Updated December 27, 2025
Threat modeling is a critical part of medical device cybersecurity and a core expectation in modern FDA premarket submissions. Under the latest FDA cybersecurity guidance, manufacturers are expected to provide a structured threat model that identifies assets, attack paths, and mitigations for their devices and connected ecosystems—not just a high-level risk narrative.
There are several ways to perform threat modeling for medical devices (data-flow–based approaches, STRIDE, attack trees, misuse cases, and more), and each technique has its strengths and blind spots. Relying on a single method can leave gaps. Leveraging a range of high-quality threat modeling resources—frameworks, templates, and tools—helps teams improve coverage, uncover realistic threats earlier, and generate defensible evidence for FDA-aligned Secure Product Development Frameworks (SPDFs) and ISO 14971 risk management.
What Is Threat Modeling?
Threat modeling, as per the “MITRE Medical Device Threat Modeling Playbook,” aims to answer the following questions:
- What are we working on?
- What can go wrong?
- What are we going to do about it?
- Did we do a good job?
These questions become further refined and build upon each other as the unique situation is analyzed. Threat modeling can be complex, especially when it comes to medical devices. A new area that is not often found in other areas of cybersecurity is patient safety. This is the primary concern with medical device threat modeling.
Of course, while patient health is the primary concern, typical cybersecurity threats still often apply to medical devices. Hackers demonstrate boundless creativity, so defenders must do the same. Understanding the scope of a device in depth is critical to properly securing it. Answering questions about how it should and should not be used can serve as a good starting point for understanding the potential problems that can arise.
The ultimate goal of threat modeling is to prevent attacks before they occur. To do this effectively, threats must have appropriate compensating controls tied in. Compensating controls must be rigorously tested to ensure that no bypasses are available. If any bypasses are identified, they must also have controls in place. One often-overlooked aspect of threat remediation is the functional impact that security may have. Perfect security often means that a device will be completely unusable. This is where the expertise of the testing team comes into play, as they will be able to craft appropriate solutions without overly disrupting the device’s normal operations.
Top Threat Modeling Tools And Resources
Blue Goat employs various techniques and tactics when it comes to threat modeling. There is no one-size-fits-all solution since everything must be custom-tailored to the unique environment and challenges the client presents. To accomplish this, Blue Goat relies on a wide range of tools, frameworks, methodologies, and resources when performing threat modeling. Here are some of our go-to resources for the threat modeling process:
- OWASP Threat Dragon – Threat Dragon is an open-source threat modeling tool provided by the Open Web Application Security Project (OWASP) Foundation. It’s designed to be easy to use and focuses on creating data flow diagrams for software applications, including those used in medical devices. It helps identify potential security threats during the design phase and suggests mitigations to enhance the security posture. Its visual interface and drag-and-drop functionality make it accessible for both technical and non-technical users involved in medical device development and security.
- Microsoft Threat Modeling Tool – A comprehensive tool developed by Microsoft aimed at helping security and development teams identify and mitigate security risks early in the software development lifecycle, including the development of medical devices. It employs a structured approach to identify potential threats by analyzing data flow in system architectures and recommending relevant security controls. Its use in medical device cybersecurity ensures that devices are designed with security in mind from the ground up.
- STRIDE Framework – An acronym for Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privileges. STRIDE is a threat modeling framework used to identify potential security threats in software systems, including medical devices. It helps categorize and consider the various types of threats that could compromise the confidentiality, integrity, and availability of device data and functionality, informing the development of strategies to mitigate these threats.
- CIA Triad – A widely-used model for guiding information security policies within organizations, including those involved in developing and maintaining medical devices. The CIA Triad stands for Confidentiality, Integrity, and Availability. It emphasizes the importance of ensuring that medical device data is kept confidential, accurate, and trustworthy (integrity), and readily available to authorized users when needed. The model helps prioritize cybersecurity efforts and design systems that safeguard patient information and device functionality.
- MITRE Medical Device Threat Modeling Playbook – Developed by MITRE, a not-for-profit organization that operates research and development centers sponsored by the federal government. This playbook is a specialized guide for identifying and mitigating cybersecurity threats specific to medical devices. It provides a structured approach to threat modeling, drawing from real-world scenarios and vulnerabilities identified in medical devices. The playbook aims to standardize the process of threat modeling within the healthcare sector, making it easier for manufacturers and healthcare providers to understand and address potential cybersecurity risks.
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Medical Device Threat Modeling FAQs
Threat modeling is a structured way to identify how an attacker could realistically compromise your device or ecosystem, what could happen, and which controls and tests reduce that risk.
Because a good threat model shows you understand your system’s attack paths and have designed and verified controls to reduce cybersecurity risk across the lifecycle—exactly what reviewers want to see.
Common approaches include STRIDE-style analysis, attack trees, and system-based models that map assets, interfaces, trust boundaries, and misuse cases—then tie them to controls and verification evidence.
At minimum: system scope, external interfaces, trust boundaries, assumptions, realistic attack scenarios, risk ratings, security controls/requirements, and traceability to test evidence.
Model the whole ecosystem: device, mobile apps, cloud services, APIs, update mechanisms, and real deployment environments. That’s where many real attack paths live.
As early as possible (architecture stage), then update it when major design changes occur—especially new interfaces, connectivity, update features, or third-party components.
Teams often use tools like Microsoft Threat Modeling Tool, OWASP Threat Dragon, and diagramming tools (Visio/Lucidchart/draw.io) paired with a consistent method and a traceability approach.
Threat modeling helps you identify which third-party components matter most and where they’re exposed. SBOM then supports ongoing vulnerability monitoring and faster “are we affected?” decisions.
Base it on real architecture diagrams with trust boundaries, focus on plausible attack paths, and require traceability: threats → controls/requirements → tests → results.
Yes. Blue Goat can build or refine system-level threat models, connect them to security requirements and testing, and package the result in a reviewer-friendly format for FDA submissions.