Implementation of a Lean 4.0 Project to Reduce Non-Value Add Waste in a Medical Device Company

Abstract

The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many changes within the manufacturing industry. The purpose of the study is to demonstrate how an Industry 4.0 project was scoped and deployed utilising Lean tools to reduce non-value add wastes and aid regulatory compliance. A case study research approach was utilised to demonstrate how the Lean Industry 4.0 project was implemented in a Medtech company to enhance Lean processes while increasing digitalisation. This research demonstrates that Industry 4.0 can enhance Lean, improve flow, reduce nonvalue add waste, and facilitate product lifecycle regulatory compliance to reduce defects, enhance quality, improve cycle time, and minimise reworks and over-processing. Lean and Industry 4.0 combined offer many benefits to the MedTech Industry. This research will support organisations in demonstrating how digital technologies can synergistically affect Lean processes, positively impact product lifecycle regulatory compliance, and support the industry in building a business case for future implementation of Industry 4.0 technologies.

Keywords

• Industry 4.0
• medical device
• Medtech
• regulatory compliance
• engineering change management
• product lifecycle management