Since the 1950s, failure mode effects analysis or FMEA has been the cornerstone for medical electronics assurance of reliability. In short, the FMEA methodology meticulously analyzes component failures and specifically targets the resultant effects and consequences on system operations and reliability.
FMEA is a step-by-step approach for identifying all possible failures. Those failures can be found at the various stages a medical electronics product undergoes. They include the design, assembly, and/or service portion of a medical electronics device.
FMEA steps are listed in the sample chart below. Failure can occur at multiple stages such as in Stage A when he product is designed, or Stage B when it is manufactured and assembled. It can fail at Stage C, as well, when the product is fully deployed in the hospital or medical institution.
A failure or group of failures are identified and closely studied. During the effects analysis, a broad spectrum of all types of possibilities and consequences related to a failure are carefully analyzed. If the product fails at either Stage A, B, or C associated risks and ways to mitigate them undergo meticulous study.
In this day and age, it becomes exceedingly prudent for medical electronics OEMs to work even closer with their EMS Providers to assure FMEA objectives. Medical electronics PCBs are becoming increasingly smaller with wearables coming on the scene. Consequently, prudent OEMs are collaborating with their EMS Providers in greater detail to assist in higher levels of product reliability, and FMEA provides a vital role in this regard.
Regardless of the stage where the fault or failure occurs, the same or very similar steps are followed to evaluate the fault or failure. Then root cause is determined, followed by proper recommendations to rectify the issue and have these faults resolved and properly eliminated.