Failsafe testing of medical devices is a non-negotiable pre-requisite for release of a device to the market. Most realize that simplistic truth but there are far too many who do not appreciate the “devils in the details” of test applications engineering—both functional and leak testing.
An example is the reliance on pressure decay leak test sensors by those who think it is always a less expensive test method. Often single direct measurement with mass flow leak sensors is not only the more economical route but more importantly far less suspect to errors introduced by temperature variations in a two-step measurement process.
Bottom line: Medical device design teams need to include test applications engineers to ensure they get the details right