ABSTRACT

A few years ago, I was part of a design team to develop a medical device. This particular equipment had utilized an electronic circuit board to drive an electric pulse at ultrasonic frequencies. The design team had completed the rst and second engineering builds and we had high condence that the product would function as expected. On the basis of this gained knowledge and information, a decision was made to build enough units for subsystem verication testing. Low and behold, during this activity, it became very evident that the subsystem did not behave as expected. Needless to say, this was not news that upper management considered lightly. As the entire team conducted an investigation to identify the root cause of this issue, it was discovered that one of the engineers had approved a slight deviation on an inductor without sharing the information with anyone else or giving it a second thought. I do not recall the exact deviation at the moment but it had to do with the way the wire was wound on the inductor’s core. Although the problem was rectied, it did cost both time and money-and a black eye for the team.