# 152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-09-04
- Length: 40m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/152---Global-Medical-Device-Podcast-Interview-Behind-the-Combinate-Podcast--Combination-Products-Why--Unique-Episodes--Pyramids-and-Books-with-Etienne-Nichols--Subhi-Saadeh-e2mlqec

## Summary

Subhi Saadeh, host of the Combinate Podcast and International Committee Chair for the Combination Products Coalition, joins Etienne Nichols to discuss the complexities of combination products. They define single-entity, co-packaged, and cross-labeled products, and explain the regulatory frameworks involving the FDA's CDRH, CDER, and CBER. Saadeh emphasizes that the primary mode of action determines the lead review office and highlights the importance of understanding QMSR updates and sterilization methods like VHP. The conversation also covers Saadeh's approach to podcast production, his use of coaching for career and fitness, and his recommendation of books like 'Quality is Free' and 'Bottle of Lies'.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=0) Introduction: Subhi Saadeh and the Combinate Podcast
- [2:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=176) Origin Story: Creating the Podcast for Learning and Networking
- [8:25](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=505) Defining Combination Products: Single-Entity, Co-Packaged, and Cross-Labeled
- [12:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=749) Regulatory Frameworks: FDA Offices, CTD Format, and Misconceptions
- [20:46](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=1246) QMSR Updates and Sterilization Trends (VHP, Gamma, ETO)
- [25:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=1556) Unique Podcast Episodes: FOIA, Market Access, and Sterilization
- [29:24](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=1764) The Role of Coaching and Mentorship in Career and Fitness
- [35:23](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina#t=2123) Recommended Books: Quality is Free, Man's Search for Meaning, Bottle of Lies

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies

## Mentioned

- Combinate Podcast (other)
- Global Medical Device Podcast (other)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- AAMI (other)
- FDA (other)
- CDRH (other)
- CDER (other)
- CBER (other)
- EMA (other)
- QMSR (other)
- VHP (other)
- ETO (other)
- Gamma (other)
- E-Beam (other)
- Quality is Free (other)
- Man's Search for Meaning (other)
- Bottle of Lies (other)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina. 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 Let's Combinate.