Medical Device Cybersecurity: SBOM & SAST

Part of our Medical device SBOM and VEX series for FDA submissions. For the full overview, start with Medical Device SBOM: FDA Requirements and Submission Guide.

Updated December 25, 2025

Medical device cybersecurity is a cornerstone of patient safety and data protection. The FDA recognizes this and has put clear expectations on the table. Two tools sit at the center of those expectations: the Software Bill of Materials (SBOM) and Static Application Security Testing (SAST). Both are essential for building and maintaining secure medical devices.

SBOM and SAST work together to give manufacturers visibility into what their software contains and whether that software is securely implemented. One without the other leaves significant blind spots.

This post covers how SBOM and SAST work, why the FDA cares about both, and how to evaluate the tools available for each. We'll also look at popular SBOM analysis tools and their tradeoffs, grounded in how they apply to FDA testing guidelines.

Key Takeaways

• SBOM inventories software components, aiding vulnerability tracking and compliance.
• SAST scans code for security flaws, enabling early detection and remediation.
• Combined, SBOM and SAST bolster medical device cybersecurity and regulatory adherence.
• The FDA emphasizes both for premarket and postmarket security assurance.
• Proactive use of these tools minimizes risk and safeguards patient data.
• Implementing SBOM and SAST supports continuous security monitoring.

Table of Contents

• Key Takeaways
• Understanding SBOM and Its Synergy with SAST in Enhancing Cybersecurity
• SBOM's Growing Importance in Medical Devices
• SAST's Growing Importance in Medical Device Cybersecurity
• Tools for SBOM and SAST: Navigating Strengths and Weaknesses
• Elevating Cybersecurity through Strategic Integration of SBOM Tools and SAST
• Medical Device Cybersecurity FAQs

Why this matters

Vulnerabilities in medical devices can lead to data breaches, operational disruption, or direct patient harm through device failure or compromise. The stakes are not abstract. The FDA's Cybersecurity in Medical Devices final guidance, dated February 3, 2026, establishes concrete expectations for manufacturers: understand every software component through an SBOM, and proactively identify weaknesses through SAST. Section 524B of the FD&C Act now gives the FDA authority to refuse acceptance of premarket submissions that don't meet cybersecurity documentation requirements.

Standards like IEC 81001-5-1, ISO 14971, and AAMI TIR57 reinforce the need to manage software supply chain risks and validate security controls throughout the device lifecycle. Skipping SBOM and SAST isn't a shortcut; it's a path to recalls, FDA deficiency letters, and reputational damage that's hard to undo. Proactive security through these two tools is foundational to responsible device manufacturing.

Understanding SBOM and Its Synergy with SAST in Enhancing Cybersecurity

What is SBOM?

An SBOM is a detailed inventory that enumerates all software components used in building a software product. This includes open-source components, proprietary code, and third-party libraries. Think of it as a recipe that lists every ingredient in a dish, providing complete transparency into the software's composition.

The Purpose of SBOM

SBOMs serve multiple critical functions in software development and maintenance, particularly in sensitive sectors like healthcare:

1. Security Management: They enable better tracking and management of vulnerabilities within software components.
2. Compliance and Licensing: SBOMs are instrumental in ensuring adherence to licensing requirements and regulations, which is crucial in regulated sectors like medical device manufacturing.
3. Software Integrity: They maintain the integrity of the software throughout its lifecycle, from development to deployment.

What is SAST?

SAST is a method that analyzes an application's source code, bytecode, or binary code for security vulnerabilities without executing it. It's akin to thoroughly examining a building's architectural blueprints to identify structural weaknesses before construction begins.

The Purpose of SAST

SAST supports the software development lifecycle, particularly in sectors that demand high security and reliability, such as healthcare technology:

• Early Vulnerability Detection: SAST enables developers to identify and rectify security flaws early in the development process, thereby reducing the cost and effort of remediation at later stages.
• Enhanced Code Quality: By integrating SAST into the development pipeline, teams can ensure higher code quality, leading to more secure and reliable software products.
• Compliance and Risk Management: SAST helps organizations comply with industry regulations and standards by systematically identifying potential security issues that could lead to non-compliance or expose sensitive data.
• Security Assurance: For sensitive sectors like medical device manufacturing, SAST assures that the software embedded within devices is free from vulnerabilities that could be exploited, ensuring patient safety and data protection.

Combining SAST with SBOM for Medical Device Cybersecurity

While SBOM provides a list of software components, ensuring those components are free from vulnerabilities is equally essential. This is where SAST comes into play.

