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PODCAST

The Med Device Cyber Podcast

Blue Goat Cyber

In a time where healthcare and technology are deeply intertwined, understanding medical device cybersecurity is not just important—it"s essential. Welcome to The Med Device Cyber Podcast, your go-to resource for understanding the complexities of this critical field of cyber security. As the definitive podcast on medical device security, we explore everything from identifying and mitigating vulnerabilities to navigating this ever-evolving regulatory landscape. Hosted by Christian Espinosa,

technology alternative health

All Episodes

30:47

Vulnerability, Penetration & Other Cybersecurity...

The Med Device Cyber Podcast ·

2025/08/19

Which cybersecurity tests are the most crucial, and which ones does the FDA require for medical device approval?In this episode, Christian and Trevor break down the many types of cybersecurity testing required for medical devices. They explore the distinctions between vulnerability assessments, penetration testing, and other critical methods like fuzz testing, security requirement testing, and dynamic analysis. Along the way, they share real-world examples, FDA compliance insights, and practical

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44:59

Webinar: Medical Device Penetration Testing: What...

The Med Device Cyber Podcast ·

2025/08/14

What are the unique challenges and regulatory requirements of medical device penetration testing?In this webinar episode with Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, you’ll learn:* How Medical Device Penetration Testing Differs from Traditional IT Security.Unlike conventional IT security testing, medical device penetration testing prioritizes patient safety and device functionality. Discover how attackers exploit firmware, wireless protocols, and

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44:54

From Surgery to MedTech Startups: Dr. Dylan Attard’s...

The Med Device Cyber Podcast ·

2025/08/12

What cybersecurity challenges face hospitals and medical devices today that medtech innovators should know about?Today’s guest is Dr. Dylan Attard, who swapped his scalpel for startups when he founded MedTech World, a global conference series elevating healthcare innovation. He’s passionate about connecting startups with investors and sparking conversations that turn bold ideas into life-saving solutions.In this episode, Dr. Attard shares his transition from surgeon to founder of MedTech World and

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33:28

Webinar: Medical Device Risk Assessments -...

The Med Device Cyber Podcast ·

2025/08/07

Medical devices are becoming more connected, but with that connectivity comes risk.In this episode, Christian and Trevor dive into risk assessments for medical devices—a crucial process in ensuring both patient safety and cybersecurity compliance.They discuss:* The difference between risk management and risk assessment* How risk scoring works using exploitability vs. impact* Why traditional cybersecurity metrics don’t fully apply to medical devices* The importance of traceability and compliance with

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24:08

Understanding Cybersecurity Measures and Metrics for...

The Med Device Cyber Podcast ·

2025/08/05

How do measures and metrics differ, and why is this distinction crucial for FDA submissions?In this episode, Christian and Trevor demystify the difference between cybersecurity measures and metrics in the context of FDA guidance. They explore what the FDA expects in submissions, emphasizing patch timelines, vulnerability tracking, and post-market data collection. They also discuss the importance of actionability over mere compliance and include real-world challenges like device downtime and risk in

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43:18

Webinar: Mastering Threat Modeling for Medical Device...

The Med Device Cyber Podcast ·

2025/07/31

Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, Director of Medical Device Cybersecurity, explore the critical topic of threat modeling in medical device cybersecurity. This session covers essential practices and frameworks that ensure the safety and security of medical devices, aligning with FDA guidelines.We cover the DFD3 standard for threat diagramming and the STRIDE framework for identifying potential threats. Learn how to visualize and assess risks effectively, understand

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32:47

FDA Cybersecurity Gets Real with Monica Montañez of...

The Med Device Cyber Podcast ·

2025/07/29

How have medical device cybersecurity requirements changed since 2023, and what does this mean for your product development?In this episode, Christian and Trevor welcome Monica Montañez from NAMSA to unpack the evolving landscape of FDA cybersecurity requirements. From new laws introduced in 2023 to the ambiguous language in FDA guidance, they dig into what it really takes to meet expectations for cyber device submissions.(0:32) NAMSA and Industry Shifts* Monica introduces NAMSA’s role in regulatory

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43:18

Webinar: Risk Management Frameworks For Medical...

The Med Device Cyber Podcast ·

2025/07/24

Join Trevor Slattery, Director of Cybersecurity, and Christian Espinosa, CEO of Blue Goat Cyber, for a comprehensive webinar on medical device cybersecurity.Trevor and Christian explore the critical interplay between safety and security risk management, offering guidance on conducting effective risk assessments that address vulnerabilities across both domains.This presentation will give you a deeper understanding of key standards like ISO 14971 and AAMI TIR57 and learn how to implement robust risk

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27:55

What the FDA Wants in Security Architecture Views for...

The Med Device Cyber Podcast ·

2025/07/22

What are the four security architecture views that the FDA prioritizes, and how do they impact your device's design?This episode explores the FDA-defined security architecture views essential for medical device cybersecurity. Christian and Trevor break down the four views—global system, updatability/patchability, multi-patient harm, and secure use cases—with real-world examples and practical advice.Key points:(5:25) The Global System View* Companion apps and cloud infrastructure must be part of the

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49:41

5 Key FDA Cybersecurity Standards with Jordan John

The Med Device Cyber Podcast ·

2025/07/17

How can you integrate relevant cybersecurity standards early in your medical device development process? Also, how do FDA cybersecurity standards help reduce the time to market for new medical devices?In this episode, Trevor Slattery, CTO of Blue Goat Cyber, and Jordan John, Director of Regulatory Affairs and Compliance at Blue Goat Cyber, explore:* The importance of integrating standards into the QMS from the start.* How TIR57 complements ISO 14971 for security risk management.* Why cybersecurity

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52:54

Shared Responsibility in Medical Device Cybersecurity...

