The Med Device Cyber Podcast
Episodes
Early Design Decisions that Shape Medical Device Success with Chris Danek, CEO of Bessel
26 Mar 2026
Contributed by Lukas
Early design decisions define the trajectory of a medical device long before commercializa...
Edge Cases, Alarm Fatigue, and Why AI Cannot Replace Clinical Judgment with Brandon Fertig, Senior Manager at Philips Healthcare
19 Mar 2026
Contributed by Lukas
Alarm fatigue happens when monitoring systems raise so many false flags that clinical staff begin ignoring them, even when real critical events occur....
Alarm Fatigue, Workflow Integration, and the Intelligent Operating Room (Professor Aamer Ahmed)
12 Mar 2026
Contributed by Lukas
Devices that do not integrate into the clinical workflow sit unused regardless of technical sophistication. Physicians work in high-pressure environme...
How to Move Stakeholders from Awareness to Sustained Adoption Without Friction
05 Mar 2026
Contributed by Lukas
Marketing medical devices requires understanding that stakeholders are different, buying processes are longer, and friction points are more complex th...
Prevention Is Better Than Cure: Applying Medical Principles to Medtech Cybersecurity
26 Feb 2026
Contributed by Lukas
Medical device risk assessments are failing patients, not because the process is too hard, but because nobody doing the assessment has ever been in th...
How AI Code Security Became a Medical Device Problem with Jun Xiang Tan
19 Feb 2026
Contributed by Lukas
Ten years ago, Singapore's healthcare system got hacked. Patient records were stolen at a national scale. The government responded by building one of ...
How to Build an SBOM That Passes FDA Review
18 Feb 2026
Contributed by Lukas
SBOMs are one of the most common sources of FDA deficiencies in medical device submissions. Most companies think they're doing it right, but then they...
From Idea to FDA Clearance: What Nobody Tells Medtech Founders with Darcy Bachert
12 Feb 2026
Contributed by Lukas
Building medical device software is hard. Building it the right way is harder. And getting it through FDA approval while managing cybersecurity requir...
What MedTech Startups Get Wrong About Cybersecurity Documentation
05 Feb 2026
Contributed by Lukas
Marc Zemel has been building Retia Medical for 15 years. The company started as two guys with slides and licensed technology. Now their data-driven he...
Why Most Medtech Companies Fail at Global Expansion (And How to Fix It)
30 Jan 2026
Contributed by Lukas
Thinking about taking your medical device to China? Or maybe you're a Chinese company looking at the American market?William Jin has spent over 30 yea...
Why Most Medtech Companies Fail at Global Expansion (And How to Fix It)
27 Jan 2026
Contributed by Lukas
Thinking about taking your medical device to China? Or maybe you're a Chinese company looking at the US market?William Jin has spent over 30 years hel...
Why Most Medtech Companies Fail at Global Expansion (And How to Fix It)
21 Jan 2026
Contributed by Lukas
Thinking about taking your medical device to China? Or maybe you're a Chinese company looking at the US market?William Jin has spent over 30 years hel...
What It Takes to Succeed in the Medtech Industry
14 Jan 2026
Contributed by Lukas
Ever thought about what it really takes to launch a successful medtech startup?Omar M. Khateeb knows the challenges firsthand. As a founder with a tra...
Untangling Software Composition Analysis for MedTech Teams
06 Jan 2026
Contributed by Lukas
Why does software composition analysis matter beyond regulatory compliance?This episode explores SCA (Software Composition Analysis) and explains how ...
When Medical Device Cyber Failures Become Fatal
30 Dec 2025
Contributed by Lukas
What past ransomware and medical device incidents might reveal gaps that manufacturers are still overlooking today?In this episode, Christian and Trev...
Trevor Slattery Answers Tough Medical Device Cyber Questions
23 Dec 2025
Contributed by Lukas
This episode puts Trevor in the hot seat. If you were put in the hot seat, could you clearly explain cybersecurity, safety, and lifecycle terms like T...
The Differences Between Black, Grey, and White Penetration Testing
16 Dec 2025
Contributed by Lukas
MedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?In this episode, Christi...
How Cybersecurity Shapes Regulatory and Quality Success with Jim Goodmiller
09 Dec 2025
Contributed by Lukas
What risks do you take when cybersecurity is left off your development roadmap?In this episode, Christian, Trevor and guest Jim Goodmiller explore how...
Webinar: Why FDA Cybersecurity Submissions Fail and How to Get Yours Approved
04 Dec 2025
Contributed by Lukas
Medtech innovators and medical device manufacturers, how can you prevent cybersecurity deficiencies from delaying your FDA submission?In this webinar,...
