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    Podcast · FDA Postmarket

    Episodes on FDA postmarket cybersecurity.

    Coordinated vulnerability disclosure, patching legacy devices, and meeting the FDA's postmarket cybersecurity expectations after launch.

    FDA Postmarket Cybersecurity Services All episodes

    17 episodes

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    1. Episode 88

      AI, Medical Devices and the Next Cybersecurity Arms Race with Liam Dowd

      With Liam Dowd

      AI is becoming more capable, more autonomous and more accessible. What does that mean for medical device cybersecurity? Liam Dowd joins Christian Espinosa to discuss the changing security landscape, from continuous SBOM monitoring and vulnerable hospital environments to the growing role of AI on both sides of the cyber

    2. Episode 85

      Building Cyber Resilience Into Medical Devices with Joe Saunders

      With Joe Saunders

      What if a medical device could prevent an attacker from exploiting a vulnerability, even before a patch becomes available? Joe Saunders, CEO and co-founder of RunSafe Security, joins Christian Espinosa to explore a different approach to protecting the software inside medical devices and other critical infrastructure. J

    3. Episode 74

      The Future of Cardio-Oncology Wearables with Ryan Neely

      With Ryan Neely

      Cancer treatment is already difficult enough without adding more hospital visits, more testing, and more delays. Yet many cancer therapies carry a significant risk of damaging the heart, forcing patients to undergo regular cardiac screening throughout their treatment journey. What if clinicians could monitor cardiac fu

    4. Episode 62

      Edge Cases, Alarm Fatigue, and Why AI Cannot Replace Clinical Judgment with Brandon Fertig, Senior Manager at Philips Healthcare

      With Brandon Fertig

      Alarm fatigue happens when monitoring systems raise so many false flags that clinical staff begin ignoring them, even when real critical events occur.

    5. Episode 56

      What MedTech Startups Get Wrong About Cybersecurity Documentation with Marc Zemel

      With Marc Zemel

      Marc Zemel has been building Retia Medical for 15 years. The company started as two guys with slides and licensed technology.

    6. 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, and guest Jim Goodmiller explore how cybersecurity intersects with regulatory expectations and quality systems, creating new challenges and opportunities for MedTech

    7. 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?

    8. 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.

    9. 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?

    10. 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 demystify the difference between cybersecurity measures and metrics in the context of FDA guidance.

    11. 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 to break down the evolving landscape of medical device cybersecurity from a national policy perspective.

    12. 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.

    13. 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 dig into the underestimated role software documentation plays in cybersecurity, especially in the medical device space.

    14. 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 to discuss SBOMs, vulnerability prioritization, and why companies should stop fearing software transparency.

    15. 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.

    16. 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 discuss the latest FDA AI guidance and how it will impact real-world AI applications in healthcare.

    17. 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 discuss the critical importance of cybersecurity for medical devices, sharing real-life stories and insights into how device vulnerabil

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