2-Year Support and Evolution of CE-Marked Laboratory Diagnostics Software

About Our Client

The Client is a European manufacturer of genetic screening kits and accompanying software products for diagnostic laboratories.

Improving Lab Software to Anticipate User Needs

With the assistance of ScienceSoft’s healthcare software development team, the Client launched the CE-marked laboratory software for its screening kits. The software automated the processing of genetic screening tests in the laboratories and helped validate the quality of the tests. 

The end users were satisfied with the new tool for lab test results interpretation and quality control, but the Client had several ideas on how to improve the software functionality. Plus, it needed a trusted team to resolve software issues that could emerge after the updates.

Having a positive experience with ScienceSoft, the Client offered us a one-year software support and evolution contract.

Returning Team to Deliver New Software Capabilities

During the development of the lab software, the Client commended our team's proactivity and expertise, so ScienceSoft engaged some of the same IT specialists in the follow-up project. This helped eliminate the time-consuming software knowledge transfer and team onboarding activities.

Early on, the Client decided that ScienceSoft wouldn’t work with the requests from the end users (laboratory technicians) but would rather receive a set of support tasks directly from the Client’s team.

The Client didn’t expect many support and change requests, so we settled on the monthly service subscription approach to optimize the long-term project costs. We agreed on the number of hours each team member would dedicate to the project tasks per month. As a result, the team composition and their project engagement looked as follows:

• Scrum master/project manager (6–8 hours per month).
• Business analyst/proxy product owner (on-demand).
• Senior C++ developer (20–25 hours per month).
• Senior functional test engineer (20–25 hours per month).

With this approach, the Client had achieved the desired collaboration flexibility. The number of monthly hours for each role could be increased if the Client had planned major software changes or decreased if the Client anticipated fewer support tasks.

The team was available during the Client’s business hours to timely address the support and modernization requests.

Targeted Improvements in Lab Software Functionality

Following the service level agreement, ScienceSoft resolved critical software issues within 24 hours, high-priority issues within 48 hours, and medium-priority tasks within 72 hours. This approach helped the Client ensure the business of the partnering labs was not affected by any unexpected technical challenges.

The scope of lab software improvements was determined by the Client’s team and described in detail by ScienceSoft’s business analyst. Here are some of the changes and improvements that were implemented by ScienceSoft:

• Changing import parameters for the files from laboratory equipment software (e.g., uploading raw test files with fewer rows).
• Improving lab diagnostics results view: adding a warning triangle to problematic wells in the well-plate view, adding a warning triangle next to abnormal quality parameters, and changing the warning triangle to a yellow circle for individual sample targets.
• Displaying new values (e.g., calculating the average value of selected genes per lot, changing allowed blank cut-off values for the tests).

The implemented changes increased software convenience for the laboratory technicians and improved user satisfaction rates.

2-Year Partnership Upholding High Quality of Lab Diagnostics

Thanks to ScienceSoft’s cost-effective services covering the optimal package of monthly support hours, the Client did not have to hire a full-time team to maintain its lab diagnostics software product. ScienceSoft’s software engineers who previously worked on developing this software returned to gradually upgrade its capabilities and improve convenience for the end users, fulfilling up to 10 support and change requests per month.

When delivering changes, ScienceSoft followed ISO 13485, IEC 62304, and IEC 82304-1 standards to ensure the high quality of the medical software and its documentation.

Satisfied with ScienceSoft’s performance, the Client prolonged the contract for another year.

Technologies and Tools

C++, Jira, Confluence.