The Prosthetics and Orthotics Podcast
The Prosthetics and Orthotics Podcast is a deep dive into what 3D printing and Additive Manufacturing mean for prosthetics and orthotics. We’re Brent and Joris both passionate about 3D printing and Additive Manufacturing. We’re on a journey together to explore the digitization of prostheses and orthoses together. Join us! Have a question, suggestion or guest for us? Reach out. Or have a listen to the podcast here. The Prosthetic and Orthotic field is experiencing a revolution where manufacturing is being digitized. 3D scanning, CAD software, machine learning, automation software, apps, the internet, new materials and Additive Manufacturing are all impactful in and of themselves. These developments are now, in concert, collectively reshaping orthotics and prosthetics right now. We want to be on the cutting edge of these developments and understand them as they happen. We’ve decided to do a podcast to learn, understand and explore the revolution in prosthetics and orthotics.
The Prosthetics and Orthotics Podcast
Dynamic 3D Printed Knee Orthoses with Dave Johnson
Maybe the solution to your knee pain is a high-tech 3D-printed brace inspired by an injury from the football field. Today, we’re talking to Dave Johnson, the CEO and founder of the startup Icarus Medical, about his unusual path from a childhood on a dairy farm to inventing innovative knee braces. Dave describes how his life journey and a successful career in chemical engineering for the Department of Defense provided the inspiration for developing a high-performance, metal-free knee brace for fighting patellofemoral osteoarthritis.
And 3D printing how? Dave provides an ingenious step-by-step, from the first heavy, bulky prototypes to their eventual lightweight, contour-fit, form-fitting incarnation. His descriptions of the iterative development, including his incorporation of an elastomeric band to improve fit and tolerance, as well as the employment of a biomedical engineering intern, are both fascinating and informative. Moreover, he recounts how his team realised that the heaviest components came from the support material used in the printing process and, thus, shifted to Multi-Jet Fusion technology, which is cheaper and can be produced in much shorter runs. By the time we had finished, we wondered whether perhaps the biggest takeaway was that these state-of-the-art, individualised, contour-fit, 3D-printed, durable, adjustable, lightweight knee braces for leverage-control osteoarthritis became economically viable in greater number because of the strategic application of HP’s Multi-Jet Fusion technology.
But as much as it’s about the tech and engineering, it’s also about the people who are running the ship. In this episode, we spotlight the empathetic, patient-centric culture at Icarus Medical, where no two braces are ever the same, and every person is accommodated for, because – simply put – they can be. Dave takes us through the extensive process of getting a custom brace, from scanning to finishing to quality control to shipping, and into the nitty‑gritty of maintaining good relationships with outsourced contractors. And along the way, Dave shares some of his hard-won lessons on cost management, market research, and the power of staying true to your vision and having conviction in your product. If you’re at all interested in technology, medicine and innovation, you do not want to miss this episode.
This episode is brought to you by Advanced 3D.
Welcome to Season 9 of the Prosthetics and Orthotics Podcast. This is where we chat with experts in the field, patients who use these devices, physical therapists and the vendors who make it all happen. Our goal To share stories, tips and insights that ultimately help our patients get the best possible outcomes. Tune in and join the conversation. We are thrilled you are here and hope it is the highlight of your day.
Speaker 2:Hello everyone, my name is Joris Peebles and this is another episode of the Prosthetics and Orthotics Podcast with Brent Wright. How you doing, brent?
Speaker 1:Hey, joris, I'm doing well. Man, you wouldn't believe this. You remember having a deal Akhtar on from Psionic. He actually came down and visited us and I'm actually going to be taking him back to the airport here soon. So we've had just a great kind of time together. And then he brought his patient ambassador down as well that we 3D printed a color socket for, and she's doing really well with it. So we're just talking about some of the ideas of what can go into the prosthetic socket. How do we get more things to where upper extremity patients and potentially other patients can actually feel what they're doing with a terminal device? So I thought that was pretty neat.
Speaker 2:That's super. It sounds super cool, man, and I'm really envious as well, because I haven't met you yet. So we haven't met. After doing this now for a couple of years, we still haven't met each other. It's just, it's actually terrible. We're going to terrible. We're going to need to do an agenda planning kind of deal session to make this happen, because it's ridiculous.
Speaker 2:Now, after knowing each other for so long and so well and then never having met each other. But we do meet lots and lots of people virtually through this podcast. That's wonderful. So who's on today?
Speaker 1:Yeah, well, I'm super excited to have Dave Johnson on today. He is the CEO and founder of Icarus Medical. They do a really innovative knee brace design and I'm looking forward to hearing his journey. But it's fully 3D printed, no metal, and so it's uh. I think that I think we're going to have a good uh conversation around it for sure. All right man, so um welcome to the podcast, dave.