• SAST is a security testing method that analyzes source or compiled code versions to identify potential vulnerabilities. It scans the code to detect flaws that could lead to security breaches.
• SAST complements SBOM by examining the code that comprises the listed components. While SBOM tells you what is in your software, SAST tells you about its security.

Synergy in Medical Device Cybersecurity

In the context of medical device cybersecurity, SBOM and SAST provide the following benefits:

• Enhanced Vulnerability Detection: SBOM's component listing and SAST's code analysis offer a dual-layered approach to identifying software components and implementation vulnerabilities.
• Regulatory Compliance: This combination enables companies to comply with stringent regulatory standards, such as those set by the FDA, which require transparency in software composition and assurances of its security.
• Proactive Risk Management: Together, they provide a proactive approach to managing risks, which is crucial in the medical device industry, where software flaws can have dire consequences.

Examples of SBOM in Action

• Vulnerability Management in a Pacemaker System: Consider a pacemaker system that utilizes various software components, including open-source libraries. A SBOM for this system would list these components, enabling the manufacturer to quickly identify and patch a recently discovered vulnerability in one of the libraries, thereby preventing potential life-threatening device malfunctions.
• Compliance in Imaging Software: In a hospital's imaging software, used for MRI or CT scans, an SBOM helps track the usage of proprietary and third-party software components. This tracking ensures compliance with healthcare regulations and standards, such as HIPAA in the United States, which demands strict data protection controls.
• Supply Chain Transparency in Hospital Management Software: An SBOM provides transparency in the software supply chain for a hospital management system, revealing all the underlying components. This transparency is crucial in assessing the system's security posture, mainly due to increased cyber threats targeting healthcare data.

Examples of SAST in Action

• Secure Development of a Drug Infusion Pump: Drug infusion pump software developed with SAST would undergo rigorous code analysis to identify and rectify potential security vulnerabilities such as incorrect handling of numerical limits, thus preventing overdosage incidents before the software is executed.
• Ensuring the Security of Electronic Health Records (EHR) Systems: When developing an EHR system, SAST can identify common vulnerabilities, such as SQL injection or cross-site scripting, in the codebase, enabling developers to correct these issues. This proactive measure ensures that the EHR system is resilient against attacks that could lead to unauthorized access to patient data.
• Compliance and Security in Telehealth Applications: For a telehealth application, SAST identifies vulnerabilities that could compromise the confidentiality and integrity of patient communications. The application complies with health information privacy regulations by rectifying these vulnerabilities early in the development phase. It also builds trust with its users by providing a secure platform for telehealth services.

Consider a medical device software with an open-source encryption library listed in its SBOM. SAST can analyze how this library is implemented in the device's code, ensuring that it is used securely and doesn't introduce vulnerabilities.

SBOM's Growing Importance in Medical Devices

In healthcare, where patient safety and data security are non-negotiable, the SBOM has moved from optional to expected. This isn't purely about checking a regulatory box. It's about taking ownership of every software component in a device and having a defensible answer when something goes wrong.

SBOM in Medical Device Cybersecurity: A Crucial Pillar of Protection

Integrating SBOM into a medical device cybersecurity program is a critical safeguard in an industry where software flaws can have life-threatening consequences. As the FDA sharpens its focus on cybersecurity documentation, manufacturers without a solid SBOM practice are starting to feel the pressure in the form of Additional Information requests. Here's why it matters:

A Linchpin for Vulnerability Management

• In-Depth Analysis: SBOMs provide a granular view of each software component, allowing for a deeper analysis of potential vulnerabilities. This is particularly crucial in medical devices, where even a minor flaw can have significant repercussions.
• Proactive Response: With a clear SBOM, manufacturers and healthcare providers can swiftly identify and respond to emerging threats, reducing the risk of exploitation and ensuring continuous device functionality.

Foundation for Regulatory Compliance and Reporting

• Meeting FDA Standards: A SBOM helps comply with the FDA's stringent regulatory standards for medical devices, ensuring all software components meet the required safety and security benchmarks.
• Streamlined Documentation: SBOMs serve as documented proof of compliance, simplifying the regulatory review process and providing a clear audit trail.

Enhancing Supply Chain Security

• Transparency and Trust: By delineating every software element, SBOMs create a transparent ecosystem, building trust among manufacturers, suppliers, and end-users.
• Mitigating Third-Party Risks: SBOMs help identify and assess risks associated with third-party components, a crucial aspect considering the complex supply chains in medical device manufacturing.

