RISK ANALYSIS TECHNIQUE CAN CATCH EARLY FLAWS IN DEVICE DESIGN, EXPERTS SAY
Device firms can save a lot of money and trouble by using an engineering technique to identify product risks during the design phase, experts said in an Aug. 16 FDAnews audioconference titled "Medical Device Failure Analysis During the Design Process."
Marta Villarraga and Dan Mazzucco, principal engineer and senior engineer in biomechanics at Exponent, a global consulting firm, focused on failure mode and effects analysis (FMEA), an engineering technique used to define, identify and eliminate problems or failures in a product before it reaches the end user.
FMEA helps device developers:
Identify unacceptable risks;
Better understand how to reduce risk across the different types of failure modes: system, design, process (manufacturing) and service; and
Design changes that are more feasible, easier and less costly to implement.
FMEA also helps developers determine the causes and effects of each failure mode by estimating: the likelihood, or rate of occurrence, of device failure; the detectability of device failure; and the severity of device failure.