A group of determined -- and increasingly vocal -- medical technology investors and entrepreneurs from Minnesota recently met with the new head of the Food and Drug Administration's medical device division to offer a few pointed suggestions on improving the way medical devices are cleared by the controversial regulatory agency.
The prominent figures from the medical technology community -- who call themselves the Minnesota Medical Device Alliance -- met with Dr. Jeffrey Shuren on April 9 to discuss impending changes at the FDA, which regulates medical devices. A medical doctor and lawyer, Shuren was appointed director of the FDA's Center for Devices and Radiological Health division in January.
At the top of the group's concerns: Changes in the way the FDA approves medical devices that may soon require more testing.
The vast majority of devices are now approved through a process called 510(k) clearance, which simply requires manufacturers to prove a device is "substantially equivalent" to another currently on the market -- usually without conducting studies on patients.
The rumored modifications to the process may require additional clinical studies to prove a device is safe, something consumer groups have clamored for since several high-profile device recalls. That would mean devices could take much longer to be cleared for use in patients.
This would be particularly harmful to smaller companies, which are often the engines of innovation in med-tech, members of the alliance say. Larger companies such as Medtronic Inc. may be able to absorb additional costs of more studies and longer timelines before approval, but cash-strapped smaller companies would be disproportionately affected, they say.
"It seems like industry input is tainted," said Kristine Johnson, general partner of Affinity Capital in Minneapolis. "Our view gives them valuable perspective for FDA to listen to. Then they can decide how to interpret the information."
Venture funding for med-tech companies declined 34 percent from 2007 to 2009 -- from $3.8 billion to $2.5 billion, according to the National Venture Capital Association. Part of the reason for the decline is the uncertainty associated with the FDA, according to Pete McNerney of the health care venture capital firm Thomas, McNerney & Partners.
The average decision time for 510(k) clearances has increased to 140 days this year, compared with 90 days in 2006.
The 510(k) approval process is under scrutiny by the Institute of Medicine, and a report is expected next year. But the FDA may forge ahead with changes before then. Shuren will travel to Minneapolis -- a national hub for med-tech -- May 18 for a town meeting to discuss possible changes to the 510(k) process. In the meantime, members of the alliance will press members of Congress to take up their cause.
The various meetings come at a time when the FDA is under intense scrutiny by some members of Congress and consumer watchdog groups who claim the agency has been too cozy with industry and lax in tracking malfunctioning medical devices once they've been implanted. They also come at a time when the FDA's leadership has changed under the Obama administration -- under Commissioner Margaret Hamburg, the agency is expected to be more aggressive about drug and medical device regulation.
The leaders of the Minnesota Medical Device Alliance reportedly expressed frustration to Shuren with the FDA's perceived inefficiency and unpredictability -- traits they say make it nearly impossible to raise money for medical device start-ups.
"Companies may follow the rules and raise large amounts of money, only to be told there are new requirements," McNerney said.
At least one local medical device company -- Disc Dynamics -- ran out of money and shut its doors; company officials said the FDA kept asking for more and more data. Another company, Plymouth-based Atritech Inc., received a favorable recommendation for approval by an FDA advisory panel, but is now required to conduct more studies to further prove its heart device is safe and effective. To date, Atritech has raised about $90 million in venture capital.
A series of high-profile recalls of devices by Guidant (now Boston Scientific) and Fridley-based Medtronic in recent years has made the FDA increasingly risk-averse, according to members of the alliance.
Rich Lunsford, CEO of the Minnetonka start-up Anulex Technologies Inc., attended the meeting with Shuren and was encouraged.
"He was taking a lot of notes, it was very interactive, and he asked questions," Lunsford said.
Shuren reportedly brought 16 staff members to the meeting. (The FDA did not respond when asked for a comment.)
The alliance wants the 510(k) framework preserved, but with improvements in communication and collaboration with medical device companies.
At least one group applauds the FDA for taking a more aggressive stance on the 510(k) process. The American Association for Justice, a Washington, D.C.-based group of plaintiffs' attorneys, said the current process is not adequately protecting patients. The group has called for increased surveillance of devices once they've been implanted; penalties for companies submitting inaccurate data to the FDA, and more reviewers for each 510(k) submission.
"There's nothing in our suggestions that would stymie innovation or even substantially slow down the process," said Sarah Rooney, regulatory counsel for the group.
Janet Moore • 612-673-7752