Facilitating Continuous Monitoring and Improvement

• Ongoing Risk Assessment: An SBOM is not a one-time checklist; it's a dynamic tool for ongoing risk assessment, enabling manufacturers to continuously monitor and update their cybersecurity practices.
• Data-Driven Decision Making: With a detailed SBOM, manufacturers can make informed decisions about software updates, patches, and security enhancements, further fortifying device security.

Implementing SBOMs in medical device cybersecurity goes beyond compliance. It signals a genuine commitment to transparency in a sector where the pace of change is fast and the consequences of security failures can be severe. The SBOM becomes a fundamental component of a resilient cybersecurity strategy, essential for protecting patient data and ensuring the safe operation of medical devices.

SAST's Growing Importance in Medical Device Cybersecurity

Patient safety and data security demand more than good intentions. In healthcare, software supports the operation of devices that directly affect patient outcomes. SAST is the mechanism that confirms that software is actually secure before it reaches a patient.

SAST in Medical Device Cybersecurity: A Critical Defense Mechanism

Incorporating SAST into a medical device cybersecurity strategy is a vital layer of defense in an industry where security breaches can be life-threatening. As the FDA intensifies its scrutiny on cybersecurity, the understanding and implementation of SAST have become indispensable. Here's why:

Proactive Vulnerability Detection and Management

• Early Identification: SAST enables the early detection of security vulnerabilities within the medical devices' codebase, ensuring that potential threats are identified and mitigated before deployment.
• Preventive Measures: With SAST, manufacturers and healthcare providers can proactively address security concerns, minimizing the risk of exploitation and ensuring the uninterrupted functionality of devices.

Supporting Regulatory Compliance and Documentation

• Adherence to FDA Guidelines: SAST helps ensure that all software components in medical devices meet the FDA's rigorous safety and security standards, which are crucial for regulatory approval.
• Facilitated Compliance Process: SAST's systematic approach simplifies the demonstration of compliance, streamlining the regulatory review process and facilitating audit trails.

Bolstering Supply Chain Security:

See also: VxWorks Vulnerabilities in Medical Devices, CI/CD Security Gates for Medical Devices: SPDF in Practice, and FDA Section 524B Explained Subsection by Subsection: What Each Requirement Means in 2026.

• Enhanced Transparency and Trust: SAST promotes a culture of transparency in software development, building trust among manufacturers, suppliers, and users.
• Mitigation of Third-Party Risks: By identifying vulnerabilities early, SAST supports assessing and mitigating risks associated with third-party components, which are essential in the interconnected supply chains of medical device manufacturing.

Enabling Continuous Monitoring and Improvement

• Dynamic Risk Assessment: SAST is not a static process but a continuous one, allowing for the ongoing evaluation of security practices and the adaptation to new threats.
• Informed Security Decisions: With insights provided by SAST, manufacturers can make knowledgeable decisions regarding software updates, patches, and security enhancements, bolstering the resilience of medical devices.

Adopting SAST in medical device cybersecurity goes well beyond regulatory compliance. It reflects a genuine shift toward transparency and continuous improvement in an industry where innovation is relentless and the consequences of security breaches can be severe. SAST is not just a compliance tool. It's a foundational element of any credible cybersecurity strategy, essential for safeguarding patient data and ensuring the reliable operation of medical devices.

Tools for SBOM and SAST: Navigating Strengths and Weaknesses

Selecting the right tool for SBOM and SAST analysis is a meaningful decision in medical device cybersecurity. These tools support FDA compliance requirements and sharpen your defenses against cyber threats. Here's an honest look at the industry-leading options, including their real tradeoffs:

1. FOSSA: A Leader in License Compliance Management

• Strengths:
  • Offers an extensive license compliance analysis, critical for adhering to legal and regulatory standards.
  • Automated policy enforcement streamlines the compliance process, thereby reducing the need for manual oversight.
  • integration with development workflows enhances operational efficiency.
• Weaknesses:
  • Complex setups can pose challenges for teams without specialized knowledge.
  • The cost factor might be a consideration for smaller organizations or startups.

2. Black Duck by Synopsys: The Comprehensive Vulnerability Tracker

• Strengths:
  • Maintains an expansive database for vulnerability tracking.
  • Delivers in-depth security risk assessments, crucial for high-stakes medical devices.
  • Broad integration capabilities with various development and operational tools.
• Weaknesses:
  • Potential for false positives necessitates manual review and adjustments.
  • The extensive feature set might overwhelm new users, requiring a learning curve.

