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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
Print, Heal, Repeat: 3D Printed Casts with Diana Hall
Diana Hall shares her journey from chemical engineer to founder of ActivArmor, a company revolutionizing fracture care through 3D printed waterproof and breathable casts that allow patients to maintain normal hygiene and activities while healing.
• Started after seeing children with wet, dirty casts who couldn't practice basic hygiene
• Worked directly with FDA to develop test protocols for 3D printed medical wearables
• Created a turnkey point-of-care fabrication system that clinics can operate with minimal training
• Uses iPhone scanning technology for easy, accessible shape capture in under a minute
• Allows custom design while maintaining standardized mechanical properties
• Enables targeted immobilization that restricts only necessary joints
• Popular with pro athletes, pediatric patients, and workers who need hand washing
• 93% of patients choose Active Armor over traditional casts when given the option
• Now used internationally by top orthopedic surgeons in 15 countries
If you're considering innovating in the medical device space, surround yourself with experienced advisors who understand the regulatory environment—it's challenging but rewarding when you can improve patients' quality of life.
Special thanks to Advanced 3D for sponsoring this episode.
Welcome to Season 11 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 is 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're here and hope it is the highlight of your day.
Speaker 2:Hello everyone, my name is Joris Peebles and this is another edition of the Prosthetics and Orthotics podcast with Brent Wright. How are you doing, brent?
Speaker 1:Hey, Joris, I'm doing well. Supposedly, the US is in some sort of frigidness right now. I'm in North Carolina and it's 19 degrees, which is cold, but I was. I was talking to Katie and I think she said it was minus two this morning and so yeah it it's. It's cold all over, it seems like.
Speaker 2:OK. Well, yeah, I hear it's a bit cold as well, but I don't think it's as cold as I've been seeing the news of. I hope you guys all stay safe and it doesn't end up being like super crazy weather eventy stuff again all right.
Speaker 1:So I did have another question, because my son actually he's a senior this year wants, he wants to go to spain, and so I said I know somebody that's in spain and so I don't know when, when we're going to try to make it happen. But like you're in valencia, right, and is that close to like the water?
Speaker 2:Yeah, kind of like five kilometers yeah.
Speaker 1:Okay, so, yeah. So I'll have to get up with you on that. How would you get to Valencia if you were coming? Would you go Barcelona or Madrid?
Speaker 2:Either one will do Whatever you want to stop over, so no problem.
Speaker 1:And I heard the food's good.
Speaker 2:Food is amazing, dude. You're always welcome. Dude, I don't think my apartment's not big enough for your whole family, but you can definitely. We'll figure something out. We'll figure something out. So who is our long-suffering guest today?
Speaker 1:Well, I'm super excited to introduce Diana Hall from Active Armor. I've actually followed her work for quite a while. She started with 3D printing casts and braces and such. I actually had a patient who had a broken foot go out to her one of her facilities I believe it was in Colorado. They actually flew out to get that because the patient was going to be going to the beach and didn't want to be in a regular cast and so I said, hey, this is something that you guys should look at and they did and they enjoyed their time immensely in the water. So I'm excited to hear her journey, where they're at, where they're moving forward and just how they're also incorporating not only some computational design, maybe some AI so maybe we go down that road but also additive manufacturing as the main product. Super excited to hear about that.
Speaker 3:Hi, yeah, thanks for having me.
Speaker 2:Cool Dan. So tell us, how did you first get involved with prosthetics and orthotics?
Speaker 3:Well, I'm a chemical engineer. I went to Colorado School of Mines and, after working in software engineering for many years, I was running a mentoring program for children in poverty, and the kids would have domestic violence, substandard living conditions and they'd often have casts or immobilizers, bracing, that would stop their basic lifestyle functions and their basic hygiene. They wouldn't even be able to wash their hands to have a snack. So kids, just being kids, you know they want to get dirty, they need to wash and it would trap moisture and bacteria against the skin.
Speaker 3:There was one little boy that ended up with permanent scarring on his arm from wearing a wet, soggy cast for too long. So one little girl had bedbugs under her. So it just seemed like it was ripe for disruption. So I started 3D printing out of ABS plastic any sort of biocompatible plastics immobilizers that were custom designed and fitted for every single patient to replace traditional casts for fracture care. And that was 10 years ago. So now we're an international, nationwide and international company. We work with, you know, the top orthopedic surgeons and hospitals in the country and in 15 other countries.
