Building a Startup in the MedTech Industry
Duane Mancini, president and founder of Project Medtech, explains why MedTech startups must integrate reimbursement, regulatory, and clinical strategies from the outset to avoid costly rework and ensure investor confidence. He argues that while regulatory approval (such as 510(k), De Novo, or PMA pathways) is necessary, it is not sufficient for commercial success, as market access and reimbursement determine whether a device can actually be sold. Mancini emphasizes that a robust Quality Management System (QMS) is critical for startups aiming for acquisition by larger strategics, who often reject deals with poor quality infrastructure. He also highlights the importance of building a strong team and advisory board, noting that investors bet on the team's ability to execute a holistic go-to-market plan rather than just the product itself.