Weronika Michaluk on Medical Devices development

The Pragmatic Embedded Podcast · 4 Sept 2024 · 48m

What this episode covers

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.

Mentioned

Companies
HTD Health, Boston Scientific, Apple
Tools
Jira, GitHub, Greenlight Guru, Confluence, X-ray

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 55m

    #335: Accelerating SaMD Development in a Compliant Agile way

    Zach Markin, CEO, and Weronika Michaluk, Digital Health Principal at HTD Health, discuss accelerating Software as a Medical Device (SaMD) development through a methodology they call 'Compliant Agile.' They explain how HTD uses its 'SaMD Chassis' accelerator to handle common non-differentiating software functions, allowing clients to focus on novel clinical value while maintaining regulatory compliance. The guests detail their selection of Greenlight Guru as their Quality Management System (QMS) because it supports flexible, agile workflows and integrates with tools like Jira, helping them achieve ISO 13485 certification and reduce time-to-market.

  • Global Medical Device Podcast · 45m

    #371: Achieving ISO 13485 Certification

    Weronika Michaluk and Zach Markin from HTD Health discuss their journey to achieving ISO 13485 certification, emphasizing the critical role of gap analysis and the use of Greenlight Guru’s eQMS software to manage traceability and compliance. They explain how HTD Health implemented a 'compliant agile' approach, writing SOPs that reflected their actual software development processes rather than idealized templates, which helped them pass their audit with an impressed auditor. The conversation highlights the importance of internal expertise, proper tooling for risk management and CAPA, and maintaining continuous improvement in the medical device software space.

  • Global Medical Device Podcast · 25m

    Meet a Guru: Karen Schuyler

    Karen Schuyler, a Medical Device Guru at Greenlight Guru, discusses her 15-year career spanning product engineering at Gore, startup scaling, and quality strategy at large medical device companies. She highlights the industry's shift toward collaborative regulatory approaches and the challenges of adapting to frequent standard updates like ISO 13485 and EU MDR. Schuyler explains how Greenlight Guru’s software solves the inefficiency of manual traceability by automating linkages between design controls, risk management, and documentation, preventing the 'painting yourself into a corner' scenarios common in legacy systems.

  • Global Medical Device Podcast · 38m

    Waterfall vs. Agile: Battle of the Product Development Methodologies

    Jon Speer, host of the Global Medical Device Podcast, interviews Devon Campbell, founder and CEO of Prodct, to debunk myths surrounding waterfall and agile methodologies in medical device development. They argue that the FDA's Design Control Guidance is often misinterpreted as mandating a rigid waterfall process, when it merely illustrates one possible approach. Campbell and Speer emphasize that successful product development relies on defined processes, traceability, and hybrid models rather than adherence to a specific named methodology. They advocate for 'documenting early and revising often' to manage the high costs of late-stage changes in electromechanical hardware.

  • Global Medical Device Podcast · 32m

    Understanding the Value of a Medical Device Guru

    Tom Rish, Senior Medical Device Guru and manager of the Guru team at Greenlight Guru, explains how the company provides mentorship and regulatory support to medical device companies beyond its QMS software. He discusses the 'Guru Edge,' emphasizing a phased 'build as you go' approach to quality systems to help startups launch products and pass audits without being overwhelmed by paperwork. Rish highlights industry trends including the rise of wearables, software as a medical device (SaMD), and the impact of EU MDR and IVDR regulations on In Vitro Diagnostics (IVD).

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by The Pragmatic Embedded Podcast. The episode itself belongs to its publisher.