Sign up to save your podcasts
Or
Share Master Medical Device Cybersecurity: Avoid FDA Delays | Blue Goat Cyber Webinar
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
Master Medical Device Cybersecurity: Avoid FDA Delays | Blue Goat Cyber Webinar
How can medical device manufacturers meet FDA cybersecurity requirements the first time around?
What are the most significant challenges medical device manufacturers face in ensuring FDA cybersecurity compliance?
In this webinar, Trevor Slattery, CTO of Blue Goat Cyber, dives into what it takes to master medical device cybersecurity and avoid costly delays with the FDA. He outlines common pitfalls companies face, including poor documentation, lack of threat modeling, and mismatched security controls. Watch this webinar for practical, actionable advice for navigating FDA expectations and building more secure, compliant devices.
Topics Trevor explores in this webinar:
(00:30) Why Devices Get FDA Cybersecurity Pushback
* Many devices are rejected due to poor threat models and vague documentation.
(06:36) What the FDA Is Really Looking For
* The FDA expects a structured, traceable cybersecurity story from architecture to testing.
(13:20) Building Strong Documentation and Threat Models
* Good threat modeling identifies specific risks and aligns them with appropriate mitigations.
* Fuzzy, generic statements about “zero trust” or “encryption” are red flags for reviewers.
(19:56) SBOMs, Known Vulnerabilities, and FDA Red Flags
* FDA reviewers expect to see every SBOM component mapped to known vulnerabilities.
* Missing VEX (Vulnerability Exploitability eXchange) documentation slows down reviews.
(26:54) What to Do If You’re Stuck or Behind Schedule
* If you’re behind, don't scramble—step back and rebuild the cybersecurity narrative.
* Professional guidance can help realign your strategy with FDA expectations.
This webinar was 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/
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
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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://spoti.fi/3XX95g0
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
This was produced by Story On Media: https://www.storyon.co/
View all episodes
By Blue Goat CyberHow can medical device manufacturers meet FDA cybersecurity requirements the first time around?
What are the most significant challenges medical device manufacturers face in ensuring FDA cybersecurity compliance?
In this webinar, Trevor Slattery, CTO of Blue Goat Cyber, dives into what it takes to master medical device cybersecurity and avoid costly delays with the FDA. He outlines common pitfalls companies face, including poor documentation, lack of threat modeling, and mismatched security controls. Watch this webinar for practical, actionable advice for navigating FDA expectations and building more secure, compliant devices.
Topics Trevor explores in this webinar:
(00:30) Why Devices Get FDA Cybersecurity Pushback
* Many devices are rejected due to poor threat models and vague documentation.
(06:36) What the FDA Is Really Looking For
* The FDA expects a structured, traceable cybersecurity story from architecture to testing.
(13:20) Building Strong Documentation and Threat Models
* Good threat modeling identifies specific risks and aligns them with appropriate mitigations.
* Fuzzy, generic statements about “zero trust” or “encryption” are red flags for reviewers.
(19:56) SBOMs, Known Vulnerabilities, and FDA Red Flags
* FDA reviewers expect to see every SBOM component mapped to known vulnerabilities.
* Missing VEX (Vulnerability Exploitability eXchange) documentation slows down reviews.
(26:54) What to Do If You’re Stuck or Behind Schedule
* If you’re behind, don't scramble—step back and rebuild the cybersecurity narrative.
* Professional guidance can help realign your strategy with FDA expectations.
This webinar was 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/
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
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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://spoti.fi/3XX95g0
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
This was produced by Story On Media: https://www.storyon.co/