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
Crafting Hands-Free, Adjustable Prostheses with Sydney Robinson
Innovative adjustable sockets stand to revolutionize prosthetics, promoting comfort and user satisfaction for amputees. Sydney Robinson shares her journey in creating Vessl Prosthetics, emphasizing design iterations, user feedback, and strategic positioning within the market that enable transformative solutions in limb care.
• Introduction to Vessl and its mission to revolutionize prosthetic sockets
• Sydney Robinson's engineering background and entry into prosthetics
• The key problems with traditional prosthetics and the need for adjustability
• Mechanical solution for adaptive sockets without electronics
• Feedback loops from users and prosthetists for iterative design improvement
• The roadmap for product launch and future plans in the market
• Discussion on market consolidation versus independent practices
• Importance of collaboration between engineers and clinicians in prosthetic design
Special thanks to Advanced 3D for sponsoring this episode.
Quiet. Now can I turn up my headphones from my phone. Why would that be a thing? What about now?
Speaker 2:I can hear you Check one, two, one, two. Hello, hello, hello.
Speaker 1:You're just really quiet. I will pay attention.
Speaker 2:I'll turn myself up a little bit. How's that? Oh, that actually yeah, that helps.
Speaker 1:What about you, sydney? You talk Maybe. How am I doing?
Speaker 2:Okay, we're in a good spot, all right, so we are recording. Let me make sure that I've got Sydney. We got 6%. Katie's at 89. I'm at 90. There you are, you're climbing now Sydney, perfect, all right. So we're going to go off video here.
Speaker 1:Brent, it definitely makes a difference when your mouth is closer.
Speaker 2:Okay, I will eat my microphone. All right, we ready, you ready, katie, yep, all right, hey y'all, welcome to another episode of the Prosthetics and Orthotics podcast. Yoris is actually traveling, and he gets to travel all over Europe. It's apparently very inexpensive to do so. A little jealous, so some well-deserved time off, and he's got a lot of travel coming up. But I've got my trusty sidekick, katie Richmond, with me today. So hi, katie.
Speaker 1:Hey there.
Speaker 2:Happy New Year to you. To you as well. So you're kind of buried in snow, I hear.
Speaker 1:Yeah, about, I'd say about 11 inches.
Speaker 2:So nothing overnight, huh, just cold.
Speaker 1:No, this was all yesterday and hey, it's all good, my street isn't plowed, but the major ones are. And no, just enjoying this winter wonderland.
Speaker 2:I hear you Well and we're also talking like you have been with Advanced 3D for almost a year now.
Speaker 1:I know it's crazy, it's crazy, yeah.
Speaker 2:So can you just take us through some of the projects that have been memorable and then kind of what you're looking forward to for 2025?
Speaker 1:I feel like everything has been memorable but some of the most fun and impactful devices that I don't know how I would have done it or that's a lie, I would have done it traditionally, but how I could have even been helpful from where I am is Katie Leatherwood in Latvia. She is a wonderful prosthetist and working on a hip disarticulation socket with her, knowing the pain of what it is to lift a plaster, even with vermiculite in it, mold up onto your bench and carve out your mods. The pain of going through that. I know that. And instead, on the other side of the globe, she sent me an email I worked on something, sent it back to her, she had it printed locally and the patient is in it and not once did I have to strain my back and lift up 90 pounds.
Speaker 1:The other would be in California working out of Salinas Valley and doing some partial hand prostheses. That the ability to iterate quickly and provide some static, low cost, functional devices for people who, because of insurance reasons Medicare and Medicaid coding issues they wouldn't be able to have anything, and to be able to quickly go back and forth across the entire country, iterating with the prosthetists on site. It makes the world feel pretty small compared to how it did before I joined Advance 3D.
Speaker 2:Yeah, and I'd just like to echo that. I mean, I think one of the neatest things, and especially with Bamboo Labs printers being so accessible with the Bamboo Mini. I'm guessing it's still on sale for $179. But going to like the A1, which is roughly $400, you get a little bit more build volume to the one that you have, which is the what is it the X1 Carbon?
Speaker 2:X1 Carbon. But it's been nice because these prosthetists have been able to leverage our design experience your design experience and then print on site. So there's literally no shipping and we're able to get through this iterative process really quick on something that's super detailed, and I think that's super exciting and I really see that as a trend for 2025. I've been working with a couple clinics that have now 3D printers in their offices. We're helping with the design side of things. We send them files and then, when they're ready to go to a definitive socket, we're there to help them out on that journey as well. So I'm really excited about 2025 for that and being able to help those clinicians, some manufacturers, that sort of thing, on the design side of things. So I'm excited. So what are you excited for for 2025?
