Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection

Introduction

In the realm of post-market vigilance and product security, precise vulnerability detection is crucial. For Medical Device Manufacturer (MDM) product security experts tasked with ensuring the safety and security of products in the field, selecting effective tools is essential. While there are numerous options available, this case study explores how Medcrypt’s SBOM and Vulnerability Management Tool, Helm, offers enhanced accuracy in vulnerability detection compared to an open-source alternative.

Summary

Upon thorough analysis, it was found that Helm surpasses its counterpart in several key aspects of vulnerability detection, meeting the stringent demands of post-market vigilance. Helm not only identifies more valid Common Vulnerabilities and Exposures (CVEs) with greater precision but also substantially reduces false positives, enabling product security teams to concentrate on genuine threats.

In our comparison, Helm identified a total of 24 CVEs that the alternative tool missed. Which if added to the total number of CVEs (81), the alternative tool results in an ~23% false negative rate.

Conversely, the alternative tool found only 9 CVEs that Helm did not, Helm demonstrated only an ~10% false negative CVE rate. Moreover, Helm detected 73 valid CVEs, compared to 59 valid CVEs by the alternative tool.

Helm’s CVEs affected 32 dependencies in the SBOM, while the alternative tool’s CVEs affected 37 dependencies, with only 32 of those dependencies present in the SBOM.

Comparison

To ensure a fair and accurate comparison, an SBOM for a medical device running on Debian Linux was utilized. This choice was made because the alternative tool is more tailored to open-source software and Linux packages, while Helm has a broader focus on medical devices and software. The results can be found in the comparison table in the Appendix

Methodology

In this comparative analysis between Helm and the alternative tool, we utilized the same SBOM (Software Bill of Materials) and subjected it to both tools to evaluate their outputs. Each CVE (Common Vulnerability and Exposure) identified by either tool underwent thorough validation to ensure its legitimacy. This validation process involved verifying that the CVE pertained to a dependency listed in the SBOM and that it affected the correct version of said dependency.

In addition to CVE validation, we also examined other potential issues, such as whether the vulnerabilities impacted dependencies such as whether or not the vulnerabilities impacted dependencies running on the correct platform (in this case Linux). Notably, the alternative tool exhibited errors such as misidentifying dependencies and reporting CVEs that didn’t impact the version of the dependency that was actually included in the SBOM, while Helm did not.

Implications for Post-Market Vigilance

Key Insights

1. Precision in Detection: The study highlights the importance of precise vulnerability detection in post-market vigilance. Despite returning a higher total of CVEs initially, the alternative tool’s significant false positives resulted in Helm identifying more valid CVEs, enabling teams to address real risks efficiently.
2. Handling Linux Packages: Managing Linux packages with unique names and versioning schemes presents challenges for SBOM and vulnerability management tools. Despite its general-purpose nature, Helm demonstrated commendable performance in handling Linux package complexities compared to specialized tools.
3. Focus on Vulnerability Management: Product security teams rely on accurate tools without extensive manual intervention. Helm’s minimized false positives allow users to focus on preventing and mitigating vulnerabilities, rather than dealing with inaccuracies in the detection process.

Conclusion

In the domain of SBOM and vulnerability management, the primary focus lies on effective vulnerability management. Medical Device Manufacturers (MDMs) and their product security teams are constrained by limited time and resources, making it imperative to avoid wasting efforts on filtering out false positives from lengthy lists of vulnerabilities. Given the critical nature of medical devices and software, MDMs stand to benefit significantly from the accuracy and precision offered by Helm.

In comparison to alternative tools, Helm demonstrates superior performance by delivering a larger number of valid vulnerabilities relevant to the medical device outlined in the SBOM. Its precision significantly surpasses that of its counterparts, mitigating the risk of overwhelming false positives.

Considering scenarios where MDMs handle multiple SBOMs with numerous dependencies, the impact of false positives on workload management becomes apparent. Sorting through results from alternative tools can consume several hours, potentially leading to substantial delays in product releases, regulatory submissions, or vulnerability patching.

In today’s competitive market for medical devices and software, such delays can have severe repercussions, increasing risks and costs for MDMs. Medcrypt, dedicated to addressing MDMs’ security needs, offers Helm as a solution characterized by precision, ease of use, and robust customer support. By leveraging Helm, MDMs can optimize their resource allocation, ensuring compliance with regulatory requirements while focusing on enhancing their products and services.

Enhancing Software Security with Helm:

Incorporating Helm into your development process is crucial for seamless security integration. Choosing the right Software Bill of Materials (SBOM) vulnerability management tool is fundamental for compliance, cybersecurity, and operational integrity in today’s software landscape, where reliance on open-source and third-party components is increasing.

Key Considerations:

• Scalability: Helm efficiently handles projects of varying sizes and complexities to adapt to evolving needs, managing dependencies across different software projects.
• Seamless Integrations: Helm seamlessly integrates with existing development, security, and operational frameworks, automatically generating and updating SBOMs throughout the development lifecycle to enhance vulnerability management.
• Automation: Automated SBOM vulnerability management tools reduce manual efforts, minimize errors, and ensure continuous compliance and security.
• User Experience: Helm offers a user-friendly interface and intuitive workflows, enabling stakeholders of all technical expertise to effectively generate, read, and utilize SBOMs.
• Focused Analysis: Prioritizing security alerts by differentiating between actively used and unused software components streamlines risk management processes, enabling security teams to address vulnerabilities impacting operational security efficiently.

Interested in learning more about how Medcrypt helps medical device manufacturers meet regulatory requirements? Contact us at info@medcrypt.com and visit us at medcrypt.com to discover our full suite of medical device cybersecurity products and services.