Cybersecurity Qs MedTech Innovators Ask: Christian’s Hot Seat
02 Dec 2025
Contributed by Lukas
MedTech manufacturers, how can you avoid the cybersecurity pitfalls that most often lead to FDA rejection?In this episode, Trevor puts Christian “in...
What Is Required for an FDA Pre-Market Cyber Submission?
25 Nov 2025
Contributed by Lukas
What are the 18 required cybersecurity deliverables for a pre-market submission, and how do they map to eSTAR’s 13 sections? This episode break...
Webinar: Postmarket Cybersecurity Management
20 Nov 2025
Contributed by Lukas
MedTech manufacturers, how prepared are you to monitor vulnerabilities continuously once your medical device reaches the market? Also, would you like ...
How Market Intelligence Shapes MedTech Growth with Kevin Saem
18 Nov 2025
Contributed by Lukas
In the MedTech space, how can you leverage market intelligence and machine learning for business development and sales enablement? In this episod...
Designing Secure Medical Device Software with Randy Horton
11 Nov 2025
Contributed by Lukas
In medical device software development, why should cybersecurity be viewed as an element of product quality, not an add-on?In this episode, Christian ...
Cyber Risk Management for MedTech Legacy Devices
04 Nov 2025
Contributed by Lukas
What options do MedTech manufacturers have to bring older devices up to modern cybersecurity standards? Also, how does the FDA’s latest guidance cha...
Webinar: Security Architecture Views: Protecting Medical Devices Through Strategic Design
30 Oct 2025
Contributed by Lukas
How can security architecture views strengthen a medical device manufacturer’s FDA submissions?This episode/webinar dives into the four critical sec...
Why AI Literacy Matters for the Future of Healthcare with José Acosta
28 Oct 2025
Contributed by Lukas
How can AI literacy reduce patient risk in healthcare settings? In this episode, Christian Espinosa and Trevor Slattery are joined by Dr. José A...
What Is A Medical Device?
21 Oct 2025
Contributed by Lukas
MedTech developers and manufacturers, could your medical device unknowingly qualify as a “cyber device”?In this episode, Christian and Trevor brea...
5 Most Common Misconceptions of Medical Device Security
14 Oct 2025
Contributed by Lukas
In this episode, Christian and Trevor unpack the five most common misconceptions that put medical device manufacturers at risk. From confusing data pr...
What Happens When AI in Medical Devices Make Mistakes?
07 Oct 2025
Contributed by Lukas
MedTech manufacturers and developers, what happens if your AI-powered medical device makes a terrible, life-threatening mistake?This episode explores ...
Medical Device Startups and Cybersecurity Challenges with Suzy Engwall
30 Sep 2025
Contributed by Lukas
What are some of the greatest challenges medical device startups face when bringing their products to market?This episode features Suzy Engwall, a hea...
Top 10 Medical Device Vulnerabilities with Myles Kellerman
23 Sep 2025
Contributed by Lukas
How safe are the medical devices I rely on, and what are the biggest cybersecurity risks I should know about?In this episode, the team goes behind the...
Overcoming AI and Data Security Challenges in MedTech with May Lee
16 Sep 2025
Contributed by Lukas
How can you prepare your device for future quantum computing risks?In this episode of The Med Device Cyber Podcast, Christian and Trevor talk with May...
When Cybersecurity Becomes a Crime
09 Sep 2025
Contributed by Lukas
What happens when cybersecurity flaws in medical devices cross the line into criminal violations?In this episode, Christian and Trevor unpack the grou...
Balancing Innovation and Regulation in MedTech Development with Karandeep Singh Badwal
02 Sep 2025
Contributed by Lukas
How can medtech innovators balance speed with compliance in medical devices?In this episode, Christian and Trevor sit down with Karandeep Singh Badwal...
Webinar: Hacking Med Devices—What Penetration Testing Reveals Before the FDA Does
28 Aug 2025
Contributed by Lukas
Cyber threats targeting medical devices are increasingly sophisticated. A single undiscovered vulnerability could delay your FDA submission and put pa...
Integrating Project Management to Strengthen Cybersecurity Outcomes with Steve Curry
26 Aug 2025
Contributed by Lukas
What project management mistakes can med tech innovators avoid? What methods and tools can help med tech companies manage projects?In this episode, Ch...
Webinar: Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals
21 Aug 2025
Contributed by Lukas
When you’re working with a manufacturer to ensure that a medical device has strong cybersecurity, what do you need to know from a regulatory perspec...
Vulnerability, Penetration & Other Cybersecurity Testing Types Explained
19 Aug 2025
Contributed by Lukas
Which cybersecurity tests are the most crucial, and which ones does the FDA require for medical device approval?In this episode, Christian and Trevor ...
