and risk management planning, and the regulatory pathways for novel devices and/or for devices that are substantially equivalent to already marketed predicate devices.

Each of the fictionalized case studies includes a student module and an instructor’s guide with ideas for exercises and class discussion. Kalush says the curriculum has been tested at several universities and given high praise.

“More case studies are being planned to help train the next generation of entrepreneurs and keep the U.S. a leader in medical device innovation,” she writes. “Regulatory training is particularly important in the development of medical devices, as the industry is heavily populated by small companies that may not have the expertise to navigate FDA’s requirements.”

Jim Dickinson is MD+DI's contributing editor.

[image courtesy of FDA]