Bringing Medical Devices Into The Home

Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use and want to use, without sacrificing any elements that would otherwise exist in a clinical setting.

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Dylan Horvath, Founder, President, and Chief Product Officer at Cortex Design.

Dylan has a degree in Systems Design Engineering and founded Cortex Design to be a firm that fosters human connection, improves health outcomes, and allows people to do things that they couldn’t do before.

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Some highlights of this episode include:

• Dylan describes design as a tool for understanding how people react and relate to technology. The design of those experiences should create empathy and fit in with a person’s lifestyle and their experience.

• When people bring home and use a new medical device or product, it should not be a completely foreign object. There should be familiarity with it already because it has features that exist in the person’s cultural landscape.

• When developing new medical products, engineers and scientists use different human-led design activities to get something to fit in someone’s home design.

• When designing a product, it’s important for engineers and scientists to understand that they may not be the audience. Ultimately, they’re designing the product for those that are going to use the product.

• Objects tell people how to interact with them. Unexpected behaviors and accordances signify improvements to bad design. Even small changes early on in the design process can have a big impact on user experience.

• Adding risk management methodologies to a product design/development approach and decision-making process is to use economic, regulatory, and market constraints to accurately assume, define, and validate user needs.

• The role beauty plays in medical products and devices is subjective, but there is beauty in well-functioning devices. The thing that is beautiful is when something considers how it appears and how it lives with the people that have it.

• Design only works within the constraints in which both manufacturability and aesthetic perception are successful. You can’t get away with one or the other.

Links:

Dylan Horvath on LinkedIn

Cortex Design

FDA - Medical Device Overview

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Global Medical Device Podcast Email

Memorable quotes from dylan horvath:

“Design is a tool for understanding how people react to a technology and how people relate with technology, and specifically the design of those experiences so that we can empathize and create products that fit in with a person’s lifestyle and fit in with their experience.”

“The challenge when developing medical products is the people and the skill sets and the activities that engineers and scientists typically go through to develop a new product can be very different from the types of activities that you go through to try and get something to fit in someone’s home.”

“People design their environments, unknowingly, to sort of fit with the image that they want to project about themselves.”

“When you’re designing a product, if you’re designing it for yourself, you can guarantee one sale.”

“I really got interested in medical systems because of the opportunity for improving lives. That’s our philosophy to this day.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey everyone. This is Etienne Nichols. Welcome back to the Global Medical Device Podcast. Today, we're going to be talking to Dylan Horvath. He's the Founder, President and Chief Product Officer at Cortex Design. Dylan holds a degree in system design engineering from the University of Waterloo. Cortex, the company that he founded is a firm that fosters human connection, improves health outcomes and allows people to do things they couldn't do before. So today's conversation is going to be focused on human centered design, in his time growing Cortex into a leading product development firm, Dylan's worn almost every hat in the organization. So he can speak to a lot of different sections of the business. He's worked as an industrial designer. He's worked with firmware. He's been a PCP developer, worked on international production and has made many trips to China. He's done a lot of different things. Today, Dylan provides leadership coaching to his team. He sets strategic objectives. He provides positive work culture. He does a lot of different things. His passion seems to be human centered design. I really enjoyed the conversation where we got to talking about beauty in design. So pay attention for that. Without further ado, we hope you enjoy the episode. Let's get started. Hey everyone. Welcome back to the Global Medical Device Podcast. This is Etienne Nichols, co- host of the podcast. With me today is Jon Speer, the host of this podcast, founder of Greenlight guru. Today, we also have Dylan Horvath, who is the Owner, Founder of Cortex Designs. And we're going to be talking well, maybe kind of a broad ranging topic, but the main thing we'd like to focus on today is bringing medical devices to the home. So without a whole lot more ado, Dylan, do you want to kick us off any comments on that so far?

Dylan Horvath: Yeah, for sure. So my name's Dylan. Thank you so much for having me on your show. I really appreciate it. It's always fun to talk about design as it relates to healthcare. And that's where our focus is as a firm as well. We're a full service product design firm in Toronto, and we focus on the human experience and we frame all of the product design development work that we do through the experience that someone who's using the product is going to have with your product.

