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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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5.5 Quality and Process Management

Introduction
An engineer looks at a monitor over the shoulder of a cardiologist to observe a problem with his device. The nitinol stent is broken and embedded in a patient’s artery. Shortly thereafter, several other doctors from hospitals across the country start reporting the same issue, although many others indicate that they have experienced no problems at all. After studying all the films, it is confirmed: despite the fact that all of the cycle testing before commercial launch was completely successful, some of the stents are now breaking in the field. In an effort to understand why some are breaking and others are not, the engineer thoroughly reviews the causes of failure. By checking the detailed records ...

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