027 - "Become a Historian of the Problem" with Duane Mancini

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link ------------------------------------------------------------------------------------------------------------------------------------------------------ Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal Chemistry from the University of Toledo.  He started his medical device career at NAMSA as a technical advisor who specialized in overall biological safety planning including the use of chemical characterization to reduce the amount of biocompatibility testing needed for approval. He then moved into a senior technical advisor role at NAMSA and worked with clients on regulatory, reimbursement, and clinical strategies.  This unique and end-to-end background enabled him to be chosen to help lead NAMSA’s MRO team.  In this role, he applied the NAMSA MRO approach (end to end CRO services) to medical device companies in order to accelerate time to market.  This role required working with mostly medical device start-up companies in developing and executing a get-to-market strategy. Duane then worked for Labcorp on the Medical Device and Diagnostic team as a Business Development Director bringing regulatory, reimbursement, pre-clinical and clinical support to his Medtech clients. He is currently the CEO and Managing Partner of Project Medtech.  Project Medtech is a media and advisory firm that is committed to supporting the delivery and development of innovative medical technology.