Reinventing Cybersecurity - candid conversations on connected security.

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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 66

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

With Jake Rodriguez

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.

Episode 65

Why Clinical Trials Are the Most Expensive Capital Outlay for Startups with Rob Bedford, CEO of Franklyn Health

With Rob Bedford

Early planning prevents expensive corrections when startups address clinical strategy, regulatory pathways, and cybersecurity requirements from day one rather than improvising solutions before launch.

Episode 64

Traceability Requirements and Documentation Audit Trails with Dr. Basant Bajpai, CEO of Compliance MedQRA

With Dr. Basant Bajpai

Quality management system implementation delays create cascading failures across medical device development timelines.

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 62

Edge Cases, Alarm Fatigue, and Why AI Cannot Replace Clinical Judgment with Brandon Fertig, Senior Manager at Philips Healthcare

With Brandon Fertig

Alarm fatigue happens when monitoring systems raise so many false flags that clinical staff begin ignoring them, even when real critical events occur.

Episode 61

Alarm Fatigue, Workflow Integration, and the Intelligent Operating Room (Professor Aamer Ahmed)

With MedTech leader

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 it.

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 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 58

How AI Code Security Became a Medical Device Problem with Jun Xiang Tan

With Jun Xiang Tan

Ten years ago, Singapore's healthcare system got hacked. Patient records were stolen at a national scale. The government responded by building one of the most comprehensive medical device security frameworks in the world. The Cybersecurity Labeling Scheme has four tiers.

Episode 00

How to Build an SBOM That Passes FDA Review

With MedTech leader

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 get feedback asking for missing components or clarification on what's included.

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 56

What MedTech Startups Get Wrong About Cybersecurity Documentation with Marc Zemel

With Marc Zemel

Marc Zemel has been building Retia Medical for 15 years. The company started as two guys with slides and licensed technology.

Episode 55

Why Most MedTech Companies Fail at Global Expansion (And How to Fix It) with William Jin

With William Jin

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 years helping companies do exactly that, and he'll tell you straight up that most of them aren't ready.

Episode 54

What It Takes to Succeed in the MedTech Industry with Omar Khateeb

With Omar Khateeb

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 track record of building healthtech companies, he’s lived through the hurdles that come with innovating in the MedTech space.

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 52

When Medical Device Cyber Failures Become Fatal

With MedTech leader

What past ransomware and medical device incidents might reveal gaps that manufacturers are still overlooking today?

Episode 51

Trevor Slattery Answers Tough Medical Device Cyber Questions

With MedTech leader

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 Trevor?

Episode 50

The Differences Between Black, Grey, and White Penetration Testing

With MedTech leader

MedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?

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 00

Webinar: Why FDA Cybersecurity Submissions Fail and How to Get Yours Approved

With MedTech leader

MedTech innovators and medical device manufacturers, how can you prevent cybersecurity deficiencies from delaying your FDA submission?

Episode 48

Cybersecurity Qs MedTech Innovators Ask: Christian’s Hot Seat

With MedTech leader

MedTech manufacturers, how can you avoid the cybersecurity pitfalls that most often lead to FDA rejection? In this episode, Trevor puts Christian “in the hot seat” to tackle the most common - and sometimes misunderstood - cybersecurity questions MedTech innovators ask.

Episode 47

What Is Required for an FDA Pre-Market Cyber Submission?

With MedTech leader

What are the 18 required cybersecurity deliverables for a pre-market submission, and how do they map to eSTAR’s 13 sections?

Episode 00

Webinar: Postmarket Cybersecurity Management

With MedTech leader

MedTech manufacturers, how prepared are you to monitor vulnerabilities continuously once your medical device reaches the market? Also, would you like a free checklist for your Cybersecurity Management Plan?

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 45

Designing Secure Medical Device Software with Randy Horton

With Randy Horton

In medical device software development, why should cybersecurity be viewed as an element of product quality, not an add-on? In this episode, Christian and Trevor speak with Randy Horton of Orthogonal about the future of medical device software development.

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 00

Webinar: Security Architecture Views: Protecting Medical Devices Through Strategic Design

With MedTech leader

How can security architecture views strengthen a medical device manufacturer’s FDA submissions? This episode/webinar dives into the four critical security architecture views required by the FDA: global system, multi-patient harm, updatability and patchability, and secure use case

Episode 43

Why AI Literacy Matters for the Future of Healthcare with José Acosta

With José Acosta

How can AI literacy reduce patient risk in healthcare settings? In this episode, Christian Espinosa and Trevor Slattery are joined by Dr. José Acosta.

Episode 42

What Is A Medical Device?

With MedTech leader

MedTech developers and manufacturers, could your medical device unknowingly qualify as a “cyber device”? In this episode, Christian and Trevor break down what the FDA considers a “cyber device” and why so many manufacturers misunderstand this definition.

Episode 41

5 Most Common Misconceptions of Medical Device Security

With MedTech leader

In this episode, Christian and Trevor unpack the five most common misconceptions that put medical device manufacturers at risk.

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 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 37

Overcoming AI and Data Security Challenges in MedTech with May Lee

With May Lee

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 Lee of CS Life Sciences about the fast-changing world of medical device cybersecurity.

Episode 36

When Cybersecurity Becomes a Crime

With MedTech leader

What happens when cybersecurity flaws in medical devices cross the line into criminal violations? In this episode, Christian and Trevor unpack the groundbreaking case of Illumina, where cybersecurity misrepresentation led to Department of Justice enforcement.

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 00

Webinar: Hacking Med Devices - What Penetration Testing Reveals Before the FDA Does

With MedTech leader

Cyber threats targeting medical devices are increasingly sophisticated. A single undiscovered vulnerability could delay your FDA submission and put patient safety at risk.

