President & CEO
George Serafin is a 35+ year seasoned professional possessing a unique blend of industry, technology, and management consulting experience spanning R&D, engineering, supply chain, manufacturing, quality, regulatory, compliance, corporate/operations, and information technology across medical device and diagnostics, pharmaceuticals, biotechnology, and consumer healthcare.
With his broad and deep knowledge and “concept-to-patient” perspective, George has worked with Top-Ten to pre-revenue companies spanning late-stage development through commercialization and post-market surveillance. He has assisted clients globally (having worked in five continents) in the development and execution of business strategies, that promote innovation and growth, operational efficiency and process excellence, and sustained regulatory compliance.
George is a strategic advisor to the FDA, assisting them in various areas, including product quality, patient safety, advanced manufacturing, data integrity, cloud computing, and digital health. Most recently, he has been supporting FDA’s Case for Quality Initiative, having co-led several projects with the FDA and the Medical Device Innovation Consortium (MDIC) including the Voluntary Improvement Program.
He is recognized as a subject matter expert and has recently testified to the United States International Trade Commission (USITC) and Federal Trade Commission (FTC).
Before joining FTI Consulting, George served in various national and global leadership roles at Grant Thornton and Deloitte & Touche while always serving clients as his top priority. He started his career at Novartis in research and development. He then progressed across the value chain with increasing responsibility in engineering, manufacturing/operations, quality, and regulatory roles working for Roche and Fresenius Medical Care. While at Fresenius, George was part of the management team responsible to address an FDA Consent Decree impacting domestic and international sites and successfully remediated all sites leading to successful termination of the agreement within specified time frame while also still achieving minimal disruption to supply chain and the business.
Subsequently, he transitioned to the technology sector, leading the development, release and maintenance of SAP’s life sciences solution through several critical releases and assisting clients around the globe in the design, development, and implementation of their global enterprise solutions.
He holds a B.E. in Biomedical Engineering with a double minor in Electrical Engineering and Biophysics and a M.S. in Technology Management both from Stevens Institute of Technology.
Mike Sampson is an accomplished global commercial leader with a successful 26-year track record in business development, strategic sales & commercial marketing management within the medical device and diagnostics point-of-care IVD industry. Mike has led teams across the globe establishing strategic partnerships to drive success within sales, marketing and information technology. Leveraging his background in lab and point-of-care diagnostics, Mike has launched numerous GTM plans into new markets and rebuilt approaches to traditional markets to drive success into the future. Across the last 12 years, Mike has focused his passion on POC as a true solution that improves the interaction and outcomes with the patient, while also delivering the ability to reduce the overall costs of healthcare.
Dr. John E. Kelly, III
Scientific & Strategic Advisor
Dr. John Kelly has nearly four decades of experience innovating and leading in the Information Technology industry. Throughout his distinguished career, he has held significant technical and business roles driving IBM’s leadership in technologies ranging from semiconductors to supercomputers to artificial intelligence cognitive systems. A champion of IBM’s technical community, he has steered IBM’s leadership in U.S. patents for the last 27 years.
Kevin J. Reagan, PhD
Dr. Kevin Reagan is virologist/immunologist and a consultant on the assay development component of the NanoDx platform. Over a 40-year career, Kevin has led product development and operational activities at multiple international biotechnology and medical device companies. Kevin considers his expertise to be the integration of life science tools (recombinant proteins, monoclonal antibodies and immunoassays) with various engineering platforms to create a unique offering with tactical advantages over competition. Kevin has supported company’s strategy with over 12 acquisitions or mergers where he did technical evaluations, integration and served as a board member on companies prior to acquisition.
Rajeeva Lahri is a seasoned Executive with over 40 years of experience in the Semiconductor Industry. He has a proven track record in building value that has led to several successful exits. Rajeeva has held Senior leadership positions in Supply Chain, Operations, R&D, and Business Management. He has worked for several Tier I companies like Global Foundries, Freescale Semiconductors, National Semiconductors, VLSI Technology/ NXP, Intersil and Hewlett Packard.
Senior Director, Quality
Lawrence A. Mammah is an ASQ Certified Quality Systems Engineer, Quality Systems Auditor, and a fellow of the American Association of Manufacturing Engineering with four decades of Engineers and Quality Management Systems experience. Mr. Mammah started his career at General Motor Corporation as a Manufacturing Quality Engineer and later transitioned into the Quality division of GM as a Principal Quality System Engineer. Since departing from GM twenty-seven years ago, Mr. Mammah devoted his professional career and expertise in the Medical Device and Pharma industry and have worked for major medical device companies such as Stryker, Dentsply Sirona, to name a few. He is highly experienced and knowledgeable in ISO13485, ISO 19001, FDA QSR, GMP, EU MDR concepts, guidelines including national and international regulations/ standards. Mr. Mammah graduated from Central Michigan University, Mt. Pleasant, MI with a degree in Industrial Manufacturing Engineering & a Minor in Quality Systems Engineering. Mr. Mammah also hold a master’s degree in Engineering Management from the University of Michigan, Ann Arbor and an MBA in Operations Management from the University of Miami, Coral Gables Florida. Mr. Mammah is also a member of the Institute of Industrial Engineers and the Society of Manufacturing Engineers.
Dr. Ross Zafonte, D.O.
Chief Medical Advisor
Dr. Zafonte is the President of Spaulding Rehabilitation Network and the Earle P. and Ida S. Charlton Professor and Chairman of the Harvard Medical School Department of Physical Medicine and Rehabilitation (PM&R). He also serves as Chief of PM&R Massachusetts General Hospital, Chair of the Department of PM&R at Brigham and Women’s Hospital, and Senior Vice President of Medical Affairs, Research and Education at Spaulding Rehabilitation Network.