A practical approach for Medical Device Testing

The critical role of medical devices can be understood from the fact that any component or software failure can put the lives of patients in jeopardy. To ensure these devices function to their optimum level on a consistent basis, they are subjected to a plethora of regulations and compliances such as IEC 60601-xx, IEC 17025, ISO 14708-3, and ISO 14971. In fact, the World Health Organization (WHO) has recommended to all governments the need to set-up regulations for medical devices. This is to assure all stakeholders of the ability of devices in offering necessary risk mitigation and minimizing harm in case of any malfunction. As a result, manufacturers have undertaken medical device testing to check various components and embedded software within such devices for enabling consistent performance.

The above requisites called for the medical devices testing specialists to define and implement the right testing strategy throughout the manufacturing process. To cite an example, manufacturers should validate every functionality of the medical device right from the concept and design phase for better test coverage. On the other hand, should they test the manufactured devices for functionalities and identify glitches therein, the cost of implementing solutions will be high and time-consuming.

Medical device testing identifies the risks and impact of various environmental conditions and focuses on the reliability of devices vis-a-vis the inputs. It involves various types of testing related to the lifecycle, compliance, interoperability, reliability, and performance of medical devices. Medical device functional testing also focuses on risks concerning electrical, mechanical, and environmental aspects. The medical devices testing experts conduct technical testing on the subassemblies, components, and the finished product to ensure the latter’s effectiveness.

Devising an impactful strategy for medical device testing

The medical devices testing specialists should take inputs from the design team to create test structures that conform to the software, hardware, and other requirements. Moreover, the test requirements for devices are based on the manufacturing process, component specifications, and other functional specifications. These help manufacturers in carrying out tests throughout the manufacturing process - from selecting individual components to their final assemblage.

Practical approach to medical device testing

Any practical strategy to test medical devices should involve phases like analysis, design, deployment, closure, and maintenance. To validate testing as per the test requirements and parameters, the following types of testing are undertaken.

Microprocessor testing: To conduct effective performance testing of medical devices, they should be subjected to solid electronic testing. Since most medical devices come with built-in microprocessors, the test process should commence with microprocessor testing. Importantly, medical devices testing experts should execute such testing prior to the integration of microprocessors to the Printed Circuit Boards (PCBs). Testing the transistors and integrated circuits inside a microprocessor should consider their interconnection and logic gate functions.

Post integrating the components to the PCB, the QA team uses common defects of an assembly model and identifies the wrong component, open interconnect, and missing component. Moreover, any modern test equipment allows direct measurement of device components in small units. However, care must be taken to ensure these components within the PCB should not impact the functioning of the whole medical device. Even though functional testing is a crucial part of the testing process, it does not suffice to find other manufacturing defects. This necessitates additional troubleshooting.

Test automation: This process is conducted by using an electronic system comprising instruments, a computer, and software. While testing high-tech medical devices with varying current and voltage requirements, the test team might grapple with generating test cases and measuring their accuracy.

Interoperability: Testing medical devices should invariably check for the interoperability of devices and applications to uphold data privacy and security. The tests should be recorded for the purpose of audit and compliance. With innovations involving the Internet of Things, there is a need for the applications, devices, and controls to integrate with the software at the core.

Security: In today’s challenging digital scenario there is an urgent need to make the embedded software within medical devices hack-proof. These include adopting measures like firewall testing, encrypting the user data, and the authentication and validation of user log-ins, among others. The security testing of devices should aim at protecting the health information of patients and ensure they adhere to the provisions of the Health Insurance Portability and Accountability Act.

In addition to the above types of testing, medical devices should be tested for regulations and compliance, especially as per FDA. Finally, the practical approach to testing medical devices should include GUI testing, performance testing, non-GUI testing, compliance testing, interoperability testing, behavior testing, reliability testing, and user acceptance testing.

Conclusion

A robust approach to testing medical devices is critical to ensure its effectiveness. It can help manufacturers from preempting situations like device recall and save money in retesting devices should glitches be found. In an industry that requires stringent adherence to quality, manufacturers should engage organizations with domain knowledge and experience.