Diffblue’s AI-powered unit testing software delivers powerful results for Software as a Medical Device (SaMD) customers through advances in comprehensive testing, traceability, documentation, risk mitigation, and increased efficiency. These advances help them comply with FDA and EMA regulations and accelerate the delivery of vital medical solutions to the market.
Developing medical device software presents unparalleled challenges, especially when meeting stringent Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements. These challenges include managing potential risks, thorough verification processes, and comprehensive record-keeping throughout the software development lifecycle.
Comprehensive unit testing is essential, but traditional manual methods are often time-consuming and resource-intensive. This was the challenge for a leading software company focused on innovative cancer diagnosis solutions. To stay competitive and meet regulatory requirements, speeding up their medical device software development became crucial to their success.
To address these challenges, the software company turned to Diffblue Cover—a powerful AI solution that automatically generates unit tests, including those for edge cases and complex scenarios. This approach not only greatly expands test coverage but also significantly reduces the time and effort required compared to manual testing.
To achieve regulatory compliance, the CTO leading software development team realized they needed increased unit test coverage to meet current medical device software standards. This required quickly generating a substantially larger number of unit tests for their backend code. Automation and artificial intelligence (AI) provided the solution.
They faced several challenges that underscored the need for a robust unit testing solution. Low initial test coverage, particularly in legacy applications, made it difficult to ensure software quality and meet standards. The pressure was heightened by the stringent regulatory requirements of the medical device industry, which demand high levels of test coverage — something their CTO took very seriously.
Along with these external pressures, the organization realized that effective troubleshooting and test quality improvement relied on the development team’s ability to understand and analyze tool-generated logs. This highlighted the need for robust logging capabilities and the skills to interpret the data effectively. Additionally, it became clear that more comprehensive documentation was necessary, as incomplete or unclear records could impede the effective use of testing tools.
Finally, their legacy systems, not designed with modern unit testing practices in mind, limited the SaMD organization’s ability to accelerate development and stay competitive. The team recognized that manual testing alone was too time-consuming to meet project deadlines and regulatory demands, highlighting the critical need for automation tools to speed up the testing process.
Diffblue Cover helps SaMD companies tackle the complexities of regulatory compliance by offering a multifaceted solution. It generates a comprehensive suite of unit tests, automatically covering diverse scenarios including edge cases and unusual inputs. Diffblue Cover’s extensive testing and verification process is invaluable for identifying potential software defects that could jeopardize patient safety or compromise data integrity, all while aligning with stringent regulatory requirements.
Additionally, Diffblue Cover enhances traceability that is essential for demonstrating compliance during regulatory audits and inspections. It does this by creating tests that exercise various code paths and functionalities, establishing a clear link between software requirements, design, and implementation. The automated test generation process also contributes to improved code documentation and provides tangible evidence of testing activities, further bolstering compliance efforts for the company.
By detecting and addressing potential software defects early in the development lifecycle, Diffblue Cover plays a crucial role in reducing the risks associated with non-compliance, like costly product recalls, market entry delays, and a variety of common legal complications. Furthermore, the automation facilitated by Diffblue Cover streamlines the testing process, freeing up valuable developer time to focus on other critical compliance-related tasks and reducing the time and effort needed for regulatory submissions.
Through these capabilities, Diffblue Cover helps SaMD companies build and maintain robust software development and testing processes that not only minimize compliance risks but also meet regulatory expectations and expedite market access for their life-saving products.
Before using Diffblue Cover unit test generation had previously been outsourced to a 3rd party development team who created the unit tests manually. Despite working on the code for weeks they were only able to achieve 2% code coverage.
In the first two days of using Diffblue Cover, the medical software company saw immediate and substantial results across both new and legacy server-side code, demonstrating the tool’s effectiveness in generating unit tests for their entire codebase. They increased their code coverage by over 40% and generated 6,000 unit tests in less than 20 minutes — a task the team says would have taken a single developer 143 days to complete.
Analysis of Diffblue’s logs provided the developer team with insights that helped them optimize test generation. By identifying missing objects and conditions within the code, the team fine-tuned the solution’s performance and improved overall test quality.
Despite these improvements, challenges persisted in achieving higher coverage for specific application areas, particularly those involving SQL. These areas highlighted opportunities for continued improvement and refinement of testing strategies.
To maintain and gradually increase coverage over time, the company adopted a continuous integration practice that ensured that newly developed code was consistently tested, preventing coverage regression and promoting ongoing software quality enhancements.
Overall, the results demonstrated substantial progress in the company’s efforts to meet regulatory requirements and elevate software quality through improved test coverage. More importantly, by implementing systematic unit testing for new code and utilizing Diffblue for existing code, the company improved the overall reliability of their cancer diagnosis software.
Given the stringent regulatory landscape governing medical device software, Diffblue Cover offers an invaluable solution for developers. It helps meet US and EU compliance standards by providing:
If you're an SaMD developer, you know that precision, speed, and scalability are as important as meeting today's rigorous regulatory standards. Discover how our AI-powered unit testing can enhance your medical software's safety, effectiveness, and marketability.
See how Diffblue Cover can transform your code and your engineering team.
