Reinventing Cybersecurity - candid conversations on connected security.
Conversations with security leaders, founders, and operators on how to actually build secure connected products - without slowing the business down.
Latest episode
All episodes
60 episodes · Hosted by Christian Espinosa
Searches episode titles, guests, summaries, and full show notes.
What we cover
Built for regulatory and quality leaders, product security engineers, MedTech founders, and clinical IT teams who need to make sense of FDA, EU MDR/IVDR, and international cybersecurity expectations, without the marketing fluff.
- FDA premarket cybersecurity (510(k), De Novo, PMA)
- Section 524B and the February 2026 final guidance
- Threat modeling for connected devices
- SBOMs and supply chain risk
- Postmarket vulnerability management and CVD
- Real-world deficiency letters and how to close them
Hosted by Christian Espinosa & Trevor Slattery - practitioners running FDA submissions, threat-modeling sessions, and pen tests for real device manufacturers.
Jump to what matters for your role.
-
FDA Premarket
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 Postmarket
FDA Postmarket Cybersecurity
Coordinated vulnerability disclosure, patching legacy devices, and meeting the FDA's postmarket cybersecurity expectations after launch.
-
SBOM
SBOM Management
Software Bills of Materials for medical devices: generation, monitoring, and using SBOMs as a continuous security tool, not a checkbox.
-
Threat Modeling
Threat Modeling
STRIDE, attack trees, and risk-driven threat models that satisfy ISO 14971, IEC 62304, and FDA reviewers.
-
Penetration Testing
Penetration Testing
Device, network, wireless, and protocol penetration testing for medical devices - what to scope, who to trust, and how to report it.
MedTech cybersecurity, answered.
Quick answers to the questions we hear most from product security, regulatory, and engineering teams.
Bring this rigor to your next FDA submission.
Book a 30-minute strategy session - we'll map the lessons from the show to your actual device, timeline, and gaps.
30-minute call · Fixed-fee proposal in 24-hours · No sales pressure.
Prefer video? Watch our on-demand webinars or browse written field guides.
Know someone listeners need to hear from?
We feature founders, regulatory leads, security researchers, and clinicians shipping connected medical devices. Tell us what they'd bring to the show.