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May guide device design to mitigate failure modes; leaves open prospective validation in clinical outcomes.
The design of cardiovascular devices is a complex process that is partially, but never completely, illuminated by scientific information and precise specification of the performance wanted of the device. No design satisfies by only accomplishing its intended goal; it must also avoid unintended, unwanted effects, termed in this chapter failure modes. Discussion of these modes is the principal goal of this chapter, which, however, concludes with a discussion of a feasible process of design that can be carried out in the presence of substantial ignorance. Natural components of the cardiovascular system as models for the exploitation of current technology are suggested to be, at least at present, less useful than are precedent artificial systems.
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Edward F. Leonard (1993) studied this question.
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