This study examines the implementation of lean tools within the medical device manufacturing supply chain to address persistent inefficiencies and enhance performance.

The medical device sector plays a vital role in providing essential medical products globally. With rising demand, there is a pressing need to streamline operations while maintaining high standards of quality and cost-effectiveness.

Despite the adoption of modern management techniques, challenges such as overproduction, excess inventory, and inefficient resource allocation continue to affect the industry [1]. These issues lead to increased costs, reduced agility, and potential quality risks [2]. To address these problems, this research focuses on applying lean methodologies, including 5S for organizing and standardizing work environments, root-cause analysis to diagnose underlying process issues, and the PDCA (Plan-Do-Check-Act) cycle to drive ongoing improvement [3], [4].

The study explores how these lean tools can help eliminate waste, optimize processes, and improve productivity in the medical device supply chain [5], [6]. Lean principles, which originated in the Toyota Production System, are particularly relevant for addressing inefficiencies such as unnecessary transportation, excess inventory, and overproduction [7]. By implementing these principles, the study aims to enhance supply chain efficiency, reduce operational costs, and improve product quality [8], [9].

Additionally, the research investigates the impact of lean tools on key aspects such as supplier coordination, resource allocation, and overall supply chain management. It seeks to develop a comprehensive framework for applying lean tools in this context, ensuring regulatory compliance, and promoting a culture of continuous improvement.

Ultimately, this study aims to expand knowledge of lean manufacturing in the medical device industry, helping manufacturers achieve operational excellence, respond more effectively to market needs, and foster the industry's growth and sustainability.

The medical device manufacturing industry, which produces essential products such as diagnostic equipment and surgical instruments, faces challenges in optimizing supply chains to meet rising demand efficiently. Lean tools, which originated from Toyota's production system in the 1950s and focus on reducing waste and improving efficiency, offer solutions to these challenges [10].

Lean principles such as just-in-time production, continuous flow, pull systems, and total employee involvement are highly relevant to this sector. The medical device supply chain is complex and regulated, presenting issues such as inefficient processes, excess inventory, compliance risks, and coordination difficulties among suppliers. Applying lean tools can help address these issues by reducing waste, enhancing efficiency, and improving quality and collaboration [11].

In Bangladesh, the medical device manufacturing sector is experiencing growth and exploring lean tools to boost competitiveness and efficiency. Studies indicate that lean practices such as just-in-time manufacturing and the 5S methodology can reduce inventory costs, improve production efficiency, and create a safer work environment [12]. However, issues such as organizational resistance, insufficient expertise, and strict regulatory requirements continue to pose obstacles.

Successful implementation of lean tools in Bangladesh's medical device manufacturing industry requires overcoming these barriers through best practices, including top management commitment and employee involvement. Integrating lean principles with digital technologies can also enhance supply chain visibility and efficiency. Further research is needed to provide practical insights into effective lean adoption in this context, ultimately leading to improved operational performance and competitiveness [13], [14].

This research aims to explore the application of lean tools within the supply chains of medical device manufacturing industries using a mixed-methods approach [15], [16]. The study combines qualitative and quantitative methods to provide a comprehensive understanding of lean integration and its effects on supply chain management.

Respondents answered the research questions based on the developed themes for both companies. The objectives of the research project are to determine how lean tools work in the medical equipment manufacturing industry.

Global Pharmaceuticals employs more lean tools than Team Pharmaceuticals, leading to better outcomes. For the fiscal year 2023-24, Global Pharmaceuticals received only 3 market complaints, compared to 10 for Team Pharmaceuticals. This suggests that effective use of lean tools enhances efficiency and compliance. Global Pharmaceuticals' extensive use of lean tools across its supply chain improves performance, whereas Team Pharmaceuticals’ limited use may lead to less effective problem-solving and quality control.

The data indicates that Global Pharmaceuticals benefits from using a broad range of lean tools, leading to fewer market complaints. To enhance performance, Team Pharmaceuticals should expand its lean toolkit to address additional areas of its processes. This could improve quality control and reduce complaints. Additionally, Team Pharmaceuticals could invest in developing its team’s lean skills through targeted training programs and fostering a culture that supports continuous improvement. Exploring new methodologies and incorporating feedback loops into their processes can further drive efficiency and effectiveness.

The authors would like to express their sincere gratitude to the General Manager at Global Pharmaceuticals and Team Pharmaceuticals for their invaluable assistance with data analysis. Your support has been crucial to the success of this study.

We would also like to extend our appreciation to the Supply Chain teams at both organizations. Your insights and collaboration have greatly enriched our research and deepened our findings.

The primary author, Abu Shahriar Partho, was responsible for leading the formulation of the concept, research design, data collection, formal analysis, and manuscript writing. Co-authors Md. Tanbin Haque, Fahmida Binta Fulzar Nabila, Bidhan Kar, and Md. Sohan Hossain played a critical role in project design, data assessment, and data verification. Additionally, they reviewed the supplemental cases and contributed substantively to the article's writing and refinement.

This research did not receive any specific funding from public, commercial, or not-for-profit agencies.

This study does not involve any research with human or animal subjects conducted by any of the authors.

Data is available upon reasonable request from the corresponding author.

The authors declare no conflicts of interest related to this work.