Balancing regulatory approvals with the need to keep the product up to date for users in a fast-evolving space can be challenging during the ongoing development of software as a medical device (SaMD) and other medical devices. Use data, internal development, and other factors may support a case for continuous updates to approved products. But how do you continue to improve a product without triggering a need for re-submission and approval?
While the FDA 2022 guidance, Content of Human Factors Information in Medical Device Marketing Submissions, provided an overview of how to deal with these changes from a regulatory point of view, there are still additional nuances involved. These include determining which changes necessitate testing (and what kind of testing might be required) as opposed to what can be justified with other evidence.
Our human factors research team has developed a basic framework based on the guidance. This framework can be modified and manipulated to fit manufacturer’s needs, making these decision points easier.
Our framework breaks down into several components:
Impact to intended use, users, use environment, required training, and labeling.
Impact to task flow and use-related risks (Would the change require a new task? Does the change impact existing tasks, and if so, what is the criticality of those task(s)?)
If the team recommends and approves testing, align on the scope of the study and the study outcomes required for the change to be approved for commercial release. Determine if there is a threshold for success that must be met.
Finally, assess the risk observed in testing and determine if the proposed change meets the previously determined threshold.
Following a framework can help streamline your post-release human factors process by providing a structured and efficient approach when evaluating changes. My colleague, Anke Adenwala (Partner at Bold Insight) and I will share this process in detail at this year’s Human Factors and Ergonomics Society (HFES) 2024 Symposium in Chicago. To discuss how to successfully craft a framework catered to your human factors needs, come chat with us at the Symposium Tuesday, March 26 from 4:45-6:15 PM CDT.
If you won’t be able to make it to the event, let’s grab some virtual time at your convenience! Reach out!