The Human Factor in MedTech Design with Dylan Horvath | Ep. 20

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. So, yeah, I think it's really important, as you said, if you consider some of these constraints too late in the game, it's very expensive to change. So that includes cybersecurity and access to microcontrollers or computing devices on the device, making sure that they're hardened or protected in a way that's going to be accepted first round. So rather than hiding behind a sort of ill-informed market submission or something that isn't 100% complete, I think the recommendation we're pushing forward is you have to have a very high-quality submission right at the beginning. Yeah, that's a good point. It sounds like if you do it the first time right, it'll save you a lot of effort because what you alluded to is, due to the cutbacks to the FDA and things, the back and forth is going to just really, really delay your submission much more than it used to, it sounds like. I think there's a lot more uncertainty right now. And certainly there's a lack of resources or diminishing resources there. So, you have to do more with less, and that certainly means minimizing back and forth communications, trying to get things right the first time. And being open and honest about what your gaps are. If you're honest about your gaps, that's great with the FDA personnel that you're dealing with, but that's probably not going to get your market accepted or your product accepted. I've heard a couple different things about the changes in the FDA and the current administration in the United States. That some people have a theory that it's going to be easier to get things through because there's not as many people at the FDA looking at medical devices anymore, so they might just stamp it easier. And some people have a theory that it's going to take longer because there's not as many people, so it's going to take longer to go through the approval process. And I guess time will tell basically. Yeah, time will tell. And if I was going to make a prediction, I would say you're probably going to have some that go through faster and some that just don't go through rather than more of a middle ground. I was looking at your website, and I'm interested in your culture. On your website is awesome. You have these six points on your culture, and I think they're very good things to have when you're working with a client. Like one of them, you have this empathy for the user, and I wrote a book about empathy and bringing some emotional intelligence to high-tech industries. Like, can you talk a little bit about your culture and how you got to where you have those six points? Like your last one is,