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PODCAST

The Med Device Cyber Podcast

Blue Goat Cyber

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 vulnerabilities to navigating this ever-evolving regulatory landscape. Hosted by Christian Espinosa,

science life sciences

All Episodes

43:44

De-Risking Product Decisions in MedTech Startups with...

The Med Device Cyber Podcast ·

2026/04/23

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 and Trevor Slattery explore product management with Brent Lavin, Chief Product Catalyst of Ironwood MedTech Partners, covering why 510(k) pathways average four years while PMA programs require seven to nine years, and how feature set alignment shapes

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39:10

Vibe Coding Security Risks and Malicious Code...

The Med Device Cyber Podcast ·

2026/04/16

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. Supply chain attacks become easier when developers blindly trust AI implementations.Jake Rodriguez, Founder and CEO of Triangle Tech, joins Trevor Slattery and Christian Espinosa to explore the security implications of vibe coding, how attackers exploit AI

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41:36

Why Clinical Trials Are the Most Expensive Capital...

The Med Device Cyber Podcast ·

2026/04/09

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 de-risks strategies before execution.Clinical trial design shapes feasibility for startups with limited budgets. Understanding target markets determines sample requirements since UnitedStates sales need United States samples while Korean sales need

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35:26

Traceability Requirements and Documentation Audit...

The Med Device Cyber Podcast ·

2026/04/02

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 version control, and no evidence of systematic processes.Dr. Basant Bajpai discusses why design controls begin at the concept stage, regardless of whether companies acknowledge them, how reverse documentation costs 6-12 months when manufacturers reach the

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50:56

Early Design Decisions that Shape Medical Device...

The Med Device Cyber Podcast ·

2026/03/26

Earlydesigndecisionsdefinethetrajectoryofamedicaldevicelongbeforecommercializationbegins.Choicesrelatedtosoftwarearchitecture,third-partycomponents,andsystemconnectivityestablishboththeopportunityandtheriskprofileoftheproduct.Cybersecurityintroducesalayerofcomplexitythatmanyteamsunderestimate.Itextendsbeyondprotectingdataandintosafeguardingpatientoutcomes,ensuringsystemreliability,andmeetingincreasinglystringentregulatoryexpectations.ChrisDanek,CEOofBessel,joinsChristianandTrevortoexaminehowasingleov

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42:39

Edge Cases, Alarm Fatigue, and Why AI Cannot Replace...

The Med Device Cyber Podcast ·

2026/03/19

Alarm fatigue happens when monitoring systems raise so many false flags that clinical staff begin ignoring them, even when real critical events occur. A surgeon during an operation gets alarms indicating patient bleeding, but observes stable blood pressure and no visible bleeding. The surgeon trusts direct patient observation over machine output because edge cases require human judgment that AI cannot reliably provide.Brandon Fertig discusses why patient monitoring systems with visual indicators

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38:13

Alarm Fatigue, Workflow Integration, and the...

The Med Device Cyber Podcast ·

2026/03/12

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.Professor Aamer Ahmed, a Consultant in Cardiothoracic Anaesthesia, Professor of Anaesthesia and Critical Care at the University of Leicester, and co-founder of Hemeo, a medical technology company designing AI-based personalized Clinical Decision

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40:51

How to Move Stakeholders from Awareness to Sustained...

The Med Device Cyber Podcast ·

2026/03/05

Marketing medical devices requires understanding that stakeholders are different, buying processes are longer, and friction points are more complex than consumer products or software. Most companies build websites and attend trade shows hoping prospects will decode their message, but prospects do not have time for that.Sustained adoption is not the same as initial purchase. It means the device is used continuously with no friction, no concerns, and no barriers, causing users to stop or switch

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32:26

Prevention Is Better Than Cure: Applying Medical...

The Med Device Cyber Podcast ·

2026/02/26

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.Medtech quality and regulatory leader Stephen Smith describes sitting in a risk session for a device going into an intensive care unit. Twelve people in the room, and not one had ever set foot in an ICU. If you have never been in the environment your device will operate in, risk identification becomes

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37:40

How AI Code Security Became a Medical Device Problem...