3. WhiteSource: Real-Time Security Vigilance

• Strengths:
  • Provides immediate alerts for security vulnerabilities, enabling swift action.
  • policy enforcement features to maintain consistent security standards.
  • Effective in identifying and managing open-source components within the software stack.
• Weaknesses:
  • May occasionally overlook less common or emerging vulnerabilities.
  • Resource-intensive operations could impact system performance.

4. SW360: The Open-Source Customizable Solution

• Strengths:
  • As an open-source tool, it offers high customizability to fit specific organizational needs.
  • Ideal for managing complex software compositions in large-scale organizations.
  • Capable of integrating with external databases for enhanced vulnerability management.
• Weaknesses:
  • Demands significant technical expertise for effective configuration and ongoing management.
  • The feature set may be less compared to some proprietary solutions.

5. OWASP Dependency-Track: Specialized in Component Analysis

• Strengths:
  • Focused on Software Composition Analysis (SCA), crucial for pinpointing component vulnerabilities.
  • Supports standard SBOM formats like CycloneDX, facilitating industry-wide interoperability.
  • Effective real-time tracking of known vulnerabilities enhances proactive security measures.
• Weaknesses:
  • The user interface lacks the intuitiveness of some more user-friendly commercial tools.
  • Relies on integration with other tools for a complete cybersecurity solution, potentially increasing complexity.

6. Sonatype Nexus: The Integrated Repository Manager

• Strengths:
  • Provides an integrated platform for managing software components and their dependencies.
  • It offers detailed security and licensing analysis, which is crucial for compliance and risk management.
  • Strong community support and frequent updates enhance its effectiveness.
• Weaknesses:
  • Configuring it can be complex, requiring in-depth technical knowledge.
  • Some features might be overkill for smaller projects or organizations.

7. JFrog Xray: The Continuous Security Tool

• Strengths:
  • Delivers continuous security and compliance analysis, which is crucial for dynamic development environments.
  • Effective vulnerability scanning across a wide range of package types and databases.
  • Integrates with JFrog Artifactory, creating a ecosystem for artifact management.
• Weaknesses:
  • The learning curve for new users is steep due to its extensive range of features.
  • It can be resource-intensive, demanding significant computational power.

8. Bitbucket Pipelines: The CI/CD Enabler

• Strengths:
  • Integrates directly with Bitbucket for continuous integration and delivery (CI/CD), streamlining the development process.
  • Automates the build, test, and deployment processes, enhancing efficiency and reducing errors.
  • Provides a scalable solution that grows with the project or organization.
• Weaknesses:
  • Primarily beneficial for teams already using Bitbucket; it may require migration for others.
  • It is limited in terms of built-in security features compared to specialized SBOM tools.

9. Snyk: The Developer-Friendly Security Tool

• Strengths:
  • A user-friendly interface makes it accessible for developers with varying levels of security expertise.
  • Provides detailed vulnerability reports and offers remediation guidance.
  • Strong integration capabilities with popular development and deployment tools.
• Weaknesses:
  • Some advanced features are available only in the paid version.
  • It may not cover all programming languages and frameworks extensively.

10. GitLab: The All-in-One Platform

• Strengths:
  • Offers a complete DevOps platform, integrating SCM, CI/CD, and security testing in one place.
  • Facilitates collaboration and streamlines workflows, which is particularly beneficial for large teams.
  • Continuous scanning and monitoring capabilities enhance real-time security.
• Weaknesses:
  • The complexity of the platform can be overwhelming for small teams or simple projects.
  • Some features may require a premium subscription, which will impact budget considerations.

Elevating Cybersecurity through Strategic Integration of SBOM Tools and SAST

In medical device cybersecurity, combining SBOM tools with SAST produces something greater than either delivers alone. This integration doesn't just layer controls on top of each other; it closes gaps that neither approach can address independently.

Holistic Security Coverage: A Dual-Front Approach

• Vulnerability Detection: While SBOM tools excel in cataloging and tracking known vulnerabilities in software components, SAST covers the code structure, identifying potential security flaws from the ground up. This dual-front approach ensures no stone is left unturned in safeguarding software against cyber threats.
• Proactive and Reactive Security Measures: SBOM tools enable a reactive stance towards known vulnerabilities, while SAST offers a proactive guard, detecting vulnerabilities early in the development cycle. This combination allows for a dynamic and responsive security strategy, which is crucial in the cyber landscape.