Speaker 1:Lots of things adjustable sockets.
Speaker 2:Huh, Fancy that. I think we we might have something to say about that today.
Speaker 1:Yeah, yeah, yeah. Yeah, I'm having the code has been around for some months now, but just building up that knowledge and more practitioners feeling comfortable using it, making sure that there are, as much as we can, 3d devices to assist those mechanical devices. Yes, it is very relevant to today's topic. Don't want to spoil it, but then again it's a podcast, so you probably read the title.
Speaker 2:Yeah, so I want to introduce our podcast guest today, and that is Sydney Robinson, with Vessel Prosthetics, and they are developing something that is a user-centric, adjustable socket and, yeah, I'm really excited to hear the story. I've heard bits and pieces. We met Sydney at Aopa, and so I'm really excited to have her on board. One of the neat things that what I see in her is she has chosen to be a part of the orthotic and prosthetic field industry, so to speak, but she's not a clinician, and that is great, and so one of the things that I always love is when people use their gifts and talents to help people, and not necessarily from a clinical side, but it really does scale in a big way. So I'm excited to have you here, sydney. Welcome to the show.
Speaker 3:Thank you so much, Brent. I'm really excited to be here and really appreciate you having me on.
Speaker 2:Yeah, so we always ask how did you get started in orthotics and prosthetics? But you can also take us through your school journey and your engineering journey as well.
Speaker 3:Yeah, absolutely Kind of. As you identified, I'm a bit of an outsider when it comes to prosthetics, so I came at it. I was doing engineering as my undergraduate degree in Canada and I was doing mechanical engineering but really my heart was in the biomedical field. I've always been really fascinated with how the human body moves and how it works and I've just really loved all of that, both the problem solving aspects of that but also just seeing it all come together. And that was my first foray into prosthetics was for my capstone project in my fourth year of my undergraduate degree. We were working on an ankle foot orthosis for a little girl and she wanted to go in and out of the water quickly but she was really struggling because with her AFO she had to use like thick wool socks and it was really annoying to go back and forth in the water, out of the water, trying to take all of her gear on and off every time. And at five years old, her friends weren't exactly waiting around for her to get all set up.
Speaker 3:That was my first experience with the problem solving aspects and design aspects of prosthetics. With the problem-solving aspects and design aspects of prosthetics, I didn't want to be a clinician myself ultimately, but I did really want to stay in the field and in medical devices in general and stay more on that device design aspect of it. So I did my master's in biomedical engineering and I got the opportunity to do a program it's in Canada, but it's modeled after Stanford's biodesign which basically brings engineers, phd scientists and doctors together to innovate within medicine, with a real focus on teaching us about entrepreneurship and what it's like to start a company. It was something that I was interested in for a long time but didn't really know what it took to start a company, which is why this program was so interesting to me. So right off the bat in that program they let you kind of go out into the world and experience or find a problem, interview a bunch of different clinicians and then choose which problem you would like to solve and that you'd really like to make a business out of.
Speaker 3:And so when we were interviewing clinicians from cardiovascular surgeons to neurologists to physiotherapists and everybody in between we shadowed a doctor at a diabetes clinic, and what I didn't know at the time was that diabetes is the leading cause of leg amputation, and so we met a lot of patients there that all struggled with how their leg was fitting inside of their prosthesis, and this is a very obvious problem to people who are in the field or who have lived experience with prostheses. But it was totally new to us in doing the program and I was just struck with how debilitating it is when your limb is changing size, which you know. There's things you can do to maybe mitigate some of that, but it's really out of your control and the prosthesis isn't changing size and just that misfit seemed to be to be very frustrating both for the patient and the prosthetist, and so that really got the gears turning in mine and my co-founder's heads as we were kind of thinking about this. Throughout the fellowship program we spent a lot of time interviewing prosthetists and interviewing people with leg amputations and limb difference and learning.
Speaker 3:You know what does a day in the life look like, what are some of the considerations when you're developing prosthetic legs or designing sockets and things like that. And at the end of the day, what we noticed was it would be really nice if you had a socket that could adjust its volume. It would be really nice if you had a socket that could adjust its volume and it would be really nice if that adjustment happened automatically, because then people don't have to worry about engaging with the prosthesis and you circumvent a lot of the frustration both on the amputee side but also on the prosthetist side. So that was how Vessel was born.
Speaker 2:Wow, that's a neat kind of evolution, I would say, of that Now when you were doing your research. How does all that kind of tie into the program that you were at? Is it not only kind of first-person research with the patients and the clinicians but also, I'm guessing, some historical literature reviews and that sort of thing?
