The Prosthetics and Orthotics Podcast

What the "L" happened...Is getting an L-code risky?

Brent Wright and Joris Peels Season 12 Episode 12

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We break down how L code pricing is set, why crosswalk and gap-fill can fail innovators, and how appeals drain time and cash. Two case studies—Point Designs’ digits and Ethnocare’s volume system—expose how “divide by five” logic and invoice anchoring distort value, while 3D printing and hybrid workflows offer a path forward.

• crosswalk vs gap-fill pricing methods and trade-offs
• pitfalls of 99 miscellaneous codes and ALJ appeals
• point designs digits priced against a mechanical hand
• Ethnocare’s volume management tied to sock costs
• framing comfort as adherence, safety and savings
• click medical as a data-backed reimbursement win
• Medicare recognizing 3D printing as manufacturing
• desktop tpu print farms and reliability advances
• hybrid workflows using load-bearing capture and automation
• fragmentation in O&P advocacy and need for alignment

Thank you for listening. We’re in 118 countries and nearing 35,000 listeners—keep learning with us and share the show.

Special thanks to Advanced 3D for sponsoring this episode.



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SPEAKER_00:

Welcome to season 12 of the Prosthetics Orthotics Podcast. This is where we connect with experts in the field, patients who use these devices, physical therapists, and the vendors who help bring it all together. Our mission remains the same: to share stories, tips, and insights that help improve patient outcomes. Tune in and join the conversation. We're glad you're here and hope it's the highlight of your day.

SPEAKER_01:

Hello everyone, my name is Yoris Peels, and this is another episode of the Prostetics and Methodics Podcast with Brent Bright.

SPEAKER_00:

How are you doing, Brent? Hey Yoris, I'm doing well. It's it's the close of a new year. Okay. Uh-oh. Or an old year. However you want to look at it, it's the close of it. So I wanted to take a uh uh we said we foreshadowed a couple episodes that we were gonna take a look at how L codes get their pricing and what the benefits and or pitfalls are if you go through all the work and what it means when it doesn't work out. So I'd like to jump jump into that a little bit. So it seems very simple, right? Yeah. Yes. But it isn't. I'm getting I'm your tone just tells me this is not going to be simple. Well, you know, if you're looking at just common sense stuff, it's like, okay, if if we're doing something good for people and it doesn't exist, and we start getting some data, we show the data, it's definitely better. So I'm I'm thinking like the point designs type of thing. We collect years and years worth of data, and then we say, hey, this is different enough. We want to go for an L code. And you know, you would want the the process not necessarily to be easy, but there is a slight barrier to entry. But you would think that uh maybe you would use some common sense in this and really take a look at the product for what it is, what the what the the the benefits of of it is, and then uh not reward the people that do it, but you reward innovation. Like if it's a good innovation, it's making a difference for patient, it's it's a cost effective, you see patients doing better with it, then then maybe you give a good reimbursement for that or a reasonable reimbursement. And that is not what we've seen on this last kind of go-around with there's two products that I'm specifically talking about, and that's the point designs digits, and then the other is uh a product from Ethnocare. They're not based out of the US, but it's you remember those Reebok shoes where you you pump them up and you, you know, it kind of fills the air bladders. They do the same sort of thing, but you and I have talked that uh patients have variability in their size throughout the day, fluid retention or or such. And so they have this kind of sock sleeve sort of thing that you pump up rather than keep on putting on socks, like take your prosthesis on, put another sock on because you're getting smaller. You can literally just convenient, I think.

SPEAKER_01:

Yeah, and you could regimely do this with like one hand or something, or correct, correct. Okay, so it seems like a lot of convenience if you're at the office or if you're wearing a suit or whatever.

SPEAKER_00:

Yeah. So I would say both of these companies in the US, we would say, got hosed uh for their decision to pursue an L code.

SPEAKER_01:

Okay, okay. So so talk to me first about the situation. What happens if I don't pursue this L code? Then I can't get reimbursement at all, or I have to sell everything commercially? How does that work?

SPEAKER_00:

Yeah, so there is what's called miscellaneous codes, and miscellaneous codes are are really a pain to bill, but you can get reimbursed for miscellaneous codes. So, but you have to have good descriptors, and then you have to work with customers, like clinicians like myself or other companies, both large and small, to be willing to put up with the aggravation of submitting a 9-9 code. So if you submit a 9-9 code, which is called a miscellaneous code, then it goes through multiple levels of appeal, uh, you know, back and forth, pricing. And then when they finally say that they have approved it and you go to bill it, they can still deny it and not pay it. Wow.

SPEAKER_01:

Okay.

SPEAKER_00:

So that's that's the that's how you can still be in the market and you find people that are, say, like-minded or whatever, that are willing to put up with that, and then the reward is great enough that they'll put up with it, and then they get billed on the other side of it. A lot of companies want clarity for the clinicians and even people like myself, like those nine nine codes really slow down our billing team, and our our team's time is actually better off doing other things rather than trying to pursue getting paid for nine nine codes. So it's it's really only in ultra rare cases that we will take on a project or a client that requires those kind of devices because the paperwork is so steep and the risk is still there that you won't get paid at the end, and then you have to fight and fight and fight for it. And so, just for instance, and this is part of the reason why the US healthcare system is so broken. So let's just say you spent six to nine months getting an authorization for let's call it a point-digit 599 code. So you go through all the cost and expense of doing that. You actually go through the cost and expense of providing the device. You go and you provide the device and then you bill it, and then the insurance denies it, saying that it's experimental or whatever after they've approved it. So then now you're out like all that time. Now true money of the cost of the device. Now you're gonna have to have your billing people again go in and fight, fight, fight. And if they don't pay, then they have what they call the AL ALJ, which is the the final decision maker of it, it's typically some sort of uh medical judge, and they look at both sides. So they look at the side of the insurance company, the your side. And I would say most of the time when you get to that level, if you have your documentation in place, you're going to win, and then the insurance will then pay. But that process can be a year or more. Oh, wow. That's just so you have all this money tied up, and then I just talked to somebody that won an ALJ and then still lost. So the so we thought that the ALJ was like the pinnacle. Like if you win there, you're done. But apparently there's still one more level where somebody can appeal or the insurance company can appeal and overturn that, and then that's the end. Like you have no other options. And so I mean, like I I'm just saying, so if you were in say my position, would you want to do that?

