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. Most recently, he was the Managing Materials Scientist at Xoft. Previously he was Director of Engineering for Aerogen, 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 – Board Member and Treasurer
Patrick Lee is a regulatory affairs professional in medical device and cell therapy; he is involved in Regulatory Affairs, Quality Assurance, and Clinical Research. He was most recently the Director of Regulatory Affairs at BioCardia, Inc. in Sunnyvale, California. Patrick has been involved in RA, QA, and CA activities at Bay Area medical device companies for over 20 years. He has worked on products such as neuro-implants, cardiovascular devices, cellular therapy, blood processing, stem cell harvesting, drug delivery, laser, and electro-mechanical devices. Patrick has been involved in FDA, CE mark, and many OUS regulatory submissions and approvals. He has been a long-time instructor for RA/QA organizations and institutions including the University of California at Santa Cruz, RAPS, and ASQ. Patrick received his academic degrees from Cornell (BS), Columbia (MS), and UCLA (MBA). He is a licensed Professional Engineer in the states of New Jersey and California. Patrick is RAC (US) and CQA certified.
Stan Levy – Board Member
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.
Darshana Nadkarni, Ph.D. – Board Member, Vice President and Chair, Speaker Committee
Darshana Nadkarni, Ph.D., Principal, Winning Difference, does Recruitment for Medical Device and Biotech companies with her extensive network and an ability to match individuals with business requirements. Darshana offers a total package of recruitment that includes initial screening, complete reference checks, and all required follow up discussions. Some of her past and present clients include Incube Labs, Spinal Modulation, Robodoc, Intrapace, NfocusNeuro, Guidant, Victhom, G-Tech and so on. Darshana also facilitates trainings in areas of Diversity, Working Effectively with India, and a variety of other topics. Some of the companies she has facilitated training workshops for include Medtronic, IBM, Michelin, United Illuminating, Xerox, Coca Cola, Roche, Siemens, HP, SUN, NetApp, Inktomi and others. She writes blogs and contributes articles in Indian papers. Her blog is www.darshanavnadkarni.wordpress.com and Twitter Handle is @DarshanaN.
Ronald Schoengold, RAC, FRAPS – Board Member
Ronald Schoengold is an active consultant to medically regulated companies in biotechnology, pharmaceuticals and medical devices. He is a certified regulatory affairs professional and RAPS fellow. For the past 16 years, Ron has provided private consulting services in the areas of quality, regulatory and product development, helping businesses effectively commercialize and maintain their products and laboratory services. His prior experience with Beckman Coulter and its predecessor companies over 35 years was in product development, quality assurance and regulatory affairs. He has developed commercially successful pharmaceutical, screening and diagnostic products for gastrointestinal medicine, infectious disease and point-of-care testing. Ron earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry, and completed additional studies in genetics, molecular biology and immunology. He holds 8 patents related to point-of-care diagnostics, has published scientific articles and presented webinars on current trends in regulatory compliance and screening for gastrointestinal disorders.
BOARD ASSOCIATES
Susy Chen, MD – Board Associate
Susy Chen has over 20 years of professional experience starting in clinical practice and later transitioning to the pharmaceutical industry. As a medical professional, she has experience across the entire product life cycle, from clinical development and safety to medical affairs. She has in depth experience in building Medical Affairs departments from the ground up and working collaboratively with brand team members to develop a cohesive strategy for product launches. She has successfully hired and trained numerous Medical Affairs team members, including Medical Science Liaisons. She has worked in drug development, biologics, biosimilars and drug/device combinations. She continues to be licensed to practice medicine in the state of California.
Kerri Gogolin, MA, APCC, AMFT – Board Associate
Kerri Gogolin is a software technologist turned patient advocate and behavioral health clinician. Her graduate studies focused on the comprehensive needs of patients with cancer or psychological trauma, and she maintains California board registrations. Prior to healthcare, Kerri engineered new software products targeting a variety of industries for multinationals like Adobe Systems, Lucent Technologies, and also Fujitsu in Japan, where she got her start in artificial intelligence. Kerri holds degrees in computer science, linguistics, and clinical psychology, and has special interest in decision support for practitioners, patients, families, and stakeholders throughout the healthcare ecosystem. Along with her clinical endeavors, Kerri supports digital and med tech strategy for start-ups.