The Anatomy of Connected Medical Devices: A Non-Technical Guide to the Ecosystem

Connected medical devices aren’t just “devices with an app.” The moment you add Bluetooth, Wi-Fi, Ethernet, or even a connector you “aren’t using yet,” you add risk, regulatory scope, and long-term security obligations. In this Friday In-Focus session, Mark Omo (Engineering Director & General Manager, Marcus Engineering) walks through the anatomy of connected medical devices in plain language: the core building blocks, common connection architectures, where data (and security keys) actually live, and why most real-world cyberattacks happen through communication channels, not physical device access. You’ll also learn why “accidentally connected” devices are a common trap, why relying on phones for critical functions can be risky, and how to think about post-market cybersecurity as an ongoing engineering commitment—not a one-time submission deliverable. What you’ll learn: • What counts as a “connected device” (and why unused radios still create risk) • The four building blocks: sensing/actuation, processing/storage, transmission, and connectivity • Why transmission channels are the primary attack surface • How phone-connected, gateway-connected, and hospital/internet-connected architectures differ (risk + regulatory burden) • What can go wrong when connectivity drops—and why you must analyze those scenarios for safety • Why custom wireless protocols often fail (and the real-world consequences) • Practical cybersecurity expectations: hostile network assumptions, pen testing, and post-market planning • How to bridge cybersecurity vulnerabilities with patient-safety risk management • A preview of emerging challenges: AI behavior in medical software and “fail-safe” design Chapters below 00:00 – Welcome & session setup 07:05 – What’s next: upcoming sessions and why this topic matters now 09:23 – Announcements: AI Forward MOV100 release party 13:37 – What “connected” really means (Bluetooth/Wi-Fi/Ethernet—even if unused) 16:10 – The four building blocks of connected devices (sensor → compute → transmit → connect) 20:05 – Where processing happens (device vs cloud) and why it changes scope 23:10 – What data is stored (PII + security keys) and why uncertainty is a red flag 27:21 – Attack surfaces: why transmission is the #1 cyber entry point 31:31 – Why custom wireless protocols are dangerous (St. Jude pacemaker example) 34:35 – Phones as controllers: reliability risks, app termination, OS/device variability 40:33 – Remote commands & overrides: designing controls around the “worst possible” command 49:43 – Tooling for non-technical teams: the connected device Q&A chatbot 52:51 – Common connection architectures (phone / gateway / hospital-internet) and risk differences 55:47 – Why cybersecurity expertise is mandatory for internet-connected devices 01:03:48 – Pen testing vs ISO 27001: what they do (and don’t) cover 01:07:23 – AI as a “fallible user”: limiting permissions and designing safe failure modes 01:10:19 – ISO 13485 V&V when interfacing with other software/devices (apps/SaMD) 01:12:45 – Third-party/off-the-shelf software validation challenges 01:13:48 – Bridging security vulnerability analysis with patient-safety risk analysis 01:14:30 – Resources, slide deck, and continued content plans 01:16:41 – Closing + engagement and follow-ups Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers. 👉 Join the MLVx community: https://members.mlvexchange.com 🎟️ Use code SEAN20 to save 20% on membership.