The Differences Between Black, Gray, and White Penetration Testing | Ep. 50

The Med Device Cyber Podcast · December 30, 2025 This episode of The Med Device Cyber Podcast delves into the critical distinctions between black, gray, and white box penetration testing, specifically within the medical device cybersecurity landscape. Hosts discuss the varying levels of information provided to testers in each approach: black box (no prior insight, mimicking a

Key Takeaways

• Black box testing simulates an attacker with no prior knowledge, offering a realistic but potentially less thorough assessment of low-hanging fruit vulnerabilities.
• Gray box testing provides some internal insight, like user credentials or architecture diagrams, allowing for a more comprehensive assessment than black box.
• White box testing offers the most complete access, including source code and engineering contacts, enabling the deepest and most targeted vulnerability assessment.
• The FDA, while not explicitly mandating a specific penetration testing type, effectively steers manufacturers toward white box testing through requirements like static application security testing and SBOM analysis.
• Opting for white box penetration testing from the outset can prevent costly delays, repeat testing, and potential FDA deficiencies by ensuring comprehensive coverage and adherence to regulatory expectations.
• Prioritizing comprehensive white box testing not only satisfies regulatory requirements but also significantly enhances patient safety by thoroughly identifying and mitigating potential security risks.

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