Speaker 2:That's super cool. And where did like specifically the idea of Active Armor come from? Is it really where you were like, just working on this, okay, you saw this need for this kit and you were like I'm going to engineer a solution, that's it.
Speaker 3:Yeah, so I literally didn't. Well, I didn't have scanning or any capability back then, but it was just. It went from concept to finished product within a couple of days because the kids were suffering with these wet, soggy, dirty casts on, and so I would simply measure their little arm with calipers and try to make a digital model of their arm, before we had 3D scanning. And then I just made a little patterned cast that would allow for breathability but also immobilize, well, and printed it out of plastic. And I said to the kids you know, take this to your doctor and ask them if you can wear this instead.
Speaker 3:And the doctors just started calling me saying, hey, can you make some more of these for us? And I called the FDA and I said, hey, I'm just a person, I'm not Don Joy or something. Can I do this? And this was way back, when they were still developing the test protocols for 3D printed wearables, and so they referred me over to Dr Lex Schultheis at the University of Maryland's Robert Fischel Medical Device Institute and I worked with him directly to help develop the test protocols for the FDA test protocols that they were working on, and I published research abstracts in collaboration with them, and still continue to this day.
Speaker 2:Well, that's really cool. Continue to to this day? Well, that's really cool. And so, if you, I love how proactive the FDA has been in engaging with the 3D printing community and engaging in this inventing community, not just being like no, no, no wait, or you know, they really have been like super proactive. I think this is just another side of that. So imagine, I have a 3D printer dimension and I have it at home. I'm an orthotist, prosthetist, whatever. What advice can you generally give me if I'm going to actually try and get this to market as an official kind of class two medical device or something like that? What kind of like? What kind of things should I be doing?
Speaker 3:So you definitely want to make sure that you have the regulatory environment. You know that, you're comfortable with that, you know what, what your classification should be, and you know make sure that you have everything ISO certified for biocompatibility and just make sure that you're following all of the rules to make sure that your products are safe and effective. And then I would make sure that you get the right people behind you. So, for example, you know Dr Lex Shalthaise and a lot of physicians. I would make sure that you run through all of the clinical scenarios, the tests, making sure that it functions in a way that would be at least as good as the traditional casting methods for fracture care, immobilization, but ideally better. And so that's what we're doing. And then just get the research done. Just make sure that you do enough studies that everyone is comfortable with the outcomes before you try to bring it to market.
Speaker 2:That's the same sound advice. And then, and on top of that, like if I'm looking at printing stuff, how do I document this stuff? So I know that I'm like, for example, we all know that if the file's a little bit different, the slicing is a little bit different, how do I document my device? Like, what am I actually supposed to be doing in order to make sure that it comes out like it's supposed to come out? And later on I can, I can explain it to a regulator or a partner or a hospital, that kind of thing.
Speaker 3:Right. So here at Active Armor, we do all that for you. So we standardize the design. That's that's what we are. We're a software company. Right At the end of the day, we make sure that every single custom design is standardized to the point of strength. Custom design is standardized to the point of strength, durability, breathability, accessibility. You know all of the mechanical properties and physical properties that are required while still being custom, and so we're really talking about a mass customization scenario, which is kind of a difficult thing to explain to orthotics and prosthetics right, that entire market, because you still want to maintain the customization of it but also make sure that it's standardized enough that you can produce these at scale and at volume so that you can compete with, you know, traditional casting.
Speaker 2:Oh, that's really cool. And then and then, and did you yourself have any problems with your device, like, for example, testing it and stuff like that? Was that difficult, did you did? Was that expensive?
Speaker 3:because that's what I think a lot of people yeah, yeah, it's expensive and there's so much to to do.
Speaker 3:Right, you got the mechanical test, you've got the chemical. You know what is the chemical composition of it and does it change through the 3d printing process? Right? So you're going to do mass spectroscopy and you're going to check it before and after the 3D printing. And you wouldn't think that you know the properties would change by just melting the plastic from one shape into another, but they actually do. So you want to make sure that you maintain biocompatibility through that, that the raw materials are ISO certified and then the final products are ISO certified, and then the entire process is standardized enough that you can be sure that you don't have to test every single device coming out, that they're going to be consistent, and so that entire standardization process is another reason that AI is and I know you brought this up earlier that AI is so important and interesting and potentially valuable, because you don't have to do all of the iterative changes to every single design over and over again. The software can do it for you.
