# 070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-02-01
- Length: 50m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/070---The-First-Auto-Injectors--ISO-11608-History--and-Managing-Product-with-Paul-Jansen-e1tjofu

## Summary

Paul Jansen, a drug-device consultant and former Associate Vice President at Sanofi and Eli Lilly, discusses the history of auto-injectors and his role in developing ISO 11608 standards. He explains how Eli Lilly’s early development of the Lantus SoloStar pen and Sanofi’s subsequent scaling efforts required balancing startup-like agility with enterprise-level resources. Jansen details the evolution of Technical Committee 84, noting how standards initially focused on diabetes expanded to cover other therapeutics, necessitating revisions to remain relevant. He also reflects on his career, including a brief stint managing a product line with full P&L responsibility, and the importance of customer-centricity in both product design and standard-setting.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=0) Introduction: Paul Jansen and Career Overview
- [5:26](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=326) Retirement, Consulting, and Work-Life Balance
- [14:47](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=887) Career Origins: From Electronics to Eli Lilly
- [18:52](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=1132) The Rise of Auto-Injectors at Eli Lilly and Sanofi
- [26:40](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=1600) Scaling Production: Startup Culture vs. Enterprise Resources
- [33:52](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=2032) Managing Product Lines and P&L Responsibility
- [38:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=2305) Developing and Evolving ISO 11608 Standards
- [46:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja#t=2762) Committee Dynamics, Customer Centricity, and Future Tech

## Topics

- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

large enterprises

## Mentioned

- Eli Lilly (company)
- Sanofi (company)
- Novo Nordisk (company)
- Lantus SoloStar (product)
- ISO 11608 (other)
- Technical Committee 84 (other)
- FDA (other)

## Related episodes from other shows

- [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)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [Meet a Guru: Brittani Smith](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith) (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)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)

## 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/2023-02-01-070-the-first-auto-injectors-iso-11608-history-and-managing-product-with-paul-ja. 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.