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

33 episodes

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Episode 87

How Ethical Hackers Find Weaknesses in Medical Devices with Parker Daudt

With Parker Daudt

What makes medical device penetration testing different from traditional cybersecurity? Christian Espinosa is joined by Blue Goat Cyber penetration tester Parker Daudt to explore what ethical hacking looks like when the device being tested can directly affect patient safety. Parker explains how penetration testing push

Episode 85

Building Cyber Resilience Into Medical Devices with Joe Saunders

With Joe Saunders

What if a medical device could prevent an attacker from exploiting a vulnerability, even before a patch becomes available? Joe Saunders, CEO and co-founder of RunSafe Security, joins Christian Espinosa to explore a different approach to protecting the software inside medical devices and other critical infrastructure. J

Episode 84

Can We Detect Skin Cancer Without a Biopsy? with Stefan Mazy

With Stefan Mazy

What if the biggest problem in skin cancer diagnosis is not finding suspicious lesions, but what happens after we find them? Stefan Mazy joins Christian Espinosa to discuss the personal experience that led him to explore a different approach to skin cancer testing after his mother underwent extensive surgery for an agg

Episode 82

Why the Best MedTech Candidates Aren’t Applying to Your Jobs with Darwin Shurig

With Darwin Shurig

What happens when AI starts screening job candidates who are also using AI to get through the screening process? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Darwin Shurig, founder of Top Talent Accelerant, about why recruiting in MedTech is becoming increasingly difficult and what co

Episode 81

The Hidden Barriers to Clinical Adoption with Amel Havkic

With Amel Havkic

Why do so many promising MedTech companies fail even when the technology is strong, the funding is there and the product is compliant? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Amel Havkic, founder of EvoMed Consulting, about the hidden barriers that prevent medical technologies fr

Episode 79

Why Technical Intelligence Is Not Enough with Samantha Silk

With Samantha Silk

A strong résumé may get someone an interview, but technical ability alone does not determine whether they will succeed within an organization. In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Samantha Silk, CEO of Apex Pro Placement, about recruitment, emotional intelligence, and the chal

Episode 73

Navigating U.S. Market Entry for MedTech Developers with JJ Amell

With JJ Amell

When you develop a groundbreaking medical device, you assume the engineering and clinical data will carry you across the finish line. The legal landscape of U.S. market entry involves layers of corporate traps that most innovators completely overlook. In this episode of the Med Device Cyber Podcast, Christian and the B

Episode 69

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

With Varun Turlapati

Early-stage MedTech gets riskier when investors confuse a compelling story with a credible device. Stronger diligence starts by testing whether the science is real, whether clinicians would actually use the product, and whether the company has thought seriously about regulatory fit, reimbursement logic, and engineering

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 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 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 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 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 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 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 demystify the difference between cybersecurity measures and metrics in the context of FDA guidance.

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 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 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 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 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 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 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 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 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 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 discuss the critical importance of cybersecurity for medical devices, sharing real-life stories and insights into how device vulnerabil

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