Leveraging MDS2 and SBOM data for LLM-assisted vulnerability analysis of medical devices

This study investigated the use of a semi-automated, Retrieval-Augmented Generation (RAG)-based multi-agent architecture to analyze security-relevant data and assemble specialized exploitation paths targeting medical devices. The input dataset comprised device-specific sources, namely, the Manufacturer Disclosure Statement for Medical Device Security (MDS2) documents and Software Bills of Materials (SBOMs), enriched with public vulnerability databases, including Common Vulnerabilities and Exposures (CVE), Known Exploited Vulnerabilities (KEV), and Metasploit exploit records. The objective was to assess whether a modular, Large Language Model (LLM)-driven agent system could autonomously correlate device metadata with known vulnerabilities and existing exploit information to support structured threat modeling. The architecture follows a static RAG design based on predefined prompts and fixed retrieval logic, without autonomous agent planning or dynamic query adaptation. The developed Vulnerability Intelligence for Threat Analysis in Medical Security (VITAMedSec) system operates under human-prompted supervision and successfully synthesizes actionable insights and exploitation paths without requiring manual step-by-step input during execution. Although technically coherent results were obtained under controlled conditions, real-world validation remains a critical avenue for future research. This study further discusses the dual-use implications of such an agent-based framework, its relevance to patient safety in medical device cybersecurity, and the broader applicability of the proposed architecture to other critical infrastructure sectors. These findings emphasize both the technical potential and ethical responsibility for applying semi-automated AI workflows in medical cybersecurity contexts.