SPEAKER_01:

You couldn't really do this a lot, and you couldn't do it on really expensive things, essentially.

SPEAKER_00:

And that's the that's the thing, is typically it's a lot and an expensive thing.

SPEAKER_01:

Okay, okay. And then but then but then um and normally the other way, if I don't have an L code, it doesn't get reimbursed at all, apart from that really process that can be super laborious. But you mentioned that these companies kind of got uh shafted, no, I'm gonna let it say a hosed. Uh yeah, yeah. What what do you mean by that? Explain the cases just for people that didn't have so this these SNCAR have a you know, I I think the weird thing is I could I'm trying to empathize with insurer and all these other people. A lot of products I think you know you probably maybe don't understand, right? Or you maybe don't get it, or maybe it's too gimmicky or too robot y, you know, or it's like 50k or something.

SPEAKER_00:

Right.

SPEAKER_01:

So I understand. There's some myoelectric uh eyebrow, I don't know, something like new, right? Right. I can understand that would be really kind of pushing back on that. But the the the these both of these products don't seem super crazy, you know, in the scheme of things.

SPEAKER_00:

No, I mean, and so that's that's the that's the thing with with this. Both products fulfill a real patient need. I think what when we had Chris Baschik on, and then when we had uh goodness, his name is escaping me, but uh, he's a user of the man and he'll kill me. I'm gonna have to edit that out. Jeff. Jeff Solberg. We had him on, and partial finger amputation is makes up the largest portion of amputations, and it's the most underserved out of everybody. And and and it's the most useful. Think about how much you use your hands, and you if you're if you don't have a thumb or a first digit, that gets that's a problem that gets in the way. So like they're they're filling a real need, and then you've got the ethnocare group that is fulfilling a real need, up to it's it's almost the thing, same thing as wearing up to like 15 ply of socks. So you you don't have to carry around a purse or a MERS, right? The man purse full of socks if you fluctuate in volume throughout the day. So you think that that would be a good one.

SPEAKER_01:

But also just the conveniences, right? Like just like imagine you're at the office, you have to go to the bathroom, kind of kind of got proud partially half undressed or something, you know, and then maybe later you have to do it again, you know, and then you have a meeting, and you have you know what I mean? Just the the the the getting in the way of just life in general is really annoying as well.

SPEAKER_00:

Yeah, yeah. So so here's what happened with the point designs project. They have multiple ways that they can there's two main ways. There's uh they call it a crosswalk and then uh a gap, and I can go through that shortly. But they on this particular case said, okay, so there's a mechanical hand, and we already have a code for that. And so a point design's finger is just one-fifth of a mechanical hand, and so we're just gonna take our current reimbursement and just divide it by five, and that's the reimbursement for point designs.

SPEAKER_01:

Okay, but that that's a that's a really, you know, as a heuristic goes, that's not that. There's a certain logic to it. There's a certain logic to it. That uh and and but the logic is kind of based on the idea like let's not spend too much money, right? You know? And uh and of course it would yeah, it would mean that if your your hand is a the one finger would be it would mean that one finger, like the five fingers individually would be the same cost as the final device, which is of course really weird and of course is not gonna happen.

SPEAKER_00:

Right, right. And it's and it's yeah, and it's just different.

SPEAKER_01:

Oh, the the product is different. Goodness. Um there's no economies of scale during a hand. I can just buy the finger separately or something, or there's no there's no right, right.

SPEAKER_00:

It has no mention of say the the saga stuff, the the ratcheting aspects, how much it holds, that sort of thing. There's there's none of that.

SPEAKER_01:

And is that is this expensive? Is there just like super expensive? I I know they're made using like one click, uh, LPBF. It could be kind of expensive, the lightweight and all this. Are these things way more expensive than alternatives that are already on the market, or not really?

SPEAKER_00:

Or there's well, there's really not an alternative. So I don't know the actual cost because I've actually never fit a point design. I've made a few of them, but I've never fit them. But I want to say it's somewhere in the neighborhood of like four to six thousand dollars per digit, is what these things are. Okay. Well, when you're talking about titanium LPBF, I mean, it's pretty those those things are it's not insignificant all the all the ways to do it. So, but you're right. I mean, so that does sound expensive, but then when you take a look at all the all the things that can potentially go wrong, you've got to be FDA approved or FDA approved, you have to have your ISO certifications, you've got to have insurance if somebody is using this thing, going ziplining and for whatever finger there, a finger breaks and they fall. Like just you have to plan for the most ridiculous things, and they're gonna that person, if they get hurt, they're probably gonna come back, and you know that the US is a litigious uh country. And so now you've got to carry this ridiculous insurance because sometimes people do ridiculous things. And so that's a lot of where this expense comes in is that that layer of how do we protect ourselves from lawsuits, which is a terrible way to run a business.

SPEAKER_01:

But I'm okay, but but yeah, but so they're saying is is and now with this one sixth of the five for the hand thing, they wouldn't get reimbursed like 300 bucks or whatever, right?