Speaker 3:Absolutely. Yeah, we really dove into the literature. So when I was doing my master's program, I was doing research on wrist implants and there is a ton of data on hip implants, knee implants, wrist implants, and there's not very much data, as I'm sure you folks have noticed, on prosthesis use and different studies that have been done on prosthesis users. It's just, you know, the studies tend to be smaller or shorter term and so we were learning as much as we could from kind of literature review and then as much as we could from, as you're saying, like the first person interviews. That was really, I would say, where we got a lot of our understanding from.
Speaker 2:So I'm just curious, like from a history side of things. You know there's a lot of not a lot, but some historical stuff around, not necessarily adjustability, but flexibility. Was there anything that kind of stood out Like I can't believe they did it that way, or any of those kinds of stories from the historical perspective?
Speaker 3:Yeah, yeah, I would say yes and I would say that I mean, first it really struck us that that socks were what right, like with the you know, ai in the world and this and that and all this like high tech, high tech, high tech that it was it's sock management that it really came down to and I think for us and honestly it works really well for lots of patients, so super happy about that. From our perspective, it was interesting that the solution was a quote, unquote, a low tech solution. And why was that? And, exactly as you said, brent, as we dove into the literature, we're not the first person that's ever tried to solve this problem and it is such a multifaceted issue that you can see why things worked or didn't work out. It may be in the past.
Speaker 3:So you know, we looked at, like the bladders that people have used in the past and still continue to use, right, whether they're air filled or water filled, gel filled, like what did that look like and how is that working? And then there's some like cable based and ratchet based systems, both historically and on the market. So what are the benefits and pitfalls of some of those designs? So really, just tried to look at as many different ways of managing, as you were describing either the flexibility of a prosthesis, a prosthetic socket, or the adjustability therein, and we had some pretty outlandish like what if we could make a Chinese finger trap version but for the socket that's like interwoven, and just all kinds of different ideas that we were whiteboarding at the beginning. But I think we've come up with something that's pretty elegant and still low tech enough to be widely accessible and user friendly, but high tech enough that it provides that mental burden relief, if you will.
Speaker 2:Yeah, so can you take us through a little bit of that journey? You know we've got I think one of the things that stands out to me the most of our field is we've got a bunch of creative people in our field, so not only the fabrication side of things, but some people have an idea. They've been sitting on something for a while. Can you take us through some of that? You know, how did you actually come up? Just process wise, what were the steps? Because I mean, from what I could tell this journey kind of our vessel was born in 2022.
Speaker 3:Yes.
Speaker 2:So you know, we're going on three years into this Probably feels like a lot longer than that. Probably feels like a lot longer than that, you know. So I think part of the things that I would love to convey to our audience is you know, it is a process, right, this stuff doesn't happen overnight. It takes a long time and you got to stick with it. There's probably nights that you, or days or periods of time that you're like why am I even doing this? But At least that's what I have sometimes. Yeah, can you just take our listeners through kind of that journey of how you found, because you had a problem to solve, right, and then what were the steps to take to solve that? And then how do you land the plane? I think that's the other part is, people get a lot of the way there and then they don't realize that last percentage is really difficult to get. At what point do you say we're shipping?
Speaker 3:Yeah, yeah, there are so, so many things that I want to dive into there. I would start with saying we're still trying to land the plane, so I'll let you know when we touch ground, but certainly we're in the landing the plane phase, if you will. And absolutely it has been a process Like you should have seen. It is not embarrassing because you had to start somewhere, but fairly embarrassing Like the first few designs that we had that we thought were were going to be viable. I would say that there were. So, yes, it's definitely a process. There's a ton of steps involved.
Speaker 3:The nice thing about doing a structured program was that we were taught a lot of that in a very systematic way. So we were taught how to interview clinicians and patients, how to narrow down that list of problems Like we had a list of over 200 problems that we could have built into businesses, but really, looking at you know how severe is the problem, how common is the problem Questions like that so learned a lot about the business and what makes a good business. Learned a lot about the patenting side, how to protect your innovation, so there's a lot of different. There's, like regulatory standards that need to be considered, so there's a lot of just elements to a business that you don't necessarily think about when you're just trying to solve a problem with a design. So I would say that that's a difference. You know, if anyone out there is interested, if they've got an idea, the question I would pose is do you want to create a business from that idea or do you want to maybe partner with people whether that's a design firm or young innovators or whomever it might be that are interested in developing the idea and you just really want to make sure that that idea gets to market? So there's a little bit of a crux there For us, because we were coming at it without a prosthetics background, so no one on our team was a prosthetist or had lived experience with amputation or limb difference.
