Our Advisory Board consists of distinguished members of the medical device and diagnostic industry who play an active role in in educating industry professionals about product development, and regulatory, quality and compliance issues in the global medtech market.
Susan Alpert, M.D., Ph.D., Lead Regulatory Consultant, Cognos Therapeutics
Dr. Alpert is the Lead Regulatory Consultant for Cognos Therapeutics. She previously served as senior vice president, chief regulatory officer at Medtronic and was responsible for all of the company’s global regulatory efforts. Prior to joining Medtronic, Alpert served as vice president of regulatory sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation.
Tony Blank, Senior Director, Regulatory Affairs, AtriCure
Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).
Patrick Caines, Ph.D., Senior Director Quality Systems & Compliance Medical Devices, Intuitive Surgical
Patrick Caines, Ph.D., is the Senior Director Quality Systems & Compliance Medical Devices, Intuitive Surgical. He previously served as director, quality & post-market surveillance at Baxter Healthcare. Caines has more than 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.
Martin Cranston King, QA/RA Business Enabler for Medical Device and IVD ISO Lead Auditor
King has extensive hands-on global experience working throughout the whole life-science value chain. He has more than 40 years of experience in Electronics, Software as a Medical Device, Mechanical Engineering and Materials Science in the In Vitro Diagnostic, Medical Device and Pharmaceutical sectors. Since 2006, he has been working in Quality Assurance and Regulatory Affairs leadership roles for international organizations and today helps companies efficiently realize their goals while meeting Quality Assurance and Regulatory Objectives that are harmonized with their target markets, including the European Union, USA and ASEAN.
Steven Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding
Steven Niedelman serves as Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team at King & Spalding, LLP, specializing in regulatory, enforcement, and policy matters involving industries regulated by the FDA. He provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, tobacco and food industries. He assists firms with remediation programs, training, management oversight and responses to agency correspondence. Niedelman retired from the FDA after a 34-year distinguished career where he served as Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He also served as the Director and Deputy Director of FDA’s Office of Enforcement, where he presided as Chairman of FDA’s Compliance Policy Council. Before joining the Office of Enforcement, Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health.
Sanobar Syed, Associate Director of Forecasting, Market Insights and Strategy, BeiGene
With over 14 years of experience in pharmaceutical business strategy and forecasting, Sanobar Syed oversees ongoing innovation and enables key decisions at BeiGene ltd. She has led and forecasted multimillion dollars brands across her career in pharmaceutical giants like AbbVie and Novartis. With a masters in organic chemistry and MBA she has solidified her knowledge of long-range planning, business strategy, analytics, and forecasting. She is a subject matter expert and regularly speaks in this field at various national and international conferences globally.