SPEAKER_00:

Yeah, so it's like 280. And so and this is the interesting thing. So I think, and uh, this is probably a time that we uh give our what what do we say? We are not experts in L codes, we are not lawyers, you're just don't show me I have no money. Two two two people uh discussing this, trying to make the most of it. So, but what's interesting is so they chose to use there's two ways to create pricing. One is called the crosswalk way, and then the other is the gap fill way. So the crosswalk way is hey, there's already something similar on the market, and we're just gonna go with that L code and just divide it by five. And so essentially they're saying there's something similar, something similar. So we just kind of lick our finger, put it in the air, and we're gonna say, here's the price. The other way, which could be a combination, I'm not sure, is this gap fill. So, what they do is they'll take a look at invoices, they'll look at MSRPs, wholesale prices, any retail catalogs, manufacturing costs, uh, and then fee schedule history for other things. So, like socks. So, so here is where I think the ethnocare side of thing kind of went sideways. You know, when you have a new product, you want people to use it. And so what do you do? You price it in such a way to get people to use it. Sure, sure, yeah.

SPEAKER_01:

Right? Margis aren't really important in the beginning. You want it, you want feedback as well.

SPEAKER_00:

You want you want feedback, you want people to try different athletes, tall people, whatever, yep. Utilization, that sort of thing. But this is where things can go sideway quickly. Because if during their research, they find that you let's say it's a thousand dollar product and I have no idea how much it is, and you sold it to somebody for three hundred dollars, well, there's your new ceiling because you sold it to them for three hundred dollars because you're trying to get utilization. So this is and so I believe this is what happened is that because ethnocare had been around for a while selling, trying to get this utilization up, there were some invoices probably floating around that made it into their hands. And they're like, Well, really, it shouldn't be a thousand dollars, it should be three hundred dollars because that's what they're already charging for people. In fact, we're probably not gonna do 300, and I don't know what the final number is for them. But here's the other thing.

SPEAKER_01:

I check on the website and the pricing is like is like is like well in euros it's like 900, 700 and 900 euros, some of this. Okay, so roughly crazy expensive given the utility, right? Right, right. So but here's well, I don't know how long they last, right?

SPEAKER_00:

So yeah, and nor do I. I don't know much about them. So but here's here's the other interesting thing is from at least from some of these meetings, apparently. So they say, okay, so okay, it'll take up 15 socks. So how much does 15 socks cost? About$300 too. So now they're saying, well, you know, 15 socks you know cost about 300 bucks, and hey, the uh you invoice somebody for 300 bucks. So that's just what the price is going to be because that's what it is. And so you have this this company that's trying to do the right thing, trying to get utilization that gets burned by just trying to cover some of their costs and some of these invoices make it out into the public, and then and then there you go. So it's a really tough thing.

SPEAKER_01:

But again, I'm trying to be empathy for the other side here and a devil's advocate, I guess. And it is really difficult to do stuff like this. I've I've done this stuff where we're trying to figure out like a pricing or try to figure out a market for a startup and pricing and I it's a really difficult thing to do. So substitution type pricing, what is the value? What is the value for different people? Do you want market share? Do you want margin? You know, there's there is a lot of stuff going on there. If you're really trying to do something innovative to get a right price, it's very, very difficult. But this does, having said that, this does kind of like seem to deter people being innovative. But what what option do these guys have now? So what what's the thing? They can impal as well or or not?

SPEAKER_00:

Man, I don't know where ethnocare is. So this is the danger, right? So once you have a code and you have pricing, the the companies, like I can no longer use a 99 code because now they explicitly. There's another point. There's no point, yeah. So now I go from the potential of, say, a point designs of$6,000. I can't bill$6,000 anymore because there is a code with a price that says it's$280 or whatever it is,$300. And so that's a it's yeah, it's a really tough position to be in. Now they do have, and I think it's coming up in January, the ability to to appeal. But I can't imagine a time where, you know, they set an anchor like that,$280, and say, yeah, it's just$6,000. There's a lot of space in between. And I just, I just, how are you gonna close the gap? I don't, I don't know, man.

SPEAKER_01:

I it's and are there like super specialized lawyers for this, or would you have to do this by yourself as a company? How does that work? Do you have any idea?

SPEAKER_00:

I I don't know. The good thing though is is that all this stuff is public now. So they have public hearings, you can hear all the things, you get to hear all the justifications. And I think that's one of the things that point has going for them is they see how the L code was calculated, and they can come in and say, hey, that's that's it's not really the way that this should be calculated. And so at least they have a data point that says this is how it's calculated, and then they can just help maybe them understand that that is not a great way to calculate it.

SPEAKER_01:

Yeah, but also talking about like that that's a good thing on the one hand. On the other hand, it's also kind of a hidden negative thing, which is also the reason why no one calls you and tells you why you didn't get the interview if you get a job interview now, or no one tells you why you didn't win the deal, uh, because it opens them up to maybe lawsuits and maybe other certain sorts of things if they they motivate a certain decision behind it. So they they may actually kind of now come up with fake ones in order to in order to not get trapped on other ones that are more problematic, you know?

