Biotech Center Helps Medical Devices Get to Market
Published Apr 25, 2008
When Rick Gillespie and his partner wanted to develop a new self-injection medical device, they knew they had an innovative idea.
What they didn’t have was a fully – and expensively – outfitted laboratory that met the Food and Drug Administration’s stringent requirements for medical product development.
That’s where the Biotech Manufacturing Center in Athens came in.
The only business incubator in the country that targets medical devices, not research or new drug development, the center is fully outfitted to meet FDA standards.
“We didn’t have to go out and spend money on brick and mortar,” says Gillespie, program director for the now operational self-injection manufacturer, Pharma-Pen. “We were able to spend the money we raised directly for product development rather than capital equipment that we could use at BMC.”
Pharma-Pen is one of six tenants on site, which also has about 30 “virtual” tenants who don’t need to rent space yet but may be working on clinical prototypes, says Greg Roach, BMC’s founder and first executive director.
Roach came up with the idea for the incubator when he was at a small business center at Trinity Community College. The Athens area had lost thousands of manufacturing jobs, and the city’s economic development arm had an empty building it was about to padlock.
“We have over 1,000 incubators in the U.S., and only 60 or so are in the biotech or medical arena,” Roach says. “The thing that was missing is they couldn’t take the development to the market. In the medical development field, it is a costly key because you have to meet FDA ground rules.”
With the plan in place, Roach went bargain shopping. The center needed mold making, machining, ultrasonic welding and tubing equipment, all for work with plastic. It needed sophisticated “wet labs” and clean rooms.
BMC got its FDA certification in late 2004, and for Gillespie’s Pharma-Pen, the timing was perfect.
The company became the center’s first big success story in mid-2007, when West Pharmaceuticals acquired Pharma-Pen, Gillespie estimates BMC’s facility and technical staff saved at least two years of development time.
Story by Pamela Coyle
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