FDA Joins Partnership to Improve Device Regulation

LifeScience Alley, a Minnesota biomedical trade organization, has established a partnership between the public and private sectors to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices. The U.S. Food and Drug Administration (FDA) has agreed to join the partnership, which is the first of its kind, according to organizers.

Dubbed the Medical Device Innovation Consortium (MDIC), the independent, nonprofit corporation will receive input from industry, government, and other nonprofit organizations. The MDIC’s aim is to prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.

“By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).

According to a statement released by the FDA, “Regulatory science—the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products—is critical to the medical device industry and to public health. Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market. For example, a computer model might be developed to test an implant on a virtual patient before a manufacturer spends the time and budget to study that product in a clinical trial.”

According to the FDA, the MDIC intends to bolster the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilized to better and more efficiently evaluate new devices. FDA staff may collaborate with the MDIC on MDIC-supported research and other projects.

“The establishment of the consortium is an impactful step in the advancement of medical device regulatory science,” said Dale Wahlstrom, CEO of LifeScience Alley. “We have been working closely with Dr. Jeff Shuren, Dr. Michelle McMurry-Heath and CDRH staff over the past year to build a mechanism to solve pre-competitive technical issues. This is an exciting partnership that will have a profound impact across the nation’s medical technology industry.”

McMurry-Heath is the assistant director for science at the CDRH.

The founding members of MDIC are Abiomed Inc., Becton Dickinson and Company, Boston Scientific Corp., CVRx Inc., Cyberonics Inc., Immucor Inc., Medtronic Inc., the National Organization for Rare Disorders, and Terumo BCT of the Terumo Group.

Leading the initiative will be Maura Donovan, Ph.D., whom LifeScience Alley appointed as interim executive director of the MDIC. Most recently, Donovan served as vice president of therapy research and development at Medtronic. As interim executive director, she will be leading efforts to recruit the inaugural board of directors to the consortium, build the organization’s membership and initiate the first subcommittee teams to identify and lead specific projects. Medtronic will be providing the initial support for Donovan in this role as a loaned executive.

“Maura has provided excellent leadership to Medtronic over the years,” said Rick Kuntz, M.D., senior vice president and chief scientific, clinical and regulatory officer, strategic & scientific operations at Medtronic. “Given the magnitude of the impact regulatory science can have on the creation and approval of safe and effective medical devices, we believe Maura is an excellent choice to lead this effort, and we are glad that we are able to support LifeScience Alley by lending Maura’s time and expertise to the consortium.”