SPEAKER_00:

Yeah, and I think that's an interesting point is you know, it is it is in their best interest, like the insurance company, to have the least amount of codes possible. Like the the amount of work that it takes to bring a code to fruition, yes, it's a lot of work on point design side, but this this team that has to get together and look at all this stuff and mountains of stuff, like I don't, I do not envy them at all. So they and and all these companies, they are looking to make money, right? So it's a really hard position to be put in if you are an insurer and you're looking at some of this stuff and you're looking at potentially the risk and and such and utilization of some of these. You want to uh I would think you would want to try to be fair and you would want to try to make it as difficult of a process as possible to make sure that the people that are getting codes are the right people. And so you're not getting these, like what you kind of call the these fake codes and such. And so, you know, when when you look at these these uh ethnocare side of things, the other thing that was already interesting about that is they look at distributor pricing uh Any suppliers that brought in bulk, any lowest cost pricing from a specific period. And when they look at that, they they are looking at wholesale. They're not looking at MSRP at all. And that's difficult. And so that's the other thing that's there are some other ways to get similar performance, like the socks. You have gel inserts, air bladders, some volume pads, other lower cost items. And so I think Medicare kind of cr for on the ethnocare side of things, instead of like a prosthetic, say interface component or something to that effect, they're actually saying this is more of an accessory. It's not really part of a prosthesis. And I think that is also difficult.

SPEAKER_01:

No, but it's also that comfort thing where it's like, oh, it's comfort. We won't do anything with that. You know? We've encountered that before. And that's really weird. If you have something where somebody's walking on it every day, you know, it's like, uh uh, yes, that is a part of the equation, actually. You know, imagine being uncomfortable every day, every step you take. That's that's crazy to not not care about that, you know.

SPEAKER_00:

Yeah. But you take a look, so so I think that's an interesting point. And we've had Click Medical on, who had a very favorable reimbursement on their adjustability, and they were able to prove that, hey, this style of fabrication with the strings and the dials and all that stuff does improve comfort and potentially decreases the need for, say, a replacement socket that could be overused, right? So if you if you are able to put some adjustability in a socket and not have to remake a prosthesis because somebody shrink, that's a big benefit. And I think Medicare really looked at that in a favorable light. And I think it was the absolute right thing to do. It was different enough. And they had a bunch of data, like years and years worth of data, 10 plus years worth of data, a lot of utilization and such. So, you know, in that case, it worked out really well.

SPEAKER_01:

It's interesting because it would be interesting if Medicare, for example, said, Hey guys, we're paying a lot of money for this, or we have a lot of these devices that break, you know. You know, if they if they would take that data that they have, or the insurers have and say, you know what, we're we're paying for a lot of uh whatever these types of sockets and they're breaking, a more durable version of this socket would actually save us money. So we'd love to have that, you know? Or even like a price target. Like if they would say to the market, like, hey, a more durable socket of this type, if it lasted uh, you know, X months longer, could be$100 more expensive, or something like that, you know? You know, if they would really kind of like do it more as a kind of like a uh uh uh kind of really a task-based or kind of like a, you know, as a market would work. They would send like kind of demand signals to people and say, wow, we're noticing a lot of these cases and there's no product for it. Right. Based upon that system, this is what we would be willing to pay for a product like that. And then you could in advance kind of like, you know, of course they can't pre-approve you, if you will, but you know, is if you met these and these targets and that price target, that maybe then you would be having a really profitable product, you know?

unknown:

Yeah.

SPEAKER_01:

And that could be really interesting. I say did it did it a more in market kind of way. But if you kind of don't know in advance if this thing is actually going to, you know, get money later on, this uh that's a really problematic, also from an investment point of view, or also from just an entrepreneurial point of view, just like, hey, am I gonna spend seven years of my life on this?

SPEAKER_00:

Right, right. Yeah, because you you you know, from an I think that's an interesting point from an investor point of view. It's you take a look and you say, okay, so many people are living with this situation. If we get so many of this, then you know, we get this much money or what have you. And so the but the flip side of that is the risk of not being able to get insurances to cover it. Now, one thing I will say though, is that is on the like the Medicare side of things, private insurances, as well as say workers' compensation, which people are that get hurt on the job, or the veterans administration is always a good option too, because they are outside of the L code system.

SPEAKER_01:

And and if if they do they follow each other, kind of look at each other, or is that completely different process?

SPEAKER_00:

So they may look at each other, but they do they do have different rules. And while L codes are used, some of the the pricing I would say would be more fluid, and you have the ability to use these miscellaneous codes and get paid for for them. All right.

SPEAKER_01:

Okay, so it's a it's a kind of hiccup. I hope they can appeal or something or get a little bit more money for what they call and what they need. Um yeah, it would be good if they could find a way to to convince people that this is uh you know more necessary or deserve somehow uh more cash from the collective system, let's say. Um yeah, those uh that's an interesting look into that. I think I think I think we should look with some more people who are more expert in this stuff again, uh, at how this actually works, you know? Yeah. Yeah. I mean I would like to do that.

SPEAKER_00:

Yeah, yeah. I would definitely love to do that. I here's here's the crazy side of that aspect is many of those people, it's it's such a small when you take the you know take a look at the funnel aspect in for Medicare, there's there's really not a lot of people. I mean, I would say that there's probably from from at least my basic amount of research, there's probably less than 20 people that are making this decision. And that's that is wow scary, right? Because you know uh 20 humans, what's that?

SPEAKER_01:

We should get them to listen to our podcast.

SPEAKER_00:

I know, I know. And but I I and I think this is this is where I think you have a good understanding, you know, my side, because I'm a clinician, you know, it's always like they're the bad guys. And and I appreciate your perspective of like, hey, they're not necessarily the bad guys, they are watching out for you know potential fraud or overutilization, making sure things are fair, making sure that prices are kept in check, that sort of thing. And I I see that perspective too, and I do not envy any of theirs. So if they are listening, yes, I'd love to have them on and have them share maybe some of their perspectives on on where we miss the boat as a field. And that's but that's the other problem with our field. And I think you've said this before. We have so many, like we're a very small field, but we have so many organizations that don't even talk to each other. You know, we have the Academy, we have the American Orthodox Prosthetic Association, we have our certifying body, we have NCOP, we have the National Prosthetic Alliance or something, and and uh all these different organizations. And it's like we can't all pull in the same direction. And for the small amount of people that we have in the field, I've talked to multiple other people that are in much bigger fields, and they're like, what are you guys doing? Like we have one organization, maybe with some subcommittees or something, and you guys literally have organizations upon organizations for not a lot of people. And that's it's a really tough predicament to be in for something like this.

