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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,

science life sciences

All Episodes

53:00

What It Takes to Succeed in the Medtech Industry

The Med Device Cyber Podcast ·

2026/01/14

Ever thought about what it really takes to launch a successful medtech startup?Omar M. Khateeb knows the challenges firsthand. As a founder with a track record of building healthtech companies, he’s lived through the hurdles that come with innovating in the medtech space.In this episode, Omar dives into the highs and lows of his entrepreneurial journey, sharing key lessons, pivotal moments, and the strategies that helped him succeed. From tackling complex healthcare issues to navigating the

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29:02

Untangling Software Composition Analysis for MedTech...

The Med Device Cyber Podcast ·

2026/01/06

Why does software composition analysis matter beyond regulatory compliance?This episode explores SCA (Software Composition Analysis) and explains how SBOMs (Software Bill of Materials), SOUP (Software of Unknown Provenance), and related tooling fit into the broader medical device cybersecurity landscape. Christian and Trevor clarify common misconceptions, including licensing fears, machine-readable requirements, and the role of static testing tools.The Med Device Cyber Podcast is brought to you by

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24:58

When Medical Device Cyber Failures Become Fatal

The Med Device Cyber Podcast ·

2025/12/30

What past ransomware and medical device incidents might reveal gaps that manufacturers are still overlooking today?In this episode, Christian and Trevor examine real incidents where cybersecurity failures, software flaws, and insecure medical devices led to patient harm and death. They break down how ransomware attacks, implantable device vulnerabilities, and AI-driven therapies expose life-critical risks in healthcare. The conversation highlights why regulators are increasing scrutiny and why

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23:10

Trevor Slattery Answers Tough Medical Device Cyber...

The Med Device Cyber Podcast ·

2025/12/23

This episode puts Trevor in the hot seat. If you were put in the hot seat, could you clearly explain cybersecurity, safety, and lifecycle terms like Trevor?In this rapid-fire episode, Christian fires questions at Trevor about essential medical device cybersecurity concepts and standards. Together, they clarify how risk management, secure development, and lifecycle thinking intersect across safety, quality, and security. The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity

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20:09

The Differences Between Black, Grey, and White...

The Med Device Cyber Podcast ·

2025/12/16

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

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45:00

How Cybersecurity Shapes Regulatory and Quality...

The Med Device Cyber Podcast ·

2025/12/09

What risks do you take when cybersecurity is left off your development roadmap?In this episode, Christian, Trevor and guest Jim Goodmiller explore how cybersecurity intersects with regulatory expectations and quality systems, creating new challenges and opportunities for medtech innovators. Jim helps to explain why founders must integrate cybersecurity from concept through commercialization, especially as FDA scrutiny increases.Key points:00:48 Why cybersecurity now influences every part of the

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40:52

Webinar: Why FDA Cybersecurity Submissions Fail and...

The Med Device Cyber Podcast ·

2025/12/04

Medtech innovators and medical device manufacturers, how can you prevent cybersecurity deficiencies from delaying your FDA submission?In this webinar, Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, reveal the most common reasons FDA cybersecurity submissions fail and how you can avoid them. They explain the importance of early risk management, security-by-design practices, and comprehensive testing aligned with NIST and AAMI frameworks.Explored in this

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12:27

Cybersecurity Qs MedTech Innovators Ask: Christian’s...

The Med Device Cyber Podcast ·

2025/12/02

MedTech manufacturers, how can you avoid the cybersecurity pitfalls that most often lead to FDA rejection?In this episode, Trevor puts Christian “in the hot seat” to tackle the most common—and sometimes misunderstood—cybersecurity questions MedTech innovators ask. Christian breaks down key concepts such as ISO 13485, HIPAA vs. FDA expectations, SAMD vs. SIMD, global regulatory demands, and more.Key points:(00:30) The purpose of ISO 13485 and why traceability, quality, and documentation are

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35:11

What Is Required for an FDA Pre-Market Cyber Submission?

The Med Device Cyber Podcast ·

2025/11/25

What are the 18 required cybersecurity deliverables for a pre-market submission, and how do they map to eSTAR’s 13 sections?This episode breaks down the cybersecurity deliverables required for an FDA pre-market submission and explains why they apply consistently across all device types. Christian and Trevor walk through each deliverable in detail, outline how they map to eSTAR v6.0, and highlight common misconceptions that slow down manufacturers.Key points:(00:33) Why all devices—high-risk or

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33:12

Webinar: Postmarket Cybersecurity Management

The Med Device Cyber Podcast ·

2025/11/20

MedTech manufacturers, how prepared are you to monitor vulnerabilities continuously once your medical device reaches the market? Also, would you like a free checklist for your Cybersecurity Management Plan? (See link below!)This webinar dives into how medical device manufacturers should build, maintain, and document postmarket cybersecurity programs that align with FDA expectations. Christian and Trevor outline critical requirements such as continuous SBOM monitoring, testing timelines, update

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44:47

How Market Intelligence Shapes MedTech Growth with...

