Comprehensive Testing of Software in Medical Embedded Product

The insufflator is a device designed to pump and control pressurized gas to create a cavity inside a patient's body that will allow a variety of complex surgeries.  

Due to the complexity of the device and the strictness of the medical standards, the client decided to use the services of our experienced team of testers to comprehensively test the device and support the development team with our findings. We worked as an Agile team with close cooperation with the client.  

The main objective was to ensure that the final product would once again meet strict standards and get the certifications needed.  

Our task was to provide end-to-end software testing services for the medical device where we functioned as a separate external team. Our work included test designing, test execution, and thorough documentation of results and bugs found, as well as intensive communication with the client’s software teams.

The key challenges were:

• Adhering to rigorous health and safety standards,
• quick understanding of the test documentation provided,
• identifying its gaps and deficiencies and completing documentation according to the customer standards,
• help with root cause investigations and iterative testing of subsequent updates and fixes.

We finished the test documentation, executed our planned tests, and handed the results to our client.  

We provided dynamic testing of the software and system-software testing, mostly using the white box approach. We performed functional tests of end-to-end tasks, which included testing the software updates and software responses to inputs from hardware components, as well as hardware responses to software inputs.

Enhanced Device Reliability and Compliance

Our comprehensive testing approach significantly improved the reliability and regulatory compliance of the client's medical devices.

Key benefits included:

Improved Stability: Medical devices showed enhanced operational stability and user-friendliness.  

Thorough testing and coverage: After the implementation of the new components, our testing identified several inconsistencies and bugs in the device's behavior, which were subsequently resolved by the client's software team in cooperation with the testing team.

Issues identified included:

• Operating software freezes and inadequate software (and hardware) response,
• device hardware responses that generally differed from those requested by testers via the graphical user interface (GUI), etc.,
• we were also able to find that some new components did not work as specified.

Conclusion

At the conclusion of our work, the project was complete and documented thoroughly, and the device was prepared for the certification process.

About the process

Test Case Design

For our work with test documentation, we used the Polarion software, as well as for test management. In it, we designed comprehensive test cases based on detailed customer requirements.

This involved:

Requirements Analysis: Understanding and documenting the exact needs and expectations of the medical device users. This analysis sometimes included notifying the client’s software architects and engineers of any deficiencies and ambiguities in requirement documentation.

Test Case Development: Creating complete test scenarios to evaluate device performance thoroughly under various operational circumstances.

Test Setup Assembly

We assembled test setups that mimicked real-world medical conditions including the usage of validated patient-imitating dummies, to ensure the tested medical devices perform accurately and reliably. Our setups also included many calibrated measuring devices that were used to verify the device's functions (e.g., an oscilloscope as well as pressure and temperature meters).

Execution and Analysis

Test Execution: Conducting rigorous testing on the medical devices, capturing data on functionality, reliability, compliance, and fulfilling the client’s requirements. During the testing process, our team worked with several software tools developed by the client to manipulate the device and record its responses (some of them are used, for example, for the CAN interface or the J-link debugger).

Defect Identification and Reporting: Analyzing test results to identify performance issues and compliance gaps and documenting these defects comprehensively.

Confirmation Tests: Re-testing to verify that bug fixes in the newer software were effective against the defects.

Regression Tests: Re-testing to verify that bug fixes in the newer software did not introduce new issues.

A producer of medical equipment. The equipment is a complex (electronic) device used for Minimally Invasive Surgery (MIS).