SPEAKER_01:

Yeah, totally. It makes it really complicated. And you've got all these little empires and stuff, and and that's never really very good. And I think, you know, if I I've you know, in additive, we've seen more broadly, for example, the FDA has been super proactive uh with 3D printing generally and and super open as well. And has really tried to communicate to give off the right signals and tell people like, hey, custom devices for in the body, we're not a fan, you know. You know, other stuff like uh, you know, there there's there's there's ways that we're super, super open or super we really want to be the regulatory body for this, you know. So so so you know, my own experience is has been very, very positive in that sense. So it's been shaped by that. They they come to our conferences, but AMS, a bunch of FDA people come all the time and uh they're calling for our show in New York. And and uh um, you know, they just really actually want to be there to listen to people, to talk to people, to interact, and to really go and and and find out uh uh you know what's happening on the ground. So I've been really very pleasantly surprised. So that's colored my own kind of experience as well.

SPEAKER_00:

Well, and I think that's a really good point. I mean, I forget when it was this year. The Medicare said, hey, 3D printing is a viable way to make a prosthesis. I mean, it's super forward thinking. And I can appreciate, so there there are some people that are like, well, 3D printing needs its own code. And we always get back to the same point as like, yes, there are advantages to 3D printing, but does it really warrant its own code? Or is it just truly another way to manufactur? And I would say I'm in the camp of there are benefits, but there are a lot of descriptions in the L code side of things that describe what we're trying to do with additive manufacturing. And so, like, I really appreciate Medicare coming and saying, hey, 3D printing is a valid way of manufacturing, full stop. And my hope is that there is enough camaraderie and groups pulling in the same direction that we don't rock that boat. Like, oh, I want to do resin printing or I want to do powder printing or whatever, and I want my product to be in this, and I want an L code because I'm 3D printing this. I I just don't think that's the right way to go. And and this is my opinion. I think that 3D printing allows us to scale, and the fact that they have outlined it as a true manufacturing alternative is enough for me. Okay. All right, all right. What do you think of that? Is that a is that not a good perspective?

SPEAKER_01:

No, it's a different, it's a different way of looking at it. I don't know. It's good, it's good to be ambitious, too. And it's good to they also don't know what they're doing. No one knows what they're doing. That's the problem. In the face of this, no one knows what they're doing. So it's it's how do you grapple with that uncertainty and how you grapple with the future, you know?

SPEAKER_00:

Would you say though, would you say though that would you agree with the statement that additive manufacturing is is just a different manufacturing technique to make a prosthesis?

SPEAKER_01:

Yeah, okay, so so okay, all right. My perspective always has been to not make any specific additive rules because I come from the I we did a lot of the gun stuff and uh the the the lot of the the debate around guns and 3D printing guns and people were printing guns at home, all that kind of stuff. And there you saw local legislatures make specific rules like you can't 3D print a gun, right? Where well you could make a gun out of clay either or CNC or lathe, right? But they were making special rules for 3D printing, which kind of I I thought was like kind of like really confusing and unnecessary and made it more difficult, right? Or made it difficult to print just everyday stuff, whereas it doesn't actually necessarily make it more difficult to make a 3D printing gun. And so that's where I come from, where I always see like people make special rules for this, right? So you so on the one hand, that's my background. On the other hand, it's like if it's a production technology, we have to realize we can make geometries in very different ways. And these processes are very different. And so getting blanket approval for all of them in in kind of a general use is maybe also not like the optimal solution. Yeah, you can use this, but you could also use clay. I mean, I'm not saying that clay is going to be a normal method uh for most people, but you could use clay. All right, it's about ultimately for me, it's like about like what is the final device and how does it perform? I don't want to like kind of at one point be locked into having to do it a certain way or or not being able to do it, or for you know, one process to not work or or work. Does that make sense?

SPEAKER_00:

Yeah, well, I I just I think that I think you hit the nail on the head. Like, why why try to put limits? They came out and said 3D printing is a viable technology. You know what that means? I can use resin, I can use FDM, I can use powder, I can use metal, I can use um stuff that's coming out, I can use rapid liquid print. You know, all this stuff, it's viable. Like I think having it super broad has been one of the greatest gifts to our field. And we have to just think beyond ourselves and and look towards the future too. And if we start trying to get into the minutiae, they might start locking it down. Yeah, exactly.