The Med Device Cyber Podcast ·

2025/11/18

In the MedTech space, how can you leverage market intelligence and machine learning for business development and sales enablement?In this episode, Christian and Trevor talk with Kevin Saem about how market intelligence and cybersecurity intersect in the MedTech space. They unpack how AI and data-driven insights are transforming sales enablement, investor confidence, and device security. They also discuss regulation delays, startup runway challenges, and the growing need for proactive

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39:41

Designing Secure Medical Device Software with Randy...

The Med Device Cyber Podcast ·

2025/11/11

In medical device software development, why should cybersecurity be viewed as an element of product quality, not an add-on?In this episode, Christian and Trevor speak with Randy Horton of Orthogonal about the future of medical device software development. Together, they unpack how DevSecOps, quality systems, and modern engineering practices can elevate safety and speed innovation in MedTech. From the philosophy behind “move faster and break nothing” to lessons learned from real-world cybersecurity

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19:19

Cyber Risk Management for MedTech Legacy Devices

The Med Device Cyber Podcast ·

2025/11/04

What options do MedTech manufacturers have to bring older devices up to modern cybersecurity standards? Also, how does the FDA’s latest guidance change the process for updating legacy devices?In this episode, Christian and Trevor break down the evolving challenges of managing cybersecurity for MedTech legacy devices. They explain how the FDA’s recent guidance updates create new pathways for handling older devices without requiring full redesigns. Together, they explore practical steps manufacturers

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42:19

Webinar: Security Architecture Views: Protecting...

The Med Device Cyber Podcast ·

2025/10/30

How can security architecture views strengthen a medical device manufacturer’s FDA submissions?This episode/webinar dives into the four critical security architecture views required by the FDA: global system, multi-patient harm, updatability and patchability, and secure use case views. Christian Espinosa and Trevor Slattery explain how each view strengthens product security while aligning with regulatory expectations. They also share practical strategies and examples, from cloud environments to

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36:58

Why AI Literacy Matters for the Future of Healthcare...

The Med Device Cyber Podcast ·

2025/10/28

How can AI literacy reduce patient risk in healthcare settings?In this episode, Christian Espinosa and Trevor Slattery are joined by Dr. José Acosta. Together, they unpack the promise and pitfalls of artificial intelligence in healthcare—from the accuracy gap in diagnostics to the importance of ethics, alignment, and training. The conversation explores how clinicians can harness AI safely, ensuring innovation never comes at the cost of patient trust or care quality.Dr. José Acosta is a retired Navy

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20:09

What Is A Medical Device?

The Med Device Cyber Podcast ·

2025/10/21

MedTech developers and manufacturers, could your medical device unknowingly qualify as a “cyber device”?In this episode, Christian and Trevor break down what the FDA considers a “cyber device” and why so many manufacturers misunderstand this definition. They reveal how even basic interfaces like USB, HDMI, or Bluetooth can make a device cyber-enabled—and why that matters for regulatory compliance. Key points: (00:33) What makes a medical device a “cyber device,” and why confusion persists among

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25:52

5 Most Common Misconceptions of Medical Device Security

The Med Device Cyber Podcast ·

2025/10/14

In this episode, Christian and Trevor unpack the five most common misconceptions that put medical device manufacturers at risk. From confusing data protection with patient safety to misunderstanding what qualifies as a cyber device, the hosts shed light on the blind spots that cause costly delays and compliance failures. They also explore how medical device cybersecurity differs fundamentally from traditional cybersecurity, emphasizing the need for specialized expertise and early integration of

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24:36

What Happens When AI in Medical Devices Make Mistakes?

The Med Device Cyber Podcast ·

2025/10/07

MedTech manufacturers and developers, what happens if your AI-powered medical device makes a terrible, life-threatening mistake?This episode explores what happens when artificial intelligence in medical devices goes wrong. Christian Espinosa and Trevor Slattery break down the real-world consequences of AI failure, using a tragic mental health chatbot case to highlight the stakes of inadequate oversight. They also examine the EU AI Act, new MDCG guidance, and the ethical, regulatory, and

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46:03

Medical Device Startups and Cybersecurity Challenges...

The Med Device Cyber Podcast ·

2025/09/30

What are some of the greatest challenges medical device startups face when bringing their products to market?This episode features Suzy Engwall, a healthcare innovation consultant with experience mentoring startups and guiding hospitals. She joins Christian Espinosa and Trevor Slattery to discuss the hidden roadblocks medical device innovators face—from funding gaps to internal hospital politics to overlooked cybersecurity. Together they unpack the realities of FDA compliance, AI-driven decision

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39:31

Top 10 Medical Device Vulnerabilities with Myles...

The Med Device Cyber Podcast ·

2025/09/23

How safe are the medical devices I rely on, and what are the biggest cybersecurity risks I should know about?In this episode, the team goes behind the scenes of real-world medical device penetration testing to reveal the 10 most common and dangerous cybersecurity vulnerabilities found in medical devices. The discussion covers practical examples, industry standards, and actionable advice for manufacturers and healthcare organizations.Key points:(0:00) Introduction & Penetration Testing

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