Weronika Michaluk on Medical Devices development

Navigating Firmware and Software Collaboration in Medical Devices: Insights with Weronika MichalukIn 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 Introduction00:38 Veronica's Background and Experience01:54 Understanding Software as a Medical Device (SAMD)04:14 Lessons Learned in Cross-Functional Teams05:42 Importance of Version Control08:58 Team Collaboration and Communication21:17 Managing Requirements in Agile Development25:49 Effective Team Collaboration and Documentation26:24 Tools and Processes for Project Management26:42 Client and Team Meetings27:13 Refinement and Feedback Loops29:38 Change Order Process36:11 Client Perspectives on Agile38:09 Challenges with Agile in Medical Device Development40:18 Differences in Client Types45:47 Final Thoughts and Conclusion You can find Jeff at https://jeffgable.com.You can find Luca at https://luca.engineer.Want to join the agile Embedded Slack? Click hereAre you looking for embedded-focused trainings? Head to https://agileembedded.academy/Ryan Torvik and Luca have started the Embedded AI podcast, check it out at https://embeddedaipodcast.com/