I had the pleasure of joining Dr. Naveen Agarwal as a guest on his podcast, “Let’s Talk Risk!” on July 11, 2025. If you missed the live conversation, you can catch the recording here.
What we covered
We dug into some of the trickier questions around healthcare and wireless tech, touching on everything from the evolution of connected medical devices to the practical realities of keeping them safe and reliable in today’s crowded wireless environment. Some of the main threads included:
- How connected medical devices have grown more complex, shifting from standalone products to integrated pieces of larger systems
- The ongoing challenge of wireless coexistence and risk management in healthcare settings
- Why standards like AAMI TIR69 and ANSI C63.27 matter for device safety, and how they guide both testing and risk assessment
- What real-world immunity to electromagnetic disturbances actually looks like for developers and engineers
A few highlights
- System-level thinking: One point we kept circling back to was how modern devices aren’t really isolated anymore. They live in a networked world, where the entire system, and its environment, can affect patient safety. You can’t just test the device in a vacuum.
- Coexistence and risk: With most medical devices using unlicensed spectrum (think Wi-Fi or Bluetooth in the 2.4 GHz band), there’s always the risk of interference. It takes more than basic EMC testing to understand and mitigate those risks. Robust testing, real risk analysis, and a clear understanding of device criticality all come into play.
- Regulatory perspective: We talked about the FDA’s wireless guidance and how documents like AAMI TIR69 and ANSI C63.27 offer a structured path for risk categorization and coexistence testing. These standards help bridge the gap between technical capability and patient safety.
- Evolving immunity standards: With new technologies like 5G rolling out, the benchmarks for what counts as “immune” to electromagnetic disruption keep moving. It’s a moving target, and developers need to stay on top of not just the standards, but how their devices really perform under stress.
A few takeaways
- See the whole system: When you’re designing connected medical tech, it’s not enough to just focus on your own hardware or software. You have to see how everything works together and what could go wrong.
- Integrate, don’t silo: Hardware, software, cybersecurity, connectivity are all woven together. Addressing them in isolation creates blind spots.
- Keep risk management active: Risk isn’t something you check off once. As tech, environments, and use cases evolve, risk analysis and testing have to keep pace.
Thanks again to Dr. Agarwal for hosting such a thoughtful conversation. If you want to dig deeper into any of these topics, or if you’re interested in being part of a future discussion, feel free to reach out.