Hardware Podcasts

Building a Startup in the MedTech Industry

Global Medical Device Podcast · 10 Mar 2021 · 30m · Episode 186

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
NAMSA, Covance, Inhale Medical, Medical Markham
Also
Project Medtech, Green Light Guru, FDA, ISO 10993

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