When a group sits down to plan a major industry convention the inclination is often to land a big-name keynote speaker, a rock star of the trade, to attract attention.
In the case of the FDA/Xavier Medical Device Conference (MedCon 2010
) that "rock star" is Steven Silverman, a senior adviser at the U.S. Food and Drug Administration whose topic is, "The Strategic Compliance Program of the Center for Devices and Radiological Health."
Yes, for medical device makers, getting up-close-and-personal with the FDA is as good as having a front row seat to a Bruce Springsteen concert.
"When FDA officials come to an industry gathering, people hang on their every word," says Marla Phillips, PhD, founder and director of Med-XU, which is cosponsoring the conference with the FDA. "At first someone did suggest we budget for a keynote from an athlete or a politician. I said, 'They aren't going to care about that. They want to hear from the FDA.'"
MedCon 2010, on the Xavier campus May 4-7, is drawing over 200 attendees from five different countries and 16 states representing over 70 companies. The conference/workshop features FDA personnel from Washington and Cincinnati, along with prominent ex-FDA medical device experts and renowned global regulators, to discuss quality, regulatory and clinical challenges. In short, it's a conference on how to get your device to market.
Medical device products range from simple things like tongue depressors, thermometers, contacts lenses or blood sugar meters to X-ray machines, heart stints, defibrillators, prosthetics, pacemakers, hip replacements and diagnostic kits. That is, any device you might put in or hook up to your body.
Most significantly, MedCon 2010 puts Xavier University on the medical and biotech map and brings rare FDA access to companies based in the heartland.
"Having this here opens a lot of opportunities for companies in Ohio, Indiana and Kentucky," says Phillips. "Some are small companies that would not normally travel to your typical D.C. conferences. And the FDA has not often partnered with medical device organizations. So this is pretty unique."
The Greater Cincinnati medical device industry is considered a significant, but not huge, part of the overall regional health care sector. It does feature a mix of big and small companies ranging from the West Chester-based DiaPharma Group with 15 employees, a distributor of diagnostic kits used to study bleeding and clotting disorders, to the giant Ethicon Endo-Surgery, Inc., a division of Johnson & Johnson, which manufactures and distributes surgical devices employing hundreds at its Blue Ash facility.
It's the smaller players in the region that will benefit from one of the rare times FDA officials and other global experts come to them.
"We distribute for a lot of European manufacturers and we want their products available for clinical use, not just research. We want to help them bring their products through the FDA process," says Jennifer Kiblinger, Technical and Regulatory Affairs Manager for DiaPharma. "It can be hard to keep up with all the regulations, so to hear from the FDA directly is going to be extremely beneficial."
"What makes this very attractive for us is you don't have these types of meetings in the Midwest. They are usually on the East or West coasts. To have something like this in Middle America is a fabulous opportunity," says Susan Rolih, Senior Vice-President, Regulatory Affairs and Quality Systems for Meridian Bioscience, Inc. The Newtown-based company employs over 300 people designing and distributing diagnostic devices for infectious diseases.
There is increased interest in regulatory goals since the new FDA commissioner, Margaret Hamburg, has questioned whether the government is approving devices with enough scientific justification. "That put the industry in an uproar," says Phillips. "To be able to hear someone talk about their strategic plan is exciting."
The conference is also a feather in the cap for the Xavier Leadership Center, which has gained a reputation for "facilitated learning," with its outreach programs bringing together business, government and university resources. But until now it has not been involved with the medical and biotech industry. Indeed, when one mentions the biotech realm, it's the University of Cincinnati that comes to mind.
"I was a little surprised to hear this was at Xavier. And, I'm a Bearcat," Kiblinger says with a laugh.
Rather than setting up some crosstown biotech shootout, Phillips' efforts have fostered camaraderie between the universities.
"(UC officials) are very supportive of our program," Phillips says. "University Hospital, and other hospitals, are interested in getting FDA approval to run clinical trials involving medical devices. They are excited that internationally sought after speakers and FDA officials are coming to town. Perhaps we can partner in the future. We have the global industry connections and UC's got the research."
Credit Phillips with getting Xavier on the biotech resource radar. She was hired two years ago to start up the Leadership Center's Med-XU. Phillips holds a chemistry degree from XU and has worked in the pharmaceutical industry as a compliance consultant and a senior chemist at Merck & Co. With her pharma background she immediately began planning a conference for that industry. Then her FDA contacts suggested what is really needed is something to bring medical device makers together. According to Phillips, a large chunk of the device industry is comprised of smaller companies--at least compared to the pharma side-- and they don't often have the same access to the FDA and its thinking.
Phillips continues the XU medical buzz with a pharmaceutical conference in June. The FDA/Xavier Global Outsourcing Conference will again bring the FDA and industry compliance officials together for such issues as third party auditing, guidance for outsourcing and supply chain transparency.
"Before these conferences, no one within our industry realized Xavier existed, so they certainly alert the global industry that we are here," Phillips says. "But, ultimately, the goal is not to just have conferences. We want to make sure there is a need and we take care that we have structured them so they will make a difference."Photography by Scott Beseler