Hardware Podcasts

134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

Let's Combinate · 1 May 2024 · 41m

What this episode covers

Richard Koch, founder of KochSaMD, explains the complexities of developing cloud-based medical devices, using a closed-loop insulin pump system as a primary case study. He details how ISO 62304 governs software development within the broader ISO 13485 framework, emphasizing the shift from batch-based physical manufacturing to continuous, high-velocity software updates. Koch warns that tech giants like Apple and Google are disrupting the industry by leveraging their digital expertise to acquire or compete with traditional medtech firms, urging leaders to upskill in software development to survive.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
KochSaMD, Apple, Google, Amazon
Products
EpiPen, Alast American pumps, PuriApp
Tools
Git, Jira
Also
ISO 62304, ISO 13485

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