Etienne Nichols: The usability. I mean, it's something that's really interesting to me. It's something that also seems to be somewhat mysterious to people as far as where does it start? Where does it end? Is it a completely different subject than design? What are your thoughts and philosophies on that?

Dylan Horvath: Well, you can think of design in many different ways and what it means is different to different people. So the way we really frame it is by thinking about design is a tool for understanding how people react with technology and how people relate with technology and specifically the design of those experiences, so that we can empathize and create products that fit in with a person's lifestyle and fit in with their experience. So when you get a new product, it's not a completely foreign object, there's familiarity with it already because it's part of... it has features that are part of your cultural landscape already. And the challenge when developing medical products is the people and the skillsets and the activities that engineers and scientists typically go through to develop a new product can be very different from the types of activities that you go through to try and get something to fit in someone's home and look at home on their kitchen counter or inside their bathroom or in their bedroom, which are very intimate places. And people design their environments unknowingly to sort of fit with the image that they want to project about themselves. We are, the two of us are probably doing that to a certain extent right now. I've got a background that I want to reflect to the audience and you have this very beautiful background as well. So when we start to bring medical devices into the home, we have to be cognizant of that as well and how it fits and what it says about the people who have them in there and what we want them to feel.

Etienne Nichols: You can see different layers of, you mentioned the word challenges. I can see different layers of that. So if I was an engineer, I've designed something to a certain extent before maybe coming to you or starting to think more about the empathy or the human led design, hopefully I've thought about it from the beginning, but that's not always the case. What are the challenges you see, or maybe how do you overcome those challenges of someone being kind of married to a design or already have something in their mind?

Dylan Horvath: Well, I think it's important to understand that when you're designing a product, if you're designing it for yourself, you can guarantee one sale. So what's important to understand is that you may not be the audience that you're designing that is ultimately going to use this product. A lot of the best products that we do see do come from a founder's personal experience, and they may have some personal connection with the desire for creating that product out in the world, but certainly in medical and life science, a lot of the time those products come from technology transfer out of academia or out of a clinical setting, hospital research institution. And those are typically not very personal type of environment or experiences. And a lot of the time there's baked in complexity that starts to become a part of the product. And so our role is really to question some of those assumptions about why things are there, or what features have been put in and the reason for them to make sure that the product is considering the whole environment that you want to market to, rather than the clinical setting in which it was incubated.

Etienne Nichols: So specifically with medical device, I mean, I can see that being the case with almost any product that you want to market. Are there any specific challenges with medical devices?

Dylan Horvath: For sure, clinical and medical devices. First of all, it takes a very skilled, talented, intelligent team that may not match everyone who's using the product. So what comes natural and intuitive to the researchers, developers, especially in medical and life science, but arguably in other product categories as well, tends to start from a place of complexity and distilling the product interaction down to the few key interactions that are actually required to complete a procedure or to complete a diagnostic test is sometimes gets considered too late in the game, especially if you've started to go through certifications and product safety, and you've started to lock down what you can change because the cost of going back and redoing it after discovering a fault can be very expensive and very time consuming and may not meet your market launch requirements. So it's important to consider," Okay, we have this framework and this very strict regulatory process to follow, but at the end of that process, are we coming out with something that can be used and people want to use, and people don't feel ashamed to use and doesn't hurt people?" Hopefully, we're reducing pain points along the way, whether those are perceived or mental pain points or in the case of medical procedures that can be actual pain that's involved.

Etienne Nichols: Yeah. Dan I'm reminded of a few years ago, or actually quite a few years ago, up until this point, my career, most of everything that I had developed from a med device perspective was going to be used in a control setting, generally the OR or certainly in a hospital- like setting. And I think up to this point too, the user was a healthcare professional, but I was helping working with the startup on a device that was going to be prescribed essentially to the patient and be with them on their person in a bag or some way for everywhere they want because of the type of therapy that it was of the product. And that's when I started to realize, you really have to design things differently because the jargon or the terminology that you use, the healthcare provider may speak one language, but the person in their home wearing this device, they may not speak the jargon or they may not understand. So really, yeah, kind of forces you to think about that user interface in a huge way and what information you're sharing with that patient in a huge way. So there is quite a bit of difference, at least that I found.

