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The Med Device Cyber Podcast

Blue Goat Cyber
Cybersecurity
Medical Devices
Medical Device Cybersecurity
Software Bill Of Materials
FDA
Vulnerabilities
Artificial Intelligence
Fossa
Post-Market Management
Third-Party Components
Cybersecurity Regulations
FDA Guidance
Interoperability
U.S. Healthcare Market
User Experience
Penetration Testing
Medical Device Design
Robert F. Kennedy Jr.
Trump Administration
Threat Modeling

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 vulnera... more

PublishesWeeklyEpisodes77Foundeda year ago
Number of ListenersCategories
Health & FitnessLife SciencesScienceMedicine

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Artwork for The Med Device Cyber Podcast

Latest Episodes

Quality management system implementation delays create cascading failures across medical device development timelines. Startups using SharePoint or Google Drive for documentation discover at audit time that these tools provide no traceability, no ver... more

Early design decisions define the trajectory of a medical device long before commercialization begins. Choices related to software architecture, third-party components, and system connectivity establish both the opportunity and the risk profile of th... more

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Alarm fatigue happens when monitoring systems raise so many false flags that clinical staff begin ignoring them, even when real critical events occur. A surgeon during an operation gets alarms indicating patient bleeding, but observes stable blood pr... more

Devices that do not integrate into the clinical workflow sit unused regardless of technical sophistication. Physicians work in high-pressure environments where equipment must be 100 percent reliable, secure, and enhance workflow rather than disrupt i... more

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Recent Guests

Chris Danek
CEO of Bessel
Bessel
Episode: Early Design Decisions that Shape Medical Device Success with Chris Danek, CEO of Bessel
Brandon Fertig
Senior Manager at Philips Healthcare
Philips
Episode: Edge Cases, Alarm Fatigue, and Why AI Cannot Replace Clinical Judgment with Brandon Fertig, Senior Manager at Philips Healthcare
Aamer Ahmed
Key Opinion Leader; Co-founder of Hemeo; Professor of Cardiac Anesthesiology and Critical Care
Hemeo
Episode: Alarm Fatigue, Workflow Integration, and the Intelligent Operating Room (Professor Aamer Ahmed)
Claudia Podemos
Founder and CEO of Podemos, a dedicated medical device marketing agency
Podemos
Episode: How to Move Stakeholders from Awareness to Sustained Adoption Without Friction
Stephen Smith
A Medtech professional with 27 years of experience since 1999, focusing on quality assurance and regulatory compliance.
Episode: Prevention Is Better Than Cure: Applying Medical Principles to Medtech Cybersecurity
Jun Xiang Tan
Expert in AI and cybersecurity, currently with CareHero
CareHero
Episode: How AI Code Security Became a Medical Device Problem with Jun Xiang Tan
Darcy Bachert
Founder, CEO of Prolucid
Prolucid
Episode: From Idea to FDA Clearance: What Nobody Tells Medtech Founders with Darcy Bachert
Marc Zemel
Co-founder and CEO of Reti Medical, trained mechanical engineer with a master's degree from MIT and an MBA from Yale, known for developing cardiovascular monitoring algorithms.
Reti Medical
Episode: What MedTech Startups Get Wrong About Cybersecurity Documentation with Marc Zemel
William Jin
A medical doctor with over 30 years in the MedTech industry, focused on assisting companies expand into the Chinese market and supporting Chinese companies going abroad.
Episode: Why Most Medtech Companies Fail at Global Expansion (And How to Fix It)

Hosts

Christian Espinosa
Co-host and founder/CEO, Blue Goat Cyber; frequent speaker on medical device cybersecurity and regulatory considerations
Trevor Slattery
Co-host; Director of Medical Device Cybersecurity; leads industry conversations on security lifecycle and regulatory alignment

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Talking Points

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Early Design Decisions that Shape Medical Device Success with Chris Danek, CEO of Bessel
Q: What do you do with companies, and how do you work with them to embed cybersecurity from the start?
We engage early with clients in design reviews and threat modeling, integrating cybersecurity requirements into architecture and development to streamline FDA submissions and accelerate time-to-market, while reducing risk and cost.
Alarm Fatigue, Workflow Integration, and the Intelligent Operating Room (Professor Aamer Ahmed)
Q: How can digital twins and AI affect patient safety and decision making in the OR?
Digital twins and AI can personalize treatment and provide predictive insights, but they require highly accurate, secure data to avoid wrong interventions; clinicians must maintain ultimate accountability while relying on robust datasets and regulatory oversight.
Alarm Fatigue, Workflow Integration, and the Intelligent Operating Room (Professor Aamer Ahmed)
Q: What is a KOL, and how does this knowledge influence MedTech development?
A KOL is a recognized expert whose evidence-based guidance shapes best practices; their involvement helps ensure devices address real clinical needs and that guidelines are put into practice, improving adoption and patient outcomes.
Why Most Medtech Companies Fail at Global Expansion (And How to Fix It) with William Jin
Q: How do cybersecurity requirements differ between China and the FDA, and what should companies do about it?
China's requirements are more stringent in terms of localization and specific cyber-law compliance, often requiring two separate product configurations for China versus other markets; companies should design with the Chinese environment in mind from the start, anticipate different encryption rules, and consider alternate cloud and data storage strategies to avoid costly rework.
Why Most Medtech Companies Fail at Global Expansion (And How to Fix It) with William Jin
Q: What are the main challenges for US-based medtech companies entering China?
Key challenges include understanding local market dynamics, longer registration timelines, data localization and cross-border data transfer restrictions, local manufacturing requirements, and adapting cloud/data architectures to comply with Chinese cyber regulations.

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Frequently Asked Questions About The Med Device Cyber Podcast

What is The Med Device Cyber Podcast about and what kind of topics does it cover?

This program focuses on medical device cybersecurity, regulatory compliance, and the broader intersection of healthcare technology with security. Episodes routinely drill into practical design decisions, lifecycle security, and how regulatory expectations shape development and deployment of medical devices. Guests typically bring deep domain expertise—from device engineering and software safety to regulatory strategy, market expansion, and cybersecurity operations—offering actionable guidance for practitioners, executives, and teams building and enabling secure medical technology. One standout characteristic is the emphasis on patient safety as a driver of security decisions, with conversations often grounded in real-world incidents, regula... more

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1. Software Engineering Institute (SEI) Podcast Series

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The Med Device Cyber Podcast launched a year ago and published 77 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on The Med Device Cyber Podcast?

Recent guests on The Med Device Cyber Podcast include:

1. Chris Danek
2. Brandon Fertig
3. Aamer Ahmed
4. Claudia Podemos
5. Stephen Smith
6. Jun Xiang Tan
7. Darcy Bachert
8. Marc Zemel

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