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Device, network, wireless, and protocol penetration testing for medical devices - what to scope, who to trust, and how to report it.
With Liam Dowd
AI is becoming more capable, more autonomous and more accessible. What does that mean for medical device cybersecurity? Liam Dowd joins Christian Espinosa to discuss the changing security landscape, from continuous SBOM monitoring and vulnerable hospital environments to the growing role of AI on both sides of the cyber
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
Medical device cybersecurity is still surrounded by some persistent misconceptions. In this solo episode, Christian Espinosa breaks down seven of the most common misunderstandings he continues to hear across MedTech, from what actually makes a device “cyber” to why cybersecurity cannot be treated as a final-stage compl
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
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
With Ryan Roghaar
Why can a MedTech company have promising technology, a strong team and investor interest, yet still lose momentum when it matters most? Ryan Roghaar joins Christian Espinosa to examine the commercialization gaps that can quietly weaken a medical device company long before the technology itself becomes the problem. Ryan
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
With Sarah Ohanesian
Productivity means making meaningful progress on the work that matters most. Yet many organizations remain trapped in repetitive tasks, unclear priorities, unnecessary meetings and systems that rely too heavily on individual employees saving the day. In this episode of the Med Device Cyber Podcast, Christian Espinosa i
With Frederik Ceyssens
What if a blind person could use a pair of glasses where information is transmitted wirelessly to an implant in the visual cortex, allowing them to perceive shapes, movement, and elements of their surroundings? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Frederik Ceyssens, CEO and co
With Helen Souris
Bringing an innovative medical device to market takes far more than a great idea. It requires regulatory strategy, cybersecurity, quality systems, and commercial planning from the very beginning. In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Helen Souris, CEO of CardiHab and Board Mem
With Melissa Aarskaug
For years, cybersecurity has been viewed as an IT responsibility. Today's threat landscape demands something very different. In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Melissa Aarskaug, a cybersecurity executive with extensive experience protecting highly regulated industries, incl
With Ryan Neely
Cancer treatment is already difficult enough without adding more hospital visits, more testing, and more delays. Yet many cancer therapies carry a significant risk of damaging the heart, forcing patients to undergo regular cardiac screening throughout their treatment journey. What if clinicians could monitor cardiac fu
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
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
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.
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.
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.
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.
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.
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.
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.
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.
With Marc Zemel
Marc Zemel has been building Retia Medical for 15 years. The company started as two guys with slides and licensed technology.
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
With Jim Goodmiller
What risks do you take when cybersecurity is left off your development roadmap? In this episode, Christian, and guest Jim Goodmiller explore how cybersecurity intersects with regulatory expectations and quality systems, creating new challenges and opportunities for MedTech
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 talk with Kevin Saem about how market intelligence and cybersecurity intersect in the MedTech space.
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?
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.
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.
With Myles Kellerman
How safe are the medical devices I rely on, and what are the biggest cybersecurity risks I should know about?
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
With Steve Curry
What project management mistakes can med tech innovators avoid? What methods and tools can help med tech companies manage projects?
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.
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.
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.
What documents should engineers prepare to get ready for submitting a medical device to the FDA? In this episode, Christian dig into the underestimated role software documentation plays in cybersecurity, especially in the medical device space.
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.
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.
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.
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.
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.
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.
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.
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.
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.
How do medical device vulnerabilities pose life-threatening risks? In this episode, Christian again explore the fascinating and critical world of medical device cybersecurity.
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.
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.
FDA Premarket
FDA Premarket Cybersecurity
FDA Postmarket
FDA Postmarket Cybersecurity
SBOM
SBOM Management
Threat Modeling
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ devices supported.