SPEAKER_01:

Or or it could already be kind of so well defined before we understand what we can do with it. Like for example, now metal printing on the point design example, LPBF is very expensive, right? Uh the machine's three million dollars. If you get a one-click machine, it's 150k. But there's a Chinese machine we talk about a little bit at Formac, which was 20K. I wouldn't like to have it at my house or anything. This could get much cheaper, right? So so maybe you could use that for like a much different prosthetic than before, or larger things, you know, braces. I don't know, right? So it's like the technology is developing quite quickly. Inkjet right now isn't used for almost anything, but inkjet is changing so quickly that it could be used for very functional parts very soon. Um SLA, we've talked about this before privately, where we're both very uncomfortable with SLA or vap polarization, um, because of the way it shatters very quickly and it catastrophically breaks. So then it's not, you know, it's not a great solution generally, even though it makes really um really, really nice looking parts. It's great for molds. But but on the same, well, they're improving the strength of these materials all the time in the prints. So it's like it's it's in transition. So to say kind of yes or no, or to say, I took that as a kind of like innovate faster, please kind of thing, you know? Uh that's what I think they were saying with this, this it may it's a suitable technology. And I think that they also realize that like we don't really know how far this will go. You know, we see, for example, uh companies come up with like low temperature peak and like your PK 5,000 material and stuff, where all of a sudden with polymer, you're able to do so much more than we were like only two, three years ago. And and also like think about like five years ago, I don't I think we both would have been very if somebody would have come to us and say, Hey, I want to start a print farm to print, well, even like uh uh orthosis or something, we would have been like, well, it could work, right? But hey, you know, TPU is slow and the machines break a lot and everything. But now that it's going so quickly that's the the if if someone would come to us, I want to make orthosis, we'd be like, Yeah, you should start a print farm, you know?

SPEAKER_02:

Right.

SPEAKER_01:

Uh and that's a really big difference to to to to to a lot of people. Uh and it's a really big difference in in in in in determining what can be made when for how much, you know? So I don't know. I think I think I think I think that we're gonna have a lot more discussions about this, and I think uh I hope we get a lot more better results. But I think just generally, I think the the the future's still quite bright. Yeah. I think.

SPEAKER_00:

Well, speaking of bright, yeah, how about that transition?

SPEAKER_01:

Let's I like it. We could be we could be on local news, dude.

SPEAKER_00:

Over to you, Brock. Uh let's talk about uh we're finishing up the season. Uh this is gonna be a bonus episode for the end of this year. We've got a lot of things uh going on, you know, and and this has been wild, you know. We're over I think it's over three years into this. Uh-huh. Doesn't feel like no, this will be the 145th episode. How crazy is that? Or it might actually be more than that, because I know we've thrown in a couple bonus episodes before this. I mean, we're still learning stuff every time we do this, and I think it's so great. And we're not I know y both you and I agreed, hey, when this started being not fun, then we just need to stop. And we haven't stopped yet. And uh I don't foresee that coming here, and we are learning so much. What over the last year, I mean, what do you think what is a say two takeaways that that you have kind of learned over the many episodes that we've done, whether big big uh big ideas or an episode that you really remember?

SPEAKER_01:

I don't the big ideas for additive thing is that the the desktop 3D printing thing which and the beginning, like if you're talking about 12 months, the beginning of 12 months saw us. You were already very excited about Bamboo a couple of years ago. I was as well. Uh but now we saw that kind of broaden and we saw like the desktop machine, the rise of the desktop machine. I think for me, generally an additive, that's been the story for the last 12 months. And and the rise of the desktop machine in in farms, in production, and end used parts, in like things like you going into Guatemala and taking these really super cheap printers with you, and it works, right? So the the the desktop 3D printing revolution may actually happen after all kind of you know, five years too late, ten years too late, but it's still gonna happen, maybe. Or it may actually happen, but for certain sectors of the business. So that's my overlying like great big like learning that I'm really excited about uh going into the new year, and we're going from going to five million systems a year to maybe like around 10 million, and that's that's that's huge, right? If we look at how we're doing a million systems only like four or five years ago. And uh so that that that's the thing. On the prosthetics thing, I think, I think on the one hand, it's like the no the the the the the downside thing, the negative thing is is like how even though we're trying to let people learn along with us, and and also we're learning ourselves, right? So it's not like we're like we know everything. We we're doing it specifically because we do not so we specifically know very little, so we're we're trying to figure this out for ourselves. And we want everybody to learn as we learn, right? And across that journey, I think, I think it's it's still very, very surprising to me how a lot of process specific knowledge and a lot of for prosthetics, orthotics and prosthetics specific, is just locked away in people's minds and it's still very in the in the realm of an artisan, right? Where it's still like somebody really specific has some really uh specific knowledge and really specific way of doing things, so much as a craft still. And and on the one hand, I I I really want us to really think if we're going forward, is like how do we preserve that in that going forward? Do is it becoming like a digital artisanship thing? Is it going to be a culmination? Because I think that that personalized nature of that, that inventiveness, right, is is the um is going to be the soul of this business, has always been the soul of this business. If we if we see about the people we talk to in the sh show, it's always very, very different. And they always kind of almost all of them start with this really random story, like, well, I was meant to be an ice cream, but you know and they always end up being or or they've been doing this for three generations. Right. So it's like they're really random, or it's like three generations are doing this. And they're always these people that like to do a whole bunch of different things and invent things and make things and craft things and then and work with people. And then for them, it's this really perfect kind of combination, right? And so so to me, that that's the soul of this business. I think I think maintaining that and maintaining that level of customization and that personal touch in that that that coming 12 months is gonna be the the really defining thing for me. Because the other thing I see looming beyond that is is is in everything we've discussed with these workflows, right? AI-based or deterministic workflows, outsourcing to ever larger CFABs, maybe CFABs in different countries. Maybe I only do the scanning and somebody else does all the work on the device. It's gonna become a lot more automated and it's gonna become a lot more less personal, right? Uh and that could mean that maybe you're the better process and stuff, and I'm just better at scanning and talking to people, right? And and you know what? A lot of people aren't gonna know the difference, right? It's like uh, oh auntie Auntie uh Jane will take the wedding photos because whatever, she's so good with Instagram, you know? Right. It's that kind of thing. It's not like that she's a better photographer than Sarah, the professional photographer. It's that no one really can tell the difference. And I think that's the the the the worry, right? I have the the on the one hand, it's gonna maybe get a lot more efficient and bigger and and more massive, and maybe like, hey, you just press a button and the and the right persona gets made. But on the other hand, that artisanship should at one point kind of get lost, that personal touch.