Speaker 1:So your journey? I mean it sounds like you went straight to 3D printing right off the bat. You didn't do like any warm and form stuff, you went straight into 3D printing using your mechanical design abilities, calipers, that sort of thing. Can you just take our listeners a little bit through that journey? I mean you don't have to get into like specific materials and that sort of thing, but like what was your iterative process and what were you thinking about looking at when you were going through that?
Speaker 3:Yeah, we've tried all kinds of stuff. You know low temperature, thermoplastics that you can form, and at the end of the day you want to have the most customization of design with the least amount of work by the end user where they can screw up, you know, and not have it be consistent, but also to make it so that it is a turnkey system at the point of care. So we originally started the company where we had centralized manufacturing. But we knew that that wasn't scalable. It wasn't a long-term solution at all. It was very short-term because we were just trying to figure out the product and the process and run all the tests and do the clinical trials and make sure that we had everything in place.
Speaker 3:But at the end of the day our goal was to have it be a point of care fabrication system that could be turnkey enough and plug and play that any orthopedic surgeon's office you know their casting techs or anyone could just fabricate these in the same amount or less time labor time that it takes to do a traditional cast and ideally at the end of the day it will be printing time too. We'll be down to the you know 20 minutes or the length of time for a traditional cast. We're not there yet, but that's just a matter of time, you know it'll be like. The goal is to be like Star Trek, where you have like a microwave type machine and just you know, boop, boop, and then here it comes out right Instantly. That would be the ideal scenario and that's where we're headed with it to make it just a turnkey process.
Speaker 2:But generally, I would actually typically advise clients to not do that because it also adds a lot of complexity. Did they store the filament well, did they? Are they operating it correctly? Did they do some weird software update? Are they using a different? You know what I mean To locking that down.
Speaker 3:We took all of that out. That's the point is, it's turnkey. We hand them, train them on everything. So, as far as the material, they have to use the same kind of biocompatible, iso certified material. They keep it in a Ziploc bag with desiccant that we provide. They use our material that we give them and we show them how to load the printers. We have chosen printers for the system that are plug and play and we go over there, we set them up, we show them how to use it. It's very simple. And then it's just like running a 2D printer where you just load the cartridge for the ink.
Speaker 3:They don't know anything about slicing, they don't even know that exists. They don't know anything about positioning on the bed. Whatever. Our software does all of that for them. They simply do a 3D scan on their iPhone. They select a couple of options for the design, upload that to us through on their little iPhone app. It's a piece of cake. And then within the hour they have a 3D printable file. It's just G code that they simply download onto a thumb drive, plug it in and press start. That is it. And they are doing it. Ortho, like you know, ortho techs, casting techs right there in the orthopedic surgeon's office are doing it with less than a day of training and they're running it and treating, you know, hundreds of patients at each clinic.
Speaker 2:And that's really cool. And what is the advantage of this thing? Where is it? Where are you seeing this getting used? Why do people come to ActiveArm for devices and what are they using for?
Speaker 3:Pretty much anyone, but I mean a lot of. So we started out with pro athletes, right? So the NFL you know the athletes really see the benefits of a waterproof, breathable option. When you're immobilized because you know they're going to sweat in it, they're going to want to ice bath with it there. They need it to be low profile so that they can perform as much of their activities as they possibly can.
Speaker 3:I don't know if you guys have ever seen, like an owner radial gutter cast that someone's wearing which immobilizes their fingers as well as their wrist. But when you do it with traditional casting, it's basically a club on your hand. You're not functional at all. With this one, you can choose exactly which joints you want to immobilize and wear in a low profile way so that you're not just, you know, blocking your entire hand. You're only blocking the parts that need to be immobilized for healing and then the rest of it.
Speaker 3:You have the freedom of movement and access and that helps you, you know, have more movement. That's necessary for you to do your basic lifestyle activities, and it's not just for athletes. You know pediatrics. It's huge, you can imagine. You know little kids trying to keep a cast clean and dry for six weeks to say here, here's a cast, don't wash your hands for eight weeks Like that. That's not even I don't know if that's 1800s, you know type of thinking, but it's not reasonable and it shouldn't be and there's no reason for it to be, especially when you know these are covered by insurance, they're affordable and they're we're able to do it.
