Agile in Medical Device Software Development: A Project Manager's Perspective

A client recently asked me how we handle things like evolving requirements and budget constraints for medical device development. It’s a common and important topic, especially in medical devices. I thought it would be helpful to share a bit more broadly how we approach this at Promenade Software, and why Agile is such a key part of our process.

As the project manager overseeing most of our client programs here at Promenade Software, I’ve had a front-row seat to how our team approaches medical device software development. One of the foundational approaches we rely on is Agile. While it’s more commonly associated with tech startups and consumer apps, Agile has become an incredibly effective methodology for regulated industries too—including medtech.

In fact, Agile is at the heart of how we deliver robust, high-quality software for our medical device clients. Whether it’s firmware, embedded software, or cloud-based health platforms, the iterative and collaborative nature of Agile has proven to be a huge advantage.

This topic is especially timely now as many companies are re-evaluating their development processes in response to tighter budgets, increasing scrutiny from regulatory bodies, and the continued push to bring innovative medical technologies to market faster and more efficiently. Agile helps meet those demands without compromising quality.

Why We Use Agile for Medical Device Projects

• Faster Iterations and Feedback Loops
  Agile allows us to break down complex projects into manageable sprints, making it easier to respond to feedback quickly and continuously refine the product. This is especially important in medtech, where requirements evolve as stakeholders gain clarity.
• Improved Risk Management
  By delivering working software at regular intervals, we can identify issues earlier in the process—before they become costly or difficult to fix. This helps manage technical risk and maintain compliance throughout the development lifecycle.
• Enhanced Collaboration
  Frequent check-ins, backlog grooming, and sprint reviews keep cross-functional teams aligned. This transparency helps ensure that client needs, engineering constraints, and regulatory requirements stay synchronized.

• ‍Validation as You Go
  Agile allows us to incorporate verification and validation steps incrementally. This not only saves time later but helps reduce the traditional bottleneck of end-of-project testing.‍
• Flexibility with Evolving Requirements
  Agile’s iterative structure allows teams to adapt more easily when user needs, regulatory expectations, or design feedback change during the project. Instead of requiring a full redesign late in development, updates can be integrated incrementally with minimal disruption.

This flexibility has been especially valuable in many of our mobile app projects, where early feedback—often uncovered during sprint-based usability testing—has led to meaningful UI adjustments and feature refinements before final validation.

Catching and implementing these changes early helps avoid costly rework at the end, saving both time and budget.

A Note on Budget Considerations

One consideration to be aware of is that Agile can sometimes give the impression of budget fluidity, especially when items need rework or scope adjustments emerge mid-sprint. While this may require ongoing coordination with clients on priorities and hours, it also ensures that the end product truly meets user and regulatory expectations.

That said, one of the strengths of Agile is the ability to surface issues earlier—thanks to continuous integration and regular working software reviews. This early visibility helps avoid costly surprises later in the development cycle, ultimately supporting better budget control over the long term.

Final Thoughts

At Promenade Software, Agile isn’t just a buzzword—it’s a proven framework that supports quality, collaboration, and responsiveness in the high-stakes world of medical device software. From my perspective as a project manager, it's clear that the benefits far outweigh the challenges, and it continues to be a core part of how we deliver success for our clients.

If you're exploring software development for a medical device, I’d be happy to share more about how Agile could work for your program.

‍