How to Test Medical Devices: Best Practices

The healthcare industry has witnessed significant innovations in recent times. Medical devices must comply with numerous compliances and standardizations, ranging from improved connectivity to accurate readings, effective performance to safe usability. Therefore, it is important for the devices to have a proper testing strategy in place.

In this blog, we will outline some of the best practices for medical devices testing. Following these strategies will ensure that the device fulfills its requirements and drives value for the patients.

Effective Strategies for Medical Device Testing

#1 Microprocessor Testing

Microprocessor testing is one of the most critical medical devices tesitng. It should allow access to the interconnections in order to perform effective testing of the transistors inside the microprocessor. The testing team needs to test the chips of the microprocessor before installing it on the Printed Circuit Board (PCB). The tests for an integrated circuit consider logic gate functions and their interconnections.

After attaching the components to the PCB, it’s crucial to prioritize the testing of the mounting and interconnection process. In order to do so, the testing team seeks to identify the missing components, wrong components, shorted interconnects, open interconnects, and others in the PCB assembly process.

The team should also ensure that the small groups of components on the PCB do not interfere with the overall function of the system. It leads to several phases of functional testing. Typically, a PCB is insufficient for detecting common manufacturing flaws. As a result, more troubleshooting is required to resolve the specific issues..

#2 Test Automation

The test automation system was developed to easily execute and control the test procedure. While there are numerous commercial test automation systems on the market, healthcare testing experts frequently use customized testing systems based on their needs.

While testing complex medical equipment with excessive current and voltage demands, the testing team may face challenges in the test automation environment. An automated test is ideal for generic software and hardware design. Sometimes, the testing regulations depend on the manufacturing process and it is important to follow them for specific interface hardware and test system software. Mechanical design, electrical design, coding, and data integrity - everything is taken into account.

#3 Hardware Testing

Hardware testing involves various types of tests, including component and environment evaluation, safety evaluation, shipping tests, usability and reliability demonstration, standards evaluation, and more.

Hardware testing is often executed twice:

• Right after the design phase - to evaluate the design’s stability and robustness.
• After starting the customer units’ production - to evaluate the reliability of the product’s manufacturing process.

#4 Software Testing

Software testing is a core element in medical device testing. It comprises the following:

• Integration testing - Here, several modules are integrated with each other to test their stability and compatibility.
• Module testing - It relates to the stress testing of several modules of the software. The testers run each module independently and also check it by inserting errors through an emulator.
• System testing - Here, the software is tested with respect to the hardware to assess its compatibility.
• Acceptance testing - This is the final review of the entire system that assures a perfect collaboration of hardware and software.

#5 Validation Testing

Medical device validation testing is implemented for testing the core software and hardware. The validation process determines whether the device can meet users’ requirements or not. Therefore, it requires a strategic approach from the testing team.

A device should be tested for actual or simulated use during this process in order to understand its value to end-users. The initial approach to validation starts with unit testing of multiple stages in the process and then the entire system is validated as a whole. The testing team often resorts to a divide and conquer validation approach as it may be overwhelming to test a complex device with an automation system. Further, a functional block test is ideal for the validation of custom-built software and hardware.

Closing Thoughts

Testing teams should prepare a well-planned schedule and pay minute attention to the above-mentioned aspects. Sometimes, an in-house testing team is not adequate to provide quality assurance for a medical device. If you don’t want to compromise the quality of the device, it’s better to partner with Cigniti. We are capable of dealing with complex medical device testing methodologies and ensuring that the software performs to the highest standards. Get in touch with us to know more about our services.

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.