Episodes on FDA premarket cybersecurity.

When Should You Start Medical Device Cybersecurity?

When is the right time to start cybersecurity for a medical device? For many manufacturers, the answer still seems to be somewhere close to submission. In this solo episode, Christian Espinosa explains why that approach can create major delays, expensive redesigns and even force companies to abandon products they have

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

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

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

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

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

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

With JJ Amell

JJ Amell examines the legal and corporate challenges that can complicate entry into the United States medical device market. The discussion looks beyond engineering and clinical evidence to the business preparations innovators may overlook when planning expansion.

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

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?

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