Speaker 2:And if we're looking at patients, are they happy about that shower ability? Is it true that it's less itchy? What's the thing that really makes them happy?
Speaker 3:Well, yeah, I mean you can practice basic hygiene. I mean everyone wants to do that, right. You know if you're a swimmer or you're in sports, obviously. But even if you are a mom who has to change your baby's diaper, or you just want to do the dishes, or you know you need to do the gardening, or you want to go to the swimming pool or you need to take a shower, or let's say that you are in food handling services, or you're in a nurse or a doctor, or you know you're in a dirty job or career. You're out of work when you have to have a cast on. So workers' comp loves us, right, because we're getting their folks back to work while they're healing.
Speaker 1:That's funny. That's a really good point. On the workers' comp, so you mentioned a little bit about so. You started off with the calipers and designing that way and then you you touched just briefly on the scanning. Can you tell us a little bit of the journey on the on the shape capture side of things? It's more complex right Than just. I mean when I say complex there's a to get good data out. It takes you got to get good data in and that can be software scanning, that sort of thing. I'd just love to hear your perspective and journey on that.
Speaker 3:Yeah, sure, you know when the iPhones well, we started out with $10,000 handheld scanners. You know that were very precise and all of that. And the key to getting good data out is the patient being positioned correctly for mobilization right, so you want them positioned correctly so that you're not modifying their image before you fit them. So, positioning the patient and making them hold still for 30 seconds to a minute while you get the scan which doesn't seem like a lot for adults or whatever but when you got little kids, if they move, that movement is going to be captured by the scanner. So you want to be able to position them and have them hold for the scan. But then performing the scan is not even a big deal. With the iPhone now, right, because you've got the true depth camera, the 3D true depth cameras, and even if you don't like looking at the front facing screen while you're performing the scan, you can, you know, pop the little mirror on and then you can just look at the screen and walk around the patient, right. So it's not rocket science by any means now. And it's very user friendly.
Speaker 3:You know, our app has tactile feedback responses, so it vibrates if you're too far away or too close and it'll paint the limb white so that you can see the area that you have covered, or it'll make it into full color Right At the end of the day.
Speaker 3:There are multiple apps you know underlying SDK that you can use. You can either have it where it paints the limbs you can see easily what area you've got coverage in and where you might have any gaps or you can have it from turn to full color immediately, but regardless it's always color. That way you can draw right onto the patient where you want the cut lines of the device to be, if you want any exposure for you know a bone stimulator or an incision or a surgical hardware like a plate or pins, or if you want an offset, so that you can offset any certain area for, like, offloading walking boots for diabetics, or you know just an area that you want a channel built into the inside of the cast so that it doesn't bump onto any sort of a laceration or anything like that.
Speaker 3:So all of that customization is able to be done when you can. You know, draw with a washable marker on patients and mark up the limbs and then do a full color scan. You know, draw with a washable marker on patients and mark up the limbs and then do a full color scan, you know, in less than a minute.
Speaker 2:And where do you see the future of scanning going? I mean, scanning is like it's really iffy world. There's always new scanners coming out, cheaper ones. Are you really be like you know we've got it all on the iPhone, kind of we're hoping in the iPhone will come through for us, or do you see a lot of like inexpensive scanning apps coming out that could help you? Or do you think maybe at one point we'll have like a $200 scanner that could really do a better job? Or what is your view on the future there?
Speaker 3:the scanning is totally fine. Now I mean I don't know like the cheap apps totally work great, you know, and ours works great, and the cool thing is that every doctor has it in their pocket. You know, every, every, every casting tech, everybody. You just pull it out and it's a free app for them to use through Active Armor, you know, we have them do 10 scans so they get comfortable with the process of it and they're using it. Now it's not a barrier to entry at this point. So, yeah, and I do see it getting better and easier and faster. I mean that's always ideal in the entire process.
Speaker 3:But shoot from where we came from. I mean, yeah, the first time I did it I didn't even know about 3D scanning. But this was 10 years ago, you know, and then they were very expensive and it took a lot of training to, you know, make sure you get a good scan. But now I mean it's an iPhone app, but you know I whip them out in 10 seconds. You know a wrist scan and it's just, it's, it's easy and it's convenient and it's cheap, and I think I see it only getting getting easier. I don't like having a separate device. Personally, I don't like having any sort of requirement that you have to have sort of a snap on tool or a special scanner or whatever. I like having it on iPhone. Then any doctor anywhere in the country can just pull it out of their pocket, download the app for free and do a scan and place an order.
