Critical Success Factors for Supplier Selection and Performance Enhancement in the Medical Device Industry: An Industry 4.0 Approach

Supplier selection in the medical device manufacturing (MDM) industry significantly affects quality, operational efficiency, and overall organizational performance. Due to the industry’s dependence on advanced technologies and rigorous regulatory standards, identifying critical success factors (CSF) for selecting suppliers is essential. This study aims to analyze relationships among critical success factors (CSF) influencing supplier selection and their influence on supplier quality and the performance outcomes of MDM companies. A structured survey was conducted among MDM companies in Mexico, and the collected data were analyzed through exploratory and confirmatory factor analysis. Structural equation modeling (SEM) was used to quantify the relationships identified. Results indicate that information technology, reliable delivery, Industry 4.0 adoption, resilience, and environmental and social responsibility positively influence supplier quality, which subsequently enhances MDM firm performance. Supplier quality emerges as a critical mediator between supplier selection factors and company performance. Findings emphasize that prioritizing supplier quality, reinforced through Industry 4.0 technologies and resilient practices, ensures operational continuity, enhances competitive advantage, and supports sustainability. Companies incorporating these critical success factors into their supplier selection processes are better equipped to manage supply disruptions, achieve consistent quality, and sustain performance in highly regulated environments.