Medical Device Cybersecurity Podcast

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...

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 Chris...

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 y...

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 De...

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 an...

There are somany standards for Medical Devices. Today we're taking a look at 2 of the most used in the cybersecurity space. ISO 14971 is the main standard for managing risks in medical devices. It helps organizations find and control risks to improve device safety. IEC 81001-5-1 focuses on managing cybersecurity risks in health software. It guides how to handle and reduce digital threats to medica...

Can you imagine if we trusted that everyone who logs into a device? It would be chaotic. This is why we need to make sure the person logging in is indeed the person they say they are. This is the process of authentication. And it's critical to get it right to ensure medical devices are protected. Through this episode my ghuest and I talk about what it means to have a secure authentication proc...

The FDA is undergoing massive job cuts. Whether we like it or not, this will undoubtedly change the approval landscape of medical devices. And it already has. My guest Etienne Nichols and I talk about the implications of these changes for Manufacturers and what they can do to remain competitive in this evolving landscape. Etienne Nichols is an all around talent in Medical Devices. He started as a...

Healthcare institutions are the ones buying the medical device, ultimately. Yet, we don't often talk about their cybersecurity demands. Our guest Christopher Frenz has spent most of his career protecting hospitals from cyber attacks. And it's not an easy task. While the landscape evolves every month, medical devices often stay the same for years, if not decade. How do these challenges mani...

Today we're tackling some of the biggest questions around the EU regulations landscape in cybersecurity of medical devices. Our guest is Elisabetta Biasin, a legal researcher specializing in cybersecurity, AI regulation, and EU laws. Elisabetta provides critical insights into the complex regulatory landscape facing medical device manufacturers implementing AI in Europe. She expertly breaks dow...

I think you understand how important it is to protect medical devices. But what about the organization that makes the medical device? Well, it has its own security requirements. European legislation such as NIS2 require that MDMs maintain a certain level of security. Plus on top of just following regulation, following basic cybersecurity practices improves the company's ability to withstand at...

There's hundreds of tasks to do before releasing a medical device. What if we could make one of them fun all while being more productive? That's the idea that our guest Christoph Niehoff expanded upon. He created a card game that encourages players to have conversations around the security of the medical device. Join us to understand the benefits of this approach, the rules of the game, and how to...

Medical Devices need patching. Whether it's for functionality or security, devices must be able to be updated remotely. But what about those devices that you cannot patch? What are some things manufacturers can do still ensure security? In this episode with guest Matthew Webster, we deepdive into cybersecurity of medical devices keeping in mind the perspective of hospitals. Here are links to c...

Why reinvent the wheel? Industry-leading experts have already paved the way for medical device security. By following established good practices, you can ensure the safety and integrity of your devices without unnecessary complexity. My guest, Marina Daineko is a medical device industry expert, specializing in regulatory compliance and quality management. She helps manufacturers ensure patient saf...

CISA and the FBI have released a report guiding Medical Device Manufacturers on how to code their devices securely. At the top of the priority list is a new recommendation to phase out the use of C and C++ in medical device software. While these languages can be useful in certain circumstances, they significantly compromise the security of devices. So, what can you do about it? Efforts to improve...

Medical Devices are getting increasingly complex. We're now dealing with interconnected medical devices with tens of inputs, dozens of connections, and a plethora of connections. How can you handle security in this context? Threat modeling is the process recommended by the FDA in which you discover vulnerabilities, respond to risks, and analyze your work. It's done in a 4 question framework: What...

Everyone knows cybersecurity in medical devices is important. But how many know how to make secure devices? Our two guests Jose Bohorquez and Mohamad Foustok are packed of experience in building medical devices and they share their best practices on how to do so. Here are my top learnings from this one: ✦ Include cybersecurity from the start in architecture - have at least one security-savvy archi...

To get us started on this journey, I invited one of the most influential medical device patients in the cybersecurity space. Veronica "Vee" Schmitt is an advocate for cybersecurity in medical devices. Veronica shares her personal journey from experiencing fainting spells at 19 to becoming fascinated with the security of medical devices. Having faced this situation first hand, she underst...

Hi Folks! This introduction episode is to present the Medical Device Cybersecurity Podcast and myself, your holt, Mathieu “Cyber Doctor” Peteau. Since this episode might be the only one that focuses on me, I'll take advantage of this and your burning questions: ✔️ How I random events led me to medical device cybersecurity ✔️ Why I'm the Cyber Doctor? ✔️ How I left a top cybersecurity compa...