Dylan Horvath: Yeah. And broadly what it means for that person who's carrying that product. Or if it's wearable, it's something that becomes very closely, literally connected with them. And Holter monitor is a good example. This is something that's very embarrassing to wear and something that you have to wear for a long period of time where like, unless you're sequestering yourself to your home for the duration of a diagnostic test, people are going to see it. And you have to make all these kind of affordances in order for them not to be a stigma of wearing it out in the world, seeing all these cables poking out from under your shirts or belt loop or whatever. So sometimes small changes right at the beginning can have like a really big impact on what the adherence is to a diagnostic procedure, for example.

Etienne Nichols: I'm sure being in the field that you're in right now, you've probably seen a lot of different pitfalls, maybe the wrong way to do it. Do you have any examples of that? I like to learn from what not to do sometimes.

Dylan Horvath: Well, I want to be careful not to call out any clients that we've worked for in the past, but I think you can see a lot of the times when there's evidence of something that isn't well designed, one queue that's really helpful if you're in an operating room, for example, and you look around at the suite of equipment, anything that has a label on it that someone else has added, that's a good indication that there's been a gap in the design process. There are no affordances on that device for providing the information that now someone has felt is pertinent enough to stick a label on. So what we look for, especially early stage is what are the sort of unexpected behaviors or what are some of the affordances where if you're looking at that person operating, you may have an assumption about why it is that they're doing that thing, like writing a label on an infusion device, for example. But if you go and dig a little bit further and ask them, then you can start to get some insights or ideas about improvements that could be made.

Etienne Nichols: So you mentioned some words there just, I thought maybe it'd be good for us to establish a little bit of nomenclature. I recognize what your like affordances and signifiers from... What's that book? Design Of Everyday Things. Can you give us some, I guess, definitions-

Dylan Horvath: Examples?

Etienne Nichols: ...around some of the stuff? Yeah. Examples. Definitions.

Dylan Horvath: Yeah. I mean, objects tell you how to interact with them. And so, an affordance is a handle, for example. So a handle is telling someone who looks at that door or looks at that opening that this is the point of interaction. So if you have a handle that tends to mean you need to pull, and if you have a knob that means to twist, if you have a button that means to push, we also infer things based on color, red means one thing and it means different things to different people too. So a red button to someone in a plant could mean E- Stop, emergency stop. You got to shut the piece of equipment down. And that's used in medical devices as well. Green may be to proceed or green may be a positive check. So when you're making aesthetic decisions, especially in medical devices, you have to be aware that your aesthetic choices may impact someone's perceived way in which they want to interact with it. So yeah, those are affordances and you want to design in the affordances, which will inform the user of the proper way to use something. It could be color coding, points of interaction, making those surfaces or making those handles or latches really inform the person about how to use them rather than leaving it up to an instruction for use manual.

Etienne Nichols: So when you go upstream of this, so you talk about affordances, like a handle being something you push down to open or a knob you twist it. We learned that from an early age. And similarly with, I guess, with the color, maybe the color's inherent. I'm not exactly sure. There seems to be a lot of psychology there, is it an affordance because that's what the entire, our culture is aware of, knob and things like that. Is there something even more instinctual or could there be or how do you determine whether there could be something besides that? I don't know. Does that make sense, what I'm asking?