Speaker 3:We really needed to educate ourselves. So I would say, for anyone it's really important to understand the problem, but for us we had to understand it and spend that much more time understanding it, because you folks have a very challenging job being prosthetists and there's a lot of nuance to what you folks learned in school that we hadn't learned yet. I would say a lot of our time, especially during the fellowship program, but honestly, I'm still learning a lot. We spent a lot of that time interviewing prosthetists, interviewing amputees, learning as much as we could, and we wanted to get a solid understanding of what is the day in the life like for a patient, what is the day in the life like for a prosthetist and what are the processes that are in place that our device would need to fit into. We didn't want to rock the boat on the workflow side of things. We wanted to rock the boat on the innovation and like the benefits to the patient and to the prosthetist side of things. So a lot of education that way.
Speaker 3:And then it came to. I mean, you have to have an idea at some point. So once we felt as though we had understood the problem enough to start generating ideas, then it was generating as many ideas as you can, figuring out what makes those ideas realistic. One example is weight. Weight is extremely important in the prosthetics industry because it's something that is attached to your limb, and that was one of our driving forces in the design was just making sure that it was something that could be worn and used in a way that was comfortable. It doesn't help if we make something that's automatically adjusting if it weighs 20 pounds. So using that as a bit of a guide and then pitching those ideas to prosthetists and saying, you know, what do you think about this? And inevitably people are saying, well, that would be extremely hard for me to build for these reasons, or it would be heavy for these reasons, or no one's going to know how to use it for these reasons.
Speaker 3:So we started to iterate, iterate, iterate. So, as you said, we're two and a half years in. First year was really developing the business side, like setting some of the foundations on the intellectual property, the regulatory understanding how the business side of prosthetics works even if we'd understood the prosthetics side of prosthetics and then refining those designs to get to something that someone can actually wear. That happened in July of last year for the first time. So you know, literally two years in before someone's even wearing it. And then now we're really focused on what are the improvements we can make since that first kind of use case to then roll it out to more people and get more feedback. Because when you're landing the plane, the more data points you have, the better you can make a product that is going to be a lot more relevant to a larger group of individuals when you have more of those data points. So that was a very long winded answer but hopefully some of that was easy to follow.
Speaker 2:No, yeah, go ahead, Katie Sorry.
Speaker 1:No, it definitely did. I will be the clinical person that maybe bogs down this podcast, but I would love to get in, if it's allowed, to the nitty gritty of you know, as a prosthetist, having worked with people, you know what I always say is it doesn't matter what I feel, because I'm not wearing it. It's what the patient feels and if they're happy, I'm happy. And so how does Vessel and this product, how does it know how much to tighten the socket and where to tighten the socket? And I'd love as much detail as you can share. Maybe we'll have to cut it out because everybody else thinks it's boring, but I'm very interested in kind of the mindset.
Speaker 3:Clinically, For sure. For sure and that's one of the things we're actually really proud of is we created a way for it to automatically adjust without it being electronic. So we find that with an electronic device you're just exponentially increasing the cost. It's not as durable, sometimes hard to manage. We're trying to think of those maybe elderly patients who might forget to charge their leg overnight Heck, I forget to charge my phone overnight sometimes. So, elderly or not, sometimes it's hard to remember to do those little tasks. So we created something that was mechanical and automatic.
Speaker 3:And what it does I don't like to use the word monitor because there's no sensors, so it's not monitoring anything per se, but think of it as two mechanical pieces that are engaging and disengaging based on tension. So there's tension in a cable, a cable that runs through panels on the socket, similar to other paneled sockets that exist, and that cable runs through what we're calling isoform, this like isoform mechanical disc, and that disc sits distal to the socket and it uses shock absorption. So every step that someone's taking, or even just like weight that they're shifting around as they're standing, and it uses that shock absorption to automatically pull on the cable and tighten the panels against the leg. But, as you said, katie, to a set tension, right, we don't want to over tighten on the leg, that's dangerous. Prosthetist will be able to, on the distal face of this isoform disc, turn. I won't say turn or crank, but like, use a screwdriver and basically tighten or loosen this little piece.
Speaker 3:And if you tighten it then the panels will want to sit more snug against the leg. If you loosen it, they'll want to sit a little bit less snug against the leg. So each patient might like, like I might like my running shoes tied up more tightly than Katie likes her running shoes tied up. And the same kind of thing with people with prostheses, if you want it to fit a little bit more snug or a little bit less snug. And then the system will always try and maintain that level of tension in the cable, just based on how the internal mechanisms are engaging and disengaging. So once it reaches the tension level, internal mechanics are basically pulled apart. They can't connect anymore, they can't tighten any further. But once that pressure drops so someone loses volume, then those inner mechanics are able to re-engage and tighten the system again.