Webinar: Medical Device Penetration Testing: What Every Manufacturer Must Know
14 Aug 2025
Contributed by Lukas
What are the unique challenges and regulatory requirements of medical device penetration testing? In this webinar episode with Christian Espinosa...
From Surgery to MedTech Startups: Dr. Dylan Attard’s Journey
12 Aug 2025
Contributed by Lukas
What cybersecurity challenges face hospitals and medical devices today that medtech innovators should know about?Today’s guest is Dr. Dylan Attard, ...
Webinar: Medical Device Risk Assessments - Cybersecurity, Compliance & Patient Safety
07 Aug 2025
Contributed by Lukas
Medical devices are becoming more connected, but with that connectivity comes risk.In this episode, Christian and Trevor dive into risk assessments fo...
Understanding Cybersecurity Measures and Metrics for Medical Devices
05 Aug 2025
Contributed by Lukas
How do measures and metrics differ, and why is this distinction crucial for FDA submissions?In this episode, Christian and Trevor demystify the differ...
Webinar: Mastering Threat Modeling for Medical Device Cybersecurity
31 Jul 2025
Contributed by Lukas
Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, Director of Medical Device Cybersecurity, explore the critical topic of threat modeli...
FDA Cybersecurity Gets Real with Monica Montañez of NAMSA
29 Jul 2025
Contributed by Lukas
How have medical device cybersecurity requirements changed since 2023, and what does this mean for your product development?In this episode, Christian...
Webinar: Risk Management Frameworks For Medical Device Safety & Security
24 Jul 2025
Contributed by Lukas
Join Trevor Slattery, Director of Cybersecurity, and Christian Espinosa, CEO of Blue Goat Cyber, for a comprehensive webinar on medical device cyberse...
What the FDA Wants in Security Architecture Views for Devices
22 Jul 2025
Contributed by Lukas
What are the four security architecture views that the FDA prioritizes, and how do they impact your device's design?This episode explores the FDA-defi...
Webinar: 5 Key FDA Cybersecurity Standards with Jordan John
17 Jul 2025
Contributed by Lukas
How can you integrate relevant cybersecurity standards early in your medical device development process? Also, how do FDA cybersecurity standards help...
Shared Responsibility in Medical Device Cybersecurity with Greg Garcia
15 Jul 2025
Contributed by Lukas
How can shared responsibility models improve healthcare cybersecurity?In this episode, Greg Garcia joins Christian and Trevor to break down the evolvi...
Total Product Lifecycle Security: From Design to Disposal
08 Jul 2025
Contributed by Lukas
How well does your security strategy cover the entire product lifespan—from concept to decommissioning?This episode dives into the importance of the...
Why Cybersecurity and Quality Are One and the Same
01 Jul 2025
Contributed by Lukas
How can medical device startups avoid missteps in cybersecurity, quality, and compliance? In this episode, Trevor Slattery speaks with Ashkon Ras...
Cybersecurity Labeling and MedTech Transparency
24 Jun 2025
Contributed by Lukas
Why is cybersecurity labeling more than just a compliance checkbox for medical device companies?In this episode, Christian and Trevor dive into the nu...
From Concept to Compliance: A Guide to Med Device Approval
17 Jun 2025
Contributed by Lukas
Med device manufacturers, are you setting up your quality system early enough in product development? Also, are you misunderstanding the FDA’s "guid...
Unpacking Post-Market Management and Incident Response for Medical Devices
10 Jun 2025
Contributed by Lukas
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 ...
AI in Medical Devices: Opportunities & Regulation with Matt Lemay
03 Jun 2025
Contributed by Lukas
What does responsible AI implementation look like in medical devices?This episode explores the intersection of AI, cybersecurity, and medical device r...
Essential Software Documentation for Med Device Manufacturers
27 May 2025
Contributed by Lukas
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 un...
The Human Factor in MedTech Design with Dylan Horvath
20 May 2025
Contributed by Lukas
How can human-centered design influence medical device cybersecurity?In this episode, Christian Espinosa chats with Dylan Horvath of Cortex Design abo...
Master Medical Device Cybersecurity: Avoid FDA Delays | Blue Goat Cyber Webinar
13 May 2025
Contributed by Lukas
How can medical device manufacturers meet FDA cybersecurity requirements the first time around?What are the most significant challenges medical device...
Data Protection in Medical Devices: A Deep Dive with Kevin Derr
06 May 2025
Contributed by Lukas
How can medical device companies own their data without compromising security?In this episode, Kevin Derr from NeuronSphere joins Christian and Trevor...
