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Medical Device & Diagnostic Industry Design controls, as defined by FDA in the quality system regulation (QSR) and by ISO in the new ISO 9001:2000 standard, include classic phases of an engineering design and development process Although this model has been the default design method used by medical device manufacturers to demonstrate compliance with regulatory requirements, the use of these methods alone has not always proven effective in meeting the escalating demands of consumers and emerging technology. Consumers demand products that are increasingly faster, cheaper, and easier to use. These demands, combined with a desire to get products to market more quickly, are forcing manufacturers to reexamine historical design control processes. It is relatively easy to see technology advances in the cost/performance capabilities of PCs and in the capabilities of appliances such as cellular phones. Even in the medical device industry, the processing capacities of electronic circuitry continue to follow Moore's Law—a tenfold increase in products' memory and processing power becomes available every five years, for the same cost. This equation has proven to be a fairly reliable way to predict technology advances over the past 20 years. Traditional design control processes, however, often fail to integrate the benefits of this technology evolution into the design process. In its basic form, the design control model as defined by FDA and ISO regulations has been tested by years of use. While the model is fundamentally sound, it requires adaptation by device manufacturers in order to meet new demands from consumers and to leverage the benefits of emerging technologies. This article shares the lessons learned by some companies that have successfully enhanced their design control processes. Revised product design and development practices are discussed under the categories of quality focus, project management and personnel, and leveraging technology (see Table I). Emerging technologies bring