Integrating statistics into product development

Throughout the product development cycle, effective and systematic use of statistical tools is essential to ensure product quality and safety. Statistical tools must be identified and integrated into the Design Control and Process Control sections of the producer's quality system. This paper has three objectives. First, it attempts to survey statistical techniques that are effective during the product development cycle. Second, it provides an effective strategy for deploying these tools. Finally it demonstrates how these tools and strategies can be integrated into the quality system. The proposed strategy for integration is based on the authors' experiences in the medical device industry.