# 022 - "What Chapter are you in?" with Susan Neadle

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-03-02
- Length: 1h 23m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/022---What-Chapter-are-you-in--with-Susan-Neadle-e1dkpe7

## Summary

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen and Johnson & Johnson, discusses the regulatory and engineering challenges of combination products. She details the implementation of 21 CFR Part 4, the importance of harmonizing terminology between drug and device sectors, and her work with standards bodies like ASTM and AAMI on TIR 48 and TIR 105. Neadle explains her strategic planning frameworks, including the Merlin Exercise and Design to Value, to navigate complex quality systems and global regulatory differences.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=0) Introduction: Susan Neadle and Career Overview
- [7:29](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=449) Implementing 21 CFR Part 4 at Johnson & Johnson
- [14:38](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=878) The Challenge of Drug-Device Vocabulary and Translation
- [27:50](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=1670) Design to Value, Design Excellence, and Process Excellence
- [37:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=2247) Strategic Planning: The Merlin Exercise and Future Back
- [51:24](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=3084) Global Harmonization and ASTM/AAMI Standards
- [1:06:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=3999) Industry Committees, Consulting, and Prioritization
- [1:17:01](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle#t=4621) Personal Passions, Books, and Future Outlook

## Topics

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

## Most relevant to

established companies

## Mentioned

- Johnson & Johnson (company)
- Amgen (company)
- Unilever (company)
- IBM (company)
- 21 CFR Part 4 (other)
- ASTM (other)
- AAMI (other)
- TIR 48 (other)
- TIR 105 (other)
- ISPE (other)
- FDA (company)
- Genus (company)

## 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)
- [#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)

## Citing this page

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