Speaker 1:Yes, no, that's definitely making sense. How about releasing the panels? Because I have quite a few patients who just the reason they're in adjustable sockets not only for volume loss, but could be that some anatomy if you get it snug enough to where they like it you're going to need to release that tension before they can remove the prosthesis 100%, Absolutely, and so what we've got right now is it's a manual button, so it is.
Speaker 3:it's an automatic constriction but a manual release. So, as you said, Katie, to take the device off at the end of the day, but also like if you're in an airplane. I was talking to someone and he finds he has to drive to work I think he said an hour each way and even just sitting and having for like an hour, his leg will swell and so having it be releasable, if you will, so you can hit the release button when you get in the car and then if the leg swells as you're driving, it's just pushing up against those panels and widening them, kind of as it needs to Airplane I mentioned. But then also, if you're going to sit down for a movie for a couple hours or a meal for a couple of hours and you know your leg might swell a bit or you just want to release the tension, you can hit that manual release button and then standing back up, up and continuing to move re-engages the system and it'll tighten if it needs to.
Speaker 2:So you mentioned that you've got a couple patients on this and I saw I forget his name now, but has been in one. How do you go through? So like, once you create a device, there's got to be some sort of feedback loop and that sort of thing to iterate. So I'm kind of curious, like okay, so what was the feedback? And then what does that tell your team where you need to go?
Speaker 3:Yeah, that has been quite the journey. So we started working with Trace Wright in April, I believe, of 2024. Already freaking me out with the change in the years, I'm like trying to remember the years. So April 2024. And he brought in Stevie Crawford, who is a US Navy veteran and is training for the 2026 Paralympics for snowboarding. So he is a highly active patient and what was nice there is he's going to be very hard on a device and so if it's going to fail, he will make sure it does in one way or another.
Speaker 3:We've been working with them Again. Stevie tried it on for the first time in July and so what we've been doing so far are like what I would call touch point tests. So Stevie comes in, he meets with Trace Trace has been the one who's been fabricating the sockets and attaching isoform and then Stevie will try it on and we'll give some feedback, walk around a little bit, we'll make some adjustments as needed, kind of talk it through, come up with a list of things we need to change, and then we will change those kind of key points and ship it back out again for him to try on a second time. You'll hear me say ship out, because we are in physically different locations, so that's been interesting to work with, I would say. But Trace and Stevie have been phenomenal.
Speaker 3:The feedback on the first try was a lot of shock that it worked as well as it did, honestly, just because it hadn't been tried. We'd been working with it on bench top testing, but it was the first time it was being worn by a patient and it worked very, very well, so we were very pleased with that. The feedback from that first test was more on usability. So it was. You know we didn't have a gear ratio, for example. So what that means is that you, if you were going to manually tighten because you know the panels were super loose and you wanted to get them to touch the leg you to like turn and turn and turn and turn and turn and turn that dial, which is just annoying.
Speaker 3:So we're like, okay, we're going to need to add a gear ratio. There was a little bit of instability there was, you know. So just like different pieces of the design that needed to be iterated, and so we changed those. But you know, adding gears or adding different things will alter the weight, and so I would say that it has been a really helpful process to go back and forth with Stevie, get his feedback on the usability, the weight, the height. And we've been meeting, we meet weekly with a couple of different prosthetists to get some of those different perspectives on what the priorities need to be for the design changes that we're making. So we're working on some of those final design changes right now before we actually launch the product.
Speaker 2:Okay, so we have a product launch coming in soon.
Speaker 3:Huh, we do, we do Hopefully sooner rather than later, but certainly you know we're targeting the second half of 2025. As I mentioned, you know a few design changes needed to be made. You know some will be at AAOP and will be at AOPA and will be showing off all the latest stuff at both of those shows.
Speaker 2:I mean your journey as a CEO, and such isn't necessarily it's to be a leader, right, it's not necessarily. You need to know some of the technical stuff, but you also have to pay for this stuff, so somebody has to fundraise and things of that nature. Can you take us through just a little bit of your role within Vessel and how that's evolved over the last three years?
