I've done and am actually in the middle of a shelf life validation for raw materials and final device. We've included in it packaging, transportation, and storage studies in accelerated and real-time aging.

In the past, I've done software validations which for me have been the trickiest and most challenging. Some of the challenges I've face are software revision discrepancies - it's incredibly easy for a multinational team to lose track of revisions. Because of that, there could be major differences in software that you could not have anticipated which would result in a failure, deviation, or non-conformance depending on the situation.

I've been through a process validation before as an Engineering intern. Process validation is the gathering and assessment of data from the process design stage through production to produce scientific proof that a process is capable of consistently providing high-quality goods. This validation includes a checklist to verify functionality as well as my techniques for assembling a heart valve.

In my line of work, one type of validation that is done is Test Method Validation. This is done to identify any variation that may be present within a test method and if a method is validated, it is considered to have below a certain threshold of overall variation. Having a Test method validated is important because it can be considered acceptable for use for various regulatory body submissions since a test with low variation is able to more accurately capture the performance characteristic of a medical device. 

Does anyone have any experience working with Test Method Validations or know more about how they are used within a medical device company?

Thanks,

Matt

Just going back to TMV, its less specific for low variation, but rather determining whether that variation is consistent for different users. There is always going to be tests that have a large bias and TMV covers the aspect that the users performing the testing are consistent with themselves and the data can be held true.

I think that one area of validation that isn't covered previously is end user validation (at least for medical devices). A panel of surgeons or users are chosen to evaluate a device through the lifecycle (paid by company for their consult and discrepancy of prototypes) that will note in a validation lab whether or not the device works as intended at the end of the development cycle before launch. If the device does not work as intended, the engineers or scientists must figure out if their design is wrong or if the input was looking at a non-intended misuse that should be detailed in a memo or the surgical technique guide. 

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisions made about the product from the result of that test are valid. In the medical device industry design control cycle, if the product design or design change includes a novel test method (not a standard test), then the planning stage of the design control project should include a strategy for how the test method will be validated. In the execution or validation phase, the strategy will be put to action and the test method will be validated. Only then can the product be tested with this method and the design controls can be complete.

A validation process we are currently executing is to determine if a new testing equipment will provide the same result as the previous equipment. The equipment is used to test our raw material and final product. Essentially, the process requires us to run the same batch/lot of material and product on the same day on both the old equipment and the new equipment to ensure that they both produce the same results. I have also done product stability validations which like those have mentioned before me, require me to confirm product stability over time and determine its’ shelf life.

Throughout my time working at a company I have done many different types of validations. Essentially, validations can be done for a large array of tests and products or processes. One type that I have done is a packaging validation which included shake rattle and role testing, age testing, and testing packages for dye penetration. Another type of validation that I have done is process validation, which essentially includes running Installation, Operational, and Process Qualifications on a process. An Installation Qualification is running any utilities, set-ups, software validations, or functional validations on equipment used in a process. Operational qualifications test the limits of a process or the limits of what a piece of equipment can achieve during a process (worst case operating parameters). Finally, the process qualifications tests a number of samples based on risk when the process is being run at nominal parameters, to ensure pieces are built correctly and within tolerance. Again, there are a even more validations to run than that, but these are mainly the ones that I have worked with in the past.

There are a couple different forms of validation that I have encountered in my work experience that are interesting in their own right. One of the types of validation is process validation, where in the environment of manufacturing, a process would need to be validated because a new product is being made or this type of manufacturing hasn't been performed before. This process has multiple aspects, including the quality of the product, the equipment, cleaning, etc. Still on the topic of manufacturing, the cleaning of the process might even have its own validation because of the sensitivity of the process needing to be cleaned for the future batch or so it doesn't contaminate the material being made. This cleaning would be done mainly because bacteria, even the smallest amount, can disrupt the highly sensitive product. In this case, it could be pharmaceuticals, which are most popular. Another type of validation would be equipment validation, which factors in process validation but focuses mostly on the equipment being used. In this case, this equipment would need to be able to perform a certain task, such as having a certain flow, such as an air compressor. This air compressor would then be tested to make sure it pushes this air into the process, which can be verified through different means such as flow meters as well as looking at the quality of the product. The most interesting validation to me is the process because it encompasses multiple aspects and there are multiple things that can be investigated if something doesn't work out as expected.