Applying technology to operator requirements in medical equipment design.

The methodology used by the author consists of the following elements: Expose the design team to the user environment, followed by question and answer periods with users while still in the use environment. Place biomedical engineers in the leading teaching institutions where they will have day-to-day exposure to the use of products similar to the one being designed. Bring biomedical engineers back into the company as part of the design team. Expose concepts to focus groups while the product is in the definition stage. Bring a select group of users into the design review process. Evaluate the ease of use of the device as part of clinical trials. Establish a means of monitoring product performance after the product has been released. How well such a methodology will work in any particular environment is a function of management's recognition of the concept that ease of operator use is a vital element to the overall success of the product.