Speaker 3:Yeah for sure. So I would say, and to orient the listeners, we are a full-time team of three people right now and have been for the past year and a half. There's two co-founders and we have an engineer full-time, and then we also have a slew of different consultants or advisors that we're working with at any given moment and with the first year, year and a bit, my role was all well. My role going along has always been business and always will be. I think, the business focus. My co-founder is phenomenal on the design side of things, the product development side. So even though I'm the engineer on the team or on the co-founding team, he ends up really leading that and he does an absolutely fantastic job really leading that and he does an absolutely fantastic job. So my as you had identified, brent, my role really is more on the business side.
Speaker 3:Within the first year and a half, I really focused on getting some of those key business elements all ironed out what is the reimbursement pathway? That was something I had to learn, especially being a Canadian founder. The American system was something I definitely needed to study up on. And then even things like you know, when do we want to launch the product? What's that going to look like? What are the timelines involved? What do we want our media presence to be Like?
Speaker 3:Every aspect that you can think of with business was something that I was trying to build out and strategically plan for, and then the role evolved last year as we started to mature and as we started to hit some of those key milestones. We knew, as you said, brent, we're not selling yet, so we do need some investment, and so last year my role really focused on investment and so engaging with investors, meeting with them to figure out what they're looking for in companies, trying to find that right fit and trying to fundraise. We are successfully oversubscribed, our pre-seed round, which we're super excited about, and that is what will fund, you know, the product launch of Vessel, which is so exciting. And so now my role has really shifted, now that we're not actively fundraising, into more of the marketing and sales side and really building out what is that sales process going to look like and what are the key details that we need to be thinking of in order to set that up so that we're ready for product launch.
Speaker 2:Yeah. So I mean you really have to because you know, as a Canadian founder, obviously your, your insurance and all that stuff is different than ours. But then you're also looking at some of the global stuff. How do you balance where to go? Is the US the place, or is it one of many on the roadmap?
Speaker 3:It'll be one of many on the roadmap. For us it's going to be the first, though, and it really came down to kind of two main factors, the first being the population. America has a lot of people living in it, so it makes sense from a population standpoint and a demand standpoint that that would be one of our first markets. And then, really, what propelled us was the reimbursement. So the reimbursement in the United States is very much based on these codes that you can stack and move around, and a new code was passed in the early part of last year, of 2024, specifically for adjustable sockets. So we thought that, you know, let's use that kind of momentum to help generate demand, and it made a lot of sense for us to start in the United States.
Speaker 3:Canada has very different reimbursement province to province or state to state, and so that was something that we still need to learn a little bit more about, just because it really dictates where, within Canada, we end up launching first, and then each country is a little bit different once you get over to Europe, but for the most part, there's a lot more kind of public funding that's over there, so how does that influence the way that prostheses are adopted and especially like an addition device right. Having an automatically adjusting socket, as of today, isn't a medical necessity, isn't a medical necessity, and so when you are an addition device, sometimes groups will reimburse and sometimes groups won't. And so, trying to navigate that space, it does make the most sense for us to start in the United States and then expand.
Speaker 2:You know the Orthotics and Prosthetics podcast. One of the things that we always like to do is see how additive manufacturing plays a role in product development. How does additive manufacturing 3D printing play a role in how you guys have come up with your prototypes and things of that nature? Is it a tool that's necessary, useful? Just like to hear your feedback.
Speaker 3:Well, yeah, 100%. So we used it a lot when we were prototyping. So what we did was we created and 3D printed our own what we're calling demonstration leg, and so it was a leg that we could expand and contract so that we could put the leg inside of the socket and put the socket plus the leg into a motion simulator and then use that for some of those early product developments, so that we didn't need someone to be wearing it. We could just, you know, iterate benchtop as quickly as possible. So we used 3D printing to create the leg. We used 3D printing to create the devices to make the socket like a whole nine yards, and it was helpful because we could just iteratively prototype that much faster. You know, we didn't have to wait four weeks for someone to see and see something. We could just 3D print it at home.
Speaker 3:I will say we did try and do 3D printed sockets first to have someone try it on, but there's still you know, you would know, but there's still a lot of like clinical modifications that you need to make afterwards that the core team didn't have that kind of clinical background. So it made more sense let's test it on this demonstration, like first, and then we'll have clinicians. You know, if they use additive manufacturing for the socket, great. If they use traditional fabrication for the socket, great. We can work with either of those. But additive manufacturing was instrumental for us in the product development cycle.
Speaker 2:Very cool. So, like on the socket design side of things, it sounds like Trace is doing stuff with traditional fabrication. Is it like I mean you mentioned you can do either? Is there when you're developing these modules, and I guess it can go either way? Are you thinking, hey, yes, we're going to do either, or are we going to really tailor to because traditional fabrication has its own challenges, additive manufacturing has its own challenges? It is hard to kind of straddle that line and say, hey, we can do both, kind of. What is your take on that?
