Episodes on threat modeling for medical devices.

Episode 63

Early Design Decisions that Shape Medical Device Success with Chris Danek, CEO of Bessel

With Chris Danek

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 the product.

Episode 58

The Hidden Cybersecurity Risks When Doctors Use AI Diagnostics

In this episode of the Med Device Cyber Podcast, hosts Trevor Slattery and Christian Espinosa are joined by special guest Jun Xiang Tan, the owner of TuringLabs, who is currently working with a health-tech startup in Singapore. Jun Xiang brings a unique perspective, with a background in military cybersecurity and netwo

Episode 57

From Idea to FDA Clearance: What Nobody Tells MedTech Founders with Darcy Bachert

With Darcy Bachert

Building medical device software is hard. Building it the right way is harder. And getting it through FDA approval while managing cybersecurity requirements? That's what Darcy Bachert has been doing for 17 years.

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 40

What Happens When AI in Medical Devices Make Mistakes?

With MedTech leader

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.

Episode 30

FDA Cybersecurity Gets Real with Monica Montañez of NAMSA

With Monica Monta

In this episode of the Med Device Cyber Podcast, host Christian Espinosa and co-host Trevor Slattery are joined by Monica Montanez from NAMSA (North American Scientific Associates) to discuss the evolving landscape of medical device cybersecurity. The conversation centers on the significant changes manufacturers face f

Episode 27

Total Product Lifecycle Security: From Design to Disposal

With MedTech leader

How well does your security strategy cover the entire product lifespan - from concept to decommissioning? This episode dives into the importance of the Total Product Lifecycle (TPLC) and Secure Product Development Framework (SPDF) in medical device cybersecurity.

Episode 20

The Human Factor in MedTech Design with Dylan Horvath

With Dylan Horvath

How can human-centered design influence medical device cybersecurity? In this episode, Christian Espinosa chats with Dylan Horvath of Cortex Design about the powerful intersection of human-centered design and medical device cybersecurity.

Episode 18

Early Cyber Strategies for MedTech Trailblazers

With MedTech leader

What are some strategies founders can use to incorporate cybersecurity into the early stages of developing a MedTech product? In this episode, Christian and Trevor break down the critical role of cybersecurity in early-stage MedTech startups.

Episode 11

Advanced Threat Modeling in Medical Devices

With MedTech leader

What is threat modeling, how does it differ from penetration testing, and why are both necessary? This episode dives into the nuances of advanced threat modeling for medical devices.

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 02

Hidden Vulnerabilities in Medical Devices: Why Cybersecurity Matters

With MedTech leader

How vulnerable are current medical devices to cyberattacks, and what are the consequences of these exploits? In this episode, Christian Espinosa and Trevor Slattery discuss the critical vulnerabilities in medical devices and the cybersecurity threats they face.