Where a security flaw is a patient-safety question.
Connected devices and the systems that handle patient data carry risk that regulators and clinicians both take seriously, often over device lifecycles measured in years. ThreatModeler® Nexus™ brings architecture-first threat modeling to that world, so design risk is understood before a product reaches a patient and stays understood for as long as it's in the field.
Designed for safety means designed to be proven.
Long lifecycles, strict oversight, and no room to guess.
A medical device ships and then lives in the field for years, while the systems around patient data face continuous scrutiny. Both need a current model of how they're meant to work, and proof that the security was designed in.
From the first architecture to the last unit in service.
ThreatModeler Nexus is a threat modeling platform first: it shows what could go wrong in a system so you can design the risk out. For connected health systems and devices, that discipline holds across the full lifecycle, not just at launch.
Designed in, not bolted on
Model from architecture artifacts at design time, or infer the design from an existing product, so security is part of how the system works rather than a late addition.
True across the lifecycle
The Secure Design Graph keeps the model aligned with the product as it changes, so a long-lived device stays modeled rather than frozen at launch.
Submission-ready evidence
Versioning, approval workflows, and a full audit trail produce the documentation regulators and clinicians expect, with accountability recorded at each step.
Results from regulated healthcare programs.
Source: regulated healthcare provider case study (5× faster threat models).
Mapped to the frameworks that govern connected health.
Healthcare operates at the intersection of patient safety and data privacy regulation. ThreatModeler Nexus keeps every model mapped to the frameworks in scope for your systems: so FDA premarket submissions, HIPAA assessments, and EU regulatory dossiers are built from the threat model rather than assembled by hand after the fact.
Every control, every accepted risk, every compliance mapping traces to the architecture and carries version history, so evidence survives staff turnover and holds up in a submission review or audit.
See the Reporting AgentMedical devices and IoMT need architecture-first security.
Connected medical equipment spans clinical networks, patient monitoring systems, implantables, and diagnostic devices. Each with its own protocol, lifecycle, and exposure surface. The threat model has to reflect the actual architecture, not an assumption inferred from the firmware.
Model before manufacture
Start from architecture artifacts during product development. The System Mapping Agent builds the threat model from your design documents, IaC, and diagrams: before a device reaches clinical validation.
Model what's already deployed
For devices already in service, the System Mapping Agent infers the design from existing systems. The Secure Design Graph grounds that picture in context, so a long-lived device gets a current model without starting from scratch.
Coverage at scale
Component reuse and templates carry proven design patterns across device families, so security analysis doesn't have to restart for each variant. One approved pattern, applied consistently.