Speaker 2:Uh and uh. So you know how'd you get involved with the OMP, hey, yeah, thanks guys, thanks for having me.
Speaker 3:This is cool what you're doing and, brent, I love the stuff you're making, so keep it up.
Speaker 3:Yeah, so I got started. You know I totally came in through the back door. This was never on my radar really, but you know, I kind of credit the origins back to growing up on a dairy farm in Washington State. The origins back to growing up on a dairy farm in Washington state. Um, you know my, my dad, watching my dad and my older brother work on equipment. You know things are always breaking down farm equipment vehicles and you got to fix it and you've got to be resourceful, you've got to be creative and, um, and you know, by time I was 10, 11, 12 on the farm, it was my turn. And you know, if I'm out running a baler in the field and something breaks, I've got to go understand the problem, fix it. This is before cell phones, just a little bit before cell phones, and so that just kind of taught me. You know to always think about how do things work and if something breaks, how are you going to fix it? And a lot of times it's what do you have around you that you can work with, like that um worked as a radiator repair uh kid when I was 15, 16, 17, and then, well, got into welding.
Speaker 3:Um, you know, went into college for something completely different. Um went into chemical engineering. Uh, and I on on that journey, you know, I really liked design and so I taught myself autocad and um, well, actually I did. I I took a couple of classes. That um got me some baseline exposure to that.
Speaker 3:But, um, you know, when I was in high school, um, you know, in parallel to all of that, I, uh, I was playing football and dislocated my knee and created a? Um focal chondral defect. Um basically knocked out some cartilage behind my patella. It was in the trochlea, and so, you know, I didn't really realize the impact of that injury. My doctor at the time had said hey, you're, you're gonna have problems later, keep an eye on that. And I remember having to wear a knee brace during football to play football. And it was so frustrating, it was hot, it was uncomfortable, it was sagging down. And I even thought at that time because I was 15, 16, 17, you're trying to figure out what you want to do in life and I thought I should make knee braces. This is what I should do. These are so bad and I had the cheapest one possible, I couldn't afford a nicer one, and so, anyway, went a different direction and ended up going into engineering and ended up getting a pretty cool job working for the department of defense. I was an analyst for uh, initially energy technologies and then um, and then chemical and biological weapons as a um, as a non-proliferation, trying to prevent the use and the spread of these weapons. So that was a a really, really interesting job.
Speaker 3:But you know, meanwhile you know I'm doing things like snowboarding and wakeboarding and softball and CrossFit and everything active and just gradually wearing away my patellofemoral joint. And in my 20s, in my upper 20s, I realized that I have a very advanced case of patellofemoral osteoarthritis and I didn't really still didn't really know what this meant until I started trying to understand how do you manage this, how do you manage this in your 20s and 30s? And I ended up having a surgery called a trochleoplasty, which is um, where they deepen your trochlea and um, and then and then I also had an MPFL reconstruction, which is a medial patellofemoral ligament where they um, it's kind of like a tether that that keeps your knee from sliding off laterally Um, um, it turns out I really didn't, I really shouldn't have had the surgery, didn't need the surgery, um, but also there there was a complication in the surgery and my, my knee fractured, and so, you know, it took what was not a great joint, um, and made it, may you know, much worse. So, um, you know, I'm the time, I'm 33 years old, feeling really active, really fit, but I've got this knee problem. So I met with my orthopedic surgeon and was talking about what I can do, and he suggested hey, if you lose some weight, you'll have a lot less weight off of your knee, because every one pound on your body is five times in your patellofemoral joint, or even more, and that's the nature of that joint. And so I thought, man, you know the nerve of this guy, but I mean it was, I could lose a little bit of weight, thinking maybe 10 pounds, um, but that got me thinking, okay, well, that's not really practical. I don't know if I can even do that and maintain that. You know, I'm reasonably fit.
Speaker 3:And, um, so I thought, okay, I'm going to buy one of those knee braces that when you bend down they spring you back up. And that seemed pretty obvious to me. You just, you just take that problem and flip it upside down. And, um, so I went to Google and looking for knee braces, you know, assistive knee brace, extension assist brace nothing, nothing's coming up. And, um, I was very surprised but, um, all right, so then I go, I go to eBay, buy a, an old rebel reliever, and, um, I cut out the hinges of this rebel reliever and, uh, you know, went to the metal shop.
