A SYNTHESIS OF QUALITY FUNCTION DEPLOYMENT AND ROBUST DESIGN AND ITS APPLICATION IN THE MEDICAL DEVICE INDUSTRY
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Medical devices encompass all articles used in the treatment, prevention, and diagnosis of disease. In the last 10 years, a number of competitive, economic, and regulatory pressures have forced the medical device industry to reconsider how products are designed, developed, and maintained. Cost-cutting pressures, additional regulatory requirements, and stiffer local and global competition have demanded less expensive, more effective, and shorter time-to-market research and development efforts, yielding shorter times to market. Medical technology companies are under tremendous pressure to design products and services that exceed customer expectations and are still inexpensive to develop and maintain. In addition, the products and manufacturing process must be insensitive to the various factors affecting production and use. Although widely recognized to having a profound impact on various industrial applications, robust design and quality function deployment have attracted minimal attention as design techniques used by the medical device industry. In this article, we first present the unique design requirements and quality characteristics for the medical device industry. We then present a framework that synthesizes quality function deployment and robust design. Finally, we present the application of this integrative methodological framework on a case study for the development of a particle counter. Utilizing quality function deployment and robust design in the development process will yield a product which is effective as mandated by law, highly competitive, developed quickly, and with low unit manufacturing cost, while demanding low maintenance costs during its lifetime.
