Medical Device Link . Ten Techniques for Trimming Time to Market Savvy companies can keep up with rapidly changing regulatory requirements and still streamline processes in product development.

Medical Device & Diagnostic Industry At the same time that FDA's new quality system regulation has heightened the emphasis on regulatory requirements in the medical device community, pressure to speed up the manufacturing process is also escalating. It may seem impossible to reduce the time to market with the numerous other demands on the engineering process. However, compliance with regulatory requirements does not preclude efficient development practices. Relying on individuals to rescue lagging projects with hours of overtime is not a workable solution. A system-level strategy is needed to streamline the engineering process and achieve reduced development schedules. By effectively addressing the following 10 aspects of product development, medical device manufacturers can improve both regulatory compliance and time to market: The extent to which the following strategies for dealing with these aspects apply to a given manufacturer will vary based on the specific device and personnel experience. Manufacturers may also find additional steps are necessary in certain processes. The cost benefits and quality improvements resulting from effective review practices can be substantial, such as a tenfold reduction in errors for some development efforts. Although reviews are mandated by the new quality system regulation, they also benefit engineering by reducing development times. Moreover, specification reviews help identify errors early, when they are relatively inexpensive and easier to correct. Dunn has suggested that cost savings from error identification and correction can be as much as a factor of 25. Formal reviews also help ensure consistency and understanding of key project objectives and provide a forum for effective communication between engineering and other departments as well as among engineering subdisciplines concerned with hardware and software. The importance of documenting compliance with design control requirements is self-evident. But some companies have instituted documentation practices that go far beyond any requirements. These manufacturers falsely equate the