Dylan Horvath: Yeah. And sometimes I would say like a big temptation is to provide affordances for everything that you might want to do on a product. And that can be quite overwhelming. So when you have too many knobs, too many buttons, a piece of software that has lots of menus or lots of interactions that isn't guiding you through, the choices that you need to make at that particular time. I think user experience is very often thought about through screen based interactions. A lot of the user experience, or even what is called like a product design job now is virtual or it's screen based. Whereas with hardware, you'll often need to make a choice about what it is that you want the hardware to do for the person versus things that are faster, or close the loop faster, if a person does them. For example, we did a diagnostic system that involved adding some liquid to an assay. So that's typically something... actually, a really good example is the rapid COVID 19 test, which suddenly everyone is intimately familiar with whether you want to be or not. But this is a medical device that someone is interacting with. So everyone is familiar now with having to add drops of a buffer solution to a paper based assay. Like here's one that I did today, right? So you're adding drips to this and then the signals migrating across. So this is not an automated system. This is a very manual system and it's very inexpensive. And there's lots of benefits to that. If you're trying to do that in an automated system, you have the choice of whether or not you want that buffer solution to be added mechanically or electro mechanically, and take that variability out of the system that would otherwise be placed on a user. And it will have all sorts of trade offs if you do that, you're going to lengthen your product development time. Now you're going to have to add a buffer solution reservoir in the device, rather than a person grabbing a bottle and squeezing it up himself. You have this really amazing machine at your disposal all the time, your hands, your eyes, your brain, and as a product designer, you have to make a choice about what you are willing to load a person up with and what you can take off of them as a burden for a more successful product. And that's a hard choice. That's a hard choice a lot of time.

Etienne Nichols: Yeah. I got to imagine that in your role as a product designer, I mean, you may not describe it this way, but I got to imagine you're applying a lot of risk management methodologies to your approach and your decision making process. And just going through the example that you just mentioned, the user error is diminished if more of that system were to be automated, but it's not pragmatic. So now you have to design a workflow that's very manual, very hands on, but I got to imagine at the same time, now your risk for user error now increases. It's like how do you balance all of these? How do you weigh and make these types of decisions that go into the product design?

Dylan Horvath: Exactly. And that's the trick and the way to make those decisions is with constraints. So, you have constraints, you have economic constraints of what you as a company can afford to develop and where you see merit, you have regulatory constraints about what you actually are allowed to do to get an FDA approved medical device out in the market. And you have market constraints about when that product can be ready as well. And all of these choices do introduce risk and not just product risk, but a company risk. There may be risk to having a successful device deployment. But if you mitigate that risk too much, you may miss the window for market acceptance, or you may have a competitor come that you know is already working on these problems and they close faster because they took a few shortcuts that you didn't want to do. So having a really good conversation about those risks and realistically what it is that we can do within those constraints is part of what needs to be done right up at the front of an engagement. And the biggest problems come in when it's done too late and when those realizations come in too late.

Etienne Nichols: I think it's a big, it's a strong argument for getting those things taken care of early on. In life, there's some no matter whats. No matter what you're going to have to pay taxes sooner or later, that sort of thing. There's lots of different things like that when it comes to medical devices, no matter what, one of the no matter whats is, you're going to have to validate your user needs. You're going to have to validate the product, meets those things. So you'd mentioned making those design decisions early on and then moving through the design process. It sounds like those clearly, and maybe a better word is accurately defined user needs is one of the most important parts of your process. Would you agree or can you elaborate on that?

Dylan Horvath: Again within constraints, you have to make some educated guesses and look at the data in front of you and make a decision and ultimately go down that decision and live with the choice of that initial decision. But you mentioned user validation. That's a really important step that people love to skip because once you made a decision and you feel like it's got some merit within your own development team, it's hard to pause and it's hard to go back and say," Okay, let's take a look if we've made good assumptions here." As inherently, there's going to be some bias within the team of a choice that's made and, the expense that has been incurred to make that decision as well. But I would say that was one of the biggest pitfalls of product development is not going back and validating. That's a user will understand the choices that you've made in product development process.

Etienne Nichols: So it's really, they may go through the exercise of validation just to show that their user needs, but it almost sounds like what you're saying is it really needs to inform the design. And I'll oftentimes... that is not the case. You either pass, fail, tweak a little bit and maybe pass at that point. But what really needs to happen is go evaluate, do those user needs, are those really what they should have been? Am I understanding that right or any thoughts there?

