Mitigating risk in Applied Human Factors In Medical Device Design with Dr. Mary Beth Privitera
Every human factors design firm, in a way, are going to have some area that's dedicated personnel for risk analysis of potential and existing projects. The authors that contributed to this section of the book Applied Human Factors In Medical Device Design, Sophia Kalita and Melissa Lemke, were phenomenal in walking through the process, what to look for, and what is important to mitigate risk.
As Mary Beth Privitera stated on the most recent episode of hsDNA, "Safety-related risks. I know that it's not one of the most exciting topics but it's certainly one of the most important topics that we've talked about and reviewed. It's one of those approaches that's just inherent, regardless of the medical device. There's always some level of risk and risk that has to be managed. There's quite a number of international standards on risk identification and what that process is to mitigate the risk. The medical device industry has to address the risk and that includes human factors.
Specifically, just in what is the use-related risk analysis. What's the root cause of those problems? Then, once the product's released, how am I going to survey the product as it's being used and what am I going to do about it? How am I going to get that customer input back into the design process?"
Without going through and doing that risk analysis, you're going to have to understand that root cause. First is identifying it and then looking for that root cause of what's going to go on. Mary Beth continued and explained, "Lastly, was the chapter that I authored in regards to no use error and post-market surveillance. That just points down to all of the databases and the research that's available for us to look at."
Our lives would be in peril if risks factors were not incorporated in the release of a device and its' inherent concept. For that, we can be thankful that there are measures in place that help evaluate what is important, what is not, and ways to move forward.