Enhanced Regulatory Adherence and Reporting

• Alignment with FDA Regulations: Integrating SBOM and SAST is particularly beneficial in meeting the FDA's stringent requirements. It ensures that every software layer adheres to the highest security standards, from composition to code.
• Streamlined Compliance Processes: With documentation from both SBOM and SAST, medical device manufacturers can more effectively demonstrate compliance during audits and regulatory reviews, simplifying what is often a complex and time-consuming process.

Building a Culture of Security

The strategic integration of SBOM tools and SAST represents more than a best practice in medical device cybersecurity. It reflects a thorough, proactive approach to ensuring the safety and efficacy of medical technologies. As healthcare continues to digitalize, this integration will be central to protecting sensitive patient data and keeping life-saving devices running reliably.

Each tool in the SBOM and SAST ecosystem brings distinct strengths: integration capabilities, user-friendliness, continuous monitoring, or deep security analysis. Tool selection should align with organizational requirements, device risk profile, and specific cybersecurity goals, balancing compliance, security, and operational efficiency. In a field where technological innovation and regulatory compliance are tightly connected, those choices matter.

Taken together, SBOM and SAST represent a meaningful shift in how the industry thinks about medical device security. SBOMs bring transparency and accountability, clearly mapping the software components of a device. SAST provides the foresight to identify and fix vulnerabilities at the code level before they can be exploited.

By building out a tool set for SBOM analysis, each selected for its specific strengths, organizations can tailor their cybersecurity approach to their device's actual risk profile. That's not just about satisfying the FDA. It's about building devices that actually deserve the trust patients place in them.

Conclusion

Combining SBOM and SAST is more than a regulatory requirement. It's a commitment to patient safety and data protection in a healthcare environment that runs on software. As medical technology advances, that commitment must evolve with it.

Continuous learning, adaptation, and cross-functional collaboration are what keep manufacturers ahead of the threat. By staying informed and proactive, the industry can deliver devices that are safe, effective, and genuinely secure.

Explore our medical device cybersecurity and FDA compliance package.

How Blue Goat approaches this

Blue Goat Cyber assists medical device manufacturers in meeting FDA cybersecurity requirements. Our approach integrates SBOM generation and SAST implementation early in the development cycle to address vulnerabilities before they reach a submission. We analyze device software components to create accurate SBOMs, then conduct thorough static code analysis to identify security flaws before they manifest in deployed devices. Our team, comprised of certified professionals including CISSP and ex-military red team members, applies practical experience to identify and mitigate risks. We focus on effective, efficient security practices tailored to your specific device and regulatory needs. Our process streamlines compliance efforts, aiming for regulatory submission acceptance. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost. Learn more about our specialized support at FDA Premarket Cybersecurity Services.

FAQ

What is an SBOM in the context of medical devices?

An SBOM for a medical device is a complete inventory of all software components used in the device. This includes commercial, open-source, and third-party elements, providing transparency into the software supply chain needed for identifying and managing vulnerabilities as required by the FDA.

How does SAST improve medical device security?

SAST improves medical device security by analyzing the device's software code for vulnerabilities like SQL injection or buffer overflows without executing the program. This allows developers to identify and fix security flaws early in the development process, reducing the risk of exploitation and ensuring compliance with FDA expectations.

Does the FDA require SBOMs and SAST for medical devices?

The FDA's February 3, 2026 final guidance on cybersecurity in medical devices emphasizes the importance of both SBOMs and secure development practices, including static analysis, though it does not explicitly mandate specific tools. Manufacturers are expected to provide an SBOM and incorporate security testing like SAST as part of their premarket submissions and postmarket management.

What is the primary benefit of combining SBOM and SAST for medical devices?

The primary benefit of combining SBOM and SAST for medical devices is enhanced vulnerability detection and risk management. SBOM reveals what software components are present, while SAST verifies the security of how those components are implemented and interact, providing a complete view of the device's security posture and aiding compliance.

Can SBOM and SAST help with postmarket medical device security?

Yes, SBOM and SAST are vital for postmarket medical device security. An SBOM facilitates rapid identification of devices affected by newly disclosed vulnerabilities in specific software components. SAST insights from development can inform ongoing security analyses and updates, ensuring devices remain secure throughout their lifecycle.

Are there specific tools for performing SBOM analysis or SAST for medical devices?

While the FDA does not endorse specific tools, there are many commercial and open-source tools available. For SBOM generation, tools like SPDX, CycloneDX, and commercial solutions are used. For SAST, common tools include Veracode, Checkmarx, SonarQube, and other static code analyzers, many of which can be tailored for medical device development. The choice of tool depends on the development environment and specific needs.

About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.