SPEAKER_00:

Yeah. Yeah. For me, I would say I agree with you on the desktop printing. And I think, you know, I'm looking back through these episodes, and you know, we saw a lot of acquisitions this past year, and one of the big ones that sticks out is filament innovations getting acquired by a Proteur, right? So now you've got something that's gonna go on more corporate. And, you know, I think uh the jury's still out. Is that does that enhance innovation or does it actually stifle innovation? And that was that was a big one. And I think that there's a big opportunity. Opportunity for smaller companies, companies like you know, our company, Advanced 3D, with some of the things that uh we have coming down the pike, because we're gonna be able to be more nimble and such when we're making some of these decisions, because it doesn't have to go through a bunch of levels of corporate and all that stuff. However, they're way better funded than we are, right? And so sometimes the the dollar bills do make a difference. So I think that's that's interesting, but yo I we this you're gonna laugh at this. So we love the bamboo. We have a H2D, the H2S is I don't have one, but I have a couple people that have them because we bought an H2S or H2D right when the H2S came out. Um but I would have an H2S because of the the Z. So you've got that, you've got Prusa coming out with their stuff. But here is something crazy, and you're you may laugh, but we have actually implemented two Neptune or Elegou Neptune Max 4s or whatever, very inexpensive printers, but we upgraded to a Bontech uh extruder hot end setup. I bought them on Black Friday. So now it's gonna like break and look pretty well doing that, or what's the what's the plan? No, I mean you I'm gonna I know you're laughing because it's like, oh my goodness, uh, what have you done? You you have introduced some Chinese stuff into your your your market uh low cost. I'm telling you, these are some of the most beautiful prints that I've seen. What? No, no, okay, wait. Now I'm gonna go on myself. Okay, wait, which one? The Eliku Neptune 4 Max or Plus.

SPEAKER_01:

That's the okay, that's uh the Creality 3 kind of with the Ana, yeah.

SPEAKER_00:

For TPU. So, yeah, so we put this Bontec extruder on. So they made Bontech makes a upgrade kit, and we didn't even try with the Neptune stuff, which maybe we shouldn't have done that, but we actually run this extruder on another machine, and we're like, this does TPU really nice. And I'm telling you, it is so I bought everything on Black Friday, and for two of those printers and the Bontech upgrade, I don't even think I was into it for a thousand dollars.

SPEAKER_01:

All right. I think this is interesting in the competitive landscape thing. I think a lot of people are just screwed. Bamboo is just better at the software and better at the experience and and really great making system. But the one thing where they're weak is TPU, and they've always been weak at TPU. And with a large-scale printer like that, I didn't know about this one working well. I'm not real big LAGU fan, by the way. Apart from the SLA stuff they do is is okay. It's like, you know, if you want something for 200 bucks, it kind of works, it's fine. Um, but I'm not a really big fan of the FDM systems. Um, and I'm and I'm much a lot more likely to in that price category and that same type of that larger max uh MK3S kind of uh I would much rather take like a artillery or uh A net even you know if I'm not dead yet. Um so so I think it's interesting, but I think this is an interesting choice is going forward. It's like it looks like bamboo is kind of all conquering, but hey, but there's also Snapmaker, there's also uh Creality. And I think on a TPU front, we could be seeing some interesting things if these guys decide to make like a$500 printer specifically for prosthetics or something like that. So these guys have very little space to go, but I'm pretty sure the these big kind of simple printers do tend to work really well for TPUs. So that could be really interesting, I think. Yeah. So interesting that you do that. Keep me abreast of this because I'm really interested, because I'm not I know people that, for example, are working in like fabric, clothing, shoes, and and they're kind of tending to stick with this kind of the same architecture you went with, the big kind of big MKS2 kind of model, S3 type model. And and that's working out well for a lot of these people. And they're not upgraded. These are the only people I know that aren't upgrading to like the more K1, K2 bamboo HCD system. So that could be really interesting to see if that would actually work. And the other thing, which is I think is also uh really interesting, is what Recreos has done. Yes. Right. And and they've just introduced, and I still don't know, I need to test it, but I just don't want uh I don't have the time at the moment, but I want to. And they've just introduced a 2.2 millimeter um kind of filament standard, essentially. And they're saying that this is makes a lot more sense and can actually lead to them uh printing more reliably, more repeatably. Uh, I don't I have no idea if it's true. I know Recreation a long time. They're you know Spanish-based, you know, one of the leaders, innovators in this TPU filament stuff. And so they've been they've been making quite good products for a really long time now, but I haven't tested it yet myself. But the idea of them saying, you know what, for TPU specifically, we're gonna come up with this 2.2 millimeter uh filament. You have a little kit that you can buy, and then you can transition to the new filament. The kit seems like it's gonna be quite interesting and to implement, not gonna be crazy expensive. And then you they said it's much more higher reliability, repeatability, and maybe even speed as well on TPU. So that could be in and of itself, that's the single innovation I'm looking for the most in the next year. Is what platform is gonna be the default platform for printing a TPU and other elastic materials for the for the desktop for uh prosthetics orthotics, orthotics specially, I think, because that could be huge. And is it gonna work? Is this right, you know, because it seems like a crazy idea. Oh guys, we should use a third filament standard. It's like, what? No, go away. I don't want that, you know? But if you're gonna be printing like these insoles all day, every day, and the material's not that expensive, then yeah, I don't think you would really care, right?

