Minnesota Med-techies tell of snags in approval process

  • Article by: JANET MOORE , Star Tribune
  • Updated: May 19, 2010 - 5:31 AM

The FDA's Dr. Jeffrey Shuren mostly listened to speakers at a local, 4-hour town hall meeting.

One by one they stood up, approached a microphone and vented in a suburban hotel ballroom. Some were politely pointed. Others told tales. Many rambled on.

As Minnesota's medical technology community fumed about the machinations of the Food and Drug Administration on Tuesday, the object of their ire -- an erudite and occasionally droll government bureaucrat -- listened patiently.

Mostly, the 400 or so people who attended the town hall hearing at the Hilton in Bloomington spoke to FDA device division director Dr. Jeffrey Shuren about the difficulties they've experienced attempting to win agency approval of new medical devices. Each year, the FDA approves or clears for sale more than 4,000 devices.

The FDA-sponsored hearing in the Twin Cities was the first of three scheduled nationwide as a kind of regulatory listening tour.

Several speakers on Tuesday protested a lack of predictability in the FDA approval process, which constricts funding for start-up companies. They detailed what they see as bloated timelines and an unprepared, unresponsive agency staff that is often hostile to industry input.

Others plugged Minnesota's rich med-tech history and economy, arguing that an efficient regulatory process is a key component to nurturing a desirable device industry. Some complained the agency has grown too risk-averse, pointing out that no medical device is 100 percent risk-free.

All of the speakers were unerringly polite.

Shuren, a neurologist with a law degree, took it all in over the course of the four-hour meeting. He generally spoke without notes and occasionally engaged in a bit of humor. When a participant handed over a document detailing his ideas for improving the FDA, Shuren replied, "Now I won't be reading that Nora Roberts novel on the plane ride home."

The meeting began with Shuren outlining initiatives he's put in place since taking over the device division in January.

"This period of change at the [Center for Devices and Radiological Health] will end with a greater sense of predictability and transparency for those of you who work with us and rely on us each and every day," he said.

Shuren touched on possible changes to the 510(k) program, the pathway under which most medical devices are cleared for sale in the United States. The program permits a medical device to be cleared if it's "substantially equivalent" to one already on the market, often without clinical evidence showing that the device is safe and effective.

"I can say without reservation that we have no intention to scrap the 510(k) program," Shuren said, noting some changes to the program will be announced in a few weeks.

Shuren's speech was followed by about a dozen speakers, including politicians or their representatives, venture capitalists, doctors, academics and officials from companies and industry organizations.

A later question-and-answer session featured about a dozen people who expressed real-world frustrations with the FDA, often in great detail. One woman said she was trying to get a device treating sudden cardiac arrest approved but faced repeated questions from an FDA reviewer about whether the device affected patients' sense of taste.

After the meeting, participants gathered around Shuren, business cards in hand.

Several said they were impressed with the device chief's message, but remain cautious. "I appreciate the fact that he listened," said Pete McNerney, a partner in the Minneapolis venture capital firm Thomas, McNerney & Partners. "I hope this is the beginning of serious interaction with FDA."

Dr. John Sherman, an Edina spine surgeon who has consulted for medical device companies, said he was pleased with the meeting. "But it's one thing to say what he's saying. It's another to see if he can act on his words."

Janet Moore • 612-673-7752

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