Overcoming AI and Data Security Challenges in MedTech with May Lee

How can you prepare your device for future quantum computing risks?

In this episode of The Med Device Cyber Podcast, Christian and Trevor talk with May Lee of CS Life Sciences about the fast-changing world of medical device cybersecurity. They discuss the growing regulatory demands from the FDA, EU, and China, and why cybersecurity can no longer be an afterthought in device design. The conversation also dives into quantum computing, supply chain risks, and how manufacturers can balance compliance with innovation.

May Lee is a medical device consultant at CS Life Sciences who specializes in AI, machine learning, and cybersecurity. With experience ranging from startups to global corporations, she brings a practical perspective on navigating regulations and helping innovators bring safer devices to market.

(03:21) Why cybersecurity is moving from afterthought to design control.

(05:49) Key takeaways from the FDA’s finalized cybersecurity guidance.

(08:04) Comparing U.S. FDA and EU MDR cybersecurity requirements.

(10:44) How quantum computing raises new risks for health data.

(16:26) The balance between compliance, over compliance, and innovation.

(18:23) Differences in regulatory approaches across the U.S., EU, and China.

(28:05) Why third-party supply chain and software components matter for device security.

(32:48) When medical device companies should engage cybersecurity consultants.