# Weronika Michaluk on Medical Devices development

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2024-09-04
- Length: 48m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development
- Listen: https://agileembeddedpodcast.com/episodes/weronika-michaluk-on-medical-devices-development-JIzDX7DF

## Summary

Weronika Michaluk, Software as a Medical Device Practice Lead at HTD Health, explains how her company bridges firmware and software teams through shared backlogs, daily stand-ups, and mutual technical leads. She details the implementation of a compliant agile process that integrates tools like Jira, GitHub, and Greenlight Guru to manage requirements and version control without sacrificing regulatory compliance. Michaluk highlights the importance of aligning on versioning schemes and documentation standards to prevent bottlenecks and ensure that change orders are efficient rather than just bureaucratic friction. The conversation also covers the evolving understanding of agile methodologies among medical device clients, ranging from technical startups to non-technical founders.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=0) Introduction: Weronika Michaluk and HTD Health
- [1:53](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=113) Defining Software as a Medical Device (SAMD) and Classifications
- [3:42](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=222) Cross-Functional Collaboration: Firmware and Software Team Alignment
- [5:40](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=340) Version Control Strategies: Git Flow, Branching, and Tagging
- [8:57](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=537) Team Culture, Daily Stand-ups, and Code Review Processes
- [21:16](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=1276) Managing Requirements in Compliant Agile Development
- [26:22](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=1582) Tools and Processes: Jira, GitHub, and Greenlight Guru Integration
- [36:08](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development#t=2168) Client Perspectives on Agile and Feedback Quality

## Topics

- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)

## Most relevant to

early-stage companies

## Mentioned

- HTD Health (company)
- Boston Scientific (company)
- Apple (company)
- Jira (tool)
- GitHub (tool)
- Greenlight Guru (tool)
- Confluence (tool)
- X-ray (tool)

## Related episodes from other shows

- [#335: Accelerating SaMD Development in a Compliant Agile way](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way) (Global Medical Device Podcast)
- [#371: Achieving ISO 13485 Certification](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-28-371-achieving-iso-13485-certification) (Global Medical Device Podcast)
- [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)
- [Waterfall vs. Agile: Battle of the Product Development Methodologies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies) (Global Medical Device Podcast)
- [Understanding the Value of a Medical Device Guru](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru) (Global Medical Device Podcast)

## Citing this page

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