A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

The purpose of this study is to review the Lean tool application and its utilisation in medical device design and the new product introduction process to establish the benefits and best practices for its integration with existing new product introduction processes. A review of the literature on the current state of medical device New Product Introduction (NPI) processes is completed along with a comprehensive review of the literature on the history and development of Lean NPI. The review indicates that Lean can be combined with the predominant NPI execution tools, Stage-Gate and Concurrent Engineering within the medical device industry to achieve a best-in-class continuous improvement methodology within the NPI process. This integration eliminates waste, focusses on customer value, and ultimately reduces cost and lead time to market. This review highlights for the first time the main challenges and issues with Lean in the medical device sector NPI processes, identifying possible future strands of research. Limitations of the current review are that despite the heavy emphasis placed on Lean manufacturing processes, comparatively little emphasis is placed on the use of Lean in the medical device NPI process. Future longitudinal case studies on case study application of Lean in medical device NPI processes would be useful. This study has implications for identifying best practices for Lean in NPI in the device industry, improving what is considered state-of-the-art for the introduction of devices into the public domain.