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

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

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses:

- His experience leading combination product focused organizations at Eli Lilly & Sanofi

- The first autoinjectors and the history surrounding ISO 11608

- Managing a product line, owning P&L and the product development mindset shift that came with that

Paul Jansen is currently working as a Drug Device Development Consultant. He is also on the Board of Directors at Subcuject and sits on the Advisory Boards of Evoleen, Windgap & Kymanox. He was formerly Associate Vice President, Medical Device Development, Sanofi until his retirement in January 2017. Paul has extensive experience in the design, development, manufacturing and lifecycle management of medical devices. Paul has multiple patents to his name and has deep experience in the creation and management of intellectual property portfolios. He has successfully led teams that have developed and launched several award winning devices, including Lantus SoloStar the world’s most popular insulin pen injection device. In addition, he has expertise in the design and development of injection molding systems and electronic components. Paul has been a long time member of the International Standards Organization serving as Working Group Convenor and Expert on many work groups responsible for standards related to injection devices. Until January 2022 he was the Chair of Technical Committee 84, Devices for the Administration of Medicinal Products and Catheters.

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