# #369: Advice to Medical Device Inventors

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-23
- Length: 43m
- Episode: 369
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-23-369-advice-to-medical-device-inventors
- Listen: https://podcast.greenlight.guru/episode/369-advice-to-medical-device-inventors

## Summary

Ron Richard, author of 'Someday is Today' and a medical device expert with 35 years of experience, advises inventors on navigating the path from concept to commercialization. He emphasizes the critical importance of a concise 30-second elevator pitch to secure initial funding from family and friends, validating ideas through stakeholder focus groups, and choosing evolutionary 510(k) pathways over risky revolutionary PMA submissions. Richard also details the financial realities of medical device development, warning that projects often require twice the expected money and four times the time, urging founders to maintain strict burn rates and clear cap tables to survive the 'chasm' to market.

## Outline

1. Introduction: Ron Richard's background and invention origins
2. Validating ideas through focus groups and stakeholder interviews
3. Regulatory pathways: 510(k) vs. PMA and the 'pioneers get shot' philosophy
4. Class I products, direct-to-consumer strategies, and reimbursement codes
5. Funding strategies: Family and friends, VC, and IPO milestones
6. Avoiding pitfalls: Shiny object syndrome and gold plating
7. Navigating the chasm: Funding, burn rates, and the 'dip'

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- USPTO (other)
- Apple (company)
- Fitbit (company)
- Massimo (company)
- CVS (company)
- Walmart (company)

## Related episodes from other shows

- [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)
- [116: How to Turn an Invention into a Product Business](https://hardwarepodcasts.com/podcast/product-startup/2022-03-02-116-how-to-turn-an-invention-into-a-product-business) (Product Startup)
- [S2E37 Defied the odds:  A Physical Product Development Firm That Focuses on Startups & Small Businesses, Mako Design + Invent –Kevin Mako](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-08-23-s2e37-defied-the-odds-a-physical-product-development-firm-that-focuses-on-startu) (Being an Engineer)
- [Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa) (The Hardware Story)
- [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)

## 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/2024-05-23-369-advice-to-medical-device-inventors. 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.