Episodes on medical device penetration testing.

Episode 20

The Dangerous Gap in Global MedTech Security Awareness with Shahbaz Ahmed

With Shahbaz Ahmed

In this episode of the Med Device Cyber Podcast, hosts Christian Espinosa (CEO of Blue Goat Cyber) and Trevor Slattery (COO) are joined by Shahbaz Ahmed, an expert calling in from Pakistan and the founder of Leadership Studio. The conversation explores the nuanced differences between Eastern and Western leadership styl

Episode 70

Why MedTech Needs Specialists with Zoltan Kevei and Saby Toth of Bishop & Co

With Zoltan Kevei

In this episode of the Med Device Cyber Podcast, host Christian Espinosa is joined by Zoltan Kevei, Founder and CEO, and Szabolcs Tóth, a Regulatory and Quality Expert, from Bishop & Co., a Hungarian software and regulatory consultancy specializing in the MedTech industry. The discussion revolves around the complex and

Episode 69

Science Before Hype in MedTech Investing with Varun Turlapati of Chaanakya Capital

With Varun Turlapati

In this episode of the MedDevice Cyber podcast, host Christian Espinosa welcomes Varun Turlapati, Managing Director of Chaanakya Capital, an early-stage venture capital firm specializing in Neurotech and MedTech. Varun, whose background is in software engineering, explains that his firm focuses on pre-seed to Series A

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 65

Who Owns Patient Data Security in Trials with Rob Bedford, CEO of Franklyn Health

With Rob Bedford

This episode of the MedDevice Cyber podcast, hosted by Christian Espinosa and Trevor Slattery of Blue Goat Cyber, features a detailed discussion with Rob Bedford, the co-founder and CEO of Franklyn Health, a Contract Research Organization (CRO) specializing in serving the medical technology (MedTech) sector. Rob Bedfor

Episode 66

Vibe Coding Security Risks & Malicious Injection with Jake Rodriguez of Triangle Tech

With Jake Rodriguez

In this episode of the Med Device Cyber Podcast, hosts Trevor Slattery and Christian Espinosa are joined by special guest Jake Rodriguez, CEO and Founder of Triangle Tech. Jake shares his unconventional journey from a pre-pharmacy track at Virginia Commonwealth University to becoming a B2B marketing entrepreneur specia

Episode 67

De-Risking Product Decisions in MedTech Startups with Brent Lavin of Ironwood MedTech Partners

With Brent Lavin

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.

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 62

AI in Healthcare: Why Humans Still Matter with Brandon Fertig, Senior Manager at Philips

With Brandon Fertig

In this episode of the MedDevice Cyber Podcast, hosts Trevor Slattery and Christian Espinosa are joined by Brandon Fertig, Senior Manager at Philips, to discuss the intersection of military experience, healthcare cybersecurity, and the evolving role of artificial intelligence. Brandon shares his unique career trajector

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 60

How to Move Stakeholders from Awareness to Sustained Adoption Without Friction

With MedTech leader

Marketing medical devices requires understanding that stakeholders are different, buying processes are longer, and friction points are more complex than consumer products or software.

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 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 59

Prevention Is Better Than Cure: Applying Medical Principles to MedTech Cybersecurity

With MedTech leader

Medical device risk assessments are failing patients, not because the process is too hard, but because nobody doing the assessment has ever been in the room where the device actually gets used.

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 54

Why MedTech is the Future of Entrepreneurship with Omar Khateeb

With Omar Khateeb

In this episode of the Med Device Cyber podcast, hosts Christian Espinosa and Trevor Slattery are joined by Omar M. Khateeb, host of the State of MedTech podcast. With a background that spans medical school, surgical robotics, and marketing, and having produced over 300 podcast episodes interviewing key figures in the

Episode 55

The Hidden Reason Medtech Products Get Recalled (It's Not Quality Issues) with William Jin

With William Jin

In this episode of the Med Device Cyber Podcast, hosts Trevor Slattery and Christian Espinosa are joined by special guest William Jin, a seasoned expert with over 30 years of experience in the medical technology industry. With a background as a medical doctor in Shanghai and extensive work with major companies like Med

Episode 53

Untangling Software Composition Analysis for MedTech Teams

With MedTech leader

Why does software composition analysis matter beyond regulatory compliance? This episode explores SCA (Software Composition Analysis) and explains how SBOMs (Software Bill of Materials), SOUP (Software of Unknown Provenance), and related tooling fit into the broader medical devic

