Design and Validation Strategy for Medical Device Product Transfer

Abstract

The transfer of medical device products from development to manufacturing presents multifaceted challenges that demand meticulous planning and execution to ensure product quality, regulatory compliance, and cost-effectiveness. This article proposes an integrated approach leveraging principles of lean manufacturing and Six Sigma methodology to streamline the design and validation processes during product transfer. The application of lean manufacturing principles enables the identification and elimination of non-value-added activities, thus optimizing the transfer process for efficiency and resource utilization. Concurrently, Six Sigma methodology offers a structured framework for reducing variation and enhancing product quality through data-driven decision-making. This article outlines a comprehensive strategy encompassing key stages of product transfer, including design transfer planning, process validation, and risk management. Each stage is systematically analyzed and optimized to achieve seamless transition while meeting regulatory requirements and customer expectations. Key Term − Design validation, Lean manufacturing, Product transfer, Six Sigma.