How to Plan a Medical Device Testing Strategy and Deal with Regulatory Affairs

The healthcare ecosystem is greatly benefited by the medical device industry for providing innovative solutions and improving treatment outcomes. And since these devices play a critical role in saving human lives, their quality is of paramount importance. Hence, manufacturers must conduct stringent medical device testing to ensure the delivery of effective and safe healthcare services. The focus should be on implementing a robust medical device testing strategy and ensuring the quality, effectiveness, safety, and reliability of such devices. Given the critical role of such devices, these are subjected to compliance from multiple regulatory bodies.

At the same time, users of such devices expect them to perform exceptionally well in terms of accuracy, safety, usability, efficiency, and functionality. To cite an example, the manufacturer needs to test each device’s functionality during the design stage only, for in the later stages, especially after the device is manufactured, testing can be extremely costly and time-consuming.

How to strategize medical device quality assurance

A realistic medical device testing strategy calls for collecting test requirements based on the device’s manufacturing process and critical functional specifications. The test requirements include delineating the setup conditions and expected response parameters as essential test steps. Since medical device testing is conducted at various stages of the manufacturing process – from selecting components to final assembly – there are different requirements.

Any medical device software testing takes into account the testing of sub-assemblies, components, and the final product. Also, software and hardware requirements for individual test stages are considered with the methods of measurement and the expected outcomes. Further, during the validation process, the testing device is divided into blocks where the process is customized based on risk analysis.

Microprocessor testing: Most medical devices have microprocessors at their core, and to test the transistors inside them, all interconnections must be made available. The QC team should conduct the testing of the microprocessor chip before fitting it into a printed circuit board (PCB). Testing the integrated circuits includes validating the logic gate functions and their interconnections. When all components of the PCB are attached, the test team looks for the wrong/missing component, open interconnect, or shorted interconnections, among others. It must be ensured that the components fitted into the PCB do not impact the functioning of the system.

Test automation: It is an electronic system comprising a computer, software, and instruments to conduct medical device testing. However, when it comes to testing complex medical devices with strong power requirements, the QC team may be challenged for a host of reasons. These include not generating enough test cases and the lack of ability to measure test accuracy. In such cases, the test requirements are broken down into hardware and software specifications. Moreover, certain test specifications are needed to be gathered from the test environment consisting of compliance with data integrity and security. But to simplify the testing process, specific blocks of hardware and software can be reused at a place where many medical devices have been designed, developed, and tested.

Validation: Once the testing process is finalized, the entire test infrastructure is validated to test if the medical device meets specific outcomes. Here, the test approach and structure become important. The process of validation must be conducted on the initial production unit involving the end-user, whether simulated or real. Validation should begin with the unit testing of components followed by testing the whole system. The functional testing of medical devices also forms part of the validation process wherein different functional blocks, namely, hardware, instruments, software, and operating systems, among others, are validated for their expected usage. This comes in handy to validate the custom-developed software and hardware for medical devices.

Regulatory strategy: During the development of medical devices, experts dealing with device’s compliance with regulatory affairs should advise the team about the regulatory strategies to use. This is to ensure the finished product can be legally marketed. The experts dealing with regulatory affairs must advise the development team about decisions that may affect the type of regulatory submission and the associated timelines. If the product needs to be distributed globally, then the expert for regulatory affairs must ensure the development team tests and validates the device as per the international regulatory requirements.

Conclusion

A robust and well-defined medical device testing strategy can help manufacturers meet all functional specifications and end-user expectations. It reduces the risk of device recall and saves substantial sums of money for the company. To ensure testing is done effectively and comprehensively, the services of experienced and credible medical device testing services can be used.

James Daniel is a software Tech enthusiastic & works at Cigniti Technologies I'm having a great understanding of today's software testing quality