Speaker 1:With the 3D printing and things of that nature. I know most people say that healthcare is kind of ripe for innovation in that because it's patient specific customization, that sort of thing I would say like on your entrepreneurial journey, what has it been like-specific customization, that sort of thing I would say like on your entrepreneurial journey, what has it been like to try talking people into some of the technology and such, and what has caused you to be more successful? Like what is that tipping point for people to really adopt the technology?
Speaker 3:Yeah, especially in an old-school market like healthcare. I mean, healthcare is very risk averse, you know, for a good reason. But you've got with traditional casting, for example. In that kind of a market you've got people who have done the exact same thing for 200 years and now you're trying to say, hey, this is an analog process. Usually, you know, grab some fiberglass out of your drawer and wet it and smack it on the patient and then saw it off Right, which seems archaic, but that's what they've done for 200 years. So you know that's what they want to, that's what they're used to.
Speaker 3:And so when you try to bring in a new technology into a space like that, you can't bring in technology for technology's sake Like there has to be a very strong reason and motivator for them to change. And then you have to find the right people to bring it in. You have to find those innovators, those early adopters that you know sports medicine doctors, the athletic trainers, the folks that really see the benefits to the patient and are willing to implement it into their clinical flow process so that companies like mine can standardize the process and the product and the equipment and the procedures and everything to make it turnkey enough that even the general mainstream orthopedic surgeon can use it, and it's not entirely there where it can become the standard of care yet. I would love to see this get faster and easier to that point, but for right now, I mean, you know you're talking about a $23 billion industry right now as it stands, you know. So you know even coming in and taking 10%, and you know the clinics that we are working in that have adopted this are using, you know, active armor for far more than 10% of their casting. They're using it for the vast majority and they prefer it. And if you speak to the doctors who have implemented it, they're like, yeah, this is the only thing I use on my patients, unless it's, like you know, displaced fracture that needs to be reduced into a cast first, and then I'll move them into this later. So it's gaining traction and it will become, you know, as the tech improves, as the speed improves, as the ease of use improves, it will become the standard of care, but not just because of that, but because patients are demanding it.
Speaker 3:Right, I mean, nobody is accepting the old school casting anymore as, oh, this is the best that we can do and the best that the patient can do. I mean, if you have ever had a cast before and you've had to hold your arm or your leg outside the shower for eight weeks in a bag and it smells and it itches and all those kinds of things. I mean you know exactly what I'm talking about. And especially when something like this is covered by insurance and it can be fabricated on site in a couple of hours. I mean when you ask we have found with our clinics that when they ask patients, hey, do you want this traditional cast? And then you have to come and have it sawed off and reapplied and pay for it every exam and x-ray, or you can come back in a couple of hours and get a 3D printed cast and then you can swim, bathe, shower like normal and it's reusable, it's adjustable for changes in swelling or atrophy and we'll pop it on and off, you know, if you need, for exam and x-rays, but it's radiolucent and you know you can practice your normal lifestyle activities and sweat and whatever.
Speaker 3:93% will choose it, regardless of even if they have to pay out of pocket for it. It's a patient-driven product. But again, the end customer is not the patient for us. Our end customer is our providers, and so if they will not prescribe it? That's why you see some 3D printing companies and tech companies now.
Speaker 3:They're making super thin, spider webby like, oh, this is a cool cast, but no doctors are prescribing it. It's because they don't know who their customer is Like at are prescribing it it's because they don't know who their customer is. At the end of the day, a doctor wants a cast to be protective and immobilizing and strong and all of those things on a patient and they want it tested and proven that it is going to force patient compliance, that they're not going to be taking it on and off, that it is going to be protective if they're out there on the NFL football field or if they're doing their normal, like, let's say, they slip on the ice again. You want them to be protected. It's about what the providers want and giving them what they want and making sure that it's as easy as possible for them to replace their what they've been doing for the last 200 years.
