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.

The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com 

If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session 

Thanks to May Lee for being on the show. Connect with May on LinkedIn: https://www.linkedin.com/in/may-lee-a1b16186/ 

Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber. 

Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/ 

Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9 

Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ 

Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/ 

Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/ 

Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber 

Feedback? Questions? Contact: https://bluegoatcyber.com/contact/ 

Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/ 

Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial 

The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast. 

Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh 

Subscribe via Apple Podcasts: https://apple.co/483OJ9I

Subscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/podcasts

This episode was produced by Story On Media: https://www.storyon.co/