Dylan Horvath: For sure because you need to set certain rules to make decisions. And sometimes when we're being brought into a client's work, we'll start to question where those assumptions came from just to test them a little bit, because it's not obvious. Sometimes having completely green eyes on something is really helpful and the assumption may be made to de- risk something, or it may just be made because somebody had to say a decision, someone had to make a decision to go forward and those decisions may have impact. We're working with the company right now that is developing a mechatronics system that has articulated joints and the degree of freedom is limited at each joint. Like the amount of rotation or the angle of rotation is limited. I'm trying to speak in general terms here. And that was one of the questions that we asked," Why is it limited to 22 degrees? Why isn't it 22 and a half, why isn't it 45?" And we found out that there actually wasn't a really strong reason for that. It was at that time of prototyping, what was convenient to develop and then that became baked into the product, whereas a higher angle of rotation means that the product can do a lot more with fewer pieces. And so catching it at that time and pushing back and checking some assumptions can be a really helpful exercise for a client that's been developing things in a certain way for a long period of time.

Etienne Nichols: Makes a lot of sense. So, Jon, I don't know if you're going to say something. I keep jumping in here.

Jon Speer: No, keep rolling. You're doing just fine. I'm not going to miss an opportunity to butt in if I need to, but no, that's good.

Etienne Nichols: Yeah. So I was just thinking about, starting from the beginning with those user needs all the way to the end, think about that whole process. I didn't go too much into your background necessarily, but with the systems engineering, how would you say that background or that training kind of put that in you or?

Dylan Horvath: Well, so my background is in engineering. I've got an engineering degree, systems design engineering from University of Waterloo, which teaches a particular approach to engineering problems, to think of things in a systems context. And my background up until that point and throughout university and beyond was really developing technology systems and automation systems, mechatronics systems. I was heavily involved in robotics. And one of the things that I sort of had this light bulb moment, or perhaps a crisis where I realized that the systems that I was developing and reasons, I didn't really have a reason for developing those systems. And I realized that like a lot of my work was not involved with people and what I was really interested in was the interaction between people and systems. And I had never heard of industrial design at that point. It wasn't a program that was offered by the University of Waterloo and wasn't on my radar for whatever reason. Anyway, I discovered that as a discipline and that was a real light bulb moment where I realized there was a whole discipline that dealt with this very problem of how it is that people interact with technology and what those gaps are. And so I dove into that type of work, but with this technology background, and for the first few years of starting Cortex, I was really just trying to find an excuse to create beautiful objects that had a technology feature that gave me a little bit of a leg up on the other industrial designers I was competing with at the time to really have things that were unique in the world and created brand new experiences. And as the years rolled in or rolled on, I should say, I really got interested in medical systems because of the opportunity for improving lives. And that's our philosophy to this day, applying technology and our knowledge and our knowledge of humanities to solving tangible human pain points in medical.

Etienne Nichols: But Jon and I had recently had a conversation with one of our product owners, Andrew de Mayo, actually about Zen And The Art Of Motorcycle Maintenance. And I don't know if every engineer comes to a crisis at some point or not, but you mentioned a few things in there that really peaked my interest, I guess. One being you wanted to create beautiful objects that, you know, have this technology purpose. And I know it's kind of a pendulum, some engineers, they want to build something that it's going to do what it's supposed to do. It may be built out of 80/ 20 aluminum extrusion, you search around and find the buttons. You have no idea how to interact with it, but it does something amazingly well, because the other object, the other direction, it could just be something beautiful, but doesn't actually do anything. But what role does beauty play? I mean, I don't mean to pick on you before using that word, but I'm curious if you have any thoughts on that.

