The Med Device Cyber Podcast

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 cybersecurity equation. They explore how AI could make attackers faster while also gi...

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 pushes beyond vulnerability scanning to uncover the real impact of an exploit, why o...

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 compliance task. He also explains why medical device cybersecurity is fundamentally d...

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. Joe goes through how RunSafe's technology changes the way software functions load...

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 aggressive basal cell carcinoma. Stefan explains how his team is developing a micro...

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 explains why companies often move through fundraising, regulatory strategy, sal...

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 companies can do to avoid costly hiring mistakes. Darwin explores why traditional...

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 from achieving real clinical adoption. Amel explains why clinical adoption is ofte...

AI is moving quickly, but medical devices cannot afford to treat every new model like an ordinary software update. In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Tyler Harmon, CEO and co-founder of IASO Automated Medical Systems, about the risks and responsibilities surrounding AI as a medical device. Tyler explains why consumer tools such as ChatGPT and Claude sho...

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 challenge of identifying the right people for highly technical roles. Samantha expla...

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 is joined by Sarah Ohanesian and Jeff Gibbard, co-founders of Super Productive, t...

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-founder of ReVision Implant, about the development of a visual prosthesis desig...

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 Member of the Medical Technology Association of Australia (MTAA), to discuss why so...

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, including banking and casino gaming. Melissa shares lessons from an industry where o...

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 function with a simple wearable patch instead? In this episode of the Med Device C...

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 Trevor sit down with JJ Amell, the founder of Amell Law, to unpack the complex realit...

When you try to communicate cybersecurity risks to medical device manufacturers, do you feel like you are speaking ancient Hieroglyphics? You are not alone. In this episode of the Med Device Cyber Podcast, Christian and Trevor sit down with Shahbaz Ahmed, the Founder and CEO of Leadership Studi. Together, they explore the intersection of human psychology, cross-cultural leadership styles, and the...

Philippe Gerwill manages to be a board advisor for nearly 30 companies without losing his humanity. In this episode of the Med Device Cyber Podcast, Christian Espinosa sits down with the world-renowned futurist to discuss why “unlearning” is the most vital skill for today’s healthcare leaders. They explore the shift from traditional medicine to consumer-led health and why patients are flocking to...

Medical software is still underestimated by teams that think generic engineering habits will carry over cleanly into a regulated environment. They do not. The work gets harder when requirements, traceability, security, testing discipline, and approval timelines all collide. A stronger strategy starts earlier, uses specialists sooner, and avoids making AI or code velocity the headline when architec...

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 durability. That framework becomes even more important in neurotech, where publ...

A device can clear regulatory hurdles and still struggle commercially if the evidence is too narrow. MedTech companies need proof that speaks to affordability, care quality, operational impact, and long term value, not just technical performance. Market selection matters just as much. The same solution may fit the United States, the UK, Germany, or the Netherlands very differently because reimburs...

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 aver...

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 Slat...

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 determ...

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 wheth...