Speaker 1:So, like, especially with that journey on the like, the two 3d printing, what would you say is some of the funniest requests that you've gotten Just kind of almost left field like, are you serious, are you trying to get me to do that? Or maybe even a misrepresentation of the technology or what could be done? Yours and I always get a good chuckle on just 3D printing. I mean it is magic, magic, but it's not necessarily the magic box. But I just love to hear because I'm sure you have plenty of stories on that.
Speaker 3:I'd love to hear, like, what your thoughts are well, that's the thing too, and you know some of them are kind of, you know, sad because you'll get a scan and you don't even know what it is, you know, and and we'll say, gosh, you know, I don't know what this is. And then, and then you'll have a scan and you don't even know what it is, you know, and we'll say, gosh, you know, I don't know what this is. And then you'll have to call them and figure it out, because you're trying to figure out what they want you to do with that, and I'm sure you get that in prosthetics a lot too, and you're like you know, how can we help this person? We're not even sure what this is. So, and that's the cool thing about humans, right? I love it. I think that you know having it be customized and everything should be customized medicine, you know, I mean my brother. I grew up in children's hospital because my brother had cystic fibrosis and I saw little kids with all kinds of different limb shapes and sizes and deformities and injuries and conditions, and all that having to adapt to the devices instead of the other way around. So I love this journey that I'm on in this mission that I get to do because you get to see those. But anyway, two funny stories is. But that's the cool thing about 3d printing, right? Is you can make it work for anyone. Whatever they have, it's customized for them because, no, there's not a one size fits all. You know, patient, it just doesn't work like that.
Speaker 3:But there was one where, you know, every time my CAD designers call me and giggle on the phone, I know it's going to be something. And so they called me one time and they're like hey, diana. And I'm like what? And they're like we got a butt. And I'm like you got a butt. And they're like, yeah, we got a butt. And I'm like, ok.
Speaker 3:So I called the doctor and I'm like, hey, buddy, what's going on? And he's like, hey, oh, yeah, I wanted to ask you if you could make me a mountain biking seat. And I said OK. So first of all, we don't do that. But second of all, you got to like let me know if you're going to send some body part. That's like not. You know, my guys were like we don't even know what to do with this. Did you need a butt cast or you know whatever? And so, um, the guys are always laughing about who knows what limb you know we're going to get.
Speaker 3:And then, um, there was another one where we got a wrist and the middle finger was up. It was just a flip off finger Right, and so they thought that somebody was messing with me. You know, they're like Diana, I think this one's for you, you know. And I'm like hey, hey. So I called the, the clinic and I said, hey, are you guys just messing with us or what? And they're like no, we actually have a division, one football player who he's a quarterback, and his middle finger, metacarpal just the MP is broken and he doesn't want any other fingers immobilized. And the doctor said that that was okay. So we made him a. It was just a hand-based cast that just immobilized the MP joint, the bottom knuckle of the middle finger, and that's it, like nothing else. And so stuff like that is really cool that you would not be able to do with a traditional cast, you know, you'd block your whole hand and you wouldn't even be able to play. So the fact that these guys are being able to play, but anyway, you know we the doctor was also saying that he would like me to print the hand model with it, um, and send that to him and he was gonna, and he ended up taking that hand model with the flip off on it and putting it on people's desks whoever he was angry at at the moment, so that I know that that hand model goes around that office quite a bit. We're on the bad list so, but yeah, we do get a lot of you know, you know how it is body parts in different positions and things like that, and it's always interesting to see what comes through.
Speaker 3:I mean, we'll get one day we'll get an infant, that's, you know, just a tiny little pink cast that you know can fit on your finger. And then you know the next one we'll get like a giant NFL player. It doesn't even look like a human arm. I mean, my daughter is 20 and she put an NFL player's arm cast on her thigh, you know, and just was. You know, put it up like that.
Speaker 3:And then and then you'll get some like you know, some very big. You know diabetic patients and you know they'll need a full leg cast and we're talking about, you know, multiple pieces that we're printing it in and and it's just a giant one and then all the way down to a tiny little baby ankle. So super fun to be able to do. And then you know you're looking at other cool stuff, like you know, spinal bracing for infant scoliosis or a little hip spiket cast that allow the kids to be able to you know swim and shower while they're in these casts. For, you know, serial casting for even a year at that age and changing them, parents being able to change diapers and give them a bath, and things like that. When they have a hip spike they cast on. So really cool stuff that we get to do every single day.
