Board of Directors

Harry Wachob, Ph.D. - Founder & President

Harry Wachob is the Founder and President of the Bio2Device Group. He is an experienced engineering leader in materials science, biomedical device engineering and R&D. He has directed and mentored multidisciplinary teams in solving complex technical issues in order to improve the safety, reliability, and performance of medical devices. He is currently the Managing Materials Scientist at Xoft, Inc. Previously he was Director of Engineering for Aerogen, Inc., a biopharmaceutical company specializing in novel aerosol drug delivery. Prior to that, Harry was Managing Engineer at Exponent/Failure Analysis Associates where he guided research and development, and product failure investigations covering a broad range of medical and industrial applications. He received his engineering degrees in Materials Science & Engineering from Cornell University.

Patrick Lee, P.E., RAC - Treasurer

Patrick Lee is currently the Manager of Regulatory Affairs at Micrus Endovascular Corp. in San Jose, CA. Mr. Lee is involved in regulatory activities worldwide for Micrus in obtaining regulatory approvals and meeting regulatory compliances. Prior to Micrus, he was involved in the development of drug-delivery devices. Mr. Lee has over 15 years of experience in FDA-regulated industries including health-care, medical device, and nutritional products. Mr. Lee received his Chemical Engineering BS from Cornell, MS in engineering from Columbia, and MBA from the Anderson School at UCLA. He is a licensed Professional Engineer in the states of New Jersey and California and holds several patents. Patrick holds the US Regulatory Affairs RAC (US) designation.

Stan Levy - Secretary

Stan Levy has over twenty years of experience developing and manufacturing medical products including electro-surgical devices and generators, catheters and guide wires, and ultrasound instruments. He has directed R&D and manufacturing departments at three start-up companies, delivering several products to market. Stan is currently consulting to medical device companies. Prior to this, he was Director of Imaging Development at iScience Interventional, Inc., Vice President of Research & Development at SURx, Inc. and Vice President of Manufacturing and Director of Instrumentation Research & Development at Cardiometrics, Inc. Stan is a graduate of Stanford University holding Bachelor and Master of Engineering degrees in Electrical Engineering.

Jim Beebe, Ph.D - Board Member

Jim Beebe has managed US and EU regulatory compliance for 23 GE Healthcare nuclear medicine, X-ray, CT, and PET imaging systems, from regulatory design specifications through post-market product complaint reporting. His excellent relationships with FDA often saved weeks of delay during the regulatory approvals, decreasing time to market. In another circumstance, many states had backlogs of 18 months and longer to approve new PET systems. Jim negotiated an alternative approval in 3 months that could be used in several states. As a result, GE increased its PET sales by more than $30MM. Presently Jim consults with startups and small device companies about the impact of regulations on their business. Jim holds a Bachelor degree in Mathematics from Stanford University and Ph.D. in Biomedical Engineering from University of Virginia. His dissertation explored a novel non-invasive respiratory measurement as a clinical indicator of cardiac health.

Audrey Erbes, Ph.D. - Board Member

Audrey Erbes, Ph.D., Principal, Erbes & Associates, is a life-science business development and marketing consultant, organization leader, public speaker, and educator teaching courses to working professionals at UCSC Extension. She has 30 years of managerial experience in biopharmaceuticals including Executive Vice President & Co-founder of Kowa Research Institute, a licensing and investment subsidiary of Kowa Company Ltd., Japan. Previously, she held U.S. and international management positions at Syntex Corporation in product management, strategic marketing, business development, and market research with a international emphasis on Europe and Asia/Pacific/Canada. She writes an industry blog at www.audreysnetwork.com. Audrey was named the NCC—Association for Women in Science, “2006 Distinguished Professional” and Professional Women’s Healthcare Alliance (PWHA), “2006 Innovator of the Year”. She holds an M.A. and Ph.D. in political science from the University of Florida.

Darshana Nadkarni, Ph.D. - Board Member

Darshana Nadkarni, Ph.D., Principal, Winning Difference, provides executive search services in medical device and biotech industry. Her clients include Incube Labs, Guidant, Intrapace, W. L. Gore, Spinal Modulation, Integrated Surgical Systems, Victhom Human Bionics, and Nfocusneuro. Darshana also provides training workshops in areas of cultural diversity, organizational development, leadership development, and conflict management to such companies as IBM, HP, 3M, Rosche, Siemens Medical, Verisign, Mastercard, Coca Cola, Verizon Wireless, and Dow Corning. She is a writer and contributor to the India Post, India West, & India Currents publications and is a regular volunteer at TiE. Darshana received her Doctor of Philosophy-Social Psychology, from the University of Cincinnati.