Develop Safe and Effective Medical Devices with Model-Based Systems Engineering

Whereas traditional “waterfall” Engineering provides an intuitive and instructive linear workflow of design activities and defines clear deliverables, it struggles to cope with the iterative and integrative nature at the early stage of conceptual or basic designs. It also fails to cope with the complexity of multidisciplinary concurrent design. The fact that the current practice in Medical Devices industry still heavily relies on documentation is another hurdle to ensure cross-disciplinary consistency, requirement traceability, change impact assessment and knowledge capitalization. Model-Based Systems Engineering has strong capabilities to address complex systems (and system of systems), by using models from the ideation. It provides a deep understanding of the contexts and behaviors for the full project lifecycle, allows a clear and methodic cascading and tracking of requirement to downstream activities, with a full control of the interfaces and change impact analyses, fulfilling the stringent Quality Management requirements.