Episode 50

The Differences Between Black, Gray, and White Penetration Testing

In this episode of the Med Device Cyber Podcast, hosts Christian Espinosa and Trevor Slattery from Blue Goat Cyber delve into the critical topic of penetration testing for medical devices. The discussion centers on clarifying the distinctions between the three primary methodologies: black box, gray box, and white box t

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 46

How Market Intelligence Shapes MedTech Growth with Kevin Saem

With Kevin Saem

In the MedTech space, how can you leverage market intelligence and machine learning for business development and sales enablement? In this episode, Christian and Trevor talk with Kevin Saem about how market intelligence and cybersecurity intersect in the MedTech space.

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 42

What Is A Medical Cyber Device?

In this episode of the Med Device Cyber Podcast, hosts Christian Espinosa and Trevor Slattery from Blue Goat Cyber tackle a common and critical question in the medical technology industry: What constitutes a 'cyber device'? They address the widespread confusion among manufacturers who often mistakenly believe their pro

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 36

When Medical Device Cybersecurity Becomes a Crime

This episode of The Med Device Cyber Podcast discusses a significant shift in the consequences of cybersecurity flaws in medical devices, moving beyond simple data breaches to legal prosecution. The hosts, Christian Espinosa and Trevor Slattery, center their conversation on a recent enforcement action by the U.S. Depar

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 35

Balancing Innovation and Regulation in MedTech Development with Karandeep Singh Badwal

With Karandeep Singh Badwal

How can MedTech innovators balance speed with compliance in medical devices? In this episode, Christian and Trevor sit down with Karandeep Singh Badwal about the challenges of balancing innovation with quality and regulatory compliance in medical devices, especially with the rise

Episode 34

Integrating Project Management to Strengthen Cybersecurity Outcomes with Steve Curry

With Steve Curry

What project management mistakes can med tech innovators avoid? What methods and tools can help med tech companies manage projects?

Episode 33

Vulnerability, Penetration & Other Cybersecurity Testing Types Explained

With MedTech leader

Which cybersecurity tests are the most crucial, and which ones does the FDA require for medical device approval? In this episode, Christian and Trevor break down the many types of cybersecurity testing required for medical devices.

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 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 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 22

AI in Medical Devices: Opportunities & Regulation with Matt Lemay

With Matt Lemay

What does responsible AI implementation look like in medical devices? This episode explores the intersection of AI, cybersecurity, and medical device regulation with guest Matt Lemay, CEO of Lemay.ai.

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 17

Cybersecurity Challenges & Trends in US MedTech with Paul-Lukas Hoffschmidt

With Paul-Lukas Hoffschmidt

In this episode of The Med Device Cyber Podcast, host Christian Espinosa and co-host Trevor Slattery are joined by Paul-Lukas Hoffschmidt of Alpha Sophia. Paul's company provides a commercial intelligence platform designed to help medical device, digital health, and life sciences companies successfully launch their pro

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 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 16

Collaboration is Key: Bridging the Gap Between Developers and Cybersecurity Experts

With MedTech leader

What are some of the biggest barriers to effective collaboration between coders and cyber experts, and how can they be overcome? This episode explores the essential components of successful collaboration and teamwork.

Episode 14

The Growing Importance of Interoperability and Third-Party Component Security

With MedTech leader

Why is interoperability increasing cybersecurity risks in healthcare, and what can we do about it? Interoperability is making healthcare more efficient but also more vulnerable to cyber threats.

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 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 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 08

The Human Factor: Why Cybersecurity Awareness is Key in Medical Device Manufacturing

With MedTech leader

How does human behavior impact medical device cybersecurity? Also, why do cybersecurity awareness programs often fail to make a lasting impact? This episode dives into the human factor in medical device cybersecurity.

Episode 06

The Evolution of Medical Device Cyber Threats: Past, Present, and Future

With MedTech leader

How do medical device vulnerabilities pose life-threatening risks? In this episode, Christian and Trevor again explore the fascinating and critical world of medical device cybersecurity.

Episode 05

Avoid the Dumb Tax: Cybersecurity Lessons for MedTech Startups with Steve Bell

With Steve Bell

What are the most common mistakes MedTech startups make in cybersecurity, and how can founders avoid them? In this episode, Christian Espinosa and Trevor Slattery dive into the challenges MedTech startups face with their guest, Steve Bell, a 35-year veteran of the 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.