Episode 21 · May 20, 2025 · 34m listen · 1,315 words · ~7 min read

The Human Factor in MedTech Design with Dylan Horvath | Ep. 20 - Full Transcript | The Med Device Cyber Podcast

Read the complete, searchable transcript of Episode 21 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

In this episode of The Med Device Cyber Podcast, Christian Espinosa interviews Dylan Horvath from Cortex Design about the critical role of human factors engineering and user-centric design in medical device development. Horvath emphasizes the need to integrate human factors from the initial stages of design to ensure commercial success, noting that devices must be not only safe and effective but also desirable and intuitive for users. The discussion highlights the challenges of market adoption and the necessity of considering all stakeholders, from users to buyers and reimbursement decision-makers, in the design process. The conversation also addresses the increasing importance of cybersecurity in FDA submissions, stressing that early integration of security measures is crucial to avoid costly redesigns and delays, especially with the current FDA resource constraints. Horvath shares insights from his company's journey into MedTech, including their participation in the Qualcomm Tricorder XPRIZE, and underscores the value of an organizational culture that embraces experimentation and continuous improvement. The episode offers valuable perspectives for product security teams, regulatory leads, and engineers seeking to navigate the complexities of MedTech design and compliance effectively.

Key takeaways from this episode

Human factors engineering must be integrated into medical device design from the very beginning to ensure both safety, effectiveness, and commercial success.
A comprehensive design approach considers not only the end-user but also all stakeholders involved in market acceptance, including purchasers and those involved in reimbursement decisions.
Early integration of cybersecurity considerations into the design process is crucial to avoid significant costs, delays, and potential redesigns during FDA submissions.
The current FDA environment, characterized by resource constraints and uncertainty, necessitates highly buttoned-up and complete market submissions, making back-and-forth communication more difficult and costly.
Organizational culture that values continuous improvement, empathy for the user, and an acceptance of iteration and "failure" as part of the design process is vital for bringing innovative medical devices to market.
The MedTech industry offers significant opportunities for impact and innovation, driven by demographic shifts and the need to democratize healthcare access, making robust design and security practices more important than ever.
Design decisions made early in the development lifecycle, such as microcontroller selection, can have profound and costly regulatory and functional ramifications if not carefully considered from a security perspective.

Full episode transcript

Hi, welcome back to The Med Device Cyber Podcast. I'm your host, Christian Espinosa. I'm here with a guest today, Dylan Horvath from Cortex Design. How's it going today, Dylan? It's going well. How are you, Christian? I'm doing good. A little bit tired. I was at the LSI conference last week and didn't get much sleep. Very busy, you know, trying to get business and networking and just meeting more people in the community. So, I think it's an important topic with design, and I know you focus a lot on human factors with your design. Can you talk a little bit about, I guess, what some of the biggest challenges are in the industry from a design perspective? Well, there's certainly a greater appreciation of the need for great human factors engineering and how that relates to design. I think, you know, broadly in the medical device industry, design has been a bit of a laggard in being core to the development process, and the understanding of industrial design within North America isn't really very well understood either. It's largely thought of as look and feel, and in medical design, it's sort of thought of as human factors engineering, whereas we think of those things cohesively as a whole. So, you know, at Cortex, we have a very human-centered design philosophy and process, but that is wrapped around an ISO 1345 Quality Management System designed to get devices into the market quickly. So, as you know, safe and effective is core to all medical devices, but that doesn't mean they're commercially successful. Commercial success really means about market adoption, making sure you're designing a product that people want, people that people understand how to use, and can resonate with at first glance from a design perspective. And I took a class in college, human factors engineering. I never heard of what it was before then, but it's obviously super important for a physician or surgeon or anyone that's using these instruments because they're often in an operating room or somewhere where the circumstances are pretty high from a risk perspective. What are the main items that go into design? Is it done initially or do you design it and get it on the market and then kind of get some feedback and tweak it, or how does that process work? Well, so it's so expensive to get a product launched and through regulatory, and you really can't make very many changes without incurring a lot of expense. So, design really has to—a good designer, a good product understands that human factors engineering has to take place from the beginning, from the very beginning. So, a lot of the clients that we work with, they've gotten things past the point of a benchtop prototype and understanding that the science works and that there is likely to be a market there and there's reimbursement codes. But now they need to accelerate that towards commercialization and bring it under design controls. Design controls for us really start with user requirements, saying there are indications for use and intended use statements that have to be understood from the beginning, and that leads into what a user requires the device to be. But beyond the user, those are the bare bones requirements. Beyond the user, there are a lot of stakeholders that have to be involved in accepting your product into the market. So, the people that use it may not be the people that buy it, and the people that buy it may not be the people that decide whether or not it's going to be reimbursed. So, all of those stakeholders have to be understood as well, and what their journey is, what their criteria for accepting a new product into the market is going to be. So we broadly think of human factors engineering or actually just the industrial design process of involving those stakeholders too from a very early stage. Yeah, that makes sense. And it sounds like, very similar to cybersecurity, it should be done in the requirements phase and designed into the system, but often people wait till the very end, and it causes all kinds of issues. I imagine with the design and human factors, the earlier on, just like cybersecurity, the better. And from your experience in the industry, I see you've been in the industry for quite some time, have you noticed any trends in as far as design or cybersecurity that are moving one way or the other? Well, I mean, certainly cybersecurity is becoming an increasing concern at the FDA. And with recent changes in the administration and some of the uncertainty around staffing and timing for market submissions, the FDA is under-resourced right now. Hopefully, that won't continue to be the case, but making sure that your market submissions are buttoned up from A to Z, and that certainly includes cybersecurity, it's going to be increasingly difficult to go back and forth with the FDA and negotiate or try to understand what gaps there might be in the market submission.

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