Should medical device manufacturers be driven more by engineering or medical considerations? Guidant Corporation, which came down on the engineering side on this question, was scolded for doing so by an expert panel it had commissioned to analyze its handling of defects in its equipment. The panel said that "under no circumstances should a potential or manifest risk of preventable death be superseded by statistical analyses."
It remains to be seen whether Guidant will follow the advice of the panel, particularly as the company has been bought by Boston Scientific, which has also had problems with its devices.
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