Abstract

Digitalization has emerged as a dominant force in transforming business processes, significantly enhancing overall performance. The impact of Industrial Revolution 4.0 (IR4.0) on traditional business models presents attractive opportunities through disruptive technologies. In the medical device sector, a crucial part of the modern economic supply chain, embracing digitalization is essential for adapting to a dynamic marketplace. This transformation requires manufacturers to rethink their business models and create innovative solutions to stay competitive. This study aims to identify key areas of improvement in the production of prosthetic sockets by integrating digital tools such as 3D scanning, CAD/CAM design, and additive manufacturing. Utilizing a Business Process Reengineering (BPR) framework, the research systematically evaluates and redesigns traditional workflows within the Malaysian orthotics and prosthetics (O&P) industry. A pilot study will compare conventional methods with a new digital approach in manufacturing Below Knee Prosthesis Sockets. The findings reveal significant improvements in operational efficiency, accuracy, and business performance. The study underscores the importance of digitalization and BPR in optimizing business processes, reducing manual labor, and accelerating time-to-market, ultimately helping companies maintain a competitive edge in the rapidly evolving medical device sector.