In this paper, Model-Based Systems Engineering (MBSE) has been proposed as a robust methodology to tackle the inherent complications in designing biomaterial-based medical devices, such as system complexity, interdisciplinary coordination, and lengthy product life cycles. The application and advantages of Model-Based Systems Engineering (MBSE) are illustrated through a case study focused on a hip prosthesis. The Integrated Systems Engineering and Pipelines of Processes in Object-Oriented Architectures (ISE&PPOOA) methodology has been applied, using System Modeling Language (SysML) for system modeling and specification. Various diagrams, including Use Case, Requirements, Block Definition, Parametric, and Activity Diagrams, illustrate a comprehensive modelling strategy. The findings indicate that MBSE facilitates systematic requirement capture, enhances traceability, and fosters interdisciplinary collaboration. In conclusion, the successful modelling and analysis of the hip prosthesis case study affirm MBSE’s significant potential to improve the design and development of biomaterial-based systems and devices.