Speaker 3:Uh, a friend of mine, let me use his metal shop, jeff fletcher, thank you, um, and took some piano wire and basically started making torsion springs. And you can, you can figure out how much force you're going to get based on, you know, the properties of that, of that material, and and the, the number of turns, um, to get your range of motion and the thick, the gauge of that steel. So I thought, okay, this is, uh, you know, this is about the force I need. Um, and I had a, uh, I had a friend's birthday coming up and we were going to go on a ski trip and I, you know, this is within a year of my surgery and I was determined to kind of feel like I've, you know, got this thing under control and I'm not gonna, you know, let it, you know, ruin me here. So, so I've got to find a way to make this ski trip, and so I've got a self-imposed deadline of getting this brace working. So, um, you know, I build these torsion springs and then I end up I actually used ratchet wrenches on in a way to adjust tension, and so actually the brace worked outstanding, in an outstanding way Uh, I mean, it was.
Speaker 3:It was, it was heavy, it was clunky. You know, it looked ridiculous cause I had to wear it outside of my ski pants. But I, it was. I, you know, I snipped somewhere the whole weekend and I was really, uh, excited that this, this worked. And, um, so, you know that that was that, uh, I, yeah, I proved it worked.
Speaker 3:And then I went back to work on Monday and didn't really mess with it until the next season, and so every year I was making this better and better and I pretty quickly realized I need to move from metal. It's just never gonna get the right force profile, it's never gonna get the right weight uh, weight and bulk, um, that's required. So, you know, I switched over to, um, making it with, you know, enter 3D printing. Here I ended up 3D printing these hinges that have a tension system where the elastomeric bands are actually, you know, as the hinge articulates, it draws the band apart, generating torque, and you can modify that torque based on, you know, the strength of the elastic band. And, yeah, that worked out great, it was way. It was way lighter, um, way more form-fitting, um, and worked on that for a while and then realized, hey, I need to be able to adjust this. You know, we need to be able to incrementally change tension in the device to really make it useful.
Speaker 3:And again, my main application here is snowboarding. So I'm thinking how do I crank up the tension, go down the mountain with my knee unloaded and assisted, and then when I get to the bottom, I release that tension and and come back, come back up, and at this point I'm thinking, I'm just thinking about myself and, um, and then I had friends asking to make them a brace and people would take my brace and go somewhere for the weekend, and so I started thinking and then I started to understand like this is a major, a major problem patellofemoral knee arthritis. It's the most common form of knee arthritis and there's nothing you can do about it. There's, you know, corticosteroids can help kind of mask, but the shear forces are so high in that joint that a lot of times that doesn't work well and actually a couple of studies show that that will accelerate the wear of your cartilage. When controlling for the increase in activity from getting that. So, um, you know, prp has mixed results with um, with patellofemoral, and so in physical therapy is um not great. It should always be tried, but you're not going to really change the situation with um your bad to put them all away.
Speaker 3:So, you know, I started realizing that this has a greater role here and um, you know, kept making the brace better and better.
Speaker 3:But the limitation in my mind was, um, you know, we were using fdm printing. You know, at this point it was me and a UVA biomedical engineering intern, um Ben, and so Ben and I are designing braces and printing them FDM and of course it's uh, you know, single extruder. So you have to be very um, you know, get very thoughtful of how you design this because you have internal tunneling and features. You know, get very thoughtful of how you design this because you have internal tunneling and features, and so they kind of kind of looked weird. But you know, 3d printing at that point to me was I was always thinking this is, this is the means to an end where you know I'm at some point going to. You know, prove it out and get a design and then think about how would I uh, injection mold this or something? But then I realized none of my 3d printing parts the gear teeth, all 3d printed none of them actually broke uh.
Speaker 2:So it turned out to be far more durable than I expected and the materials you were using, like was it what printer, what material?
Speaker 3:you said, uh, yeah, well, specifically, so started off just making the hinges and, and that was, um, trying to think of the material I haven't used it in so long it was, uh, um, it was just just the one above pla, but, uh, it was the very first one was a dual extrusion where you dropped it in a, uh, a hot, um water bath and dissolved one of the layers and then we were just using a PLA. Um, you know, we ended up using Prusa's, um, and then we were, we were actually 3d printing TPU using Prusa's and then making the whole, like one half of the brace frame, the upper half and lower half, using Prusa's. And we, you know, we quickly realized that is, uh, that's not gonna scale us very well and the design isn't great, um, you know. And then, and then the game changer of HP, um, you know, I knew, I knew it existed and I'd seen some parts, and, you know, pretty quickly realized this is a, this is has huge potential, um, you know, and so I took my, my frame, my, you know, the original frame, and sent it over to one of the contract 3d printers and got a quote back and twelve hundred dollars, you know, just just to print the thing.
Speaker 3:So I thought, well, okay, well, that that's just not even in the realm of being possible and reasonable. Um, but as time went on, um, you know, and as we looked around more and got to know more people, we found ways to make this cheaper and cheaper and got it down to a point where, hey, actually we can, um, we can sell this. I mean, we're not making profits that, uh, you know, any other brace maker would make. We're still. It's costing us, you know, four to eight times more to make a knee brace. But we can run in a lean enough way where we can make these, and this is scalable. This is now scalable based on the number of printers and as long as there's demand, and so that's basically how we got started.
