Case study · FDA Cybersecurity Readiness
Medcrypt Transforms SBOM Management: 90% Faster Vulnerability Review for Global MDM
From Manual Bottleneck to Automated Intelligence
Read case studyExecutive summary
What this whitepaper covers
This whitepaper explores a critical blind spot in medical device cybersecurity: the lack of correlation between vulnerability severity and patch availability.
Analyzing data from the ICS-CERT advisory database (2013–2019), MedCrypt found that despite a 400% increase in vulnerability disclosures since FDA issued its postmarket cybersecurity guidance (2016), patching practices remain inconsistent across the industry.
The paper reveals that while patch frequency has increased by 46.5%, the CVSS score of a vulnerability has no statistical relationship with whether it gets patched. The findings emphasize the need for proactive, security-by-design architectures and continuous vulnerability management to reduce reliance on reactive patching.
Why it matters
The regulatory and product context
Medical device security cannot depend on patching alone. For devices embedded in critical care environments or implanted in patients, patching can introduce new risks: downtime, data loss, or interference with clinical workflows. Yet, FDA guidance explicitly requires manufacturers to design devices that “anticipate software patches” and support secure, rapid updates.
This whitepaper helps manufacturers and regulators understand:
- Why traditional patching models are insufficient for connected medical devices
- How proactive design and secure architectures mitigate risk
- Why patch frequency and vulnerability severity remain misaligned
- How industry transparency through ICS-CERT reporting reflects maturity in security management
Key insights
What you’ll take away
- 46.5% increase in patch frequency since FDA’s postmarket guidance (2016).
- No correlation between CVSS severity and whether a patch is issued.
- Patching remains concentrated among large vendors and high-visibility devices.
- Security researcher collaboration increases patch likelihood and disclosure transparency.
- Future resilience depends on proactive design and continuous monitoring, not reactive patching.
Who should read this
- Medical device manufacturers (MDMs): engineers, cybersecurity teams, and regulatory professionals
- Healthcare delivery organizations (HDOs): IT, biomedical, and clinical security leaders
- Regulatory and standards bodies: professionals involved in FDA, NIST, and ISO security frameworks
- Product security officers and executives: developing lifecycle vulnerability management programs
Related resources
Go deeper on the topics in this whitepaper with Medcrypt analysis and real device programs.
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