18. My biggest learnings

18. My biggest learnings

Season 1 has been filled with wonderful conversations. I feel like I've learned so much about medical devices, cybersecurity, and entrepreneurship as a whole. Today we listen again to the most impactful moments from our conversations. I also reflect on what these extract meant to me and what it means for you as a medical device manufacturer. It's been awesome sharing my passion for medical device cybersecurity with you for a season! Thanks for being part of the journey. Securely yours, Cyber Doctor

17. Documentation & Security for your Medical Device with Richie Christian

AI is everywhere in Medical Devices. How do you manage documentation around them? In this episode we are crossing the themes of documentation process and cybersecurity for AI-driven medical devices. We answer questions like: - What documentation process is expected from thr FDA and the EU's NBs? - How to collaborate to build effective documentation? - How to manage documentation debt? Richie Christian is a seasoned medical device consultant with over a decade of experience in regulatory affairs, quality management, and market access for digital health technologies, including AI/ML-enabled software as a medical device (SaMD). With a Master’s in neurophysiology from the University of Auckland and additional training in drug commercialization from UC San Diego, he has led regulatory initiatives at companies like Formus Labs, Aroa Biosurgery, and Fisher & Paykel Healthcare. Now based in Switzerland, Richie advises MedTech firms at wega Informatik, helping them navigate regulatory pathways and implement robust quality systems for innovative healthcare software. Thanks for listening, folks! Securely your, Cyber Doctor

16. The state of Medical Device Cybersecurity Part 2 with Axel Wirth and Christopher Gates

We're back for part 2! In this one we dive deeper in the topic of what it's like to lead cybersecurity at a hospital, the specifications that Manufacturers look for, and take a deeper dive into the controversial questions around cybersecurity. Axel and Chist wrote a book together called Medical Device Cybersecurity for Engineers and Manufacturers, and recently published their second edition. If you'd like to buy it,, they've share their disount code that's available to use on the publisher's website. ⁠Website⁠ [ http://us.artechhouse.com/Medical-Device-Cybersecurity-for-Engineers-and-Manufacturers-Second-Edition-P2416.aspx] Code: WIRTH25 More ways to follow: ⁠https://www.linkedin.com/in/mathieupeteau/⁠ [https://www.linkedin.com/in/mathieupeteau/] ⁠https://www.linkedin.com/in/axelwirth/⁠ [https://www.linkedin.com/in/axelwirth/] ⁠https://www.linkedin.com/in/christopher-w-gates/ [https://www.linkedin.com/in/christopher-w-gates/] We're neating the end of the season with one more episode coming. After that we'll do a recap of all the learnings I've had in the 17 first episodes of the series. Be sure to subscibe/follow to be on the loop. Securely yours, Cyber Doctor

15. The state of Medical Device Cybersecurity Part 1 with Axel Wirth and Christopher Gates

Widely regarded as the main contributors of the sharing of knowledge around medical device industry, Chris Gates and Axerl Wirth share their perspectives on what has changed in the past decade around medical device cybersecurity. Thisepisode is agnostic of geography or legislation and includes learnings for all medical device engineers to get. Axel and Chist wrote a book together called Medical Device Cybersecurity for Engineers and Manufacturers, and recently published their second edition. If you'd like to buy it,, they've share their disount code that's available to use on the publisher's website. Website [ http://us.artechhouse.com/Medical-Device-Cybersecurity-for-Engineers-and-Manufacturers-Second-Edition-P2416.aspx] Code: WIRTH25 More ways to follow: https://www.linkedin.com/in/mathieupeteau/ [https://www.linkedin.com/in/mathieupeteau/] https://www.linkedin.com/in/axelwirth/ [https://www.linkedin.com/in/axelwirth/] https://www.linkedin.com/in/christopher-w-gates/ [https://www.linkedin.com/in/christopher-w-gates/] The second part of the episode is coming out next week, folks. Can't wait to hear what you think of it! Securely yours, Cyber Doctor

14. How to do the "As low as possible" approach the right way with Tibor Zechmeister

Picking the right approach to look at risk is very important. Get it wrong and you're in for a denied submission. MDR requires manufacturers to use the As Low as Possible Approach. And it ahs consequeces on the way we look at cybersecurity in general. Our gest today is an all-around expert in medical devices. Tobor Zechmeister was a medical device entrepreneur, and now works as a consultant and an auditor in medical devices. His different perspectives make this episode unique in the angles of conversation it brings. Through this episode you'll understand which method to choose to submit a device in Europe, how it differes from other risk management methodologies, and the implications it has on cyber as a whole. Feel free to connect with us on our LinkedIn accounts: https://www.linkedin.com/in/tibor-zechmeister/ https://www.linkedin.com/in/mathieupeteau/ Be sure to follow the podcast, we have some nice episodes coming, including a two part epsiode with the people I consider to be the Fathers of Medical Device Cybersecurity. Stay tuned. Securely yours, Cyber Doctor