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Health/Life Sciences company

How a life-saving medical device company saved nearly 2,000 hours of testing & QA approvals in one year with Tricentis qTest and Tricentis Vera™

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of mobile application testing automated (4 Apps supported)

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of API testing automated

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of web testing automated

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Company overview

As a top prescribed BGM (blood glucose monitoring) brand, a leading Health/Life Sciences (HLS) company has provided life-saving medical services for users for over 20 years, with more than 20 million people across 28 countries depending on their patented products to help them manage diabetes worldwide.

After shifting to independent ownership after decades as a Fortune 50 Health Services subsidiary, they found the freedom to explore more agile IT strategies to deliver the digital experiences that support their mission of improving the quality of life for people living with diabetes.

Balancing compliance requirements with software delivery goals

The Senior Manager of Digital Product Excellence knew he had a rare opportunity to set the standard for Quality Engineering in the medical device industry. Once his team was granted autonomy over software delivery practices, he recognized two significant opportunities to improve the speed and quality of software delivery: shifting testing left and replacing manual validation methods with an automated, integrated approach.

“When I came on board, we were testing around 1 product line per year at one time… all told, it was a very manual process,” he said.

Although the company already had a mature product – a patented glucose monitoring technology with overwhelmingly positive reviews – he saw room for improvement. As a medical device manufacturer, the company was required to operate in strict accordance with FDA compliance requirements, which prescribes a stringent approvals and validation process at each step of the testing lifecycle. But the traditional, manual approach did not align with the fast, iterative nature of agile software delivery.

Testing each new release of the company’s glucose monitoring technology required multiple compliance steps at several checkpoints:

  • Several different reporting document management systems
  • 3 timecard tracking systems
  • Mobile operating systems for both Android and iOS devices
  • Systems for storing patient data from the glucose monitors (caloric data, sleep data, etc.)

Challenges

  • Managing compliant testing across numerous systems and data sources was tedious and complex.
  • Long list of Validation & Verification (V&V) stakeholder approvals and Electronic Records & Electronic Signature (ERES) checkpoints to be collected for each release.
  • Delayed go-to-market schedules down to 1-2 releases per year.

“When I joined the company, we had no CI/CD, no integrated testing, and very limited web/mobile tests,” the Senior Manager of Digital Product Quality and Excellence said. The company also lacked a modern tool for validation that would complement his vision for streamlined software delivery.

His goal was to implement all four, with the goal of scaling efficiency and accuracy while streamlining their compliance management processes. To lay the foundation for success, he sought a modern, DevOps-ready test management solution to replace ALM, which lacked the required integration capabilities, and which his team said made testing even more time-consuming to manage.

Setting the standard for quality engineering

The company adopted Tricentis qTest as the first step in revolutionizing their quality engineering approach. qTest allowed them to centrally manage their manual test processes and integrate with Jira and Confluence for real-time feedback with developers. qTest also enabled the team to make some improvements to the Electronic Records & Electronic Signature (ERES) process. By extracting individual test case and test execution instances from qTest, they could upload them to MasterControl for approval, but multiple approvers were still needed. Despite the remaining approvals management, qTest still eliminated numerous checkpoints along the approval pathway that ALM could not remove, yielding early time savings even before Tricentis Vera was introduced to their environment.

In spring 2020, they implemented an earlier version of Vera that supported manual test approvals with ERES, critically removing that initial 2019 workaround for Manual tests; however, they couldn’t solve their automation test work around, which remained until spring 2022.

That’s when the Vera upgrade for qTest was released, and now supported manual and automated test approvals with ERES in a way that worked for the company’s requirements. This eliminated QA approval in qTest and reduced the V&V checkpoints to a single owner to approve the executed tests, removing nearly a dozen time-consuming checkpoints earlier in the process.

“It’s been years, 3 different bosses, several different tools and apps, but now we work in 2–3-week sprints & can reduce formerly one-month development cycles to just one-week dev cycles”

This simplification of their QA approvals process, combined with their increased test case visibility, brought their development team and V&V quality engineering team much closer together, boasting:

  • Lower cost, streamlined resource model for testing and validation
  • Faster time to market, accelerated release cycles
  • Higher quality

“qTest already streamlined the validation process for manual tests. Implementing Vera’s upgrade in 2022 streamlined the need to approve automated tests in Vera, which allowed us to reduce the traditional lengthy QA Approvals Process for executed tests to just one V&V Owner. Now we’ve drastically increased test cases per release due to more coverage/content thanks to that Vera upgrade.”

Results

  • The company has automated over 45-65% of mobile App tests, 90% of API tests, and 50% of Web testing. Goal 70-90% across all platforms
  • Manual QA Cycles that took 5 days are now automated and being completed overnight in 5-6 hours
  • Test execution coverage increased 95% within one quarter of implementation
  • 10 different scrum teams testing 6 or more product lines at once, thanks to the automation & reduction in redundancy
  • Saving $120k in test costs / year

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