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The Med Device Cyber Podcast

Blue Goat Cyber
Cybersecurity
Medical Devices
Medical Device Cybersecurity
FDA
Patient Safety
Regulatory Compliance
Threat Modeling
Software Bill Of Materials
Medical Device Security
Medical Device
Cybersecurity Risk Management
Artificial Intelligence
Penetration Testing
FDA Regulations
Risk Assessment
Quality Assurance
Cybersecurity Testing
Risk Management
FDA Cybersecurity Standards
Medical Device Regulation

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

PublishesWeeklyEpisodes80Founded2 years ago
Number of ListenersCategories
MedicineScienceLife SciencesHealth & Fitness

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Artwork for The Med Device Cyber Podcast

Latest Episodes

Product decisions made during early development determine commercialization outcomes years later. Wrong choices about regulatory pathways, feature sets, and market segments create compounding problems limiting commercial success.

Christian Espinosa ... more

Vibe coding enables rapid development through AI-generated code but introduces security risks when developers accept outputs without verification. Malicious actors can inject vulnerabilities through manipulated training data or prompt engineering. Su... more

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Early planning prevents expensive corrections when startups address clinical strategy, regulatory pathways, and cybersecurity requirements from day one rather than improvising solutions before launch. FDA pre-submission meetings provide feedback that... more

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

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Recent Guests

Rob Bedford
CEO of a boutique CRO focused on small MedTech startups
Franklyn Health
Episode: Why Clinical Trials Are the Most Expensive Capital Outlay for Startups with Rob Bedford, CEO of Franklyn Health
Dr. Basant Bajpai
CEO of ComplianceMedQRA, regulatory consulting expert in MedTech
ComplianceMedQRA
Episode: Traceability Requirements and Documentation Audit Trails with Dr. Basant Bajpai, CEO of Compliance MedQRA
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

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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Which podcasts are similar to The Med Device Cyber Podcast?

These podcasts share a similar audience with The Med Device Cyber Podcast:

1. The Daily

How many episodes of The Med Device Cyber Podcast are there?

The Med Device Cyber Podcast launched 2 years ago and published 80 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. Rob Bedford
2. Dr. Basant Bajpai
3. Chris Danek
4. Brandon Fertig
5. Aamer Ahmed
6. Claudia Podemos
7. Stephen Smith
8. Jun Xiang Tan

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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