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Case study · October 6, 2025

FDA Cybersecurity ReadinessRegulatorySoftware as a Medical Device (SaMD)Software Bill of Materials (SBOM)

Medcrypt Transforms SBOM Management: 90% Faster Vulnerability Review for Global MDM

From Manual Bottleneck to Automated Intelligence

Seth Carmody

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The Challenge

Overwhelming Manual SBOM and CVE Review Process

At a Glance:

  • Client: Global medical device manufacturer
  • Challenge: Labor-intensive manual SBOM and CVE review process
  • Solution: Automated analysis with expert manual validation
  • Impact: 90% faster SBOM review, improved accuracy, validated program ROI

Challenge:

  • Labor-intensive SBOM management consuming engineering resources
  • Manual CVE analysis took weeks
  • Lacked automated workflows for bulk rescoring and monitoring
  • Leadership questioned continued investment without validated KPIs

Details:

A global medical device manufacturer struggled with labor-intensive SBOM management and vulnerability review processes consuming engineering resources without delivering strategic insights. Manual CVE analysis took weeks, preventing timely risk assessment and remediation prioritization. The team lacked automated workflows for bulk rescoring, data enrichment, and continuous monitoring — creating bottlenecks that delayed security decisions. Without validated KPIs demonstrating program value, leadership questioned continued investment in vulnerability management. The organization needed both operational efficiency improvements and business case validation to sustain their security program long-term.

The Solution

Automated Analysis with Expert Manual Validation

At a Glance:

  • Vulnerability management as a service combining automation with expert review
  • AI-driven automation with expert manual review for accuracy
  • Automated workflows integrating with existing tools
  • Program KPIs demonstrating security ROI

AI-Driven Automation with Expert Review:

Medcrypt implemented vulnerability management as a service, combining AI-driven automation with expert manual review to dramatically accelerate SBOM processing while improving accuracy. The hybrid approach automated routine CVE screening, bulk rescoring, and data enrichment while leveraging human expertise for complex risk assessments and false positive elimination.

Program KPIs and Sustainable Governance:

Medcrypt established automated workflows integrating with the manufacturer's existing tools, eliminating manual data transfer bottlenecks. Beyond operational improvements, Medcrypt developed program KPIs demonstrating security ROI, providing leadership with quantifiable metrics validating continued vulnerability management investment and informing future resource allocation.

The Impact

Operational Efficiency and Program Validation

Medcrypt's hybrid approach combined intelligent automation with expert validation, delivering dramatic efficiency gains while proving long-term program value to leadership.

  • Reduced SBOM CVE review time by 90% through intelligent automation that handled routine screening while preserving expert judgment for complex risk assessments
  • Increased SBOM quality and usability by combining automated data enrichment with manual validation, reducing false positives and improving remediation guidance accuracy
  • Validated long-term program sustainability with clear KPIs demonstrating business value, securing leadership buy-in for continuous vulnerability management investment and evolution

Overwhelmed by SBOM Management?

Medcrypt's vulnerability management service combines automation with expert analysis to accelerate reviews by 90% while improving accuracy.

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