Speaker 1:So I think the other thing that strikes me, like as you talked through some of this stuff, like how important the communication is on the end product, so just to give you a for example, so literally we had a box show up at our office and the only way that we knew where it was from was we read the UPS label and it was full of test sockets and all this stuff Literally no work.
Speaker 1:And it was full of test sockets and all this stuff Literally no work. We had no idea that it was coming or whatever, but because we saw the address, you pick up the phone and you call, and obviously that's not the most efficient way to go about it, but I mean it sounds like, even from your perspective, like picking up the phone, communicating with your stakeholders, is a really important part of the customer service and ensuring the outcomes that you want. I'd love to just hear your perspective on the importance of that, because everybody says I just want a one-stop shop and if you go through my portal you'll get a device back, but if you don't really have the full picture, it's hard, even though we want the full picture.
Speaker 3:Right, and we are not a prototyping shop. We don't do anything other than fracture immobilization and you know, basically immobilizers that would be in replacement of a castor splint. That's all we do, and we only do certain designs Right and we have them standardized, while being custom right, so that we are popping these out like popcorn. These are not. We're not reinventing the wheel ever. Our design software is millions of lines of code, but you can have any long arm cast, for example. It'll fit you with the standardized design that's printable and mechanically sound and will work as tested and proven in the clinical scenario. So I mean for us, how we do it is by making sure that we are laser targeted on what our area of expertise is. What's our target market, what are we out there to accomplish and what do we specialize in? And what's our target market, what are we out there to accomplish and what do we specialize in and what's our competitive advantage. And we don't deviate from that, because then you get into this space of well, this is something new and unique and it's going to take a lot of time and labor and we're going to have to retest it and all that kind of stuff. We don't do that. We are awesome at what we do, but we stay in our lane. We stay in our lane of what we know and do better than anyone else and that's how we can accomplish it and move forward in an efficient and effective way, which really is mass customization in the truest sense of the word. Right, because if you're always prototyping, it's yeah, there's going to be a lot more communication needs and all that kind of stuff, although communication is still important. Right, because patients are used to what they've had for the last 200 years and the doctor's used to that. So you got to make sure. Like, if you look at our casts, because they're so organically shaped, some people have thought that they're squishy. You know they're not. They're rigid plastic, they're Legos on your arm, it's, you know. And or your leg, and it is, you know, it's an immobilizer, it's hard plastic, so it's still comfortable because it's custom fitted to you so you can't force against it, which would make it uncomfortable. But that managing expectations for that I mean.
Speaker 3:I've had one patient where she said you know, I don't. And changing expectations for that I mean. I've had one patient where she said you know, I don't. And she was elderly person. She said I don't like the cast because it's hard. And I said, well, when you went in to get the scan and did they show you a cat? You know what it was going to be. And you felt it. And she said yeah. And I said, well, was it hard plastic? And she said yeah. And she said, but it looks squishy. And I said, okay, well, that's the thing is, you gotta like you know. And I also said, you know, does your doctor want you to be wearing something squishy? No, well, okay, well, you know what I mean.
Speaker 3:Like, there's, there's certain things where you're like you know, you gotta manage expectations with the patient too, and and and and the providers at the end of the day, like, here's what we can do, here's what we can't do. Um, you know, I've had one provider where he goes well, I just want the hand immobilized, but then I want a big hole all the way around the wrist, and then I want the forearm immobilized and I said, well, what's going to be in between those two to hold it? Nothing. And I said, well, you're not going to be immobilizing anything then, because if there's nothing on the wrist, no, I thought we could make it as custom as we want and I said no, you can, I can give you a little hand loop and I can give you a forearm loop, but you're not doing anything with it. I mean, it's not going to immobilize anything.
Speaker 3:And so in that way we don't allow them to do stuff that they can't physically print or that won't be structurally sound. So let's say they want to like a huge hole for an incision and then because of that you can't have the clamshell shape, so you can't get it around your arm to put it on and off. You know something like that. So we have the parameters set in place so that they can, you know, do something that's not printable or not structurally sound, and that's that's. You know there are going to be limitations with 3d printing and and the technology as it is, you know, and and support like nobody wants a whole bunch of supports in it. So we design everything on purpose, with the correct, with the shaping that will allow you to print it with minimal to zero support, always, and and in an FDM environment.
