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