BoneChat #26 - Accelerating Surgical Planning with Mauricio Toro at TECHfit Digital Surgery

Okay, uh, welcome everybody to BoneChat discussion number 36. Um, today Mauricio is going to— he's the founder of and CEO of TechFit Digital Surgery and an active BoneChat member. You guys all know him. He's going to share his surgical planning tools for patient-specific printed implants. And I consider this a glimpse into the future. As I preach often, I think implants are turning into commodities, and the future is all about the operating system or the process to create the implant. So handing the mic over to Mauricio.

Thank you, Tiger. Hi everyone. Yeah, I, I have a few slides. I'm going to run through them quickly, but I'll show you the software. What I'm looking forward to most is the the discussion afterwards because I'm sure all of you are going to have a lot to say and I'm very keen on to listen. So I'll talk about Techfit Digital Surgery. Our goal is to make 3D surgical planning and patient-matched implants accessible to all. And this is a, this is an ambitious goal, but I'll go into it a little bit. I'll talk about my background. I am not your run-of-the-mill orthopedic engineer that has worked in the in the industry out of school. I actually used to work in race cars. My background, I have a master's in motorsport engineering. I did aerodynamics and data acquisition for Formula 3 cars in the UK. And then I was working with some drivers that are now in F1 actually. Daniel Ricciardo was my driver when he was in Formula 3. And I went to Colombia for a vacation.. And a friend of mine, he's my co-founder at Techfit, Mauricio Vélez, he calls me and he's an MD and he was acquiring a trauma company. So he calls me and he invites me to be a part of the due diligence process. He's like, you're the best engineer I know. I told him I have no idea what bone fixation is about, but, you know, as a different thing to you, I'll go and check it out. So I went and looked at the company he was buying. This is a Imagine early 1940s, very, very artisanal company. Everything was made by hand. They didn't have one CNC machine. I'm talking mid-2000s, mid to late 2000s. They didn't have one CNC machine. There was a guy who bent the tibial nails by hand. And one day he was absent and nobody else could replicate. We calibrated the machines and every part started going off because the operators were— the machinists were so good that they actually making the machines better actually made them worse. So this is— I have a lot of stories, but I went to the due diligence. I told him, listen, these products look beautiful, it's a big work of craftsmanship, but your engineering needs a lot of work. He's like, okay, why don't you come and help me? So long story short, I moved back from the UK to Colombia and started working with this company. Bringing it to the 21st century. It got it ISO certified, developed all of the protocols, developed machining, developed anodizing, everything from scratch. We grew the company 10, 12 times. The company is actually now an approved Arteryx supplier. All of this happened within 5 years or 6 years. And I always had this thing that bothered me, and it was like, this industry is messed up. In the track, you know, it's a car that goes around in circles. There's not a lot of added value to humanity from it, but we did the computational fluid dynamics. We simulated the cars on a computer. We tested them on a wind tunnel. We used additive manufacturing and new technologies. Even before we went to the track, we had lap time simulation programs where we tested different setups and knew exactly how the car was going to perform, So when we got to the track, you know, we were 90% there. And then I got into this industry where, you know, you have trays and trays and trays and doctors are making mechanical engineering, mechanics of materials decisions intraoperatively. And they're, you know, they're placing, if it's 4 or 5 screws, it's because, you know, I like 4 screws or I like 5 screws, but there's no, and there's a lot of heuristics behind it, but there's not, like I said, you know, we can do better. So I started, playing with the custom implant space. And I had a little pet project within that company called San Pedro that was called TechFit. And we did like complicated cases and we had a couple of people dedicated to patient-specific solutions. And this is 2009. So we got in the game early and we were very lucky to do it in Colombia because back then in Colombia, basically the regulatory requirements were if a doctor signs a prescription, you can do it. So we had a very big opportunity to innovate, but then, you know, I saw the main underlying problem of it and it is that, yeah, you know, we can make surgeries 30% faster with medical modeling and patient-matched devices. This has been, you know, written and written and people still say the problem with adoption is lack of evidence. I don't buy it because that evidence has been around for a while. You say, you know what, we increase surgeon accuracy. We've written paper after paper that proves that, but it's still, you know, still people think it's lack of evidence. I think the biggest problem is the interface. So yeah, you have this technology that makes the outcomes better, but you have a bad interface. And there's 3 big drawbacks that we see in that. The first one is there's excessive surgeon time required. I mean, a surgeon has to take 45 to 60 minutes to work on a patient. They have to find the scans, upload them on a platform, then they have to set up— the rep from the company has to set up a call. So it's a Zoom call between the surgeon and the case planning engineer. So now you're not only talking about your time, but you have to fit in two people's or three people's timelines to be able to make it work. You have a call where you find all the requirements, and then, okay, you get approval for your case. It's a 3-week lead time. So it's still, I think it's a great technology with a very clumsy interface. And this is what has motivated me to start TechFit. And I've always felt, so people tell me, oh, the problem is it's expensive. I've seen a lot more expensive treatments get reimbursed. People say, oh, there's not enough evidence. I beg to differ. There's tons of evidence. So I think that the problem is the interface and that's what we are working on in TechFit. So we've created something that we call the DISRO. Which is the digitally integrated surgical reconstruction platform, but it's a play on disrupt because we want to disrupt the industry. And basically what we have, we call it the operating system, and it's based on two layers. One is the surgeon-facing layer where, you know, we have a tool that allows the surgeon to view their cases in 3D, plan them. I'll give you a quicker demo later. It also has a community where doctors can share their cases amongst them and they can educate themselves in the digital space, and then we can design custom implants or guides or whatever is needed. And then on the backend, it handles all of our quality assurance. So all of the documentation, all of the surgeon approvals, everything is documented. Then we have structured data for any algorithm we believe that we want to train in the future. So every case that runs through this platform is structured, and then it helps us with manufacturing and supply chain control. You know, as a rep, you have access as a rep, you can log log in, you can see your case pipeline, you can see what your surgeons are uploading, you can— it's very easy to keep track. If you're a sales director, you can look at what your reps are doing. If you're a CEO, you can see what everybody else is doing. So it's a— and then you hit print like you're doing a computer. So, and you have 4 things where this can go. One is, okay, a point-of-care 3D printer. So we've set up point-of-care 3D printers in multiple institutions in the country and out of the country. And sometimes all they need is a surgical guide that can be printed in a $5,000 printer that takes— that, you know, your, your printer at home takes more space than that. So you can, you can print surgical guides in biocompatible material that can be autoclavable remotely in the point of care. Then we can, you know, you can just have a case plan. So it's a— if it's a standard case where you don't need to print anything, you don't need a template, but you just want a step-by-step of how your case looks, you can print a case plan, you can visualize it. You can project it to all our visualizations. If you need a patient-specific medical device, we have a supply chain. So yeah, we have our own facility in Florida that we started and we can create custom medical devices or even patient match for maxillofacial surgery. But we also have a network, so we have suppliers in Europe, suppliers in Latin America where we can just coordinate manufacturing with them and get it locally shipped. So one of the things for us is distributed manufacturing. And then in the future, we feel like once you have the data, once you have the algorithms, once a robot application comes up for that specific indication, it's very easy for us to interface with it. And we've done like with the— we've done a few cases where we interface with navigation systems and it's very easy for them to export their plans from our software and import them into the navigator systems. I'll show you a little bit about how it works. I'm going to run through this quickly. So basically you have a— as a surgeon, you have a CAM where you have all of your cases. You'll tell in what state they are, which for me, it's very funny. You have to call a rep to know where you're, at what state your case is in today's industry. You order a pizza, you can look on your phone, you can track the delivery guy. So for me, this is something that gives them a lot of information. You can visualize all of your cases, you can different stages, you can prioritize them. You know, you can filter, so it's a very easy way to access the case database. The next step is—

