Failure Mode and Effects Analysis (FMEA) is the go-to tool for risk analysis in most medical device companies, but does it make us too mechanical in our approach? Real-world failures — like software bugs or user errors — often arise from interactions that FMEAs can’t predict.
Do we rely too much on checklists and scoring systems, and not enough on human factors or scenario-based risk thinking? Should FDA or ISO standards require more dynamic risk modeling approaches?
FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sigma Institute recognize FMEA as a critical tool. The FMEA tool can be more dynamic in various ways, considering the technological advancements today and in the future. Using AI can analyze large amounts of data for patterns. It can be used to monitor for potential risks and initiate prompt responses, thus improving periodic reviews of FMEAs.
Another way would be to incorporate feedback from customers and suppliers, thereby adding more experience for a multifaceted team. Additionally, FMEA can be applied more regularly to support continuous improvement efforts, such as better procedures for preventative maintenance. Medical devices require more communication with customers via labelling, IFUs, and advertisements. Sales reps checking in regularly with customers also serves as a means to reduce user error. Therefore, there are ways through training and maintenance that can mitigate risks. These would be examples of supporting scenario-based risk thinking or human factors. An FMEA can still be used, but it depends on the company whether or not they are using the tool adequately and sufficiently.
