# #404: MedTech 101: What You Need to Know About the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-05-01
- Length: 58m
- Episode: 404
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/404-understanding-the-medical-device-industry

## Summary

Etienne Nichols hosts Sara Adams and Chris Rush from Greenlight Guru for a foundational overview of the medical device industry. They define medical devices by intended use and labeling, distinguishing roles for Quality, Regulatory, Clinical, and R&D teams. The trio explains FDA classifications (Class I, II, III), regulatory pathways like 510(k) and PMA, and key standards including ISO 13485 and ISO 14971. They emphasize the importance of design controls, risk management, and reading regulations to navigate compliance and market access.

## Outline

1. Introduction: Defining Medical Devices and Roles
2. Regulatory Bodies and FDA Classifications
3. Key Standards: ISO 13485, 14971, and 21 CFR Part 820
4. FDA Pathways: 510(k), De Novo, and PMA
5. Design Controls: User Needs to Validation
6. Clinical Trials, Preclinical Studies, and Manufacturing

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- ISO 14971 (other)
- 510(k) (other)
- PMA (other)

## Related episodes from other shows

- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (Let's Combinate)
- [003 - “Standard Understanding” with Mark Swanson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson) (Let's Combinate)
- [092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w) (Let's Combinate)
- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner) (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/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-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.