Lean Transformation in Medical Device Manufacturing: Improving the Thermal Bond Process to Reduce Defects

Abstract

This research assessed the application of Lean manufacturing principles in the thermal bonding process of catheter production to reduce defects and improve operational efficiency. An analysis of the current state identified the root causes of the “Overflow” defect and established a foundation for process improvements. The implemented redesign allowed the transition from batch production to a single-piece flow system. Specifically for the thermal bonding process, applying Lean methodology allowed for the re-sequencing of process steps, which facilitated an optimal workload balance. Post-implementation results demonstrated a significant reduction in defect rates, from 1.91% to 0.24%, reflecting a statistical difference with a p-value of 1.59E-12. Additionally, scrap costs decreased substantially in the three months following Lean implementation, resulting in financial savings of $292K. However, despite time constraints, this study highlights the tangible benefits of process optimization through the Lean application methodologies by providing a clear example of its impact on improving operational efficiency. Keywords - Lean Principles, Medical Device Manufacturing, Operational Excellence, Thermal Bond Process.