by Liz Mauer, MHCI
This is the first in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks.
It would be hard to understate the importance of a rigorous Use-Related Risk Analysis (URRA) when developing medical devices and combination products. Not only is a URRA necessary to satisfy a regulatory requirement (and, of course, to ensure that your product is safe and effective for intended users), but the success of your human factors validation study is largely dependent on it.
Over the years we have noticed a gradual shift in how companies are thinking about managing use-related risk when developing products. It wasn’t that long ago that the prevailing attitude about URRA was to check a box on a submission. It was usually done at the end of development and the key mitigations were modifications to labeling and training. As time went on, more and more companies started to consider URRA in the larger context of product development, understanding that if it was started earlier, modifications to the product to address use-related risks could be implemented without compromising timelines or incurring excessive costs.
Today, we see more companies who want to use URRA as a tool to proactively manage use-related risk, which is great news for us all. It has been our experience that those who do it well go a long way toward making their human factors validation study easy to plan, execute, and report on. Those who leave this activity to the last minute, aren’t rigorous enough, or who create a URRA that is difficult to explain and therefore review, are in for a world of hurt during their submission process.
However, as much as people want to be proactive and prioritize URRAs in their development process, we have been seeing some misconceptions about how to do so effectively. In our experience, a URRA that isn’t effective at identifying, characterizing, and communicating a product’s use-related risk profile can cause big problems when it comes time for human factors validation and submission to a regulatory authority.
Over the course of several posts, we will share some of the most common pitfalls we have seen with URRAs, and provide advice on how to avoid them. Stay tuned!