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This paper outlines how Design for Lean Six Sigma methods aided a medical device manufacturing company in developing a new strategic space management and approval process for its manufacturing site.

The project demonstrates the application of the Design for Lean Six Sigma and structured Define, Measure, Analyse, Design, and Verify methodology in designing and implementing a process that enables the case study manufacturing site to improve its space utilisation and free up space.

The project was validated in one manufacturing department, and the Design for Lean Six Sigma methodology resulted in creating 15% new space for that area, with opportunities identified to free up 44.7% of the total manufacturing floor space and realise over €2.2 million cost savings as well as start to manufacture new products launched.

The manuscript highlights for the first time how the Design for Lean Six Sigma methodology can be utilised for space utilisation and can be leveraged by other manufacturers. The current study's limitations are that it is a single-site case study application. Future longitudinal case studies on Design for Lean Six Sigma application in more manufacturing space utilisation projects would be useful. This study has implications for identifying best practices for Design for Lean Six Sigma methodology application in the device industry, thus improving the state of the art for introducing new manufacturing lines.

This is the first published work to utilise Design for Lean Six Sigma methodology for space utilisation in a medical device company. This review will provide medical devices and other manufacturing organisations with recommendations on utilising Design for Lean Six Sigma and design for improved space utilisation to reduce costs.