Speaker 1:Hey, we're going to take a break right there and I promise we'll be right back with. Dave Wanted to introduce our sponsor for this season, which is Advance 3D. You may have heard of Advance 3D. We try to meet you wherever you are on your digital journey, whether you're starting to look at FDM sockets for check sockets or you're wanting to go all the way to definitive sockets with the latest in powder bed fusion. So, from learning to scan to printing definitive sockets, we can definitely help you along your journey. And now let's get back to Dave.
Speaker 2:And in terms of like, you know the difference between, like, the multi-jet fusion stuff and the FDM stuff, you know, are you like looking out for different technologies? Are you completely, you know, multi-jet fusion focused at the moment? What's your feeling on that?
Speaker 3:Well, I haven't seen. I haven't seen compelling information that something's remarkably cheaper and and remarkably better. Um, you know we, we were able. Finally, for us, I mean, the game changer really is, you know it's, it's, it was that technology. But uh, you know, for us as a company actually getting one when you control production and you control your timelines, and fortunately we've been able to build a really smart team and brilliant engineers and really smart people who can help run the equipment and basically get powder in the building and get a really refined product out and then do it on a short timeline. So we've got a discounted used HPMGF for you 200. And so to change, and so now we've got four. And you know we're, we are not really looking to change that ecosystem unless, you know, unless something else comes along that's drastically better.
Speaker 2:Okay. So first, like, imagine they're an inventor. It's great, you've got your little laptop, little workshop, you're doing this right. At what point does it make sense to go to a machine? You know, was it an economic thing? Did you just say, okay, we're outsourcing X amount we could get a machine? Because you know it's not just getting the machine, you have to hire people to man it, a lot of floor space, you have to set up the right kind of environment, you know. So what was that decision like for you guys?
Speaker 3:Yeah, yeah. So we, we also, we, you know, we launched during COVID. I, actually, you know I was I went out fundraising and prepared, spent months preparing the deck and all the financials and everything in, uh, you know, november, december, january, presented to these angel groups and then, you know, you know, february hits, uh, february, march, and then covid, right. So, pretty much, um, funding opportunities kind of went away. Um, you know, this really unpredictable new product, new product category, made in a new way, with, with 3d scanning, um, you know, just, a lot of investors didn't see that as a sure thing.
Speaker 3:So, um, you know, we, but we had, we had a very small place on the downtown mall in charlottesville, virginia, and it was, it was such a fun place to work in, but we were definitely not going to be able to get an mjf printer there. So, um, you know, kind of once, things just lined up, you know it was the right time, um, we did. Eventually, you actually had a lot of doctor investors, um, who would get involved and see that this, this really makes sense for what they're seeing. Um, because they don't have a solution for this, this problem, um, besides the joint placement. So, um, but anyway it, yes, so things lined up and we found a much larger space and, um, you know it's expandable and actually we're we're moving into uh, we're moving manufacturing into a second location that's even more expandable. So the beauty of this industry is totally scalable Once we outsource printing when we are over capacity, and then when we can support a new printer and justify a new printer, then we find one. So we've been really lucky finding printers.
Speaker 2:Okay, that's really good. And then I think also that you know at one point you did there were a bunch of discounted printers on the market and I love what that's done for people experimenting with them and kind of buying them, companies buying them that maybe wouldn't be able to afford the full price one. So I think that's a the secondary market stuff has really done wonders for more innovative uses of the printers. And would you give advice to someone like I mean? I think there's there's one thing that you know. It is a lot of work, right, I mean you're kind of making it.
Speaker 3:It's difficult. I mean, our team is running these printers at, I want to say, 99% uptime, 98%, 99%. We've got these things maxed out, but we baby them, we, we do um, you know, really, really meticulous with our maintenance, um, our cleaning and um, and and so that that's really important. But I think the key here, yeah, one, one person can do it. Um, but get, get a team who has the right aptitude to run it. And the person who I, when I started this company, I kind of had this collection of people who I met through different things, who I knew that they might be the right person to help with this and to help with that, and actually our our 3d printing um director here, carter, is um, he'd been working with a shoe company and he basically created all of their uh 3d printers to make shoes and he actually he was in a bad motorcycle accident. I ran into him and it just kind of stars aligned where he could work with us remotely and and then also, um, you know, do what a lot of other of our employees are doing, which is developing devices that they need that help them, and so so, yeah, part of it is, you know, you can be a one man operation or two men, but if you can find other people who connect on your mission and really believe in the mission and um, you know that that's yeah then then then you should definitely go for that.
