# 081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-04-19
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/081---ISO-TC-84--ISO11608--Committee-Work-and-Advancing-the-State-of-the-Art-with-Bob-Nesbitt-e2221a0

## Summary

Bob Nesbitt, Chair of ISO TC 84 and Senior Director at AbbVie, explains the structure and evolution of international standards for drug-device combination products, including ISO 11608 for needle-based injectors and ISO 21649 for needle-free systems. He details the governance model involving AAMI, ANSI, and ISO, emphasizing the 'Crazy Bob' heuristic used to ensure patient safety by anticipating misuse. Nesbitt discusses the expansion of TC 84’s scope from early pen injectors to complex on-body delivery systems and the integration of usability and risk management into these standards.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=0) Introduction: The 'Crazy Bob' Safety Heuristic
- [5:15](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=315) Bob Nesbitt's Career: From John Deere to AbbVie
- [12:54](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=774) Governance: AAMI, ANSI, and ISO Coordination
- [17:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=1040) History of ISO 11608 and Pen Injectors
- [22:46](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=1366) Current Scope: TC 84 Standards and Working Groups
- [35:14](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=2114) Evolution of ISO 11608 Parts and Technology
- [41:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo#t=2480) Future Trends: Usability, Risk, and Connected Devices

## Topics

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

## Most relevant to

established companies

## Mentioned

- AbbVie (company)
- Eli Lilly (company)
- Roche Diagnostics (company)
- John Deere (company)
- Baxter Healthcare (company)
- Novo Nordisk (company)
- ISO 11608 (other)
- ISO 21649 (other)
- AAMI (other)
- ANSI (other)
- FDA (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)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)
- [#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-10-401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity) (Global Medical Device Podcast)
- [#383: What Standards Apply to My Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-19-383-what-standards-apply-to-my-device) (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/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo. 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.