Mike Celentano has been influencing the Medical Devices sector since 1987.  He has acquired a broad array of skills related to product development including, but not limited to, organizational change management of systems engineering, directing technology portfolios, directing systems engineering disciplines, enterprise architecture, multi-disciplined engineering management, stakeholder management, system of systems, product line engineering, risk management, program management, advanced research and medical device prototyping. Mike has dedicated his career to developing instrumentation used to diagnose, monitor & treat disease.  He has been employed by Technicon, Miles, Bayer, Seradyn, UMM, Roche and Lilly to help develop and launch many medical devices across the world.  Before his 35+ years of MedTech R&D experience, Mike earned a B.S. in Electrical Engineering from N.Y.I.T. in 1988 and achieved his ESEP certification in 2017.  He has been granted dozens of global patents related to medical devices and helped to institutionalize the Systems Engineering discipline at 3 major MedTech companies.  Through his involvement in INCOSE Mike continues to help make Systems Engineering practices more common-place in the MedTech Industry.  He founded the INCOSE International Healthcare Working Group for INCOSE in 2008 and is still active in that group.  He has served in leadership roles within INCOSE including directorships within his local chapter and the international INCOSE Board of Directors.  Currently Mike is focusing his volunteer efforts on helping with MedTech related conferences.  Recently Mike started a Systems Engineering consulting company, continuing his mission of making systems engineering commonplace in healthcare, called S.O.S. LLC.

Meet the Panel

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and an affiliate professor at Drexel University. Previously he served as the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA). Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling medical book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

Dr. Naveen Agarwal is the visionary creator and host of Let’s Talk Risk!, a community-driven platform dedicated to advancing the understanding and application of medical device risk management. Through expertly curated content and engaging conversations, Let’s Talk Risk! has built a global audience of over 4,000 professionals, offering a robust library of practical resources, including case studies, podcasts, and webinars. Dr. Agarwal's mission is to elevate the collective capability of the medical device industry in risk management, driving improvements in patient safety, accelerating innovation, and reducing costs.

An engineer by training, Dr. Agarwal brings over 15 years of experience in the MedTech sector, having held diverse roles in R&D, Product Quality, and Business Analytics. His extensive consulting work focuses on innovative solutions to integrate complex documentation systems seamlessly while streamlining procedures, making compliance both efficient and effective.

 Dr. Agarwal is a passionate advocate for bridging the gap between technical expertise and operational excellence, empowering professionals across the medical device industry to address risk with confidence and purpose.

Dr. Steven Levine is currently the head of Human Modeling & Simulation for Dassault Systèmes, bringing more than 30 years of experience in the development of computation science and engineering software. He is the Founder and Executive Director of the Living Heart Project, a global academic-industrial-government collaboration to develop and validate highly accurate personalized digital human heart models now in use in 24 countries. He is Principle Investigator on a joint project with the US FDA to develop in silico clinical trials for cardiovascular devices. Additionally, he is director of the Life Science incubator of startup digital healthcare companies within the 3DEXPERIENCE labs as well as developing biomedical engineering curriculum at the University level and serves on several industry and academic boards. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) and holds a Ph.D. in Materials Science and Engineering from Rutgers University. He began his career in health tech at the San Diego based startup Biosym Technologies that went public as Accelrys in 2004 and acquired by Dassault Systèmes in 2014.