Speaker 3:Yeah, that's a great point. Our goal is always to make it as accessible as possible. Right, we'd love. The more people that are using it. Obviously, the better. We think that it really helps patients, we think it helps prosthetists, and so we just want to make it as widely accessible as possible. That being said, there are unique challenges to each method, and so we are tailoring it at this point to traditional manufacturing, since that is still the more common one, but we do definitely want to have additive manufacturing in the back of our minds, since that is part of the future of prosthetics, and we want to have it available. For those who are adopting more additive manufacturing or working with central fabrication sites that use additive manufacturing, we want that to be an option as well.
Speaker 2:Yeah, I think it's interesting that you bring that up, because I know that traditionally adjustable sockets are difficult to fabricate and many people will push that to a central fabrication facility. I mean, just through your research and such, what are you finding as far as trends for prosthetists wanting to create sockets? Are you finding that hey, no, we want to do this in-house. Or are you finding like we're okay with sending it out?
Speaker 3:It's interesting. You ask that it's something that I'm still discovering. To be honest, as we do more and more interviews, I'm always interested in the answer to that question. So I often ask you know, do you fabricate in-house or do you outsource? And what it seems to me is two things.
Speaker 3:I think that younger prosthetists who are newer to the field are, it seems to be more open to central fabrication if that's something that will allow them to see more patients, right. Like you know, if the goal is to help as many patients as possible, then if central fabrication helps with that achieving that goal, awesome. I do also notice that as clinics become more like what I would call clinic networks so one company that owns multiple sites the scalability of having that company either have or use a central fabrication site it's a lot more of a scalable business model for that clinic network. So I do notice that as the clinics seem to be becoming more network-based and that scalability is a big factor in their own economics, I do notice that central fabrication seems to be more popular in those groups.
Speaker 2:Yeah, I mean, we run into this all the time and it's always interesting to hear even regionally it varies and it's always interesting to hear why people do it. And then the demographics of the younger clinicians versus the older clinicians. I mean, what are you seeing as kind of this new generation of clinicians coming into practice, and I would say probably both in Canada and in the US? What are you seeing as far as the values of those people coming in and when I mean values, I mean of those people coming in, and when I mean values, I mean so, at least from my perspective, people are valuing not being in the shop till 11 o'clock at night and things of that nature that have historically been almost like badges of honor, yeah, which I mean there's a conversation for the world at large, right Like there's a conversation for just office work in general or entrepreneurship or some of these other things where it's like I'm breaking my back.
Speaker 3:Working 16 hours a day maybe used to be a badge of honor, and now it's.
Speaker 3:Well, how can I use AI or some of these other tools to optimize my work and actually accomplish more in less time?
Speaker 3:I would say, and the first disclaimer I want to make is that I'm not trying to disparage people who've been in the industry for many years, right, like, I think that there's a lot of really incredible prosthetists who have decades of experience in the industry and are super forward thinking and want to be adopting new technology, and that level of both passion and expertise is extremely valuable. I have noticed that when people are coming out of school or are newer in their careers, they maybe don't have yet their favorite tools that they know work, that they like to use all the time, and so they're more open to trying out a couple of different tools. Okay, well, will this help me help more patients? Will that help me help more patients? How can I make my practice more efficient. So I do think that, at least in the folks that I've spoken to, they tend to be more open to whether it's additive manufacturing or adjustable sockets, some of these things that just help make a clinic operation more efficient, I think yeah.
Speaker 2:So I 100% agree on that. And I mean, I think what's interesting is when I see these older clinicians really lean into the technology and try to leave a legacy. And that's what to me is exciting is you do have these people that you know were making chem, blow liners and sewing, you know thai and corset stuff, and now they're like, hey, I can actually leave something for this next generation of prosthetists and you know I love that aspect. And now you have these, the grumpy old people too. But with the grumpiness is one of the things that I've tried to do is embrace some of that, because if you can change some of those critics, sometimes they'll become your biggest fans.
Speaker 1:For sure.
Speaker 2:So I think that's interesting. Get back to the kind of the mergingetist to create as close to a near net shape of the patient as possible. So where do you see that bridge happening and how important is it? And I mean it may not be important for your technology, I don't know.
