Episode 37 · May 20, 2025 · 34m listen · 5,805 words · ~29 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 37 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, host Christian Espinosa is joined by Dylan Horvath, the CEO and founder of Cortex Design, a firm specializing in medical device design and development. The conversation centers on the critical role of human-centered design and human factors engineering within the medical device industry. Dylan Horvath brings his extensive experience, having founded Cortex in 1999 and gradually shifting the company's focus to the highly regulated and impactful MedTech space. He discusses the common challenges and misconceptions surrounding industrial design in North America, particularly within medical technology, where it's often narrowly perceived as mere aesthetics or "look and feel." Horvath argues that the medical device industry has historically been a "laggard" in integrating design as a core component of the development process. He emphasizes a more holistic, cohesive philosophy where industrial design and human factors engineering are intertwined. A central theme is the distinction between a device being "safe and effective"—the baseline for regulatory approval—and being "commercially successful." Commercial success, he posits, hinges on market adoption, which is driven by creating products that people not only need but also want and find intuitive to use. This requires a deep understanding of the user and their environment, especially in high-risk settings like operating rooms. The discussion delves into the practicalities of the design process. Horvath stresses the necessity of integrating human factors engineering from the very beginning, starting with user requirements, indications for use, and intended use statements. He expands the concept of the "user" to include all stakeholders in the device's ecosystem, including the purchasers (who may be different from the end-users) and those who decide on reimbursement. Overlooking any of these stakeholders can lead to market failure. This "shift-left" approach, as the host Christian Espinosa notes, is analogous to best practices in cybersecurity, where addressing issues early is far less costly and more effective than trying to bolt on solutions at the end of the development cycle. Making design or hardware changes late in the process, especially after regulatory testing, can be prohibitively expensive and cause significant delays.

Key takeaways from this episode

Human-centered design must be integrated from the very beginning of the medical device development process, not treated as an afterthought.
A medical device being "safe and effective" for regulatory approval does not guarantee its commercial success; market adoption depends on usability and user desirability.
The medical device industry has historically been slow to adopt design as a core part of product development, often limiting it to superficial aesthetics.
Effective design considers all stakeholders, including the end-user (e.g., surgeon), the purchaser (e.g., hospital administration), and those who determine reimbursement.
Changing design, hardware, or firmware late in the development process is extremely expensive and can cause major delays, highlighting the need for early planning.
Industrial design and human factors engineering should be viewed as a cohesive whole, working together to create a seamless and effective user experience.
To achieve market success, it's crucial to design a product that people will like and understand how to use, not just a product that the design team personally likes.

Full episode transcript

Host: 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? Guest: It's going well. How are you, Christian? Host: I'm doing good. Uh a little bit tired. I was at LSI conference last week and uh didn't get much sleep. Uh very busy, you know, trying to get business and networking and just uh meeting more people in the community. Host: So I think it's an important topic uh with design. I know you focus a lot on human factors with your design. Can maybe you talk a little bit about I guess what some of the biggest challenges are in the industry from a design perspective. Guest: Yeah, well, I mean the there's there's certainly a greater appreciation of the uh need for great human factors engineering and and how that relates to design. Um I think, you know, broadly in uh in the medical device industry, um design has been a bit of a a laggard and in being core to the development process. And uh um the understanding of industrial design within within North America isn't is really very well understood either. Guest: Um you know, it's largely thought of as look and feel and um and, you know, in in in medical design is sort of thought of as human factors engineering whereas we think of those things cohesively as as a whole. So, you know, at Cortex, we we have a very human-centered design philosophy and process. Um but that is wrapped around um an ISO 1345 QMS design to get devices into into the market quickly. Guest: So, you know, as you know, safe and effective is is core to all medical devices, um but that doesn't mean they're commercially successful. So commercial success really means about market adoption, making sure you're designing a product that people want, that people that people understand how to use and and can resonate with um at first glance. Host: From a design perspective and I I took a class in college, uh human factors engineering, I never heard of what it was before then. Um but it's it's obviously super important for a physician or surgeon or anyone that's using these instruments because they're, you know, often in a operating room or somewhere where the the circumstances are pretty high from a risk perspective. Host: Like what what are the um I guess the main items that go into the design? Is it done like initially or you do a design and get it on the market then kind of get some feedback and tweak it or how how does that process work? Guest: Yeah. Well, so it's it's so expensive to get um a product launched and through regulatory and, you know, 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, um understands that human factors engineering has to take place from the beginning, um from the very, from the very beginning. Guest: So, you know, a lot of a lot of the clients that we work with, they've gotten things, um, past the point of, uh, you know, a bench top prototype and, you know, understanding that the science works and and that there is likely to be a market there and there's reimbursement codes and, but now they need to accelerate that towards commercialization and bring it under design controls. Guest: And um, you know, design controls for us really start with um user requirements. So, you know, there's the indications for use and intended use statements that have to be understood from the beginning. And that leads into what a user requires the the device to be. But, you know, beyond the user, you know, those are those are the the bare bones requirements. Beyond the user, there's there's a lot of stakeholders that have to be involved in accepting your product into the market. Guest: So, the people that use it may not be the people that buy it. And you know, 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, um what their uh what their criteria for um accepting a new product into the market is going to be. And um, that, so we broadly think of human factors engineering or or actually just the industrial design process of involving those stakeholders too uh from a very early stage. Host: 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 to 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 then from your experience in the industry, I I can see you've been in the industry for quite some time. Like, have you noticed, uh, any trends in far as design or cybersecurity that, you know, are moving one way or the other?

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