Episodes on FDA postmarket cybersecurity.

Episode 64

Start QMS Early to Avoid Reverse Documentation with Dr. Basant Bajpai

With Dr. Basant Bajpai

In this episode of the Med Device Cyber Podcast, host Trevor Slattery is joined by special guest Dr. Basant Bajpai, the CEO of Compliance MedQRA, a regulatory consulting firm based in Dubai that also offers an automated Quality Management System (QMS). Dr. Bajpai, who holds a PhD in neuromonitoring and neurosciences, d

Episode 61

How to Design Devices That Integrate Into Clinical Workflow Without Disruption

In this episode of the Med Device Cyber podcast, hosts Christian Espinosa and Trevor Slattery are joined by Professor Aamer Ahmed, a practicing cardiac anesthesiologist and co-founder of the MedTech company Hemeo. The discussion centers on the critical role of clinical expertise in medical device innovation and the par

Episode 56

What 15 Years In MedTech Taught This CEO About Cybersecurity with Marc Zemel

With Marc Zemel

In this episode of the Med Device Cyber podcast, hosts Trevor Slattery and Christian Espinosa welcome Marc Zemel, the CEO of Retia Medical, to discuss the critical intersection of medical device innovation and cybersecurity, especially from the perspective of a MedTech startup. The conversation centers on the journey o

Episode 52

Medical Device Cyber Failures Become Fatal

In this episode of the Med Device Cyber Podcast, hosts Trevor Slattery and Christian Espinosa of Blue Goat Cyber delve into the serious and often life-threatening consequences of medical device cybersecurity vulnerabilities. They move beyond theoretical risks to discuss documented incidents where software flaws and sec

Episode 49

How Cybersecurity Shapes Regulatory and Quality Success with Jim Goodmiller

With Jim Goodmiller

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

Episode 47

What Is Required for an FDA Premarket Cyber Submission?

In this episode of The Med Device Cyber Podcast, hosts Christian Espinosa, Founder, and Trevor Slattery, CTO of Blue Goat Cyber, provide a detailed breakdown of the requirements for an FDA cybersecurity premarket submission. The central focus is on clarifying a common area of confusion: the 18 specific deliverables req

Episode 44

Cyber Risk Management for MedTech Legacy Devices

With MedTech leader

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?

Episode 39

Medical Device Startups and Cybersecurity Challenges with Suzy Engwall

With Suzy Engwall

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.

Episode 38

Top 10 Medical Device Vulnerabilities with Myles Kellerman

With Myles Kellerman

How safe are the medical devices I rely on, and what are the biggest cybersecurity risks I should know about?

Episode 31

Understanding Cybersecurity Measures and Metrics for Medical Devices

With MedTech leader

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.

Episode 28

Shared Responsibility in Medical Device Cybersecurity with Greg Garcia

With Greg Garcia

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.

Episode 23

Unpacking Post-Market Management and Incident Response for Medical Devices

With MedTech leader

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.

Episode 10

How Trump & RFK Jr Affect AI and Medical Device Cybersecurity Guidelines

In this episode of The Med Device Cyber Podcast, hosts Christian Espinosa and Trevor Slattery from Blue Goat Cyber delve into the potential impacts of a new Trump administration, along with the influence of figures like Robert F. Kennedy Jr., on the medical device and MedTech cybersecurity landscape. The conversation b

Episode 21

Essential Software Documentation for Med Device Manufacturers

With MedTech leader

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.

Episode 13

SBOMs Unpacked: Myths, Risks, & Benefits with Cortez Frazier Jr.

With Cortez Frazier Jr.

Why are Software Bill of Materials (SBOMs) critical for medical device security? In this episode, Cortez Frazier Jr. joins Christian and Trevor to discuss SBOMs, vulnerability prioritization, and why companies should stop fearing software transparency.

Episode 12

Postmarket Surveillance and Anomaly Detection for Medical Devices

With MedTech leader

What are some of the biggest cybersecurity risks medical devices face after they hit the market? This episode dives into the challenges of postmarket surveillance for medical devices.

Episode 09

FDA AI Guidance Explained: What It Means for Medical Device Cybersecurity

With MedTech leader

How does the FDA’s latest AI guidance on medical devices impact manufacturers and cybersecurity challenges in healthcare? In this episode, Christian and Trevor discuss the latest FDA AI guidance and how it will impact real-world AI applications in healthcare.

Episode 07

Startups, Regulations, & Risk: Insights from MedTech Guru Etienne Nichols

With MedTech leader

What are some of the key challenges MedTech companies face in balancing innovation with compliance? This episode dives into the intersection of quality management and cybersecurity in the MedTech industry.

Episode 01

Cybersecurity for Medical Devices: Protecting Human Lives

With MedTech leader

How do medical device cybersecurity risks differ from traditional cybersecurity threats? In this episode, Christian Espinosa and Trevor Slattery discuss the critical importance of cybersecurity for medical devices, sharing real-life stories and insights into how device vulnerabil