Weronika Michaluk on Medical Devices development

Navigating Firmware and Software Collaboration in Medical Devices: Insights with Weronika Michaluk
In this episode of the Agile Embedded Podcast, hosts Jeff Gable and Luca Ingianni are joined by Weronika Michaluk, Software as a Medical Device Practice Lead at HTD Health. Weronika shares her experiences and lessons learned from working with firmware teams, bridging cross-functional collaboration, and discussing the importance of version control, aligning technical aspects, and clear communication. The conversation delves into agile methodologies, customer interactions, and strategies for efficient requirement management in the medical device industry. Tune in to gain valuable insights from Weronika's extensive expertise.
00:00 Introduction and Guest Introduction
00:38 Veronica's Background and Experience
01:54 Understanding Software as a Medical Device (SAMD)
04:14 Lessons Learned in Cross-Functional Teams
05:42 Importance of Version Control
08:58 Team Collaboration and Communication
21:17 Managing Requirements in Agile Development
25:49 Effective Team Collaboration and Documentation
26:24 Tools and Processes for Project Management
26:42 Client and Team Meetings
27:13 Refinement and Feedback Loops
29:38 Change Order Process
36:11 Client Perspectives on Agile
38:09 Challenges with Agile in Medical Device Development
40:18 Differences in Client Types
45:47 Final Thoughts and Conclusion

Jeff runs BaseRef, a Requirements Management and Documentation tool for medical device startups, at getbaseref.com.
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