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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-05-01
- Length: 41m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/134---ISO62304--Software-Development-Process--SaMD--Closed-Loop-Systems--Complexities-with-Cloud-and-Better-Software-in-MedTech-with-Richard-Koch-e2j3ie2

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=0) Introduction: Subhi Saadeh and Richard Koch
- [2:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=149) Case Study: Closed-Loop Insulin Pump and Cloud Complexities
- [6:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=389) ISO 62304 Process: Specifications, Architecture, and Detail Design
- [17:28](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=1048) Verification, Validation, and Testing Methodologies
- [26:47](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=1607) Cloud-Based Systems: Post-Market Surveillance and Risk Management
- [32:51](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=1971) Tech Giants (Apple, Google) Disrupting MedTech
- [38:04](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities#t=2284) Future Opportunities: AI, ML, and Data-Driven Products

## Topics

- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies

## Mentioned

- KochSaMD (company)
- ISO 62304 (other)
- ISO 13485 (other)
- Apple (company)
- Google (company)
- Amazon (company)
- Git (tool)
- Jira (tool)
- EpiPen (product)
- Alast American pumps (product)
- PuriApp (product)

## Related episodes from other shows

- [How to Leverage IEC 62304 to Improve SaMD Development Processes](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes) (Global Medical Device Podcast)
- [The Future of Cybersecurity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-30-the-future-of-cybersecurity) (Global Medical Device Podcast)
- [#436: Do ISO 13485's Production Controls apply to SaMD?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd) (Global Medical Device Podcast)
- [[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd) (Global Medical Device Podcast)
- [Digitizing your SaMD Testing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing) (Global Medical Device Podcast)

## Citing this page

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