"If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science," said Jeffery Shuren, director of the US Food and Drug Administration's (FDA)'s Center for Devices and Radiological Health (CDRH) in a January 2012 meeting before members of the medical device industry.
In that January meeting, part of Shuren's "FDA Town Hall" series of events meant to drum up support for the agency's activities, Shuren also hinted at a new paradigm; one in which industry could come together as a public-private partnership to advance regulatory science-a kind of regulatory "Switzerland," he said.
Under such a proposed system, industry could share their regulatory science-based intellectual properties without fear of those secrets being leaked to industry competitors. Regulatory science, as defined by FDA, is the science of assessing the safety, efficacy and quality of new therapies using tools, standards and approaches.
Now Shuren's idea is getting some serious attention in the form of a new public-private regulatory science initiative just announced by FDA. The initiative, known as the Medical Device Innovation Consortium (MDIC), is structured as an independent, nonprofit corporation created by and overseen by LifeScience Alley (LSA).
The group, which bills itself as a biomedical science trade association, is now transitioning leadership of the MDIC to the organization itself, which will soon be overseen by a board of directors composed of both industry and government regulators and leaders. For now, MDIC will be overseen by Maura Donovan, previously VP of therapy research and development at medical device manufacturer Medtronic, Inc.
The goal of MDIC is very much in line with Shuren's thinking in January: By bringing together companies and regulators in the pre-competitive space to develop science-based tools to assess new therapies, companies can save money by being able to bring their products and therapies to market even faster. Regulators, too, can stand to benefit by being able to better protect the public from potentially unsafe products without relying as much on post-market adverse event reporting.
"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 Shuren in a statement released by FDA.
"The MDIC has been formed to add value at the intersecting needs of the medical device industry, FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the US," MDIC explains on its webpage.
The initiative already has some big supporters-Becton Dickinson, Boston Scientific, Terumo and Medtronic are all among the group's founding members, as are a number of other industry notables such as The National Organization for Rare Disorders (NORD).
The medical device-focused projects are already in the planning stages for early 2013, the group said. Subcommittees will soon be formed to develop project plans and prioritize topics with the goal of eventually sharing both best practices and the costs of developments created by MDIC.
And the initiative is also likely to receive a hefty amount of support from FDA. As reported previously by Regulatory Focus, FDA has been on a sustained push to show the public the benefits of regulatory science, mentioning it frequently in blog postings, a separate page on its website, its strategic plans, public appearances, and even launching other regulatory science initiatives.
For now, though, MDIC marks a ground-breaking regulatory science initiative for at least one reason: It's the only public-private partnership created to advance regulatory science in the medical device space. LifeScience Alley CEO Dale Wahlstrom called MDIC's founding an "impactful step in the advancement of medical device regulatory science."
"We have been working closely with Jeff Shuren, Dr. Michelle McMurry-Heath and CDRH staff over the past year to build a mechanism to solve pre-competitive technical issues," he added. "This is an exciting partnership that will have a profound impact across the nation's medical technology industry."