The pragmatist's guide to agile in an ISO 13485 environment

A common challenge in large organizations, especially in regulated industries like medical devices, is the imposition of top-down, one-size-fits-all processes and tools. While well-intentioned, these corporate mandates can often stifle the very teams they are meant to support.

During the development of the Vetscan Vue+, an ML-powered medical device, our team faced exactly this situation. We were instructed to use a corporate-standard requirements management tool that was rigid, cumbersome, and fundamentally unfit for our agile development approach. Adopting it would have buried our team in bureaucracy, reduced our velocity to a crawl, and put the entire project at risk.

The problem with "process for process' sake"

The corporate tool was designed for traditional, waterfall-style projects. It demanded exhaustive upfront documentation and lacked the flexibility needed for the iterative development, verification, and validation cycles essential for a complex hardware and software product developed under ISO 13485 guidelines. It was a classic case of the tool dictating the process, rather than the process serving the project's needs.

A fit-for-purpose solution

Instead of capitulating, we championed our team’s self-developed, agile requirements system. It was lightweight, integrated with our existing development tools, and designed specifically to support our workflow. Crucially, it still allowed us to generate all the necessary documentation and traceability matrices required for ISO 13485 compliance, but it did so in a way that was seamless and didn't impede development.

This wasn't about fighting the system for the sake of it. It was a pragmatic decision rooted in putting "People First" (before processes), and applying "First Principles": What is the most effective way to build a high-quality, compliant product in an agile setting?

The impact: Velocity, compliance, and results

The decision directly enabled our team to maintain high velocity while upholding the rigorous documentation and traceability standards required by a ISO 13485 environment.

The key lesson is that in a regulated environment, compliance and agility are not mutually exclusive. True pragmatism lies in finding or building tools and processes that support your team's workflow while still meeting the rigorous demands of the regulatory framework. Sometimes, the most effective act of leadership is to protect your team from well-intentioned but unsuitable corporate standards.