Podcast · FDA Premarket

Episodes on FDA premarket cybersecurity.

Conversations on premarket cybersecurity submissions, the FDA Refuse to Accept policy, and what reviewers actually expect in 510(k), De Novo, and PMA filings.

FDA Premarket Cybersecurity Services All episodes

37 episodes

Browse all topics →

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

Browse other topics

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.

Book strategy session Explore services