A Smart Lean-IoT Framework for Advanced Medical Device Manufacturing

This study proposes a Smart Lean-IoT framework to enhance medical device manufacturing by integrating Lean principles, IoT technologies, and advanced healthcare production methods. The framework is structured into three layers: a Lean Foundation Layer, which modernizes traditional lean tools with real-time IoT data; an IoT-Driven Smart Manufacturing Layer, which enables intelligent automation, predictive maintenance, and digital traceability; and a Healthcare Outcomes Layer, which ensures regulatory compliance, product customization, and improved patient safety through continuous feedback. Together, these layers form a connected and adaptive system that optimizes production efficiency, reduces defects, and ensures high product reliability. The study demonstrates significant improvements in throughput, cost-effectiveness, and compliance. The proposed framework provides a scalable solution that bridges manufacturing innovation and healthcare demands, contributing to the digital transformation of medical device production and the delivery of safer, higher-quality healthcare solutions.