# Building Your Regulatory Strategy for Commercialization

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-09-14
- Length: 43m
- Episode: 280
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization
- Listen: https://podcast.greenlight.guru/episode/building-your-regulatory-strategy-for-commercialization

## Summary

Duane Mancini, CEO and Managing Partner at Project Medtech, advises early-stage medtech founders on integrating regulatory strategy with fundraising and commercialization. He emphasizes that investors prioritize the team and the problem over the product, and warns founders to avoid 'bad' investors who may force premature exits. Mancini highlights that commercialization requires addressing three key hospital stakeholders: clinicians (especially nurses), patient outcomes, and economic benefit, while building a robust Quality Management System (QMS) early to maximize valuation for potential strategic acquisitions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=0) Introduction: Duane Mancini and Project Medtech
- [3:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=223) Investor Types: Good, Neutral, and Bad
- [6:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=389) Medtech Investment Nuances and Exit Strategies
- [10:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=632) Building the Company for Acquisition
- [12:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=742) Pitch Deck Essentials: Team, Problem, and Solution
- [17:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=1038) Team Building and Fractional Resources
- [20:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=1218) Understanding the Problem as a Historian
- [24:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=1449) Commercialization Models and Hospital Sales
- [27:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=1659) Strategic Fundraising and Regulatory Integration
- [31:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization#t=1897) Equity Philosophy and Finding Champions

## Topics

- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Retail, wholesale & distribution](https://hardwarepodcasts.com/topic/retail-and-distribution)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- Project Medtech (company)
- Green Light Guru (company)
- Silicon Valley Bank (company)
- Medtronic (company)
- Johnson and Johnson (company)
- Mimic (company)
- Texas Medical Center (company)

## 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)
- [S4E47 Mark Byrne | Startup Engineering, Funding, & Assumptions](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-12-08-s4e47-mark-byrne-startup-engineering-funding-assumptions) (Being an Engineer)
- [070: Financing & Acquisition for Product Companies](https://hardwarepodcasts.com/podcast/product-startup/2021-04-08-070-financing-acquisition-for-product-companies) (Product Startup)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)

## 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/2022-09-14-building-your-regulatory-strategy-for-commercialization. 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.