SPEAKER_00:

Yeah. Well, and and here's the thing that I learned, and we had Grant Michael on, I mean, it's been a little while ago, and he had a saying that stayed with me if you can print slow, print slow. Like if why why do you have to print fast? And so I think that's kind of the approach that we've taken with these, is is hey, it's still going to be faster than me outsourcing to somebody that has a multi-jet fusion printer. And we're actually getting properties as good or better than multi-jet fusion TPU, which is crazy.

SPEAKER_01:

And so it's not we've determined already that I think for a lot of these parts, it's it's if it's low and slow and and the track width is good, it's it's you know, the the the the basically uh material extrusion is probably the way to go. And also then there's also cost limit and and there's also the ability to change infill as well. Whereas in the in the a the the MGF thing, you all you only have your lattices to really kind of significantly influence geometry. So we I think we we already had this discussion, I think, yeah, uh in the beginning where you were also saying that like hey, for certain things, like you know, material extrusion is totally gonna win. I think I think I totally agree with you on on the I think for anything, like anything lower, like higher up in the body, the higher up in the body you go, maybe the more MGF-free it gets. You know, the lower you get in the body, the more uh material extrusion it gets, you know.

SPEAKER_00:

Interesting, yeah. And so then I'm uh so that was the I think that's probably the interesting thing for me is these these lower cost desktop units are actually very, very good. And if you're not trying to break land speed records for printing with TPU, then this might be a good option. And then the other thing, and you touched on it, is this idea of of workflow automation. How can you raise the water level for everybody so they get access to a well-thought out, clinically validated, quote unquote validated device? And I think, I mean, Fred kind of exposed some of that on our last episode was hey, you can be very intentional on how you design this one thing, and you can also then use that to build to design your next thing and your next thing and your next thing, saving time learning along the way. And then we had Johan Weigel from Stuttgart talking about his airfit system, where it's you know, it's manual, so it's not just taking a scan of somebody's leg, but it's what you do with that. So it's it's true load bearing. What does the tissue do under load? And then you scan that and you can automate it from there, and you barely have to touch it. And you probably I don't know if you listened to the episode where I did with uh David Slider.

SPEAKER_01:

So we No, I didn't actually. I I should.

SPEAKER_00:

So we did that. So David Slider came in Sunday night. He's uh very active below the knee amputee. He came in Sunday night. I put him in the airfit, we scanned that, I modified, sent it to the printer that night, and the next day by noon, he was walking in his final socket. And and typically you go through an iteration like a test socket and all that, but we I called it full send. So we went full send to the final socket and we did pretty well. There were a couple adjustments that I probably want to make just because there were some things that he was a new patient to me. I was new to him as far as on the clinical side. So there were some things that you know might have been some assumptions on both of our parts that didn't get the result, uh exact result that we wanted. But he was walking and we were able to actually complete a study, uh walking study in a full-on motion capture lab that was able to compare his current prosthesis to the prosthesis that we made. And it was really, really neat. And so we're supposed to find the data of that very soon. But that was really the power of 3D printing and this idea of hey, we're gonna use these tools like this this pump method using a paddleboard pump to get the shape and digitize that and and move on because there's not a lot of work that has to be done on the back side of that.

SPEAKER_01:

I thought that uh what I like, I liked about the Airfit thing, you've been a big fan of that and you use this often. And what I thought was interesting is that we've always looked at like how is there gonna be a better scanner, or is it gonna be a handheld scanner, or is it gonna be, you know, whatever, right? And I think this is interesting that that you see innovation like this where it's kind of very left field stuff, you know? Oh, I didn't think of that, you know. And that kind of stuff could really, really change things. It really disrupts stuff as well. So I I hope we see more of that where maybe this just looks, I don't know if it's like it looks inexpensive. I don't I have no idea if it's expensive or not, but it does not seem like a very expensive solution, all right? Yeah.

SPEAKER_00:

Yeah, I mean I think that's one of those things uh you know hopefully the costs and such will come down. It isn't it is an expensive solution to make because you do not want this thing to explode under pressure.

SPEAKER_02:

Okay.

SPEAKER_00:

So there's a manufacturing stuff that has to go into that, which is not inexpensive to do and validate. So but you know, if there's a greater volume and we can help do that uh better, then I think that's gonna be a a real positive thing. But I agree with you. It's like, okay, so we've talked about AI and all this stuff, but what if the answer is something that's hybrid? You do something like this that's very manual, and then you go and you use a scanner and quickly use automation after that to make the socket.

SPEAKER_01:

Yeah, exactly, exactly, exactly. So I'm that could be really cool. I hope we see more stuff like that. That'll be really cool. And and I hope we just talk to lots more people. I think that's I mean, still enjoying the people and still very different personalities, very different backgrounds. They'll have that kind of tinkerish inventor craftiness in common, but uh still really enjoying doing this. Really happy we're doing this. So awesome.

SPEAKER_00:

Yeah, 100%. Uh it's it's been fun. And so, yeah, to all our listeners, thank you for listening. We we actually had just checked the stats here. We were up to 118 countries, over 3,200 cities, and we're gonna be crossing the 35,000 listener mark very, very soon, which is pretty wild for a small kind of a niche podcast.

SPEAKER_01:

Mm-hmm. And I'm still learning, and and I hope our listeners are learning as well. And uh, I think that's that's the ultimate thing. Uh for me, that's the ultimate kind of way to keep score there. I mean, love that some people are listening, uh, but also just as long as we're learning and having fun doing this, and I'm super happy doing this uh forever and ever and ever. And uh yeah, so thanks a lot, Brent, for this, and uh thank you guys for listening to the Procetics and Orthotics podcast.