Navigation Links
Expert Panel Addresses Medical Device Development Challenges Through Honest Conversation
Date:10/4/2011

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 EventBrite.com at http://lifesciencesummit2011.eventbrite.com/.

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 www.advanceresearch.com.

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 www.fogartyinstitute.org .


'/>"/>
SOURCE Fogarty Institute for Innovation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Experts to Provide Successful Strategies for Global Biopharmaceutical Development and Commercialization at PAREXEL Tokyo Seminar
2. Virtual Radiologic Partners with Doctors Without Borders/MSF to Deliver Expert Patient Care to Underserved Countries
3. Genesis Biopharma Adds Cell Therapy Bioprocess Engineering, Clinical Trial Design, Biostatistics, Regulatory Affairs and FDA Compliance Expertise
4. PRA Experts to Speak at Drug Safety Conference Breakout Session on Risk Management Strategies
5. Leading Experts Heart Health Advice: Flush Your "Flush-Free" Dietary Supplement Niacin
6. International St. Gallen Expert Panel Highlights Importance of Molecular Subtyping in Breast Cancer Treatment
7. Independent Expert Panel Calls for Information on Fragrance Ingredients Under Review
8. PRA Experts Pulmonary Function Textbook Reissued
9. Cancer Treatment Experts from Across Latin America Gather in Rio de Janeiro to Discuss Advances in Radiation Oncology
10. BD Diagnostics Hires Leading Infectious Disease Diagnostics Expert to Strengthen New Product Pipeline
11. Edward Breast Imaging Expert Lauds Swedish Mammography Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... , April 19, 2017 Global ... This report on the prostate cancer therapeutics market ... global market. Increasing prevalence of prostate cancer, launch ... in the development of new drugs & therapeutic ... cancer drug due to lesser side effects are ...
(Date:4/19/2017)... Companion animal vaccines ... pets such as canine, avian and feline. ... such as Attenuated Live Vaccines, Conjugate Vaccines, Inactivated ... Recombinant Vaccines. Attenuated live vaccines are derived from ... have been weakend under laboratory conditions. Conjugate vaccines ...
(Date:4/18/2017)... 2017  Cardinal Health (NYSE: CAH ) ... earnings per share (EPS) guidance and providing a preliminary ... conjunction with this morning,s announcement of the planned acquisition ... Insufficiency businesses. Cardinal Health now believes that ... at the bottom of its previous guidance range of ...
Breaking Medicine Technology:
(Date:4/26/2017)... ... April 26, 2017 , ... Miami native and local periodontist ... “I could have never imagined back in 1991 that this journey would have taken ... Over the last 25 years, Dr. Gallardo has pioneered implant dentistry innovation, evolving into ...
(Date:4/26/2017)... ... April 26, 2017 , ... ... proud to announce that it has received 510(k) clearance from the U.S. Food ... and the MyoCycle Pro. , Both devices are stationary cycling systems that use ...
(Date:4/25/2017)... NY (PRWEB) , ... April 25, 2017 , ... A ... stress at work can also decrease overall productivity and performance in the workplace. The ... employees. , During the last few weeks of April, Clearview Resolution Services will be ...
(Date:4/25/2017)... NV (PRWEB) , ... April 25, 2017 , ... ... now choose a modern procedure that achieves results in a fraction of the ... in Las Vegas, NV, with Significance Dental Specialists, now offers this revolutionary treatment ...
(Date:4/25/2017)... ... ... B. Chaudhary, MD is committed to providing the highest quality of spine care to all ... care with all my patients to alleviate possible future issues. I am pleased to have ... office and my trained staff will assist you in any way possible.” , Dr. Saad ...
Breaking Medicine News(10 mins):