Moderator: Janet Webb, President/Founder, MEDVantage, Inc.
Confirmed Panelists:
- Glenn Stiegman, VP, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) - Charles Schneider, VP, Reimbursement, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) - Thomas Novelli, Director of Federal Affairs, Medical Device Manufacturers Association (MDMA) - Neal Defibaugh, VP Clinical & Regulatory Affairs, AxioMed Spine Corporation
Participant Bios Moderator: Janet Webb, President/Founder, MEDVantage, Inc. In 1993, Ms. Webb founded MEDVantage, a regulatory and clinical consulting firm that provides companies with clinical and regulatory services. Assignments have covered a range of types of devices and clinical/regulatory challenges. Ms. Webb has worked extensively with spinal implants since 1993. Ms. Webb was also the Vice President of Clinical and Regulatory Affairs at Innovative Spinal Technologies. Prior to establishing MEDVantage, Ms. Webb held senior management positions at OttoSensors, a venture capital backed medical device start-up, Picker International, a one billion dollar manufacturer of diagnostic imaging equipment and Biometric Research Institute (BRI), a CRO later acquired by Quintiles. Ms. Webb earned an MBA from the Executive Program at Weatherhead School of Management-Case Western Reserve University, an MS in Biostatistics from Georgetown University and a BS in Medical Technology from Towson State University.
Glenn Stiegman, VP, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Stiegman manages and directs the regulatory affairs for MCRA and its clients and leads the firm’s submission process, regulatory strategy, analysis, and development. Mr. Stiegman previously served as Chief of the FDA Orthopedic Devices Branch, overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US, and has represented the FDA as a member of several Orthopedic leveraging groups.
Charles Schneider, VP, Reimbursement, Musculoskeletal Clinical Regulatory Advisers As a seasoned professional with more than 20 years of experience as an accomplished industry leader and author in reimbursement, health economics, and government affairs, Mr. Schneider directs MCRA’s reimbursement department for its clientele. Mr. Schneider has held key positions with large and regional insurance carriers as well as holding leadership positions within the medical device community.
Thomas Novelli, Director of Federal Affairs, Medical Device Manufacturers Association Mr. Novelli joined MDMA after working on the Committee on Finance for former Chairman and current Ranking Member, Senator Charles Grassley, for nearly four years. At the Committee, he worked on several areas directly affecting the medical device and pharmaceutical industries including Federal reimbursement, drug and device safety and approval, and fraud and abuse in the Medicare and Medicaid programs. Mr. Novelli conducted several high-profile investigations into the pharmaceutical and medical device industries including the investigations of the use of educational grants and off-label marketing, clinical research organizations, and conflicts of interest in the healthcare industry. He is currently working on issues facing the device industry, including ensuring adequate and timely reimbursement for new medical technologies, transparency issues involving manufacturers and physicians, and patent legislation currently before the Congress. Mr. Novelli holds a Master of Arts in Policy, with Honors, from the Catholic University of America and a Bachelor of Arts in Political Science from the University of Dayton.
Neal Defibaugh, VP Clinical & Regulatory Affairs, AxioMed Spine Corporation Mr. Defibaugh has 15+ years of medical device clinical and regulatory experience focused in orthopedic devices. He has clinical and regulatory and compliance experience in both class II and III devices obtaining marketing clearance / approval in the US, EU, and other international markets. Mr. Defibaugh joined AxioMed in December 2006 from Smith & Nephew, Inc., Orthopedic Division, where he previously served as Director of Clinical Affairs. He started his orthopedic medical device career at Smith & Nephew in 1992 and advanced through positions of increasing responsibility in clinical and regulatory affairs. Mr. Defibaugh has initiated and/or managed over 20 IDE studies, as well as numerous post-market studies. He has direct experience with accomplishment in managing varied orthopedic product's pathways from clinical investigation through regulatory approval including numerous post-market and FDA regulated studies as well as success in several original FDA PMA approvals and numerous PMA supplements, EU market approvals, and other international market approvals. Prior to Smith & Nephew, Mr. Defibaugh was employed by the University of Tennessee Medical Group in a clinical research capacity. Mr. Defibaugh holds a B.S. in Biology from Rhodes College (Memphis, TN).