Integrating ERP, MES, and PLM for condition-based maintenance: a digital transformation framework for medical device manufacturing

This study presents a practical framework for digitalized asset management in a multinational medical device manufacturer transitioning toward continuous manufacturing. Using an exploratory case study supported by Weibull reliability modeling, we evaluate the shift from manual, schedule-based maintenance to condition-based, data-driven strategies. The proposed system integrates Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), and Product Lifecycle Management (PLM) within an ISA-95–aligned architecture, enabling real-time monitoring, optimized maintenance scheduling, and improved resource allocation. Results show a 9.3% reduction in conditional failure probability and a cumulative production increase of over 600,000 parts within 450 days. In addition, the framework eliminates paper-based records, enhances cost transparency, and improves resource efficiency, contributing to both economic and environmental sustainability.