Speaker 3:I mean, um, yeah, the other variable here is um SBA. So we were able to. We were able to qualify for SBA once we had revenue and we were making a case that we can sell these things. They're moving, we're getting traction, we're getting buy-in from big orthopedic surgeons and that's what funded this for us. And so, yeah, we're getting $25,000, $50,000 here and there from surgeons. But to really build out the 3D printing capability, yeah, we had to go to sba. And at that point you know you've got to be buttoned up as a company. You've got to have every aspect of your business plan not just a plan but functioning and um. So I really encourage people to look at sba and I'm happy to point point people to our contacts who helped us get through that.
Speaker 2:Okay, that's super cool. And about the printer, I think one important thing you did mention is you also do still employ an outsourcing partner, and I think it's really important to always have that good relationship with someone who can do if you're too busy or if a machine breaks down at the wrong moment or if you need something in of different material that you don't have. It's really important to keep that relationship with the contract manufacturer.
Speaker 3:Exactly and not just one. We try to. I know if we're part of somebody else's business model, we want to make sure that we're giving them business too, and so we're not, we're thoughtful with that. But yeah, absolutely yeah. And um, like you said, with all these other 3d printers in you know this, the used um secondary market here, um, I, I think that prices are coming down a little bit um and it's a little bit more accessible and and so, yeah, I think if you can create something, identify something, that's your product market fit, and um, you can protect your ability to make that um, you know that's then lean in, lean in on that okay, and then and do you have?
Speaker 2:well, one thing that's really interesting we've had a couple of people on that are like patients turned inventors kind of, and we always think it's a really very, very successful, uh kind of combination right, because you really understand what needs to be done and what's handy from your point of view, like getting it on and off, fitting it around pants, whatever, right, the actual practicalities. But is there also a point where it's kind of difficult, where you're like, well, is it springy enough for just me or am I making it for someone else? Is there a point where you have to be cognizant that it's not 100% for you, or did you just, like you know, you were just making this only for you and it's like an accident that there's a company right, or do you have to, like you know, design for other people at one point as well?
Speaker 3:Yeah, good, good question. You know it's. It started off as my quest to manage my problem, but I think we've bred a culture here that is very patient focused. You know we're here to solve problems and I think a lot of us are. You know we're that. That, that's what makes us happy, it turns out. You know, I didn't, I didn't even really know this about myself, about my team, but we, we, we really like helping people, which, which is what I actually really love about this industry and this community Everybody's out there trying to do something for their fellow human. And so when you have a community that is all like like-minded, patient, focused, um, you know, just, it just becomes, whatever we're doing, you, because you have that mission, everyone puts in a little extra effort.
Speaker 3:You know, if we're building in medial unloading, uh, in a knee brace, we basically look at this patient. You know how much medial unloading do they need? We don't just say, hey, give them three degrees, um, you know, varus unloader. So we, we think, okay, what's their height, weight, could be my, what's their pain level in that compartment and what is the amount of force that we actually want to impart in that joint? So we kept, you know, we fine-tuned this like art.
Speaker 3:You know, and I remind my team of this sometimes what we do is custom. It is the custom brace, it's not. You know, we're not a um, mass-produced knee brace. That is um, hey, just take it or leave it, it's. You know, we put your name on it, we make sure this thing conforms on your leg perfectly. We make sure it's as light as possible for your leg, we make sure that it won't migrate. So we have this thing called an lld uh, not a leg, a lower leg discrepancy, a lower load distributor that basically forms a wedge over the cap and prevents the brace from sliding down. And so we basically, you know and I think we have better insight on this problem because I have gone through many of these things and so I can really understand the problem very well and now we have targets to hit.
Speaker 3:And so you know, basically we've been going through what a knee brace is and challenging every aspect, saying is this the best it can be?
Speaker 3:Is this slot angle the right angle to be, uh, congruent with the thigh? Is the? Is the um? Is the clip? Does the clip eject the amount of engineering that went into our clip, for example? Um, where we can. You know, the idea is that you pull the clip forward and it jumps off, so otherwise the clip will just settle right back down into its groove. Um, so it's all these little things that, um, you know, fortunately, my, my team gets behind everyone from the engineers who are designing these, um, our software person thinking about how our app, our 3d scanning app, is going to be as user-friendly as possible. You know the, the fabricators in back who are basically making sure that there are no, um, you know, laser cut edges that could irritate the skin. Um, it's just being really, really thoughtful to make a premium level product because it's what I would want to wear, it's what what our Grammy, grandmas and grandpas and parents and everybody would want to wear, and it just takes a little bit of extra effort to be that thoughtful.
Speaker 2:And you yourself were quite young for an arthritic patient, right? I mean, is there a big difference between people who developed this earlier on and older, or are all patients kind of the same?
