Together with the development of any medical device, the greatest concern Is to protect the individual from injury. But device development managers are challenged with how to most efficiently allocate resources among design, test, quality, and manufacturing groups to accomplish this objective. Our experience has shown that with appropriate integration of testing into the development process of a device, you are able to effectively manage product failure rate and keep development costs low. The ideal time to start considering testing your device is in the very early stages of this project. As you develop the specifications for your device, you want to also recognize the test needs for your apparatus. By managing the evolution of your test tools as part of the device’s ecosystem, you can make sure your test tools meet your test requirements at all stages of development. Integrated project teams that have test engineers can define the requirements for the test tools, design the program and funding for their advancement, and see to the test tools such as a job such as a subsystem of the apparatus.
Being able to split a job up into smaller pieces that can be Tested early — even before being incorporated into the last apparatus — enables early detection and correction of design deficiencies. Identify points in the device development program where design engineers will have need for particular test tools and create a test tool program that offers the proper tools at those energies. Too often we hear how hard it is to receive input from the design group: They are simply too busy to discuss how the device will be tested. By working with the design team’s program and providing them access to tools they can use to inform design, however, they start to appreciate the integral role that testing can perform and devote time to provide their input. When creating the test tool program, consider how the Information in the test will be utilized when planning test tool validation activities. Test tools used in verification testing require validation, but if these very same tools are utilised to supply data for critical design choices, earlier validation of this tool is justified.
Imagine spending thousands of dollars creating a fully automated inspection system for production testing of your device, only to find that your device continually fails the review. We often observe the test tools used during design, verification, and production developed and maintained by different divisions with regard for the test demands of the other associations. By managing the lifecycle of your test tools as part of this medical device testing ecosystem, you can make certain your test tools meet your test requirements at all stages of growth. This maximizes the potential for reuse of equipment and applications. Access to high quality, rigorous test tools also allows the early detection of design flaws. The demands of the test tools that we use evolve as the device’s lifecycle progresses. Among the first steps to efficiently handling testing is to Properly identify the types of testing required. This helps to ascertain how the particular objectives and limitations for these test situations differ.