Lean-implementering för SME-företag inom medicinteknisk tillverkning : Reducering av slöserier genom förbättringsarbete

Sammanfattning

Purpose: The study was conducted at a medtech manufacturing SME with the purpose of investigating how lean production should be implemented to reduce waste within the organization. The purpose of the study was to examine how lean production should be implemented in SMEs within medtech manufacturing to reduce waste. To address the purpose, three research questions were formulated: What challenges may arise when implementing lean production in SMEs within medtech manufacturing? What types of waste may affect efficiency in medtech manufacturing within an SME context? How can the implementation of lean production contribute to reducing identified waste in medtech manufacturing within SMEs? Method: The study was conducted as a case study in which empirical data was collected through triangulation of semi-structured interviews, observations, and document studies. The empirical material was then analyzed in relation to the study’s theoretical framework. Results: The findings show that lean implementation in SMEs within medtech manufacturing is influenced by both organizational and regulatory conditions. Limited resources, dependency on key individuals, unclear division of responsibilities, and extensive documentation requirements were identified as central challenges. The study also shows that waste in the form of waiting, motion, and defects affects operational efficiency. The results indicate that standardized work, visual management, daily management, and continuous improvement can contribute to reducing identified waste and creating more stable processes. Implications: The study demonstrates that lean within medtech manufacturing SME needs to be adapted to the organization’s regulatory requirements and organizational conditions. Therefore, the focus should be on reducing unnecessary waste while improving the efficiency of necessary activities related to quality and regulatory compliance. The findings may provide practical guidance for medtech SMEs seeking to implement lean in a sustainable manner without compromising quality or patient safety. Limitations: The study is limited to a single case company and only includes the production operations, which limits the generalizability of the findings. Keywords: Lean production, SME, medical device manufacturing, waste, implementation.