The Med Device Cyber Podcast ·

2026/02/19

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. Level one means basic security controls exist. Level four means the device underwent independent code review, has advanced threat detection, and maintains continuous vulnerability management. Hospitals can see exactly what level of

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41:50

How to Build an SBOM That Passes FDA Review

The Med Device Cyber Podcast ·

2026/02/18

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.In this webinar, Christian Espinosa and Trevor Slattery explain what the FDA actually expects in an SBOM and why it's not just about listing third-party libraries. You need to include first-party code too. You need to follow the NTIA minimum elements. And you need to

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44:22

From Idea to FDA Clearance: What Nobody Tells Medtech...

The Med Device Cyber Podcast ·

2026/02/12

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.Darcy runs Prolucid Technologies, an ISO 13485-certified software development firm in Toronto. They work with medtech companies across North America, Europe, and Australia.And in that time, he's seen the same mistakes repeatedly.The biggest one? Founders build products that solve problems

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41:56

What MedTech Startups Get Wrong About Cybersecurity...

The Med Device Cyber Podcast ·

2026/02/05

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 hemodynamic monitoring technology for consistently accurate cardiac output measurements in high-risk surgical and critically ill patients is in 75 hospitals across 18 countries, sold by Medtronic in the U.S, and the company is preparing to launch their new product Argos Infinity, pending FDA clearance.But getting here meant dealing with cybersecurity

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30:09

Why Most Medtech Companies Fail at Global Expansion...

The Med Device Cyber Podcast ·

2026/01/30

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. Not because they lack good products, but because they didn't think about cybersecurity early enough.William was trained as a medical doctor in Shanghai, then moved into the medtech industry working for companies like McCulloch and Stryker. Now he helps

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53:00

What It Takes to Succeed in the Medtech Industry

The Med Device Cyber Podcast ·

2026/01/14

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.In this episode, Omar dives into the highs and lows of his entrepreneurial journey, sharing key lessons, pivotal moments, and the strategies that helped him succeed. From tackling complex healthcare issues to navigating the

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29:02

Untangling Software Composition Analysis for MedTech...

The Med Device Cyber Podcast ·

2026/01/06

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 device cybersecurity landscape. Christian and Trevor clarify common misconceptions, including licensing fears, machine-readable requirements, and the role of static testing tools.The Med Device Cyber Podcast is brought to you by

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24:58

When Medical Device Cyber Failures Become Fatal

The Med Device Cyber Podcast ·

2025/12/30

What past ransomware and medical device incidents might reveal gaps that manufacturers are still overlooking today?In this episode, Christian and Trevor examine real incidents where cybersecurity failures, software flaws, and insecure medical devices led to patient harm and death. They break down how ransomware attacks, implantable device vulnerabilities, and AI-driven therapies expose life-critical risks in healthcare. The conversation highlights why regulators are increasing scrutiny and why

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23:10

Trevor Slattery Answers Tough Medical Device Cyber...

The Med Device Cyber Podcast ·

2025/12/23

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?In this rapid-fire episode, Christian fires questions at Trevor about essential medical device cybersecurity concepts and standards. Together, they clarify how risk management, secure development, and lifecycle thinking intersect across safety, quality, and security. The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity

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20:09

The Differences Between Black, Grey, and White...

The Med Device Cyber Podcast ·

2025/12/16

MedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?In this episode, Christian and Trevor explain the differences between black, grey, and white box penetration testing and how each impacts the completeness and realism of cybersecurity assessments. They highlight why regulators increasingly expect deeper testing supported by source-code-level insights. They also outline the risks, costs, and delays manufacturers face when

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45:00

How Cybersecurity Shapes Regulatory and Quality...

The Med Device Cyber Podcast ·

2025/12/09

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 innovators. Jim helps to explain why founders must integrate cybersecurity from concept through commercialization, especially as FDA scrutiny increases.Key points:00:48 Why cybersecurity now influences every part of the

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