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Expert Panel Addresses Medical Device Development Challenges Through Honest Conversation

MOUNTAIN VIEW, Calif., Oct. 4, 2011 /PRNewswire/ -- Advance Research Associates (ARA), The Fogarty Institute for Innovation, Mountain View Chamber of Commerce, and the City of Mountain View, in cooperation with Fenwick and West, will hold a panel discussion entitled "Overcoming Challenges in Medical Device Development: An Honest Conversation." The event will be held on Thursday, October 13, 2011 at 7:30-9:30 AM at the Fenwick and West offices in Mountain View, CA (801 California Ave.).  Registration is available through at

Early-stage medical device companies and innovators throughout the San Francisco Bay Area are faced with difficult development and regulatory environments, which present significant challenges to the commercialization of revolutionary new technologies.  The purpose of the panel discussion is to give Bay Area medical device companies the opportunity to learn from industry experts who have first-hand experience developing technologies in the current regulatory environment.  Internationally renowned cardiovascular surgeon, innovator, and Founder of the Fogarty Institute for Innovation, Dr. Thomas Fogarty stated, "If there's one lesson I've learned, it's to never give up. You learn from what doesn't work. I look back and appreciate how much my mentors have done and how they encouraged me to look further, to see what you can make better."

The event, which showcases the Bay Area's significant position in the medical device industry, will encourage networking and world-class mentoring through structured time and an open question and answer period.  

"The event provides an opportunity to discuss with principals from the medical device industry, the barriers they have encountered in their efforts in getting their products approved with the regulatory authorities both in and outside the US.  And, most importantly, hear what they did to overcome those barriers," added Peter Shabe, President of Advance Research Associates, Inc.

Panelists include:

Dr. Thomas Fogarty, Founder of the Fogarty Institute for Innovation, is known for innovation (and wine). His Fogarty Balloon Embolectomy Catheter, patented in 1969, not only revolutionized cardiovascular surgery, it revolutionized medicine. In addition to being the first balloon catheter to be used therapeutically, it also represented the first minimally invasive medical technology, causing far less trauma to patients than previous surgical methods. During the past 40 years, he has acquired 135 medical patents, including the "industry standard" Fogarty Balloon Embolectomy Catheter and the widely used Aneurx Stent Graft that replaces traditional open abdominal aortic aneurysm (AAA) surgery.

Dr. Ken Sumner is currently Vice President, Worldwide Scientific Affairs for Ethicon Endo-Surgery Inc. (a Johnson & Johnson Company) in Cincinnati, Ohio.  Prior to this he was Vice-President, Regulatory Affairs and Quality Assurance for Eunoe, Inc., a medical device start-up company in Pleasanton, California.  Dr. Sumner's thirty-five year career in the medical device arena includes positions in companies of various sizes and medical specialties. 

Tessa Yamut is Vice President of Regulatory and Clinical Affairs for BioVentrix.   Ms. Yamut has over 18 years of experience in the medical device industry. She specializes in getting start-up companies regulatory/clinical approvals to begin a clinical trial or commence a product commercial launch, domestically and internationally. She has authored FDA submissions such as 510k, IDE and PMA, developing quality systems, and running clinical operations. Ms. Yamut has experience in gaining OUS approvals for clinical investigations and/or product launch in Europe, North America, South America, Australia, Asia, and Africa. 

James Stambaugh is Vice President of Clinical and Reimbursement at Intersect ENT. Prior to this he served as Director of Clinical Operations at Guidant's Vascular Intervention division, responsible for conducting clinical studies for coronary embolic protection, stents, and drug-eluting stents. During his 11 years at Guidant, Mr. Stambaugh held various positions of increasing responsibility within the pre-clinical, clinical and regulatory environment. His combined 18 years of experience in medical device, pharmaceutical, and combination product development includes design and management of human clinical trials, conduct of in-vivo and in-vitro pre-clinical experiments, and experience with design controls, design validation, and risk analysis.

Sandra J. Miller (panel moderator) is Director of the Ewing Marion Kauffman Foundation's new initiative, Labs for Enterprise Creation. She develops dynamic educational programs to catalyze entrepreneurs of high-growth, scalable businesses. She developed and led Kauffman's Education Ventures and Entrepreneur Postdoctoral Fellowship programs. Prior to this she was Managing Director of the Stanford Biodesign Program -- a landmark educational program training the next generation of biomedical technology innovators – and counseled numerous Stanford inventors and entrepreneurs on issues such as technology licensing, new firm formation, advisor development, fundraising strategy, and related university policies.

About Advance Research Associates (ARA), Mountain View, CA

ARA was founded over fifteen years ago by Peter Shabe and has conducted over 200 trials in clinical research in North America.  ARA is a data management and biostatistical partner to the medical device, pharmaceutical and biotech industries, providing consulting services according to the unique needs of each client. Further information is available at

About the Fogarty Institute for Innovation

The Fogarty Institute for Innovation is an educational 501(c) (3) non-profit committed to the mission of improving patient care by supporting revolutionary medical innovation.  The Institute offers promising innovators world-class technical and business mentoring, laboratory space, and financial support to propel medical innovations from conception to application. Further information is available at .

SOURCE Fogarty Institute for Innovation
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