The requirements associated with medical device safety testing continue to increase, which has raised the bar for device approval and slowed the delivery of needed technologies to patients. During medical device development there are several strategies employed to de-risk your device. We have extensive experience and success with de-risking devices through test method validation (TMV). TMV is critical to ensure testing performed on the devices is of the highest reliability. Occasionally, a test method validation will exist and can be applied to the device under development. However, novel medical devices are being designed constantly, and currently validated test methods are not always appropriate or adequate.
Built into our quality management system (QMS) is the ability to develop and validate a test when no standards or guidance is available. The appropriate QMS procedures and proficiency training develop the necessary expertise with MED engineers to not only test devices using available standards or validated methods, but also to develop new test methods for novel high-risk medical devices where current test methods are not adequate. We are frequently presented with devices for which there are no existing test methods to accurately evaluate device performance or safety. In these cases, our engineering team leans on the MED QMS, including uncertainty and gage repeatability and reproducibility (R&R), to develop new test methods that can apply to current and future devices in accordance with ISO/IEC 17025:2017 standards.
MED received an expedited turn-around time request from a client that had failed repeated attempts to achieve reproducible test results for their product. MED was asked to develop a test method that produced data that were consistent with previous clinical use experience. Further, the MED engineering team sought to develop a test method that did not alter the performance of the device. Working closely with the client, MED engineers developed a new test method designed to meet the client’s specific needs. Deliverables for this project included acceptance criteria, a fully developed and validated test method, and test fixtures, all designed to capture the “real-world” clinical use case.
After several iterations of test method development and multiple rounds of feasibility testing, our engineers devised an accurate and reproducible test method. The test method was efficiently developed and based on a relatively simple model that in-turn achieved the highest level of precision and repeatability. MED engineers validated the method for all factors that could impact repeatability and reproducibility of the test results. The uncertainty of the method was also evaluated as part of the validation.
Upon validating the test method and determining the factors needing control, a formal protocol for the study was developed. Having a fully-developed protocol met the client’s needs by ensuring the process was consistent between different sets of testing and different operators. Ultimately, MED significantly improved the test result reproducibility. The results generated from MED’s test protocol compared favorably to the appropriate industry standards and our pre-established acceptance criteria. The team met client expectations on a very tight timeline by delivering a validated, reproducible test method.
MED has had an independently qualified quality system since 1999, and has gained experience through involvement in the test method development and validation industry since 2004. Our team is experienced in designing and developing new test fixtures and test methods for the sole purpose of testing novel devices.
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