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 00

Webinar: Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals

With MedTech leader

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 perspective?

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 00

Webinar: Medical Device Penetration Testing: What Every Manufacturer Must Know

With MedTech leader

What are the unique challenges and regulatory requirements of medical device penetration testing?  In this webinar episode with Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, you’ll learn:  * How Medical Device Penetration Testi

Episode 32

From Surgery to MedTech Startups: Dr. Dylan Attard’s Journey

With MedTech leader

What cybersecurity challenges face hospitals and medical devices today that MedTech innovators should know about? Today’s guest is Dr. Dylan Attard, who swapped his scalpel for startups when he founded MedTech World, a global conference series elevating healthcare innovation.

Episode 00

Webinar: Medical Device Risk Assessments - Cybersecurity, Compliance & Patient Safety

With MedTech leader

Medical devices are becoming more connected, but with that connectivity comes risk. In this episode, Christian and Trevor dive into risk assessments for medical devices - a crucial process in ensuring both patient safety and cybersecurity compliance.

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 00

Webinar: Mastering Threat Modeling for Medical Device Cybersecurity

With MedTech leader

Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, Director of Medical Device Cybersecurity, explore the critical topic of threat modeling in medical device cybersecurity.

Episode 30

FDA Cybersecurity Gets Real with Monica Montañez of NAMSA

With Monica Montañez

How have medical device cybersecurity requirements changed since 2023, and what does this mean for your product development? In this episode, Christian and Trevor welcome Monica Montañez from NAMSA to unpack the evolving landscape of FDA cybersecurity requirements.

Episode 00

Webinar: Risk Management Frameworks For Medical Device Safety & Security

With MedTech leader

Join Trevor Slattery, Director of Cybersecurity, and Christian Espinosa, CEO of Blue Goat Cyber, for a comprehensive webinar on medical device cybersecurity.

Episode 29

What the FDA Wants in Security Architecture Views for Devices

With MedTech leader

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-defined security architecture views essential for medical device cybersecurity.

Episode 00

Webinar: 5 Key FDA Cybersecurity Standards with Jordan John

With Jordan John

How can you integrate relevant cybersecurity standards early in your medical device development process? Also, how do FDA cybersecurity standards help reduce the time to market for new medical devices?

Episode 28

Shared Responsibility in Medical Device Cybersecurity with Greg Garcia

With Greg Garcia

How can shared responsibility models improve healthcare cybersecurity? In this episode, Greg Garcia joins Christian and Trevor to break down the evolving landscape of medical device cybersecurity from a national policy perspective.

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 26

Why Cybersecurity and Quality Are One and the Same

With MedTech leader

How can medical device startups avoid missteps in cybersecurity, quality, and compliance? In this episode, Trevor Slattery speaks with Ashkon Rasooli about the intersection of quality systems and cybersecurity in medical devices.

Episode 25

Cybersecurity Labeling and MedTech Transparency

With MedTech leader

Why is cybersecurity labeling more than just a compliance checkbox for medical device companies? In this episode, Christian and Trevor dive into the nuanced world of cybersecurity labeling for medical devices.

Episode 24

From Concept to Compliance: A Guide to Med Device Approval

With MedTech leader

Med device manufacturers, are you setting up your quality system early enough in product development? Also, are you misunderstanding the FDA’s "guidance" documents - and risking rejection?

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 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 00

Master Medical Device Cybersecurity: Avoid FDA Delays | Blue Goat Cyber Webinar

With MedTech leader

How can medical device manufacturers meet FDA cybersecurity requirements the first time around? What are the most significant challenges medical device manufacturers face in ensuring FDA cybersecurity compliance?

Episode 19

Data Protection in Medical Devices: A Deep Dive with Kevin Derr

With Kevin Derr

How can medical device companies own their data without compromising security? In this episode, Kevin Derr from NeuronSphere joins Christian and Trevor to dive into the intersection of cybersecurity, compliance, and innovation in the MedTech world.

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 17

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

With Paul-Lukas Hoffschmidt

If you’re launching a MedTech product, what should you know about market access, cybersecurity, reimbursement challenges, and customer education?

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 15

Commercialize Your MedTech with Craig T Ingram

With Craig T Ingram

What are the 10 essential components of a successful commercialization plan in the MedTech industry, and why are they often overlooked? This episode explores the critical role of commercialization in the MedTech industry.

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 10

How Trump & RFK Jr Affect AI Med Device Guidelines

With MedTech leader

How might the second Donald Trump administration and Robert F. Kennedy Jr. impact the MedTech cybersecurity world? In this episode, Christian and Trevor discuss how the Trump administration and RFK Jr.’s policies could reshape medical device cybersecurity and regulation.

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 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 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 04

Building Resilient Medical Devices: A Look at the Essential Technologies and Infrastructure

With MedTech leader

How can some of the biggest cybersecurity concerns with medical devices be addressed in the design phase?

Episode 03

Navigating the Regulatory Landscape of Medical Device Cybersecurity

With MedTech leader

What are the main categories of medical devices, and how do regulatory bodies govern them? In this episode, Christian Espinosa and Trevor Slattery unpack the complex regulatory environment surrounding medical device cybersecurity.

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.

Episode 01

Cybersecurity for Medical Devices: Protecting Human Lives

With MedTech leader

How do medical device cybersecurity risks differ from traditional cybersecurity threats? In this episode, Christian Espinosa and Trevor Slattery discuss the critical importance of cybersecurity for medical devices, sharing real-life stories and insights into how device vulnerabil

Episode 00

Trailer - The Med Device Cyber Podcast

With MedTech leader

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 loved one’s life at risk?