Often times the business tries to push for new products or changes to existing products to be submitted to the FDA and cleared in order to meet the budget for that year or to meet a certain timeline that was communicated for the project. With this being said, the project team is usually put in this situation of trying to fit perform all required testing to ensure a quality submission and at the same time meet a tight timeline for the project. Therefore, some decisions would have to be maid in order to cut some of the time required to submit that product to the FDA. These decisions includes things that could be leveraged from existing products instead of performing new tests, justifications to why certain internal requirements are not being impacted by the design changes, providing scientific evidence to why aging is not applicable to some design verification tests, or providing deviations to justify failures instead of re-executing those tests. With this being said, it would be very hard to ensure a quality submission and the team would most likely receive questions from the FDA regarding the submission.
My question is: to what extent do you think the project team should cut corners? What can really be justified? What would the FDA consider as acceptable?
I wouldn't say a project should be cutting corners, but rather use previously reliable data to prove that the new product is not a new worst case. This can be done in multiple ways to save money and time for the company working on a project. One way is to provide evidence via tolerance stack up and risk analysis to show that the new instrument or implant or general product does not produce a higher risk and worst case compared to its predecessors. A list of mechanical tests are most likely used in general to prove this that will need to be completed. Justification can also be in the form of FEA using simulation software with hand calculations proving that the simulation is accurate. This can be tricky as the FDA does not currently accept these simulations as the full verification activity for a submission, but it is growing as an area to reduce cost during prototyping.
You can also justify the sample size of your tests as long as you use the accurate power and acceptability for the parts based upon risk. You can sometimes justify using one or two instruments with 3 lifetimes accounted for to reduce the number of samples required for testing, but there is a risk associated with this as mechanical parts will fail eventually. All in all, there are ways to save money and time for a project, but it all boils down to doing your due diligence to provide rationale that you did not create a new worst case with data driven justifications.
Its true that sometimes it feels like upper management and their timelines are the biggest challenges in a project (and many times that is the actual case), but that is the reality for most large corporations and project managers and their teams have to learn to work with it. As @jaf22 mentioned, there are ways to save time and money without cutting corners, but it is also important to remember the FDA's role in medical device development. The FDA requirements are set in place to ensure that the device you are trying to launch is both safe and effective. While they will accept test methods and design verification testing that mimics predicate devices, it still requires that design verification and validation actually be performed. Benchtop and animal testing have to be performed as well, and while some things can be rationalized, like smaller sample sizes, this testing still needs to be performed and to produce results supporting safety and efficacy. The 510k submission also includes sections on biocompatibility, toxicology, sterilization, packaging, labelling, etc. that require data and compliance.
@nm523njit-edu The key requirement for this is to establish clear communication channels between project managers, regulatory affairs, and upper management. Regular updates on regulatory progress, potential challenges, and milestone achievements can help them manage their expectations and allow for efficiency in the process. A key part of this is comprehensive documentation. This means documenting all minutes, rationales, and decisions during the development process. This not only facilitates FDA submissions but also demonstrates a commitment to transparency and accountability. Regularly monitoring the updates and communicating the ideas is essential for the success of a project.