Speaker 3:Now you can print with the HP printers or, you know, you can do powder bed or you can do resins, you can do all that kind of stuff, but we chose ours, because you know it's turnkey, it's easy, you know you're not going to be introducing toxins and you know them messing around with liquids, and we want this to be like.
Speaker 3:Anybody with a high school diploma or less can you know, learn how to run this thing and not mess up, and not know anything about slicing or that that even exists, or even the design. They don't know squat about how this stuff is designed. In fact, a lot of our users they don't even understand there is a design step. They're like oh, I do a scan and then something comes out right To them it's a closed, you know, black box thing and that's that's the magic of it, right, is, they don't need to know any of that and they don't want to know any of that. And so if we can keep that as as uh, you know as closed as possible and just let it be a magical turnkey process, that's the goal at the end of the day.
Speaker 1:Yeah, well, I'd love to end on this. We have a lot of listeners that listen to the show the Prosthetics and Orthotics podcast that are not clinicians but they're engineers and they want to make a difference in the field of orthotics and prosthetics or in the healthcare field. I mean, you've been around for a little while in the healthcare field. What would you tell those people that want to make a difference and want to have an avenue, but they don't necessarily want to be a doctor or a prosthetist or orthotist, but they want to use their skills, their mind, in ways that you have? What would be a direction or some encouragement that you have? What would be a direction or some encouragement that you would give to them to be involved in the healthcare field?
Speaker 3:I would say, if you can have it, if you can pick a product that's not a medical device, do that. And just the regulatory environment, the liability side, the insurance, the oversight that you know that all of that stuff is incredibly painful. As an engineer in chemical engineering, I had no idea what I was getting into at that point and now that I see everything that it takes like shoot, I could have been, you know, profitable and successful with the product outside of the healthcare space, you know, outside the regulated medical device space, within a year, right. But I'm over here 10 years in and we are like we're, you know, we're good, we're, we're scaling, we're doing well now, but it was a very expensive and painful. I mean, if you don't want to raise millions of dollars and, you know, buy investors and dealing with all of that and the regulatory requirements and paying, you know, for medical device liability insurance and all of the clinical trials and all that kind of stuff, if you don't want to do that, I would try to keep it outside of the medical device space.
Speaker 3:Like, if you can pick sports protective gear or any sort of, and if you can sell direct to consumer, I mean, by all means that is the ideal way to go, because for me, you know, with fracture care, you know I'm selling to doctors and hospitals and that's a much harder sell. You can't just go on TikTok and have a cool video and everybody wants to buy it. Try it. You know, if you want to do it faster and easier, I would say find a commercial product and, oh, shoot. Then you can get on Shark Tank and, if you want and you know, or just sell direct to consumer and have people buy it because they want to buy it, not because they happen to be at the very first couple of days of a fresh fracture and you're selling to the providers and stuff.
Speaker 3:It's a painful and long way to go. I don't recommend that. But if you are going to go down that pathway, get a group of advisors on board who know what they're doing. Get orthopedic surgeons, get medical device manufacturers in the tech space who have done it before and get them all on your advisory board and make sure that you listen to them and have people who know what they're doing and just follow their advice. Because don't try to reinvent the wheel, don't try to start from scratch. You will waste years and millions of dollars, trust me.
Speaker 2:Well, thank you so much for that, diana, thank you for that sound advice, and we love what you guys are doing. So thank you so much for coming on the show today and explaining your thoughts and views, and then your startup, thank you.
Speaker 3:Thanks for having me.
Speaker 2:And yeah, Brent, thanks, of course, as always, for you being here.
Speaker 1:Well, yeah, and I think this is great. I mean, I think it's a great balance, Diana, with what you have like some of the really positive stories, but this has not been an overnight success, right? So you're 10 years into this literally millions of dollars, it sounds like, and we're starting to take off, and so I think that is really the reality of this in the medical space and I think it was a good balance of that information. So thank you for that Anytime.
Speaker 2:And thank you for listening to another edition of the Prosthetics and Orthotics podcast.
Speaker 1:Have a great day. And that's a wrap for another episode of the Prosthetics and Orthotics podcast. If you enjoyed this episode, please kindly leave us a review. That would mean the world to us. If you want to catch up with us, please join us on LinkedIn and give us a shout out via direct message. And until next time, we'll catch you on the next episode.