Dylan Horvath: No, it's a great question. And beauty is so subjective. It's very difficult to create something that is universally beautiful or considered beautiful by everyone who may want to use it. But there is beauty and well functioning devices. And from an engineering background, engineers will find something beautiful because it works, but they may not have the same perspective as someone who wants to see that thing in their home. I mean, Zen And the Art of Motorcycle Maintenance, I know industrial people who have motorcycles in their living room because they're so beautiful, right? And not everyone's going to like that, including sometimes their partners. But the thing that is beautiful is when something considers how it appears and how it lives with the people that have it. And certainly in medical devices, there's beauty in a highly, a product that really considers how it's going to be interacted with. And doesn't embarrass you to have, and doesn't make you feel cold or alone or in danger as you approach it. And there are aesthetics and aesthetic tools that can be employed for that. And it's a very emotional response that we have. We are emotional being and our emotional function is actually a much more powerful brain function than our logic functions. We use our emotional response to justify logic. And so it's important to consider that initial emotional response and beauty is part of it. I was a little bit circuitous, I guess, but-

Etienne Nichols: Sounds good. Many, many, many years ago, I remember one of, some of my first interactions with some industrial design folks. Some of my experiences went sort of like this Dylan where industrial designer presented images and we had 3D cab, but a lot of the 3D prototyping and all the things that we have readily available to us now were they were around, they were a novelty. They weren't every day ubiquitous part of the process per se. But you get some concept from a design, from a product and looking at," Wow, that is beautiful. There is beauty in this thing, this medical device." And then you start to figure out," Okay, tooling and how we're going to make this." And all too often, unfortunately I was handed designs that were not able to be manufactured in a way that was pragmatic. And it was like," Oh. We had a disconnect somewhere along the line where you gave me a beautiful design that cannot be made. We cannot fabricate tooling to injection mold this part or wherever the case may be." And I know this is in every discipline for sure, but I mean, is that a stigma in your space and how do you address that? Because there's got to be that right balance.

Dylan Horvath: Design only works within the constraints, which can be successful as a product. And part of that success is manufacturing success. And having a team that understands that is really critical. On the flip side, if all you're considering is manufacturability and you're not considering what the perception of that product is going to be, when it's opened up on wraps, taken out of the box, it will also fail. So you can't get away with one or the other, but I totally understand, or can empathize with that frustration. Sometimes we've gotten products or taken over products from firms that are strictly aesthetic and Blue Sky, a concept. Blue Sky concepts are interesting, but you have to recognize the skill of the team that is executing on those. Industrial design, I think from its root was really about manufacturing and being able to work with modern tools to create products that were unique and human centered, but were very manufacturable. And I think now it's not as common to do manufacturing onshore for example. And so a lot of the interests and education that occurs in North America doesn't have that manufacturing focus. So, that is something that we really place a great deal of value on right at the beginning stages. And we're responsible for manufacturing, a lot of the products that we design. So if it's not manufacturable, it's going to hit us and it's not in our best interest to Blue Sky things that are then impossible to produce. So I think it speaks to alignment. It's really good to have clear expectations and clear alignment within your team of what it is that you're trying to achieve and what your scope is to do that. There can be great value in doing Blue Sky explorations. And sometimes that sets the product intent or creates some questions to assumptions that you may have made like, wouldn't it be great? Yes, but it does need to be grounded and brought back to how are we going to actually do this and prototype it and get it out into volume manufacturing.

Etienne Nichols: Do you find that when you work in life sciences, I mean, sometimes I think there's this perception that novelty and uniqueness, it may be what I want from a product positioning perspective, making that, or going in that direction can be challenging from a regulatory perspective. And so you're forced with these decisions or these choices, these potential compromises where," Maybe I can see where incorporating this feature or this element of this product would give me some uniqueness, but that's going to create too many obstacles and barriers when I go to prepare a submission for FDA." I mean, how do you balance that?

Dylan Horvath: Yeah, absolutely. We're working on a project with someone who involved oral swabs like saliva collection. And in order to do the diagnostic process, it would be really great to have an oral swab that was designed in a unique manner and had some features in it that would allow processing the saliva in a particular manner. However, to go down that development path was prohibitive. And to go through just the regulatory on that portion of it was prohibitive. And there are commercial off the shelf devices that would perform that, not exactly the way we would like it to, but the barrier to do it exactly the way we would like it to meant two or three years and two or three million dollars of development effort. So being realistic with what can be achieved within economic constraints and market constraints, those are when some of those decisions come in. It would be great if however, within the constraints of the regulatory system and the costs that are involved, we need to follow some standards or stand on the shoulders of another product that did this particular component that's important, but not a key part of our IP.

