What is the best approach to Medical Device Software Testing?

 

Healthcare per se involves the usage of medical devices for diagnosis and treatment. They are critical to saving lives and need to function at their best to deliver accurate results on a consistent basis. Imagine an ICU unit where patients’ life parameters are monitored every second by medical devices and decisions are taken to administer the dosage of medicines based on such devices. Should the software within these devices malfunction or contain glitches, the result could be catastrophic. So, it is important that the manufacturers of medical devices follow stringent testing guidelines and practices for verification and validation to ensure reliability and quality of devices.

On the one hand, the manufacturing processes of medical devices need to comply with many regulations; on the other hand, the end users expect the best performance, on the whole. This calls for conducting stringent medical device software testing all across the development cycle - from planning, designing, and development to production and delivery. A robust medical devices testing strategy should comprise technical testing methodologies and compliance with regulations. The ideal approach towards testing should be to integrate the testing methodologies right from the design phase, for the testing of finished products can be unwieldy, prone to errors, and ineffective.

What should be the approach to medical device software testing?

Given the critical importance of medical devices in saving people’s lives, the medical devices testing approach should begin by checking the software’s intended use. In other words, checking how the software running the medical device will be employed. This will form the basis for medical devices software validation. Thereafter, the software’s compliance requirements need to be identified. For instance, a manufacturer in the USA should get approval for the medical device from the Food and Drug Administration (FDA). And should the software development job be outsourced to another agency, the software vendor will not be held directly responsible for meeting the compliance standards. However, the device manufacturer should assess the software vendor’s capability in upholding the quality standards and in the event of any inadequacies, should ensure the continuation of additional efforts.

Any medical devices testing strategy should be based on the sets of various test requirements that are further based on the medical device’s component specifications, critical functional specifications, and the manufacturing process. Further, the test requirements refer to the setup conditions, the expected responses, and the actions for each test step. The test requirements help make the implementation of tests easy and consistent, be it from selecting the components to the final assembly of the device. Each test step is guided by its set of requirements and parameters.

Microprocessor testing: All medical devices should be mandatorily subjected to rigorous electronic testing to ensure compliance with the highest quality standards. Since a majority of such devices have microprocessors in them, their evaluation should be the first step. The testers should check the interconnections of transistors within the microprocessors and test them before incorporating them into the Printed Circuit Boards (PCBs). The testing of integrated circuits involves the checking of their connections and logic gate functions. Thereafter, the testing of interconnections and mounting begins after the components are attached to the PCBs. During this phase of testing, the testers use an assembly defect model to identify the wrong or missing component, shorted interconnect, open interconnect, and other issues in the assembly framework.

Test automation: A test automation system comprising a computer, software, and other instruments is used to execute the testing of medical devices. Even though several commercial automation systems are available, the testing team often uses a bespoke test system aligned to the actual test requirements. In such testing, the team may face challenges with respect to the test environment, say an increased need for voltage and current. Also, when it comes to medical devices security testing, the specific parameters need to be derived from the test environment.

Validation: After everything concerning the testing process is ready, the testing system, including the hardware and software, should be validated. Such validation aims to test whether the medical device under testing meets the specific user needs. The initial validation process begins with unit testing of the test stages and is executed for the first production unit. It involves the end-users and the production unit is tested either under simulation or an actual use scenario. Validation testing ensures whether the medical device functions as expected.

Verification testing: This testing process confirms if the medical device’s requirements have been met and begins with well-defined and measurable product requirements. It follows several protocols, such as comparing the device’s requirements with the approved ones. If the verification testing process fails, further investigation is necessitated to determine the requirements of the existing design.

Conclusion

Be it medical device performance testing or quality engineering, it is only a well-defined medical devices testing strategy that can help manufacturers meet stringent quality standards, user expectations, other specifications, and save money.

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James Daniel is a software Tech enthusiastic & works at Cigniti Technologies. I'm having a great understanding of today's software testing quality that yields strong results and always happy to create valuable content & share thoughts.

Article Source: medium.com