In medical device development, we talk a lot about “risk mitigation,” but rarely about whether total risk elimination is even possible. For example, implantable devices like pacemakers or insulin pumps always carry some residual risk no matter how much testing…   Read more»

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…   Read more»