Dr. Thomas J. Fogarty

Founder of Fogarty Institute for Innovation

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). 

Dr. Ken Sumner

Vice President of Worldwide Scientific Affairs for Ethicon Endo-Surgery

Tessa Yamut

Vice President of Regulatory and Clinical Affairs for BioVentrix

Tessa Yamut is Vice President of Regulatory and Clinical Affairs  for Bioventrix. Ms. Yamut has more than 18 years of experience in the medical device industry. She specializes in getting start-up companies their regulatory/clinical approvals to either begin a clinical trial or commence a product commercial launch, domestically and internationally. Her experience includes authoring various  FDA submissions, running clinical operations, and developing quality systems. Ms. Yamut also has extensive experience in gaining OUS approvals for clinical investigations and/or product launch in Europe, North America, South America, Australia, Asia, and Africa. Prior to joining BioVentrix, she has held several management positions at various start-up companies which include 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, Inc., and Sr. Manager of Regulatory and Quality Affairs at Kyphon, Inc. (acquired by Medtronic) and General Surgical Innovations (acquired by Tyco Healthcare). 

James Stambaugh is Vice President of Clinical and Reimbursement. Prior to Intersect ENT, Mr. Stambaugh 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. Mr. Stambaugh started his career as an analytical chemist at an ophthalmic pharmaceutical company, InSite Vision, and later transitioned into clinical research. Mr. Stambaugh holds a B.S. in Chemistry from the University of California at Davis.

James Stambaugh

Vice President of Clinical and Reimbursement

Moderator: Sandra J. Miller, Director of the Ewing Marion Kauffman Foundation

As Director of the Ewing Marion Kauffman Foundation’s new initiative, Labs for Enterprise Creation, Sandra Miller 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.Sandra joined the Kauffman Foundation in 2008 after 13 years at Stanford University, where she had a major role in the formation of the Stanford Biodesign Program -- a landmark educational program training the next generation of biomedical technology innovators. As Managing Director of Biodesign, Sandra counseled numerous Stanford inventors and community entrepreneurs on issues such as technology licensing, new firm formation, advisor development, fundraising strategy, and related university policies.Sandra was the Program Director for the Stanford Bioengineering Department’s translational research seed grant program. She managed medical device technologies at Stanford’s Office of Technology Licensing, negotiating several licensing agreement transactions.