FDA and Industry Collaborate to Solve Regulatory Puzzle

With the goal of speeding up the time it takes to get new medical device technologies into the hands of patients, the FDA and Minnesota’s LifeScience Alley have made good on their promise to form a partnership by announcing on December 3 the formation of the Medical Device Innovation Consortium.

Medtronic, Inc. executive Maura Donovan, Ph.D., will be on loan from the company to serve as interim executive director of the group. She will recruit a Board of Directors, build the organization’s membership and initiate the first subcommittee teams to identify and lead specific projects. The group has raised about a half-million dollars in funding from industry members, but hopes to double that amount in the first year.

Consortium Goals

According to the agreement, the Consortium will function in the “pre-competitive medical device research space, with initial objectives focused on the creation of scientific tools to assist stakeholders in developing and assessing the safety and effectiveness of new medical device products.”

The ultimate goals of the MDIC are to:

• Enhance the quality and performance of medical devices;

• Improve the timeline of availability of these products to patients; and

• Validate and qualify new methods, tools, approaches and standards in order to increase transparency and effectiveness for industry stakeholders.

“The establishment of the Consortium is an impactful step in the advancement of medical device regulatory science, ” states Dale Wahlstrom, CEO of LifeScience Alley. “We have been working closely with Dr. Jeff Shuren, Dr. Michelle McMurry-Heath and CDRH (Center for Devices and Radiological Health) 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.”

Smoothing Regulatory Pathway

It’s been almost a year to the day when LifeScience Alley first announced a memorandum of understanding with CDRH to, “realign the day-to-day interactions between medical device companies and the FDA.” The hope was that if the tools for regulatory science could be identified and new devices developed using those tools, the path to regulatory clearance would be smoother.

Shuren told OTW that one area of potential collaboration is for the parties to create new computer-based simulation models of the human body. “By refining these models so that they can be used to simulate different stages of disease development, we may reduce the need for animal and human testing of certain implantable orthopedic devices.”

FDA Commissioner Margaret Hamburg, M.D. reportedly told reporters that many medical device companies are small businesses and don’t have the research budgets to find more effective ways of testing their products. She said the new group would pull information and ideas from industry, government and academia. “This can best be done by making sure we’re applying the best science to the task and bringing together the best minds, no matter where they are found.”

“Detoxifying” FDA/Industry Relationship

LifeScience Alley’s government relations VP Shaye Mandle previously told OTW that perhaps more important than the nuts and bolts of a highly structure collaboration, is an attempt to change the tenor of the current debate and “detoxify” the relationship between industry and the FDA.

He said the current public rhetoric has turned into a blame game between industry and the FDA over the regulatory environment. By creating a conversation outside of the political arena, driven by science and technology, Mandle believes substantive strides in improving understanding between the FDA and industry can improve their relationship and interactions.

The FDA has two missions. Protect and promote public health. Getting safe and life enhancing orthopedic devices into the hands of patients faster could do much to improve the FDA’s mission of promoting public health.