In the world of connected medical devices, not every vulnerability demands a patch, and not every patch is the right response. The FDA’s 2016 Guidance on Postmarket Management of Cybersecurity in Medical Devices provides critical direction on how to determine when a...
How ELTON Works: From Discovery to Continuous Monitoring
Summary
ELTON transforms medical device cybersecurity into a continuous, context-aware process by first building a detailed product model through either virtual analysis or a connected DeviceLink box. This model drives deeper, architecture-aware vulnerability analysis by applying a tailored security profile to each component. ELTON then integrates findings from SBOMs, penetration testing, and automated tools like SAST/DAST, and continuously re-scores vulnerabilities using enhanced CVSSv4 metrics whenever product context changes. By linking vulnerabilities, identifying enablers, and recommending minimal-effort fixes that improve overall posture, ELTON reduces over-patching and improves resilience. Its always up-to-date living reports and traceable history streamline FDA compliance and provide ongoing, audit-ready oversight.
At its core, ELTON is built to streamline how medical device manufacturers manage cybersecurity risk across the entire product lifecycle. Instead of treating security as a one-time checklist, ELTON turns vulnerability management into a living process that adapts with your product.
Building the Product Model
Everything begins with discovery. ELTON digitally maps your product into a structured product model that captures components, interfaces, hardware and software elements, and data flows. Discovery can be performed virtually through code review and lab observations, or physically using ELTON’s DeviceLink box, which interfaces directly with the target device to create a digital twin. This model becomes the foundation for contextualizing all vulnerability analysis.
Adding Security Context
ELTON then applies a security profile to the model, layering in privileges, built-in controls such as isolation or authentication, and architecture-level risk characteristics. Unlike generic tools that score issues in isolation, ELTON evaluates how a vulnerability affects the system and how it interacts with other weaknesses. This context is critical for determining true exploitability and impact.
Unified Vulnerability Analysis
SBOM-driven CVE data, penetration test results, and automated scans (SAST, DAST) are consolidated into a single view. ELTON enhances CVSSv4 scoring by automating complex metrics such as Attack Requirements and producing both component- and system-level impact scores. When a new vulnerability or control change occurs, all affected findings are re-scored automatically, ensuring the security posture reflects current reality rather than outdated snapshots.
System-Level Risk Evaluation
Rather than focusing only on individual findings, ELTON analyzes the product holistically. It identifies how lower-severity issues could enable more serious exploits and shows how fixing enablers can reduce overall risk. Visualizations guide engineering teams toward changes that have the greatest impact, often revealing small fixes that deliver outsized security improvements.
Continuous Monitoring and Compliance
ELTON closes the loop with continuous monitoring. Vulnerability feeds are automatically ingested, findings re-analyzed, and living reports updated in real time. This eliminates repeated manual triage and produces audit-ready outputs for FDA submissions and postmarket compliance. With version-aware scoring, traceable history, and coordinated vulnerability disclosure built in, ELTON serves as the central source of truth for every release across your portfolio.
In today’s regulatory environment, where continuous oversight is mandatory, ELTON provides the secure development and postmarket monitoring framework manufacturers need—efficient, defensible, and sustainable.