The Med Device Cyber Podcast ·

2025/07/15

How can shared responsibility models improve healthcare cybersecurity?In this episode, Greg Garcia joins Christian and Trevor to break down the evolving landscape of medical device cybersecurity from a national policy perspective. Together, they discuss the legacy device challenge, shared accountability, and how sector-wide collaboration is critical to progress. The episode drives home the message that cybersecurity is not just technical—it’s foundational to patient safety and innovation.Greg Garcia

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35:00

Total Product Lifecycle Security: From Design to...

The Med Device Cyber Podcast ·

2025/07/08

How well does your security strategy cover the entire product lifespan—from concept to decommissioning?This episode dives into the importance of the Total Product Lifecycle (TPLC) and Secure Product Development Framework (SPDF) in medical device cybersecurity. Christian and Trevor share stories, best practices, and pitfalls from real-world cases involving update security, insecure development environments, and overlooked decommissioning risks.Key points:(1:50) Intro to TPLC and SPDF* The importance

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37:19

Why Cybersecurity and Quality Are One and the Same

The Med Device Cyber Podcast ·

2025/07/01

How can medical device startups avoid missteps in cybersecurity, quality, and compliance?In this episode, Trevor Slattery speaks with Ashkon Rasooli about the intersection of quality systems and cybersecurity in medical devices. They unpack why treating cybersecurity as a bolt-on checklist is ineffective and even dangerous. They also discuss regulatory realities, risk management frameworks, and how early-stage teams can avoid costly pitfalls by planning smarter from the start.Ashkon Rasooli is the

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31:06

Cybersecurity Labeling and MedTech Transparency

The Med Device Cyber Podcast ·

2025/06/24

Why is cybersecurity labeling more than just a compliance checkbox for medical device companies?In this episode, Christian and Trevor dive into the nuanced world of cybersecurity labeling for medical devices. They discuss the role of MDS2 and JSP2 documentation, labeling misconceptions, and how manufacturers can best disclose security information without overwhelming or misleading users.Key points:(6:30) Misconceptions About Cybersecurity Labeling* Many manufacturers worry that disclosing risks will

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39:41

From Concept to Compliance: A Guide to Med Device...

The Med Device Cyber Podcast ·

2025/06/17

Med device manufacturers, are you setting up your quality system early enough in product development? Also, are you misunderstanding the FDA’s "guidance" documents—and risking rejection?Today’s guests are Mark Swanson and Steve Gompertz of QRx Partners, and they’re passionate about helping medtech companies dodge the regulatory and quality pitfalls that derail so many startups. This episode explores how to classify your device properly, why cybersecurity documentation is required even for isolated

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28:12

Unpacking Post-Market Management and Incident...

The Med Device Cyber Podcast ·

2025/06/10

What should you do when a vulnerability is discovered in a medical device after it's already on the market?This dives into post-market management and incident response for medical devices, exploring what happens when a device is hacked or a vulnerability is reported. Christian Espinosa and Trevor Slattery discuss the processes involved in identifying, triaging, and remediating vulnerabilities, emphasizing the unique challenges faced in the medical device sector.Key points:(8:01) Sources of

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42:38

AI in Medical Devices: Opportunities & Regulation...

The Med Device Cyber Podcast ·

2025/06/03

What does responsible AI implementation look like in medical devices?This episode explores the intersection of AI, cybersecurity, and medical device regulation with guest Matt Lemay, CEO of Lemay.ai. Hosts Christian Espinosa and Trevor Slattery of Blue Goat Cyber dig into how AI models are trained, certified, and deployed in clinical contexts—and what can go wrong.Key points:(7:29) Data, Security, and Deployment Risks* Training data inconsistencies and data drift in AI models.* Cybersecurity

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27:39

Essential Software Documentation for Med Device...

The Med Device Cyber Podcast ·

2025/05/27

What documents should engineers prepare to get ready for submitting a medical device to the FDA? In this episode, Christian and Trevor dig into the underestimated role software documentation plays in cybersecurity, especially in the medical device space. They highlight how incomplete or contextless documentation can hinder everything from SBOM utility to regulatory compliance. With sharp insights and real-world examples, they make the case for elevating documentation as a strategic priority.Key

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35:16

The Human Factor in MedTech Design with Dylan Horvath

The Med Device Cyber Podcast ·

2025/05/20

How can human-centered design influence medical device cybersecurity?In this episode, Christian Espinosa chats with Dylan Horvath of Cortex Design about the powerful intersection of human-centered design and medical device cybersecurity. They explore how usability, trust, and empathy can shape safer, smarter devices from the start. Dylan also shares valuable insights into building design teams, learning from failure, and driving innovation in regulated industries.Dylan Horvath is a passionate

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33:18

Master Medical Device Cybersecurity: Avoid FDA Delays...

The Med Device Cyber Podcast ·

2025/05/13

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

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