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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-04-06
- Length: 59m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/027---Become-a-Historian-of-the-Problem-with-Duane-Mancini-e1gon4c

## Summary

Duane Mancini, CEO and Managing Partner of Project Medtech, discusses his transition from medicinal chemistry to medical device regulatory strategy at NAMSA and LabCorp. He explains the critical importance of integrating reimbursement strategy early in the development of combination products to avoid commercialization failures, noting that regulatory choices like 510(k) can negatively impact reimbursement pathways. Mancini details how Project Medtech supports startups through its podcasts, Startup Symposiums, and consulting services, focusing on capital raising, milestone mapping, and navigating the complexities of drug-device combinations like insulin patches.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=0) Introduction: Duane Mancini and Project Medtech
- [2:31](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=151) Duane Mancini's Background: From Chemistry to NAMSA
- [5:33](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=333) Biocompatibility, Toxicology, and Risk-Based Approaches
- [10:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=623) The Critical Role of Reimbursement Strategy for Startups
- [14:07](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=847) Launching Project Medtech Podcasts and Media Network
- [26:49](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=1609) Startup Symposiums and Consulting Services
- [37:41](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=2261) Common Startup Struggles: Capital, Pitch Decks, and Quality Systems
- [51:16](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini#t=3076) Combination Products: Insulin Patches and Closed-Loop Systems

## Topics

- [Crowdfunding & preorders](https://hardwarepodcasts.com/topic/crowdfunding)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- Project Medtech (company)
- NAMSA (company)
- LabCorp (company)
- Medtech Money (product)
- Galaxy Data (company)
- Green Light Guru (company)
- Mimic (company)
- Icorp Vascular (company)
- MetaView (company)
- University Hospital Ventures (company)
- Cleveland Clinic (company)

## Related episodes from other shows

- [Building a Startup in the MedTech Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-10-building-a-startup-in-the-medtech-industry) (Global Medical Device Podcast)
- [How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus) (Global Medical Device Podcast)
- [Building Your Regulatory Strategy for Commercialization](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-14-building-your-regulatory-strategy-for-commercialization) (Global Medical Device Podcast)
- [#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian) (Global Medical Device Podcast)
- [#451: Building a MedTech Powerhouse: The 5 Stages of Founder Success](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-16-451-building-a-medtech-powerhouse-the-5-stages-of-founder-success) (Global Medical Device Podcast)

## Citing this page

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