# #380: Navigating the Complex World of Combination Products with Subhi Saadeh

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-08-30
- Length: 38m
- Episode: 380
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh
- Listen: https://podcast.greenlight.guru/episode/380-

## Summary

Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

## Outline

1. Introduction: Subhi Saadeh and the Combinate Podcast
2. Origin Story: Starting the Podcast for Consistent Learning
3. Combination Product Definitions: US vs. EU Regulatory Frameworks
4. Single Entity, Co-Packaged, and Cross-Labeled Products
5. Misconceptions: Drug vs. Device Quality Systems
6. QMSR Updates and Industry Trends
7. Balancing Technical and Business Aspects with Coaching
8. Lifelong Learning and Publishing Advice

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Combinate Podcast (product)
- FDA (company)
- EMA (company)
- Pfizer (company)
- BSI (company)
- AAMI (company)
- ASTM (company)
- Rook Quality Systems (company)

## Related episodes from other shows

- [152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina) (Let's Combinate)
- [192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-11-192-what-is-a-drug-device-combination-product-non-technical-under-5-minutes) (Let's Combinate)
- [257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-05-257-21-cfr-part-4-explained-cgmp-requirements-for-combination-products) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca) (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/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh. 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.