MedTech conference to focus on regulatory affairs

CNY Business Journal (1996+), Sep 7, 2007 by Tampone, Kevin

SKANEATELES - Developing a new product is hard enough.

Add strict oversight and regulations from the federal government and it's easy to get lost in the process, says Jane Metcalf, vice president of corporate and regulatory affairs at Conmed (NASDAQ: CNMD), a medical-device manufacturer based in Utica.

MedTech, an upstate New York medical-technology trade group, will concentrate on regulatory affairs during its annual conference, scheduled for Sept. 17-18 at The Lodge at Welch Allyn.

"It's important for overall health care and the Central New York economy," Metcalf says. "We want good product development here. If you believe that the jobs that are going to stay here are the high-tech jobs, then this is what we want."

The conference will feature speakers and panels addressing a range of regulatory issues faced by MedTech's members. Susan Alpert, senior vice president and chief quality and regulatory officer at Mechronic, Inc., will deliver one of the event's keynotes.

Medtronic (NYSE: MDT), headquartered in Minneapolis, is one of the world's largest medical-technology firms. It generated $12.3 billion in revenue in its latest fiscal year ending April 27, 2007.

Alpert also spent more than 15 years at the Food and Drug Administration (FDA).

Other talks at the MedTech conference will focus on the legal side of regulation, privacy concerns, global issues, and potential future changes in the regulatory landscape.

Federal rules for new medical devices are constantly changing, Metcalf says.

And there is so much to consider when launching a new product that it's easy for things to slip through the cracks, she adds. For example, a company may run a clinical trial and then discover the data doesn't meet the latest FDA specifications.

"We want [attendees] to be painfully aware of all the ... factors they have to put together to get a product on the market in the medical arena," Metcalf says. "We want to help upstate New Yorkers get a broader view of what they need to be concerned with."

The conference is especially timely as the FDA has intensified its monitoring of medical-device firms in recent years, says Dr. Robert Corona, Welch Allyn's chief medical officer. The scrutiny is at least partially related to the very public and political outcry following problems with implantable defibrillators made by Guidant Corp.

The company, which has since merged with Boston Scientific Corp., recalled thousands of the devices in 2005.

The issue, Corona says, hit close to home at his company, which manufactures an external defibrillator. Welch Allyn has since adopted many of the recommendations for improvement the FDA made to Guidant.

"Trying to be innovative and survive in a highly regulated environment presents a unique set of problems," Corona says. "Guidant was very high profile. I think all defibrillator manufacturers came under the microscope to some extent after that."

The lineup of speakers for the MedTech conference will give participants access to major expertise on regulatory affairs, he adds. In addition to Alpert, speakers include Stephen Terman, an attorney at law firm Olsson, Frank & Weeda, PC in Washington, D.C. and former enforcement counsel at the FDA, and Cheryl Blanchard, senior vice president for research and development and chief scientific officer at Zimmer, Inc., which manufactures hip and other joint replacements. Blanchard grew up in Camillus, Corona says.

It's critical for MedTech members to keep tabs on regulatory issues in the United States and throughout the rest of the world, says Heather Erickson, president of MedTech.

"It's the one topic that drives their business every day," she says.

Among the new challenges bearing down on medicaltechnology firms are those presented by converging technologies, Erickson adds. In many cases, new devices are developed using technology from other industries.

That means they weren't necessarily designed with all the unique challenges of the health-care market in mind, Erickson explains.

"Everyone's at the table because they're looking to improve human health," she says. "There's a lot that goes into that."

Last year's MedTech conference focused on the role of medical technology and the companies that develop it in disaster response. Attendees heard from first responders who were on the scene in the aftermath of Hurricane Katrina.

The event drew 180 people.

MedTech has about 80 member companies and affiliated groups. The organization launched in 2004 in Central New York, but has since expanded across the state.

The group now has members in Rochester, Buffalo, Albany, the Southern Tier, and the New York City area.