The process of product selection in the medical instrument market.
Medical instrumentation is supplied by commercial organizations. Because the costs and risks of bringing new or advanced products to the market are high, the selection and evaluation process is critical. Moreover, the peculiarities of the medical instrumentation market add extra costs and risks. Major factors to be considered include the presence of a need, market acceptance, financial and technical viability, development time, internal resources, and the effect of FDA regulations. During the 5 to 7 years required to develop a new product, the difficulty of overcoming problems and the state of the market must be continually monitored. FDA documentation may necessitate 2 more years of effort. Market introduction includes proper market education, an appropriate plan of action, and constant monitoring of market reaction. Despite all these precautions, 70% of new products do not reach the market or do not survive in the market.
D003132:Commerce; D003657:Decision Making; D004864:Equipment and Supplies / Q000592:standards; D007221:Industry; D014481:United States; D014486:United States Food and Drug Administration