THE QUALITY PROCESS IN INSTRUMENT DESIGN, DEVELOPMENT, AND MANUFACTURE

Quality is a characteristic that cannot be manufactured or legislated into a product; it must be designed into a product. With all the issue s facing the healthcare industry today, a diagnostics manufacturing co mpany cannot begin to service the needs of its customer until it embra ces and implements the process of quality. As healthcare providers con solidate and capital purchase decisions are delayed due to uncertainty in the legislative outcome, pricing pressures on products and service s increase. Although price incentives alone may be attractive in the s hort term, diagnostic corporations recognize that a value-focused part nership with the clinical laboratory is key to the success of both ent ities. This relationship is based upon system reliability, a diversifi ed assay menu, simplicity in design and use of software, and service q uality, leading to an enhanced laboratory workflow and overall efficie ncy. These critical factors ensure reduced costs per reportable result and higher profitability for the laboratory. Ultimately, they are def ined as quality. In order to address these factors, in vitro diagnosti c manufacturers continue to explore and implement quality processes th at focus on customer-driven designs, enhanced project planning, develo pment and manufacturing cycle time reduction, improved process validat ion, increased system reliability, and quality customer service and su pport. We discuss one successful in vitro diagnostic manufacturer's ap proach to the implementation of international quality standards in the design, development, and manufacture of a random, continuous access i mmunoassay system.