Speaker 3:No, there's definitely a big difference, I'd say. I mean, you know, if you're at 30 versus you know you're still fully expecting to go. You know playing full speed with everything. If you're 50, you may not have those expectations. So, you know, but it is the same dilemma where it's like, hey, oh, you have pain. You know, but it is the same dilemma where it's like, hey, oh, you have pain.
Speaker 3:Well, your options are either getting a knee replacement, either a partial or a total knee replacement, and the more active you are, the more quickly you'll wear it out. And so you know, I've already, I'm coming off of, I've had three knee surgeries, one of them was a catastrophe. Three knee surgeries, one of them was a catastrophe, and, uh, you know, a joint replacement at this age, um, you know that that might give me another five to maybe 10 years, um, and then I need another one. And then you know the, the prospect of the prospect of living a long life that's not, um, limited by by, uh, this, this knee problem, because we see patients who have failed knee replacements quite often, and it is a miserable. It's a miserable way to live. And then it's hard to get a surgeon to operate on you after you've had a failed replacement because you're you're a problem patient. So, um, you know, but that is the. The calculus is a little bit different for me versus somebody who's 60 and they say, hey, the pain, the pain's worth it. Um, you know, I'm gonna get a replacement now and it's gonna last me for the rest of my life. Um, you know so. But we see, you know patients at 70 and say, hey, now I'm gonna wait until I'm 75 to get my knee replacement.
Speaker 3:And, um, you know, this is a perfect complement to what they're doing and the outcomes of this are it's so much better than not to disrespect any braces out there. But because the biomechanics of this and how it's actually unloading the joint, it's reducing contact pressure, it's assisting the quads unloading the joint, it's reducing contact pressure, it's assisting the quads, and so it's by by doing that, it's reducing the total amount of force the whole meat is subjected to. It's reducing the amount of force that drives the patella into the femur by a multiple right. The deeper inflection you go, the deeper that multiple, the higher that multiplier, the higher that multiplier. So, because of that fundamental principle behind this brace, you know, we're seeing outcomes that are, in some patients. It's what you would expect from some surgical outcomes. Not quite as good as joint replacement, but this is a really good supplement for helping people manage their their knee pain. It's covered by insurance and, um, you know, we find a way to make it accessible to everybody.
Speaker 1:One of the neat things about I saw, uh, this brace, you know, or definitely early on, and then, um, we had a couple of people in our facility order one and one of the things that really surprised me one is, you know, it's super lightweight, very elegant, Um, but then also that, um, we say transverse rotation like very, very stiff, you know. So the stiffness and the, the, the thought process that has gone into some of the shapes and the profiles of these braces, leveraging multi-jet fusion technology, is pretty incredible. So kudos to you guys for that. But for the people that are listening, specifically clinicians and sometimes maybe the patients, can you share with our audience just what the process is? I mean, you did mention that you guys have an app and a scanner and that sort of thing, but can you like just start from the beginning? You know, say from the script, and then what does it look like? Appointments you sell through only prosthetists and orthotists, you go through a physical therapist, doctors, how, how does all that work?
Speaker 3:Yeah, yeah. So, um, all right, brent, let's let's say that you've got some patella femoral arthritis and you've done some sports and you're starting to feel that pain going downstairs and so you want to get one of these braces. You can either reach out to us or your doctor if they know about us. We now have a rep in North Carolina, so Haley may inform you, haley may inform you. So, basically, what would happen is one of our reps would scan you or you could go to pretty much any O&P they are now carrying Icarus, say pretty much any, pretty much any. One quarter of all of them would be able to take care of you, but they would decide if they want to scan your leg or cast your leg. Well, first they would decide if you need a custom or not. To show If you need a custom which I highly recommend, getting something that's highly tailored to your leg and so we would take a scan, you could use our scanner. I recommend scan time is three to five seconds, it's really simple and then you just submit the scan to us. So when we get a scan, we can either handle the patient directly or you can go through an ORP or you can go through an orthopedic surgeon. A lot of orthopedic surgeons carry other bracing brands and they might try to steer you into any other brace. But the problem is there's no other company can unload the patellofemoral joint or unload patellofemoral and tibiofemoral medial or lateral. So that's why you would want this brace. So we're slowly working on that but we're going against the system that's been established for decades, but anyway. So once we get an order form either an order form from a prosthetist plus a scan, or some people still ship us casts which we immediately scan Our engineers receive that. They oftentimes design it the same day. And so as long as we so you might say tell us how much unloading is required or we might have to calculate how much unloading we want to build in, be it lateral or be neutral Then we design the brace. We push have to calculate how much unloading we want to build in medial or lateral, or it would be neutral. Then we design the brace, we push it to print, usually that night, maybe it's the next night and it prints overnight. Cools a day. We pull them out.
