The Agile methodology is one of the most common project management methods for software development, and for good reason. Its iterative nature lends itself to an ideal build process. Add clearly-defined team roles and a lightweight Scrum framework—with short, focused bursts of work called Sprints, which typically last 1–4 weeks—and you have an approach that enables teams to work together efficiently while simultaneously improving the process from empirical observation. But does it work for the validated laboratory?
Common challenges facing clinical labs building software
The clinical lab space is a particularly challenging environment for developing software for two reasons: the highly regulated nature of the sector and because lab operations are often extremely complex. Specific challenges include:
- Needing to continuously decrease turnaround times, improve quality, and optimize performance. This can result in labs having to automate processes, finetune or build new software, or increase the cadence of software releases.
- Adapting to constantly changing demands, such as requests for new tests or increased testing volume (COVID-19 testing is a clear example of this), or being responsive to new business opportunities or collaborations with other companies.
- Adhering to regulatory requirements, such as CAP, CLIA, and FDA approvals.
- Dealing with an array of diverse molecular technologies and tests.
Fortunately, an Agile+Scrum approach, with a lab-centered engagement methodology, can help you address these challenges. It can also help you build optimal informatics software that supports the lab’s operations and business objectives.
How does Scrum facilitate building the best clinical software?
The Agile+Scrum approach can support custom lab software development in three key ways. These are known as the three pillars of Scrum.
1. Transparency
Transparency is necessary for establishing a culture of trust—required for all projects that rely on collaboration—which is why we believe it’s critical for developing successful custom software in regulated labs.
Transparency is especially important at the end of each Sprint when the work is reviewed by the relevant stakeholders. The clinical lab team must be able to trust that the lab software team has understood their needs, delivered the required functionality, and has communicated any known issues before release. Including lab staff in user acceptance testing is necessary to build confidence in the release. It’s only by working together, that everyone on the project can be confident the software will meet regulatory requirements and fulfill the lab’s operational and business requirements.
To maintain transparency, we recommend:
- Establishing a common language, terminology, and expectations at the beginning of a project. This might entail creating a list of terms during initial requirements gathering meetings, ranging from those that describe the Agile process to technical laboratory terminology. Defining these terms upfront minimizes the potential for misunderstandings.
- Creating system documentation as part of the software development process. This ensures that every requirement is traced through the build process, which is important for meeting regulatory requirements.
- Working within the lab’s unique environment and making adjustments according to the lab’s preferences. This could include demonstrating completed work periodically to ensure the software meets stakeholder expectations.
- Sharing regular updates on the team’s progress toward upcoming milestones.
2. Inspection
Inspection means continuously evaluating and improving the process. A Scrum Master helps keep the project on track by leading quick Daily Scrum meetings, and Retrospectives at the end of each Sprint to evaluate the completed work. This process encourages team members to identify problems and things to improve in the next Sprint.
This pillar of Scrum helps labs meet the challenge of needing to continuously improve and optimize performance and eliminate manual processes. Custom software plays a critical role in a clinical laboratory’s software stack, so it’s in the lab’s best interest to produce the best possible product (as opposed to a minimum viable product). This is greatly facilitated by a continuous improvement process, which is particularly valuable in high-volume systems where thousands of samples are processed each day.
3. Adaptation
Adaptation helps labs meet the challenges of a constantly changing business environment. Sprints tend to be short so the software team can change course between releases, if necessary. The software team may also have improvements to implement based on the Retrospective process.
For customers with a faster release cadence, the software team can implement the current release and design the next one in parallel—providing the lab with the flexibility to adapt to changing priorities.
A lab-centered approach means further refining the methodology
At Semaphore, we put your needs first by adjusting our software development methodology to work within your lab’s unique environment and involving your stakeholders throughout the project, from design and development to go live. We’ve found that our lab-centered approach usually leads to an ongoing trusted partnership with the labs we work with.
When we start an engagement with a new customer, we work to understand:
- How your clinical lab works.
- Who the lab stakeholders are, and what each of them is responsible for (accessioning, wet lab operations, quality, etc.).
- The lab’s validation process.
- The lab’s end-to-end system, from incoming orders to outgoing results (we recognize the importance of not causing any disruptions to the business).
- What product documentation exists and where there are gaps.
We’re also used to adjusting to the cadence of clinical labs, knowing that some labs release a software build every 8 months while others release every 2–4 weeks. Using the Scrum approach gives us the agility to adapt to your lab’s preferred cadence and align with your lab’s priorities. Our preference is to also participate in your backlog or release planning activities so that we can understand the upcoming roadmap for the lab.
In our experience, Agile+Scrum best practices are a valuable mechanism for modernizing clinical labs, where implementing a wide range of novel molecular technologies requires the development of custom software. It’s a lightweight approach that has proven to be extensible, scalable, and cost-effective—with clear roles and responsibilities for participants, comprehensive but simple processes, and plenty of room for continuous improvement.
Contact us if you need help with your laboratory informatics software. We bring the best agile project management methodologies, refined to work in the real world, and factoring in the realities of your lab’s unique setup.
