The increasing complexity of the medical regulatory environment and the inherent complexity of medical devices, especially due to the increased use of connected devices and embedded control software, impose adoption of new methods and tools for the system design, safety and security analyses. In this paper, we propose a method and an associated toolchain to couple model-based system engineering and safety/security analyses at the design phase of medical devices. The method is compliant with ANSI/AAMI/ISO TIR57 safety and security guidance, and compatible with INCOSE Biomedical-Healthcare Model-Based Systems Engineering works. The toolchain is based on a system architecture modelling tool and supports medical device domain specific reference architecture, as well as tools for safety and security risk analyses. The proposed method and toolchain are illustrated by considering a RGB’s TOF-CUFF monitor device analyzed in the scope of the AQUAS project as a medical device use case.

Safety and security engineering have been traditionally separated disciplines (e.g., different required knowledge and skills, terminology, standards and life-cycles) and operated in quasi-silos of knowledge and practices. However, the co-engineering of these two critical qualities of a system is being largely investigated as it promises the removal of redundant work and the detection of trade-offs in early stages of the product development life-cycle. In this work, we enrich an existing safetysecurity co-analysis method in the design stage providing capabilities for interference analysis. Reports on interference analyses are crucial to trigger co-engineering meetings leading to the trade-offs analyses and system refinements. We detail our automatic approach for this interference analysis, performed through fault trees generated from safety and security local analyses. We evaluate and discuss our approach from the perspective of two industrial case studies on the space and medical domains.

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