Fogarty Institute for Innovation Announces Extension of Dr. Thomas Fogarty's Tenure with FDA’s Entrepreneurs in Residence Program
FDA Initiative Aligns with Fogarty Institute’s Goal of Promoting U.S. Medical Innovation

Mountain View, CA - April 12, 2012 -- The Fogarty Institute for Innovation today announced that Thomas Fogarty, M.D., chairman, director and founder, will continue to serve as one of more than 20 Strategic Team Members to the U.S. Food and Drug Administration’s (FDA) Entrepreneurs in Residence (EIR) Program, an initiative launched in July 2011 that promotes U.S. medical innovation.

Sponsored by the White House Office of Science and Technology Policy, this pilot program brings seasoned entrepreneurs in the medical industry who have successfully navigated FDA’s regulatory process into the agency to collaborate, identify and implement ways for the FDA and small businesses to work together to research, develop and commercialize new medical products quickly and safely. Dr. Fogarty was initially selected for this advisory position in October 2011, and his tenure has been extended through September 2012.

“We look forward to continuing our work with Dr. Fogarty as part of the EIR program," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "He has been a critical part of the Innovation Pathway and our efforts to improve collaboration between the FDA and medical innovators."

“The number of medical device innovations in the United States is distressingly sparse due to a number of obstacles, including health care reform, a complicated regulatory process and a difficult funding environment that has resulted in many U.S. companies going abroad to develop and commercialize their products,” said Dr. Fogarty. “However, new initiatives such as the EIR program are working to turn that around by encouraging innovation and addressing some of the barriers that can impede the progress of medical devices to market. Based on my recent experience over the past six months working directly with the EIR to develop new pathways for innovative products, I am highly optimistic that regulatory trends that have previously slowed U.S. device development can be reversed.”

About the Entrepreneurs in Residence Program
The EIR program brings outside expertise to the FDA to work alongside agency staff and leadership to develop the Innovation Pathway, a priority premarket review program focused on breakthrough products and technologies that demonstrate the potential to revolutionize disease treatment, diagnosis and health care delivery and that target unmet medical needs. The EIR program is working to provide technical support to small businesses that may lack the expertise to navigate the approval process.

The EIR program is supported by the White House Office of Science and Technology Policy as a component of the Administration's Strategy for American Innovation. The EIR model brings together professionals with diverse talents from inside and outside government to work together as a team, to achieve outcome-oriented solutions of national importance within a short and focused time frame. Under this program, the FDA assembled two teams of experts in medical device development, business process improvement, decision analysis, and information technology. The Strategic Team provides vision and focus during the development of the Innovation Pathway, including the review of policies, business processes and tools that may be helpful in bringing innovative and safe new products to the U.S. market. The Tactical Team builds and implements the Innovation Pathway, including the development of new policies, processes, and tools.

About Dr. Thomas Fogarty
Dr. Thomas Fogarty, chairman, director and founder of the Fogarty Institute for Innovation, is an internationally recognized cardiovascular surgeon, inventor and entrepreneur. He has served as a founder, chairman or board member of more than 30 business and research companies. During the past 40 years, he has acquired 135 surgical patents, including the "industry standard" Fogarty balloon catheter and the widely used Aneurx Stent Graft that replaces open surgery aortic aneurysm. He is the recipient of countless awards and honors, including the Jacobson Innovation Award of the American College of Surgeons and the 2000 Lemelson-MIT prize for Invention and Innovation. Dr. Fogarty was inducted into the Inventors Hall of Fame in December 2001. In February 2011, he was inducted as the first National Academy of Inventors Fellow.

About The Fogarty Institute for Innovation
Located on the campus of El Camino Hospital in Mountain View, Calif., the Fogarty Institute for Innovation is a non-profit 501(c)3 organization that serves to energize the process of medical technology innovation. Its educational activities involve teaching the skills and methodology necessary for medical innovators to translate their ideas into new patient therapies. Companies affiliated with the Institute have access to the clinical experience and clinical trial management services available through the collaboration between the Institute, El Camino Hospital and the Taft Center for Clinical Research

Media Contact:
Chris Ernst

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