# Building a Startup in the MedTech Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-10
- Length: 30m
- Episode: 186
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry
- Listen: https://podcast.greenlight.guru/episode/building-a-startup-in-the-medtech-industry

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=0) Introduction: Duane Mancini and Project Medtech
- [3:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=187) The Shift from Regulatory-Only to Reimbursement Strategy
- [6:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=414) Risks of Ignoring Reimbursement and Clinical Planning
- [11:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=707) Regulatory Pathways: 510(k), De Novo, and PMA Considerations
- [17:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=1045) The Importance of a Robust Quality Management System (QMS)
- [18:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=1114) Project Medtech Podcast Vision and Startup Generalist Needs
- [23:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry#t=1424) Building Advisory Boards and Understanding Team Dynamics

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Project Medtech (other)
- Green Light Guru (other)
- NAMSA (company)
- Covance (company)
- Inhale Medical (company)
- Medical Markham (company)
- FDA (other)
- ISO 10993 (other)

## Related episodes from other shows

- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [S5E8 Aaron Call | How to Find Money for MedTech Startups](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-23-s5e8-aaron-call-how-to-find-money-for-medtech-startups) (Being an Engineer)
- [S2E40 Voice of the Customer, Using Questions, and the Technology Adoption Life Cycle Curve | Ted Newill](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-09-17-s2e40-voice-of-the-customer-using-questions-and-the-technology-adoption-life-cyc) (Being an Engineer)
- [133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-24-133-a-year-of-saying-no-advice-good-medtech-consulting-humility-in-leadership-an) (Let's Combinate)
- [017 - "Feet First" with Ahmed Zobi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-26-017-feet-first-with-ahmed-zobi) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.