WASHINGTON, D.C. - AdvaMed's Medical Technology Learning Institute (MTLI) has received the Leveraging Collaboration Award from the U.S. Food & Drug Administration (FDA) for a program to educate small device and diagnostics manufacturers and suppliers about the agency and its regulations. The program is a joint effort between the FDA and AdvaMed and is an example of public-private educational efforts aimed to improve understanding of the device regulatory system.

MTLI is AdvaMed's educational institute that offers a variety of educational programs including regulatory, technical, and professional training courses covering all facets of the medical technology business lifecycle. Faculty is drawn predominantly from AdvaMed member companies and government, complemented by a cadre of industry thought leaders. Thomas Maeder, MTLI's executive director, received the award in a ceremony held at the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in Gaithersburg, MD, which is part of FDA's Center for Devices and Radiological Health.

Maeder accepted the award on behalf of 22 FDA employees and two AdvaMed staffers who conducted the three sessions of the class in 2007 in Irvine, Calif., Denver, Co. and Pittsburgh, Pa. The sessions educated 235 individuals from small companies with valuable insights to medical device regulation.
"Helping small businesses better understand the intricacies of FDA regulation is critical to their future and to patient care. These smaller manufacturers are the engines of innovation in medical technology. Given the level of regulatory oversight of this industry, it's critical for companies and patients that on-going and continuous education occurs to ensure compliance," said Maeder.

"Leveraging the agency's limited resources with a major medical device association allowed us to successfully design and implement a meaningful program for firms that are newly registered with FDA," said William Sutton, DSMICA's deputy director. Sutton, who also received an award for his involvement in the program, said that FDA and AdvaMed will meet later this summer to consider expanding the workshop to other regional offices.

Twenty AdvaMed member companies and associate member firms have also generously volunteered expert speakers for the nine programs that have been offered during the past four years.

Program content includes an overview of FDA authority and structure, medical device and diagnostics regulation, pre- and post-market issues, available resources and the relationship between manufacturers and suppliers. The two-day program ends with high-level reviews of the principles of medical technology reimbursement, fraud and abuse and other legal issues, as well as AdvaMed's Code of Ethics on Interaction with Health Care Professionals.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.