Hardware Podcasts

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

Let's Combinate · 19 Apr 2023 · 47m

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
AbbVie, Eli Lilly, Roche Diagnostics, John Deere, Baxter Healthcare, Novo Nordisk
Also
ISO 11608, ISO 21649, AAMI, ANSI, FDA

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