Etienne Nichols: So some of what we've talked about is I think, directly applicable to an engineer level, a team level. Is there any advice you can give to organizations, like if you were to zoom out just a little bit to give an overall organization a sense or a way to achieve this in a cultural way, any advice on an organizational level?

Dylan Horvath: That's a great question. Yeah. And identifying it as a cultural issue as well, because there can be strain when you have competing constraints. So if you've hired someone to do concept developments and then it's sent off to another engineering firm to make it real, and then you have a regulatory consultants over here who has their agenda as well to get it through market acceptance and regulatory acceptance. Those can be three very competing agendas. And what we've tried to do is create an organization where all of that is in house. And build that culture as our own internal team where we're helping each other, rather than hindering each other and enabling each other, rather than striking down ideas that could be really good. One of the little tricks that we use when we're developing new ideas, especially in the very early stage, is all ideas can be good and all ideas are precious little things that are easily damaged, and you have to present them from a place of safety in order to speak them, in order to give birth to them and let them live for a little while and see whether or not there's something there. So one of the things that we try to do is for our regulatory person who may be involved in an industrial design discussion rather than saying why something won't work, why someone else's idea won't work, the trick and the mind game is to use your experience to amplify other people's ideas. So we say, you can knock your own ideas down, but you have to use your experience to amplify other people's ideas even if you think they're lousy. And through that, you can start to get these a really multidisciplinary approach to growing solutions. And then you all work together on the execution side to see if those assumptions are valid. And if there's sort of a growing resonance and excitement throughout the product development process that," Yes, we've got something. This is great. That was a really key realization." And through each stage, this is kind of risk mitigation as well. You're mitigating risk by checking the boxes. And as you're checking the boxes, you're getting excited and going through those stages of development towards the market launch.

Etienne Nichols: I love the idea of that cross development or that cross functional team from the very beginning, I had one mentor in my career at one point, he said, because product development and quality, they can, I don't know where it is everywhere, but in some of the places I've been, they can butt heads a little bit, I want to do this. And quality's like," Nope." One man told me, he's like," Well, they can be police or they can be partners. You need to treat them like a partner and you'll get a lot further." And so the partnership versus police concept helped me a lot. And it sounds like similar to what you're saying.

Jon Speer: But I think it goes back to what you were ringing up a moment ago. You know, it's got to be cultural at least at some level, right? The situations where quality and product development engineering may not be getting along so well, that's also cultural. It's been allowed to exist that way. And it's like, how do you break down those barriers? So...

Dylan Horvath: Oh yeah. In between sales, right?

Jon Speer: Yeah.

Dylan Horvath: Like sales and sales and engineering, oh my goodness. Sales sold this thing. They've said that our company is going to be able to do this thing. We don't know how to do that, but salesperson is nuts. So having the engineers integrated in the sales process is something that's really important to us. So that there's not only buy in from the engineering team on something that we're suggesting we may want to do for this client, but also that for the clients they're speaking with the engineering team, that's actually going to make this real. And those relationships develop early on as well. So the culture that you're stepping into. But absolutely... and that goes to vendors as well, or customers for us, not all customers see life the same way that we do. And one of the things that I think is important is to see whether or not you do have compatibility on values before getting too far down a development process. And so we try to make those values really transparent so that it's either going to create resonance or dissonance. And if it creates dissonance, that's okay. Because the project is probably not going to go that well, if you don't have alignment on values.

Etienne Nichols: Well, I'll just read what you have above you. Because I think it kind of sums up some of that people deserve a better experience. And one company I was with, they did some of this personality training or whatever, the different engineers, we all fall in different categories. One guy, he was a very dominant personality. And someone asked, he said," Well, I get things done." He said," Yeah, you got things done, but Sally's got a black eye and Tom over there's unconscious." If we want to solve a problem, you know, an indication for use, you want to do that, but you also want to do it in a way that is pleasing to use and is not going to cause misuse and things like that. But I don't know, I'm sure you can be a little more eloquent than I, but...

