This second article in our series addresses a common risk analysis problem – prioritization.
In large medical device companies, the email invitation to a Failure Mode and Effect Analysis (FMEA) risk management session can strike fear (or at least dread) into the hearts of engineers and other members of the risk management team. One reason that they may not be eager to click “Accept” is that these sessions can quickly devolve into detailed investigations of issues of negligible severity or probability of occurrence that soak up the team’s time and energy – to the point that important issues may not receive the attention they deserve.
Small medical device companies, without a mature product line or risk management system, may have the opposite problem. There, the list of hazards being considered may be limited to those issues that are most obvious to the design team and may not provide a comprehensive assessment of device risks. Instead of an overly detailed analysis, these companies run the risk of not going deep enough.
This article provides an introduction to approaches that device companies have successfully implemented to focus their risk management activities and help to ensure the safety and efficacy of their products.