Basic Concepts of Medical Instrumentation

The invention, prototype design, product development, clinical testing, regulatory approval, manufacturing, marketing, and sale of a new medical instrument add up to a complex, expensive, and lengthy process. Very few new ideas survive the practical requirements, human barriers, and inevitable setbacks of this arduous process. Usually there is one person who is the ‘‘champion’’ of a truly new medical instrument or device. This person—who is not necessarily the inventor—must have a clear vision of the final new product and exactly how it will be used. Most importantly, this person must have the commitment and persistence to overcome unexpected technical problems, convince the naysayers, and cope with the bureaucratic apparatus that is genuinely needed to protect patients. One of five inventors’ stories from New Medical Devices: Invention, Development and Use (Eckelman, 1988) is reprinted here to illustrate this process. The automated biochemical analyzer uses spectrophotometric methods in a continuous-flow system to measure the amount of many clinically important substances in blood or urine samples (Section 11.2).