Dylan Horvath: Yeah, well, I mean, they can be a challenge for senior engineers and senior designers where they may feel they've already experienced all the risks and experienced all the pitfalls. And so they know the way and the trick is to allow those people to or encourage those people to listen rather than speak right away and amplify rather than consume. So it's very difficult for someone to get good if their ideas are slammed or if they're not shown by example how things can be improved. And it's also impossible to listen to new ideas if you're not open to it. So young staff have great experience and great cultural experience and awareness of trends that older or more senior staff may not have. They just don't have the clarity to go from A to B so quickly. So, I think there's a role for both staff, but yeah, absolutely like if you have a person who is demeaning or shuts people down too quickly in a conversation, that's a culture killer and they may be really terrific, but they're leaving a trail of dead bodies behind them, then they can't really be there.

Etienne Nichols: Yeah. Teamwork is definitely more powerful situation where one plus one can equal three. So, yeah.

Dylan Horvath: And you see it sometimes with clients where there's a trail of dead firms behind as well, and that's a red flag too. It's like," What, how come that didn't work out nine times? And there's maybe a great new technology or great new science, but it's taken 20 years to get into the market. Why is that?" Sometimes that reflection is important.

Etienne Nichols: Very cool. I don't know that I have any other questions because we're kind of coming up on time here. I could probably talk about this a lot, especially how to capture beauty if that's always been elusive in design. But like you said, I guess I'll just repeat one thing you said early on, and that is, if you design something for yourself, you're guaranteed one customer. I thought that was really good. That was a good point. I'm going to probably not forget that one.

Dylan Horvath: Yeah. It's going to like kill your darlings, be okay with your idea, not being the best one, it's going to be helpful and be open to someone suggesting a better way to do the same thing. And it's really difficult, right? Like you actually have to work at it. I think everyone has a desire to have the right solution. But from my point of view, having a team that can produce the right solution from many influences and many points of view is real point of strength.

Etienne Nichols: Jon, any last words?

Jon Speer: I just appreciate, Dylan, your insights and sort of the sharing some of the philosophies, I think design is really important in our everyday lives. And usually I think we know when there's good design, but it may just be an obvious or not a conscious thing maybe, I'm struggling for my words here, but we do know when it's a bad design, because we talk about that. We complain about why this just doesn't work the way I would expect it and that sort of thing. So I think just for those listening realize that you have a responsibility when you're involved in the design and development of a product and I like Dylan's north star, at least that's how I interpret it. Because it's very similar to mine is we have this opportunity to improve the quality of life. And I think doing so with well thought out design to improve outcomes is something we should all strive for in the product development space.

Dylan Horvath: Yeah. I appreciate that Jon. I mean I think we can choose to do many things with our lives and ultimately, you have your interests and you have your skillsets and you have your passions. So what I look for is people that are passionate about this pursuit because then you can get great alignments and great results.

Jon Speer: Absolutely. Absolutely. Thank you for spending time with us today.

Dylan Horvath: Thank you, Jon. Thank you, Etienne.

Etienne Nichols: Yeah. Thank you, Dylan. Where can people go to find out more about you and the work you're doing?

Dylan Horvath: Well, the easiest place is on the web. So www.cortex-design.com is our site. And also on LinkedIn, if you are in the habit of reading content on LinkedIn, we talk a lot about our approach to design and our methodology and what's going on in the company on LinkedIn. So before you engage, take a little peruse of the things that we write about and if it feels good, you should get in touch with us.

Etienne Nichols: Great. Well, thank you. Just echo what Jon said, appreciate you spending some time with us today. And for those of you listening, you've been listed to the Global Medical Device Podcast. This is powered by Greenlight Guru, the only medical device success platform that is specifically designed for medical devices. So encourage you to go check it out at www.greenlight.guru. Thanks everybody. Have a great day.

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