Product Development for the Clinical Laboratory

Abstract Clinical assays have an important role in medical decision making. Test results help a clinician answer a fundamental question, “how should I treat the patient?” Whereas these assays used to be developed in hospital laboratories and were performed by skilled technicians, the availability of automated instruments has created an industry which now provides most of the assays. The industry is highly competitive – development of assay systems requires a product development process that is efficient. Most companies use a development process that breaks product development into stages: (1) researching new opportunities, (2) proving feasibility, (3) scheduled development, (4) validation, and (5) product launch. Each stage has methods and tools that help attain the commercial goal.