Episode 62 · March 12, 2026 · 38m listen · 7,544 words · ~38 min read

How to Design Devices That Integrate Into Clinical Workflow Without Disruption | Ep. 61 - Full Transcript | The Med Device Cyber Podcast

Read the complete, searchable transcript of Episode 62 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.

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Episode summary

This episode of The Med Device Cyber Podcast features Dr. Omar Ahmed, a professor of cardiac anesthesiology and critical care and co-founder of HIO, discussing the crucial role of integrating medical devices seamlessly into clinical workflows. Dr. Ahmed, a Key Opinion Leader (KOL) in his field, emphasizes that cybersecurity in medtech is paramount to ensure data reliability and patient safety. The discussion highlights the common pitfall of medtech companies developing solutions without first identifying a clinical problem, often leading to products that don't integrate effectively within hospital IT systems or clinical workflows.The episode delves into the concept of digital twins in healthcare and their implications for personalized medicine. While personalized treatment offers significant benefits, it also introduces magnified cybersecurity risks, particularly concerning patient harm and data integrity. The speakers explore the regulatory landscape for clinical decision support systems (CDSS) versus diagnostic medical devices, noting the FDA's ongoing efforts to clarify liability in this evolving area. The conversation underscores the importance of medtech innovators collaborating with KOLs and spending time in clinical environments during the design phase to create truly effective, secure, and integrated medical devices that enhance patient care without disrupting existing workflows.

Key takeaways from this episode

Medtech companies often err by developing solutions without first deeply understanding and addressing specific clinical problems, leading to poor integration into hospital IT systems and workflows.
Effective medical device design should prioritize seamless integration into existing clinical environments, becoming indispensable without causing disruption or requiring significant changes to established processes.
Digital twins and personalized medicine, while highly beneficial, introduce heightened cybersecurity risks, including the potential for incorrect treatments due to compromised data and the magnified exposure of sensitive patient health information.
The reliability and integrity of medical data are absolutely vital for clinical decision-making, as erroneous or compromised data can lead to patient harm and misdiagnosis.
Medtech innovators should engage with Key Opinion Leaders (KOLs) and immerse themselves in clinical settings during the design and development phases to ensure products meet actual clinical needs and seamlessly integrate into real-world workflows.
The regulatory distinction between clinical decision support software and diagnostic medical devices is crucial for liability, with the FDA actively trying to clarify who is responsible when erroneous data from a device leads to patient issues.

Full episode transcript

Cybersecurity in medtech is absolutely vital because the key thing is that the doctors who are the end users have to be dead sure that what we're receiving has not been hacked. The data is reliable, and then we can use that to actually treat our patients. That is something that many medtech companies get wrong because they come out with a solution and they start looking for a problem to solve. The biggest issue, I think we find with medtech, is the integration into the IT systems of hospitals. And especially for one of these wellness tools, where it can't make any claims to anything. So, reading through it, it never says, “Oh, you need to get more sleep. You need to go to bed earlier tonight.” It just says, “You didn't sleep well last night.” Okay, cool. So, what's the response? What do you do as the next step? It's a hard problem to solve for these wellness companies because then you're bridging the line between a wellness product and a medical device, where obviously becoming a medical device is a big deal. Hi, welcome back to another episode of The Med Device Cyber Podcast. Today, we're talking about a very important topic, and a topic that is misunderstood. I didn't know much about it until maybe a year and a half ago. It's about KOLs, or Trevor, what does a K stand for? Do you remember? A Key Opinion Leader. Yes. So, we have a KOL on the call today, Dr. Omar Ahmed, and maybe you can explain a little bit about what you do and what your role is with HIO, and also as a KOL. Great. Thank you. I'd like to thank you both for inviting me to speak here. It's an honor and absolute pleasure. My background is I'm a professor of cardiac anesthesiology and critical care in the University of Leicester in the UK. And what that means is I'm a practicing full-time cardiac anesthesiologist, but also I am a co-founder of the company HIO, for which we're going to talk about a little bit later on. Now, just to go into the Key Opinion Leader business, the reason why we're called that is because a handful of us, if you like, across the world are known as leaders in our field, and we publish a lot of the academic papers, a lot of clinical research, and a lot of the international guidelines that define what the best practice or current state-of-the-art in medicine is. Each one of us works in a different field. I work in the area of cardiac anesthesia and critical care, but others work in oncology, hematology, and others. So, what we do is we publish the guidelines on the basis of best practice and evidence. So, we look at all of the papers out there, we look at all of the evidence, and we make decisions as a group, not just individuals, but as a group of us, and publish these as guidelines that other hospitals take as best practice. So that when you go into a hospital as a patient, you know that you're going to get treated with the best available evidence by your physician. And that's what defines us as a Key Opinion Leader because industry likes to call us that because we're the ones who effectively formulate opinions within all our other peer group. And so, what we tend to say is evidence-based, and what we tend to publish tends to get followed by the majority of clinicians across the world. And that's what a KOL is. So, it's a label attached to me and many of my colleagues. But essentially, once you're a real expert in the field and you are recognized as somebody who really knows what they're doing and they publish in that subject, that's how they become Key Opinion Leaders, and that takes many, many years. I've been a cardiac anesthesiologist for over a quarter of a century. So, I've been practicing this and doing this and honing my craft, if you like, and become an expert in the field over many, many years. And that's how we get known in the field. That's why we get invited to speak at scientific conferences, and then we end up in podcast rooms like this with yourselves. Well, awesome. I think it's important, like from my perspective, and I could have the wrong perspective, I'm not an expert on KOLs. I maybe I am a KOL in my field, I guess. But from my perspective, you've got a lot of medical device innovators that don't have a KOL as part of their team. So, there's pretty high opportunity for the product to not actually fit a need or not work in a clinical setting. Is that a fair assessment? Because I know what you do with HIO is you provide the real knowledge of how your device and product would work in the environment.

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