AI Threat Modeling for Faster FDA Compliance
As medical device software grows increasingly connected and complex the bar for cybersecurity compliance continues to rise. Today, threat modeling and risk assessment are no longer optional steps, they’re foundational to safe and compliant product design.
Yet, for many teams, conducting thorough, standards-aligned cybersecurity assessments remains a bottleneck. Manual processes are time-consuming, error-prone and difficult to scale across teams and product lines. That’s where automation, and more specifically, Large Language Models (LLMs), are beginning to play a transformative role.
A New LLM-powered Threat Modeling and Risk Assessment Tool
The FDA's Secure Product Development Framework (SPDF) requires a detailed, risk-based approach from design to end-of-life. Aithra – a new tool developed by our partner BG Networks – simplifies this process by automatically generating the required assessments in minutes, providing a streamlined report in an easy-to-export format. This ensures that your submission is ready to integrate with your SPDF documents and submit to the FDA without the hassle.
Aithra (pronounced eye-thra) is designed to automate cybersecurity threat modeling and risk analysis for FDA-regulated medical devices. By leveraging LLMs, Aithra streamlines the process of identifying threats, evaluating risk and producing documentation that aligns with FDA expectations.
Instead of requiring engineers to build STRIDE models and risk matrices manually, Aithra ingests system documentation — architectural diagrams, design specs, data flows — and generates a complete threat model and risk assessment report in minutes.
This is not just automation of paperwork. It’s a shift in how we integrate security into product development.
Removing Roadblocks: Improving Threat Modeling
Many development teams struggle with lack of security expertise, unstructured or inconsistent documentation, cumbersome manual workflows for modeling and risk quantification, and difficulty updating threat models as systems evolve.
Aithra addresses these by introducing automation at multiple points in the workflow. This enables early-stage threat modeling with minimal overhead and provides a foundation for continuous updates as system designs change. Significantly, Aithra’s process is designed to fit into existing design and documentation workflows.
For teams preparing a medical device submission that must generate SPDF-aligned documentation, Aithra can reduce the time and complexity involved. Further, for organizations looking for broader compliance coverage, Aithra can be paired with a full SPDF package, including templates based on FDA-recognized standards like IEC 81001-5-1 and ANSI/AAMI SW96:2023.
Here’s a high-level look at Aithra’s architecture:
Input Ingestion
Upload existing artifacts: system diagrams, specs, design documentation, and data flow descriptions. Supported formats include PDF, images and structured docs.
Threat Modeling via STRIDE
Aithra applies the STRIDE model to identify potential threats across your system components, which include Spoofing, tampering, repudiation, information disclosure, denial of service, and elevation of privilege.
Risk Assessment Workflow
For each identified threat, Aithra walks through asset identification, damage scenario mapping, attack path enumeration, likelihood analysis, risk prioritization and mitigation suggestions.
Automated Report Generation
Aithra’s output is a structured, FDA-ready document. It is aligned with cybersecurity sections of the eSTAR format, which include threat model, cybersecurity risk assessment, and mitigation requirements.
Optional QMS Integration
These outputs can be integrated into a Quality Management System (QMS), embedding security controls into broader risk management efforts.
The Takeaway: Better Security Engineering
Tools like Aithra show how LLMs can contribute more than chat interfaces — they can perform real, structured analysis of technical documentation, support engineering decision-making, and help teams deliver safer, more compliant products.
Whether you're part of a small startup navigating your first premarket submission or a mature organization integrating security into an existing SPDF-aligned process, tools like Aithra can allow you to more quickly meet rising security expectations with confidence.