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MedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?
In this episode, Christian and Trevor explain the differences between black, grey, and white box penetration testing and how each impacts the completeness and realism of cybersecurity assessments. They highlight why regulators increasingly expect deeper testing supported by source-code-level insights. They also outline the risks, costs, and delays manufacturers face when choosing insufficient testing approaches during FDA submission.
Key points:
(01:25) Learn how black box testing mimics an attacker with no prior knowledge.
(06:27) How grey box testing blends limited credentials, architecture insight, and direct communication with engineers to expand visibility.
(08:29) Why white box testing includes access to full documentation, processes, and source code.
(10:20) How attacker timeframes differ from tester timeframes.
(11:29) How the FDA’s static analysis, SBOM, and risk evaluation requirements tie naturally into white box testing workflows.
(15:06) Learn why choosing black box testing to save money often results in higher total costs after FDA rejection.
(17:47) Hear why “buy once, cry once” applies to penetration testing.
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
Feedback? Questions? Contact: https://bluegoatcyber.com/contact/
Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast.
Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
Subscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
This episode was produced by Story On Media: https://www.storyon.co/
By Blue Goat CyberMedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?
In this episode, Christian and Trevor explain the differences between black, grey, and white box penetration testing and how each impacts the completeness and realism of cybersecurity assessments. They highlight why regulators increasingly expect deeper testing supported by source-code-level insights. They also outline the risks, costs, and delays manufacturers face when choosing insufficient testing approaches during FDA submission.
Key points:
(01:25) Learn how black box testing mimics an attacker with no prior knowledge.
(06:27) How grey box testing blends limited credentials, architecture insight, and direct communication with engineers to expand visibility.
(08:29) Why white box testing includes access to full documentation, processes, and source code.
(10:20) How attacker timeframes differ from tester timeframes.
(11:29) How the FDA’s static analysis, SBOM, and risk evaluation requirements tie naturally into white box testing workflows.
(15:06) Learn why choosing black box testing to save money often results in higher total costs after FDA rejection.
(17:47) Hear why “buy once, cry once” applies to penetration testing.
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
Feedback? Questions? Contact: https://bluegoatcyber.com/contact/
Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast.
Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
Subscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
This episode was produced by Story On Media: https://www.storyon.co/