Speaker 1:Can I add kind of in with that, sure, because I was kind of thinking the same question of how are you so far positioning yourself, fessel, that is, to make recommendations or suggestions. You know, one of the things I would consider myself passionate about socket design and difficult to fit patients, and often I feel those are the people who need adjustability. So are you kind of saying, hey, this is a device that will tighten whatever it is you do, or is there some sort of education behind how you decide where to put the panels? You know a lot of that has been the Wild West with with click, and they've they've done a lot to bring up that knowledge. So, yeah, you are the mechanical, but you're dealing with us as prosthetists, so it's a fine, fine balance. So where do you find yourself there? Absolutely, absolutely.
Speaker 3:So one of the things that we were really passionate about early on was ensuring that clearly, as you had both identified, all of the clinical knowledge rests with the prosthetist. You guys are trained professionals who know how to fit a socket to a limb based on that limb's anatomy and the person's goals and all of these different things. So that was something that I haven't seen anyone be able to replicate yet that clinical knowledge or replicate or replace right, and so it's something that we are trying to augment. So we just want to or support, I guess, is a better phrase, we just want to support that. So having something where you design the best fit socket that you can design and then if the leg changes which is not within your control, the socket is able to adapt to that change. So I'd say that's like the overarching goal.
Speaker 3:As you had identified as well, there are, as new technologies come about, new ways of doing things and different levels of resources or references, use cases, things like that. So that's something actually that we're developing out right now. As I mentioned, I'm really starting to focus on the sales and marketing side of things. You're saying some of those difficult to fit groups will have you know. I don't know if they will be hard recommendations of you should do it this way or if it will be more of like in these types of patients. We found that this worked really well In these types of patients. We found this worked really well and just have some of those almost thought-provoking ideas for then the clinicians, based on your expertise, to kind of use those as guidelines going forward.
Speaker 2:No, and I think that's great insight just for other companies that are coming into the field too is, you know, I love the passion that a lot of people bring in, but you know, I also love, like what you guys have done being very intentional. And then, obviously, consulting with somebody like Trez and other clinicians is super important to truly understand the prosthetic and orthotic market, because and the reimbursement, like those those three things I've seen some people have amazing ideas, but it's a product that we can't get paid for. So it's like Yep, here we are, and so then you have to go through other avenues and that sort of thing, and then the runway becomes a lot longer. So kudos to you guys for taking all that into consideration.
Speaker 3:Thank you. Yeah, I think that the business elements can sometimes get overlooked. As you said, Brent, where you're so passionate about the problem, you really want to fix it and you have this awesome idea, but you can't get the money for it, or it'll be way too expensive, or it will be nearly impossible to manufacture, or whatever the case may be, and that's why harking back to your earlier question that's why it's's a process, that's why it takes two and a half years right to to fully develop something is there's so many design constraints, not just from the person who's going to be using it or the person who's going to be building with it, but all of the other things that surround how to sell something in the world yeah, one last question that I'll ask, and this is one that yours usually asks, because he loves seeing the variety of companies in the orthotic and prosthetic space.
Speaker 2:You have everything from corporates to, you know, mom and pops and you see this rise in consolidation among the bigger companies, but then you also see kind of a push to the independents. Like I see these independents really almost rallying around each other saying, hey, it is a great option as well as a CEO, as somebody that's been in the business side of things, and then you're kind of parachuting in to our field. As you see the consolidation and the independence like plays out, it does seem to have a really big part to play.
Speaker 3:That consolidation? I definitely see it happening. You know more and more folks that I speak to. When I'm talking to prosthetists and interviewing them, trying to get feedback on what we've developed, a lot of them will say, oh yeah, and my clinic was bought out a year ago or six months ago or 18 months ago, whatever it might be. So I do see the consolidation happening more and more but, as you identified, it leaves this space available for some of these independents who can set themselves apart in the way that they interact with their patients or the level of unique offerings that they're able to have. So maybe they really specialize in additive manufacturing or they really specialize in adjustable sockets or whatever the case may be. So I am hesitant to say what my crystal ball is showing me. I think that there's going to be a really awesome opportunity on both sides of the equation, both for that consolidation which we can clearly see is happening, but I think it also creates these unique opportunities for more of the independents and mom and pop shops to really set themselves apart.
Speaker 2:Well, hey, thanks so much for joining us. This has been great and I know our listeners will get a lot out of it. So, yes, thank you for sharing your time and your journey with us.
Speaker 3:I really appreciate it. Thank you so much, Brent and Katie, for having me on. It was a real pleasure to speak with you folks today and I'm excited to stay connected and I'm sure I'll see you at all of the upcoming shows.
Speaker 2:That's right, and Katie, thanks for chiming in as well, asking some thoughtful questions.
Speaker 1:Yeah, absolutely. Thanks for having me.
Speaker 2:And thank you. Thank you for listening to the orthotics and prosthetics podcast. Have a great day.
