Medical Device Development Has Challenges; Time for an Honest Conversation

Mountain View, CA - September 7, 2011 – 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, presented a panel entitled "Overcoming Challenges in Medical Device Development: An Honest Conversation". The event was 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).

Early-stage medical device companies and medical device 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. These technologies have the potential to improve both everyday and extraordinary patient care. The purpose of the panel discussion is to reach out to medical device companies in Mountain View and the San Francisco Bay Area, and to present an occasion to learn from industry experts who have first- hand experience in developing medical devices and working in the current regulatory environment. The event will showcase the Bay Area's significant position in the medical device industry. The sponsors will encourage networking through structured time and an open question and answer period.

As Dr. Thomas Fogarty has stated previously, "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." Therefore, we are excited to bring this opportunity for world-class medical device mentoring directly to members of the Bay Area medical device industry community to assist them in their efforts to improve patient care.

Panelists for the event include: Dr. Fogarty of the Fogarty Institute for Innovation, Ken Summer of Ethicon Endo, and Tessa Yamut of BioVentrix.

Dr. Thomas Fogarty, Founder of 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 over 100 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. In addition to Eunoe, he has been affiliated with two other start-up companies including ATI Medical (prostate cancer) and Cytyc Corp. (cancer diagnostics). Dr. Sumner has also been associated with mid-large companies, including Nellcor Puritan Bennett (respiratory care), C.R. Bard (interventional cardiology), Zimmer (orthopedics), and Warner Lambert (hematology reagents).

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. Prior to BioVentrix, she held management positions at start- up companies including Vice President of Regulatory and Clinical Affairs at Cabochon Aesthetics, Sr. Director of Clinical and Regulatory Affairs at Spinal Kinetics and Relievant MedSystems, Director of Regulatory and Quality Affairs at Cardiovention.

Peter Shabe, President of Advance Research Associates, Inc. says "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."

The panelists and sponsors offer a look forward with the "Honest Conversation" panel on October 13, 2011. Registration is available now at There is a $75 fee for each attendee.

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

About the Chamber of Commerce Mountain View, CA
The Chamber of Commerce Mountain View is a non-profit, business organization working for the mutual benefit of its members and the community by enhancing an environment in which business can succeed. Further information is available at:

About the City of Mountain View, CA
The City of Mountain View, home to over 74,000 residents and its notable Downtown on Castro Street, has an environment that encourages innovation to its many communities in private, public, civic and educational endeavors. The Economic Development Division builds alliances with all industries and organizations. Further information is available at

For additional media inquiries, contact Ann Fyfe, Fogarty Institute for Innovation at 650.962.4560.

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