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Warrants caution translating research sensors to care; leaves open targeted validation studies for clinical standards.
Biological sensors intended for clinical use can have requirements which are quite different from those normally associated with biological research. In fact the requirements can be surprisingly severe when involved with the diagnosis and/or treatment of the seriously ill. Such requirements, if not realized and fully understood at the beginning of development, can greatly increase the time and cost of development and can endanger the acceptance of a new instrument by the medical fraternity. I shall discuss some of these special requirements and consequent developing problems. I have chosen to limit my considerations to cardiovascular sensors partly because of time limitations and partly because they do afford succinct examples of problems involved with seriously ill patients.
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W. H. Guier (1970) studied this question.
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