Speaker 3:Post-processing multiple cycles of bead glassing, dyeing and then assembly. There's multiple cycles of bead glassing, dyeing and then assembly, and then stringing these braces up with our tensioning system, and then we've got a quality check where each of these are inspected to make sure that the padding is covering every aspect of the brace Didn't miss anything with the bead glass, actually, that's earlier making sure that everything's to spec for each order and then it ships out and, um, we can get things turned around pretty quickly and so we actually, you know the one, the one thing I'm really really proud of with with this company and with this team, is that we, we've just done it all I don't want to say all ourselves, because of course, people helped along the way, but whatever we didn't need we built. So we built the software to support it, the app, the software, the ERP that takes orders in, manages that process all the way through and make sure that the order's done, and we call them digital travelers that make sure that that thing is designed to spec and it's delivered to the right person. So that whole logistical platform. And we've got another person, another group, working on getting that to use that also because it's really sleek and, you know, very user-friendly. Um, so, and then also our app. We've white labeled our app for people if anybody is interested in um, you know, getting this whole system and um, yeah, and then now you know it, what started off with this, um, patellofemoral knee unloading brace, uh, you know, it just kind of naturally went into. Hey, well, can you make, can you make this a CAFO? Can you add a? You know an AFO and um, and so we've got now we're making a lot of CAFOs, which the CAFO is fascinating because, um, you know, you have it's, it's a new, it's a new class.
Speaker 3:This is a new class of device. Yeah, we've seen extension assist before, but you know already, okay, it's 3d printed plus carbon fiber. It's the latest CAFO. I want to say ever. It's less capable on the market that I've seen, and so so already going to have higher compliance for that, better fitting, better weight.
Speaker 3:But when you put this tension system, the swing assist is so useful for so many patients, um, and but the other aspects. So there are two versions. There's a standard version that has a standard swing assist. Uh, you force in the knee brace, it's up to 40 pounds of extension. Um, you know, assist and the we you can, you can change the polymer of that band, and so we've engineered another polymer that is three to four times stronger and so you can um by we've actually developed their own dial here Also um, you can adjust an increment tension to where you have, nearly effectively, a lockout, and so the patient can very quickly go between low force, high force, a lock and everything in between with a push of a button and everything in between with a push of a button.
Speaker 3:So we specifically designed our dials to be releasable by the push of a button, not just so I could control it through my snowboarding pants, but that was a factor, but really we wanted something that had between 10 and 12 to 1 mechanical advantage for these dials and we wanted something that, if I have arthritic hands and fingers, you know we were using BOA systems initially and we had a lot of problems with jamming and um patients, uh, you know, grab, having a hard time grabbing onto the dial and um and and releasing, releasing that tension and so um, so the push button is, you know it's just takes a very light touch and it's it's sunk in so it won't uh, pop on, pop in on its own.
Speaker 3:So, but anyway that sorry that's a sidetrack but the, the kfo, um, you know we're really interested to see, um, what data comes out on how this, how different ways this thing is being studied. But it seems, you know, it's not a swing phase lock and it's not a simple swing assist, it's a different category and I think we're going to see this is very useful. You know, we have a number of patients who they have other CAFOs in their closet. Um, they have even, um, like Seabraze type devices that, um, you know they're they're favoring this lighter, um, you know, adjustable system. So, um, we're really excited and this is just the beginning of that, so we're really excited to see how that thing grows.
Speaker 2:Okay, and then? And what are your goals for the company? Do you want to get you know? Do you want to stay small and just become like a possible long-term business? You want to grow, to be huge. What are your plans?
Speaker 3:um, so personally. So our, our mission, my, my personal mission, and it's just it's to solve these problems that are hanging hanging out in industry. You know I look at new bracing and, no, nobody's really said what, what is the best this can be, and gotten in there and address these problems. Um, and that's all these little nooks and crannies. Um, you know, how do you best unload the medial compartment? What is the best we can do there? Um, how do you best um address dorsiflexion? You know foot drop patients and like kindion. You know foot drop patients and like kind of not having the training that you guys have and a lot of this industry.
Speaker 3:You know it's all new to me and I'm learning. You know the nuances of these indications, but you know what we see is it's a whole new way of making bracing. You know we're basically changing force across the joint in an adjustable way and in a conforming device. So if you think about, what can you do with that technology? And so we've got a few more devices that I'd like to see come to market. And you know, once that's done, I feel like I could slow down a little bit. And then, you know, in the meantime, you know, you know we're, we're not one of those companies who's saying, um, hey, let's you know, pump, pump it up and get acquired. There's nobody on the team, that's um. You know that mindset. You know I imagine opportunities will come up, but, you know, not really worrying about that at all, we've already had opportunities, multiple opportunities, and just we're not interested in that.
