Medical devices need evidence to prove they are going to be successful when they are in the hands of physicians or medical professionals. Engineers collect evidence by testing the device against all of the requirements for its safe and effective performance. Some of this testing is performed by challenging the device in a lab or benchtop setting, animal use, and sometimes even human clinical trials. In order to test the medical device, engineers must set up a hypothesis, define the test environment, and develop a test method. All of this information is identified in the test protocol.
The objective of a test protocol is to provide a method to test the medical device’s success. The results of a test protocol are documented in a test report. For well-established medical devices or technologies, the FDA and standards organizations, like ISO, define how to test a product. However, the manufacturer needs to define how to test the medical device for new technologies. All aspects of a device can be tested: biocompatibility, packaging, labeling, clinical use, and design outputs. To test perform any of these tests, engineers must have an established protocol.
Types of Testing
Representative Testing is test instructions and parameters that test the use of a medical device in a usual manner. For example, wear and tear to capital equipment devices like MRI machinery or sterilizers may test wear and tear to the equipment under standard use cases and when the user should expect to see wear and tear on the device. This type of testing is representative because it represents the use of the device.
Challenging Testing are test instructions and parameters that test the use of a medical device in scenarios on the device’s upper limits but are within everyday use. For example, packaging testing might test how the packaging lasts in extremely hot or extremely cold climates but does not test normal ambient conditions. This allows the manufacturer to know how the packaging holds up in extreme, challenging temperature conditions, and therefore it will last under ambient conditions, which are more common.
Worst Case Testing
Worst Case Testing are test instructions and parameters that test the use of a medical device in uses it should not experience. For example, some medical devices can be sterilized and reused a certain number of times. Manufacturers may define the use and advise users to dispose of the device after a certain number of uses. However, they likely have tested how well the device remains in working conditions. This is considered worst-case testing: in the worst case a device is used beyond its normal life, the device is not expected to fail or may still be able to perform in the worst-case situation.
Protocols are required by FDA, EU, and other countries. They are regulated materials that auditors review. Protocols ensure thoughtful design. A well-developed protocol will test all the right parameters and provide meaningful information about the device’s performance.
DeviceLab’s Medical Device Protocols
DeviceLab is ready to help your medical device testing strategy, and the number of experts available can help ensure your device is tested under the right type of protocol. Contact us today to learn more.