Industry+FDA group tries to make device approval process less painful

Few things are more challenging to medical device companies than the regulatory barriers that they must overcome to bring products to market. Recognizing that scientific innovators and federal regulators were too often talking past each other, a group of industry insiders joined forces with the U.S. Food and Drug Administration in 2012 to form the Medical Device Innovation Consortium (MDIC).
The group was originally launched by Minneapolis-based LifeScience Alley and has since become an independent, public-private partnership. At LifeScience Alley’s recent 2013 conference, officials from FDA, MDIC, and several prominent device manufacturers discussed the group’s potential to bridge the gap between businesses and regulators.
Michelle McMurry-Heath, associate director for science at FDA’s Center for Device and Radiological Health, said MDIC represents a new relationship between industry and the FDA. The group is focused on improving regulatory science, she said, in order to keep up with the rapid pace of innovation in the private market.
“The federal government is many things, but it’s not set up to be quickly adaptable — but industry knows how to adapt. That’s what you bring to the conversation,” McMurry-Heath told the audience. “We need to be able to have the best and brightest points of view at our disposal.”
Former Medtronic CEO and current MDIC board chair Bill Hawkins followed McMurry-Heath and discussed ways his group is trying to promote cooperation.
“We can’t continue to sit on opposite sides of the aisle and expect to understand what the other side is trying to do,” he said.
In practical terms, the group seeks to make the regulatory process more efficient and standardize some tools used in the pre-competitive part of the process. Understanding exactly what FDA’s expectations are and reducing duplicative tests or trials could be very useful outcomes for device manufacturers, especially smaller companies with limited resources.
Susan Albert, formerly chief regulatory officer at Medtronic, said it’s important to develop measurements that can be commonly used by industry and regulators. “If you’re a small company, you can’t take the time to develop every tool by yourself,” she said. “What MDIC provides is that safe harbor where companies can come together with the FDA and talk about what are the methodologies, what are the tools, that can be used.”