The U.S. Food and Drug Administration has formed the first public-private partnership to promote regulatory science to speed the development, assessment, and review of new medical devices.

The new nonprofit Medical Device Innovation Consortium, or MDIC, will gather input from industry, government, and others to prioritize the regulatory science needs of the medical device community and then fund projects to help simplify the process of medical device design and the pathway to market for device 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,” says Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

A 2011 conversation between Shuren and Dale Wahlstrom, CEO of the Minnesota trade group LifeScience Alley, led to an agreement to form the new group, which will be led by Medtronic’s Maura Donovan.

Unlike the Advanced Medical Technology Association, the largest U.S. group representing medical devices makers, MDIC will focus exclusively on science and not address policy issues or any lobbying activity.

AdvaMed’s senior executive vice president, technology & regulatory affairs, Janet Trunzo, welcomed the new group, saying that AdvaMed “is supportive of any efforts intended to improve the efficiency and predictability of FDA’s review process so that patients may benefit in a timely manner from the latest medical technology advancements.”

The FDA in recent years has identified regulatory science—the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products—as critical to improving public health. As medical products grow in complexity, the agency is seeking to keep pace by interacting more with the industry, especially during the earliest stages of drug and device product development.

“Despite the extraordinary importance of devices to human health, there has been no concentrated effort to pursue pre-competitive medical device research, which could bring broad benefits to medical device development and review,” wrote FDA Commissioner Margaret Hamburg and Center for Devices and Radiological Health Associate Director for Science Michelle McMurry-Heath in the journal Science Translational Medicine. Efforts by the public and private sector to support research that adequately targets early-stage development of translation have been limited, they wrote.

Founding members of the new consortium, which include devices industry heavyweights, such as Medtronic, Boston Scientific; and Becton, Dickinson and Company, want to fill the current lack of funding for regulatory science research by pooling people, funding, and other resources to develop tools and methods to better evaluate new devices.

“With today’s fiscal realities, FDA cannot rely on government-funded ‘Manhattan projects’ to bridge the funding gap for regulatory science,” the FDA leaders wrote.

Donovan says initial projects supported by MDIC could support development and evaluation of key technologies, such as the safety of new biomaterials or computer models with which to test implantable devices on a virtual patient before a manufacturer spends the time and money to study that product in a clinical trial.

For now and through 2013, MDIC will remain primarily focused on formation work, say Donavan. With the assistance of LifeSciences Alley, the group is still identifying and recruiting its initial governing board. That will allow it to establish its priorities, form sector subcommittees, and develop project plans.