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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

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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39:04

Overcoming AI and Data Security Challenges in MedTech...

The Med Device Cyber Podcast ·

2025/09/16

How can you prepare your device for future quantum computing risks?In this episode of The Med Device Cyber Podcast, Christian and Trevor talk with May Lee of CS Life Sciences about the fast-changing world of medical device cybersecurity. They discuss the growing regulatory demands from the FDA, EU, and China, and why cybersecurity can no longer be an afterthought in device design. The conversation also dives into quantum computing, supply chain risks, and how manufacturers can balance compliance

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26:38

When Cybersecurity Becomes a Crime

The Med Device Cyber Podcast ·

2025/09/09

What happens when cybersecurity flaws in medical devices cross the line into criminal violations?In this episode, Christian and Trevor unpack the groundbreaking case of Illumina, where cybersecurity misrepresentation led to Department of Justice enforcement. They explore how this signals a shift from technical risks to legal and patient safety consequences, highlighting the dangers of cutting corners in device development. The conversation also outlines practical lessons for manufacturers on

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37:45

Balancing Innovation and Regulation in MedTech...

The Med Device Cyber Podcast ·

2025/09/02

How can medtech innovators balance speed with compliance in medical devices?In this episode, Christian and Trevor sit down with Karandeep Singh Badwal about the challenges of balancing innovation with quality and regulatory compliance in medical devices, especially with the rise of AI and software-driven solutions. From cybersecurity gaps to the staggering startup failure rate, the conversation highlights why building quality and regulatory compliance into devices from the start is crucial for

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40:13

Webinar: Hacking Med Devices—What Penetration Testing...

The Med Device Cyber Podcast ·

2025/08/28

Cyber threats targeting medical devices are increasingly sophisticated. A single undiscovered vulnerability could delay your FDA submission and put patient safety at risk.Join Blue Goat Cyber’s CTO, Trevor Slattery, and Director of MedTech Cybersecurity, Myles Kellerman, in this webinar as they reveal real-world vulnerabilities uncovered during penetration testing. Gain exclusive insights from actual breaches and vulnerabilities Myles has personally identified, and learn how to ensure your medical

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44:29

Integrating Project Management to Strengthen...

The Med Device Cyber Podcast ·

2025/08/26

What project management mistakes can med tech innovators avoid? What methods and tools can help med tech companies manage projects?In this episode, Christian Espinosa welcomes Steve Curry to explore how strong project management can make or break a med tech company’s cybersecurity readiness. They discuss why many innovators overlook planning, how this oversight causes costly delays, and the benefits of integrating cybersecurity into every project phase. Steve shares practical strategies for

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39:31

Webinar: Navigating FDA Cybersecurity Compliance: A...

The Med Device Cyber Podcast ·

2025/08/21

When you’re working with a manufacturer to ensure that a medical device has strong cybersecurity, what do you need to know from a regulatory perspective?In this episode, Christian and Trevor dive into the current state of cybersecurity, discussing emerging threats and defense strategies. They also explore the role of AI in both cyberattacks and security measures, offering insights into how businesses can stay ahead of evolving threats.Key topics for regulatory affairs (RA) and quality assurance (QA)

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