Speaker 2:Okay, all right, that's good and I think you know it's interesting that you know. So you started as like an inventor. You seem like a very hands-on kind of guy. Now, okay, it's nice to come out with new devices, but that's also kind of like it splits their focus as a company. All of a sudden you've got two devices. Are you afraid maybe you're going to invent too much stuff and you need to really more focus on just the one thing?
Speaker 3:Um, that that is a good question. That is a good question. Uh, so, yeah, I mean, it's the classic, uh, you know, inventor and and and company dilemma. Um, you know focus, do you? How how much do you expand? Focus? That if we started to make knee braces and that's all we did, um, we would be, we wouldn't be very far.
Speaker 3:Sometimes, people, you know it's hard for them to get the different biomechanical system to get the benefits of this brace, and a lot of times in knee bracing it's the race to the bottom, it's what is the cheapest thing I could possibly get on my patient and that still codes the same, and so, which is an unfortunate um situation, um, but, but it and it doesn't leave a lot of room for innovation.
Speaker 3:Um, but you know, now that we make an afo, the foot drop race and the kfo, now, people that interest them and they want to hear about that, and you know so, and so, for example, some investors want to see us work on one thing and they'll invest if we put, if we put, resources for this. So you know it's kind of forced us. We've had no choice but to expand our horizons. Uh, but yeah, that that is a constant internal struggle and uh, yeah, you mentioned profitability, I guess in the last question that is. That is, uh, we're aspiring to that. We're not there yet. So, um, you know, hopefully, hopefully soon on the horizon, but yeah, it's been since 2019 as a company, um, and we're hoping to break out here pretty soon, but yeah, it's been pretty slow.
Speaker 2:Yeah, well, it's always going to take longer than you think, but it's a good goal, right? You could also just go revenue, revenue, revenue and just blow the balloon as big as it can go, but I think, especially now, I think striving for profitability seems like a much more sane option. And then another thing is like so you know you've got this startup, and well, you didn't. You don't have a friend of mine and we were talking about her becoming an entrepreneur and she's like I don't know what to do, right, and I'm like but no one knows, no one has any idea how to be an entrepreneur, and what is the stuff that you learned along the way?
Speaker 3:Yeah, no, exactly Like I've never done any of this before, I've never created a device, I've never created a product, I've never launched, marketed a product, I don't know the industry, I don't know the channels, and so it's all been new. And so you know you have to just learn. I mean, first of all, it starts with a vision. It starts with an idea of you know what is, what is the thing you're going to do? What problem are you solving? And then you know you just have to voraciously learn, figure out what, what's required to do that um, and figure out who's gonna buy it. It's all very it's. You know. It's kind of like being a parent. It's pretty natural. I think you know you're either. You don't have to read a book on saying what do I? What's the next thing here, like you're gonna say, well, how, okay, how do I get my cost out? Okay, who's gonna? How much will people pay for it? What is the reimbursement? How does it reimburse? Who's's going to sell it? What else are they selling that would make them not want to sell this? Okay, and you, just you know, the more you learn, the more you weave and navigate to to, to this, and you pretty much have to do all of that for nothing in the beginning.
Speaker 3:Um, you know, I I think that's where, you know, we've been super, super lean, our whole, our whole story. And we have many people here that are underpaid and, um, you're just just to make things work. And, um, you know, we also this company, if we started a company and saying, hey, we want to make this knee brace, let's start thinking about it. That doesn't happen. You know, I, we, we would to make this knee brace, let's start thinking about it. That doesn't happen. You know, we would be out of business. We just like I see a lot of companies more in the med tech side than this industry, where they get a bunch of investors, they get big investment and then it's just, their expenses are too high.
Speaker 3:So you know what we did, was we had. We had a patent filed that was still pending. We had, um, you know, a prototype that was functioning. We knew what it did. I mean, that's one benefit here is I know, I know what this braces to people who need it and the number of people who need it, and so, with those two things, that's kind of like, hey, if you have any doubts, just come talk to me, because I know where this is going. So you do have to have that conviction in what you're doing and that it's the right thing. Ultimately, it's truly addressing the problem.
Speaker 2:Well, Dave, thank you so much for your time today. This is absolutely wonderful to hear your journey and your product. That sounds super exciting and yeah, so thank you so much for being on our podcast.
Speaker 3:Yeah, thank you guys for having me, really appreciate it.
Speaker 2:And thanks to you for being here as well, brent, and thanks to you guys for listening. This is another edition of the Prosthetics and Orthotics podcast.
Speaker 1:Hey, and that wraps up another episode of the Prosthetics and Orthotics podcast. A big thank you to Dave Johnson for sharing his expertise and insights today. If you enjoyed today's episode, make sure you hit the subscribe button so you never miss out on future episodes. Thank you for listening and we'll catch you on the next time on the Prosthetics and Orthotics podcast.