Early Cyber Strategies for MedTech Trailblazers
29 Apr 2025
Contributed by Lukas
What are some strategies founders can use to incorporate cybersecurity into the early stages of developing a medtech product? In this episode, Ch...
Cybersecurity Challenges & Trends in US Healthcare with Paul-Lukas Hoffschmidt
22 Apr 2025
Contributed by Lukas
If you’re launching a medtech product, what should you know about market access, cybersecurity, reimbursement challenges, and customer education?&nb...
Collaboration is Key: Bridging the Gap Between Developers and Cybersecurity Experts
15 Apr 2025
Contributed by Lukas
What are some of the biggest barriers to effective collaboration between coders and cyber experts, and how can they be overcome?This episode explores ...
Commercialize Your Medtech with Craig T Ingram
08 Apr 2025
Contributed by Lukas
What are the 10 essential components of a successful commercialization plan in the medtech industry, and why are they often overlooked?This episode ex...
The Growing Importance of Interoperability and Third-Party Component Security
25 Mar 2025
Contributed by Lukas
Why is interoperability increasing cybersecurity risks in healthcare, and what can we do about it?Interoperability is making healthcare more efficient...
SBOMs Unpacked: Myths, Risks, & Benefits with Cortez Frazier Jr.
18 Mar 2025
Contributed by Lukas
Why are Software Bill of Materials (SBOMs) critical for medical device security?In this episode, Cortez Frazier Jr. joins Christian and Trevor to disc...
Postmarket Surveillance and Anomaly Detection for Medical Devices
04 Mar 2025
Contributed by Lukas
What are some of the biggest cybersecurity risks medical devices face after they hit the market?This episode dives into the challenges of postmarket s...
Advanced Threat Modeling in Medical Devices
18 Feb 2025
Contributed by Lukas
What is threat modeling, how does it differ from penetration testing, and why are both necessary? This episode dives into the nuances of advanced...
How Trump & RFK Jr Affect AI Med Device Guidelines
04 Feb 2025
Contributed by Lukas
How might the second Donald Trump administration and Robert F. Kennedy Jr. impact the medtech cybersecurity world? In this episode, Christian and...
FDA AI Guidance Explained: What It Means for Medical Device Cybersecurity
30 Jan 2025
Contributed by Lukas
How does the FDA’s latest AI guidance on medical devices impact manufacturers and cybersecurity challenges in healthcare?In this episode, Christian ...
The Human Factor: Why Cybersecurity Awareness is Key in Medical Device Manufacturing
21 Jan 2025
Contributed by Lukas
How does human behavior impact medical device cybersecurity? Also, why do cybersecurity awareness programs often fail to make a lasting impact?This ep...
Startups, Regulations, & Risk: Insights from MedTech Guru Etienne Nichols
07 Jan 2025
Contributed by Lukas
What are some of the key challenges MedTech companies face in balancing innovation with compliance?This episode dives into the intersection of quality...
The Evolution of Medical Device Cyber Threats: Past, Present, and Future
24 Dec 2024
Contributed by Lukas
How do medical device vulnerabilities pose life-threatening risks?In this episode, Christian and Trevor again explore the fascinating and critical wor...
Avoid the Dumb Tax: Cybersecurity Lessons for MedTech Startups with Steve Bell
10 Dec 2024
Contributed by Lukas
What are the most common mistakes medtech startups make in cybersecurity, and how can founders avoid them?In this episode, Christian Espinosa and Trev...
Building Resilient Medical Devices: A Look at the Essential Technologies and Infrastructure
26 Nov 2024
Contributed by Lukas
How can some of the biggest cybersecurity concerns with medical devices be addressed in the design phase? In this episode, Christian and Trevor h...
Navigating the Regulatory Landscape of Medical Device Cybersecurity
12 Nov 2024
Contributed by Lukas
What are the main categories of medical devices, and how do regulatory bodies govern them? In this episode, Christian Espinosa and Trevor Slatter...
Hidden Vulnerabilities in Medical Devices: Why Cybersecurity Matters
29 Oct 2024
Contributed by Lukas
How vulnerable are current medical devices to cyberattacks, and what are the consequences of these exploits?In this episode, Christian Espinosa and Tr...
Cybersecurity for Medical Devices: Protecting Human Lives
15 Oct 2024
Contributed by Lukas
How do medical device cybersecurity risks differ from traditional cybersecurity threats?In this episode, Christian Espinosa and Trevor Slattery discus...
Trailer - The Med Device Cyber Podcast
01 Oct 2024
Contributed by Lukas
You rely on a medical device to stay healthy, but what if that device could be hacked? What if someone, miles away, could manipulate it, putting your ...