Move Fast And Don’t Break Things

By the time I joined Facebook in 2020, the company had more than 1.8 billion daily active users and my role was to help build a large part of the company’s next generation of core infrastructure. So the “move fast and break things” motto the company grew up on only half applied to my role.

Throughout my time at Facebook, I was able to ship quality code quickly without being bottlenecked on critical activities like risk assessments, testing, and documentation. These activities were embedded into my work to ensure quality without sacrificing velocity.

What struck me when I began meeting with medical device software teams was both the volume of documentation activities required by regulation and just how bottlenecked the product releases were as a result. Many teams simply avoid documentation and plan to get to it eventually, which is a recipe for bad outcomes.

I think this boils down to one critical problem: a lack of purpose-built software tooling that embeds into software engineering workflows. While companies like Facebook have tremendous internal resources to build custom tooling, innovative medtech startups don’t.

The Biggest Bottleneck: Test Protocols & Evidence

As we met with medical device software teams, we repeatedly asked, “What’s stopping you from releasing faster?”. Many of the teams we met were shipping releases every 3 to 6 months, but had an appetite to ship monthly, biweekly, and sometimes even weekly.

The primary reason that teams couldn’t release faster was the amount of time it took to produce the necessary design documentation.

Design documentation comes in many forms, so we narrowed the problem down further and learned that one particular bottleneck was causing universal pain: the creation and management of automated test protocols and evidence.

Writing test protocols and collecting execution evidence is crucial for regulatory compliance but is often time-consuming and complex. Test protocols need to be meticulously documented to ensure thorough testing, but they frequently lag behind code changes, resulting in discrepancies and potential non-compliance. Additionally, gathering evidence that tests have been successfully executed involves fragmented tools and manual processes, leading to inconsistencies and time-consuming reviews. These challenges significantly slow down release cycles, delaying critical updates and innovations.

Here are some gaps we saw with current medical device software test processes:

1. Engineering and Quality Gap: Engineers rely on Quality teams for last-minute documentation, increasing inefficiencies and the friction between these teams.

2. Documentation Drift: Protocols often lag behind code changes, leading to discrepancies and potential non-compliance, exacerbated by the labor-intensive and error-prone nature of manual updates.

3. Lack of Traceability: Poor integration between test protocols and code complicates the V&V process, making it difficult to maintain a clear traceability matrix and keep it up to date.

4. Fragmented Tools and Processes: Many teams use a patchwork of isolated tools and manual processes for collecting and documenting test evidence, leading to inconsistencies, gaps in documentation, and increased non-compliance risks.

5. Time-Consuming Reviews and Test Artifact Management: Manually collecting, reviewing and verifying automated test results, as well as managing various testing artifacts (e.g. logs, screenshots, reports), is a cumbersome and time-consuming task. Ensuring these artifacts are stored correctly and accessible for audits adds further complexity to the release process.

The cumulative effect of these challenges is a significant slowdown in release velocity. Teams spend an inordinate amount of time on documentation and evidence collection, delaying the delivery of critical updates and innovations to the market. In an industry where timely releases can impact patient care and safety, this bottleneck is more than just an inconvenience – it’s a critical issue that needs addressing.

Documentation-in-Code: Ultralight’s Approach to Accelerating Release Velocity

Ultralight addresses these challenges by providing a streamlined, integrated solution for design control, managing test protocols, and collecting execution evidence. We enable this by integrating directly into the tools software engineering teams already use, reducing the amount of time and friction to get compliant.

Ultralight works on the philosophy of Documentation-in-Code: We enable engineering teams document seamlessly within their preferred tools, and our integrations handle the actual collection and generation of documentation.

By automating the documentation process and ensuring seamless synchronization between test protocols and code, Ultralight eliminates the risk of documentation drift and reduces the manual effort required for updates, while also enabling collection and management of test execution management automatically.

This comprehensive approach not only accelerates release cycles but also enhances compliance and traceability, allowing teams to focus on innovation and quality.

Ultralight is already working with medtech software teams to enable them to overcome development bottlenecks and deliver safer, more effective medical device software to market faster. We believe that velocity and quality go hand in hand, and that teams can indeed move fast without breaking things.

Interested in joining the dozens of medical device software teams modernizing their compliance stack with Ultralight? Book a demo.

For more information on the capabilities Ultralight has built to serve medical device software development, please visit https://www.ultralightlabs.com/software