# 204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-09-03
- Length: 32m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/204---The-Dictionary--Thesaurus-of-Combination-Products-Finally-Explained-with-Susan-Neadle-e37lba9

## Summary

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of The Combination Products Handbook, explains the persistent regulatory confusion surrounding terminology in drug-device combination products. She details how terms like 'platform,' 'component,' and 'CAPA' are interpreted differently between pharmaceutical and medical device frameworks, creating significant compliance risks. The discussion highlights the failure of ASTM standards to align global definitions and emphasizes the need for a science- and risk-based approach to navigate these discrepancies.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=6) Introduction: Susan Neadle and the Lexicon Problem
- [1:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=61) Historical Efforts: ASTM Standards and the 'Platform' Debate
- [4:50](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=290) Regulatory Frameworks: US vs. Europe Definitions
- [14:20](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=860) GMP Interpretations: CAPA and Design Controls
- [23:13](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=1393) Key Terms: Component, Packaging, and Manufacturer
- [28:31](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa#t=1711) Conclusion: Top 3 Definitions and Contact Info

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- The Combination Products Handbook (product)
- ASTM International (other)
- FDA (other)
- ISO 13485 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- 21 CFR 211 (other)
- 21 CFR 820 (other)
- EU MDR (other)
- QMSR (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#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)
- [Ad Promo and The Difference in Regulatory & Legal](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)

## Citing this page

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