Can everybody see Mauricio's screen? Okay, good.

The next step is what we call the Baseline 3D. So it's the building blocks on which all of our 3D interface is built. And basically all you need to do is upload a CT scan and in a very short time window. And this process, we're automating more and more. You can get a 3D version of your patient, and you can visualize the implants you want to use. You can superimpose them, you can measure depths, you can take dimensions, you can change transparencies. So you can look inside the bones, you can, yeah, you can add screws. So it'll automatically measure your screws. You just hover on top of it, it'll tell you what screw length you need to use in that specific part of the anatomy.

So Mauricio, is the surgeon doing this on a desktop or cell phone?

So it's cloud-based, 100% cloud-based, so they can do it on an iPad, on a cell phone, on a desktop. If they want to get down and plan a complete surgery, I suggest, we always suggest using a desktop, but it's, all of the functionalities are available in every platform. And they have an engineer in the backend all the time and they can add landmarks and ask questions, and then the engineer can respond. So it's always a chat situation as well where the surgeon can have a constant conversation with the engineer, be it that they're designing a custom plate like in this case, or that they just want to— they just have a question. They can also move bone fragments. So if you upload a trauma case, you can reduce the fracture virtually and get alignment, test a plate on top of it, test different plate sizes on it. And then on top of that, we've built something that we call the— I call it the indication-specific workflows. So this is like the base that works for every case. And then on top of it, what we want to do is build like apps where each indication is an app. And in this case, the first app that we have is— we call it— it's for orthognathic surgery. And CMF has been an early adopter for us in this technology. So that's why a lot of my indications are CMF, but we do have a a very interesting portfolio of ortho cases. So in, in the indication-specific, basically what happens is the surgeon will log in and they'll find a way to visualize a step-by-step— we call them orthognathic helpers. So they'll log into their surgical plan and then step by step it'll guide them through the case. So all of the landmarks are pre-selected, are, are— so the surgeon can visualize the cephalometry They can look at all the different dimensions they need, all the different biomechanic or aesthetical dimensions in this case. And then it'll take them step by step through all the corrections they need to make. So if they want to correct the midline, they want to correct the cant of the maxilla, and then we've worked with surgeons to build something that's step by step, which is a lot of companies that try to get into this space, they want the doctors to become engineers and they want the doctors to learn computer-aided design. And I think this is the wrong approach because unless the doctor did engineering undergrad, which, you know, it's pretty common, but it's not the norm. They are not used to this way of working. So we try to make it as simple as possible to plan a case for the surgeon. And instead of having to set up a Zoom call with an engineer and taking 20 minutes out of your day, I mean, those case planning engineers, I've planned cases virtually. It's not like we're longing to plan cases in the evenings or the weekends. We want to plan our cases during the workday, and that's when the surgeons are the busiest. So this allows a lot of flexibility. It allows you to compare multiple options. So this is, this is, this is the, like, a quick overview of how the software works.

And the surgeon can, the surgeon can either take the TechFit plan and just say, yes, I, I want that, or they can change it.

Yeah, and, and that's very important because, and the more data we get, the better our plans get. But we we propose a first plan. So when you log in, it's not like you have your initial case and you have to reconstruct. If it's a fracture, we'll pre-reduce it and you'll log in. And if you like the plan, you just click okay and we print whatever guides or whatever plates you need. So it's a very easy process. If you— and then the more cases we get, the better our data gets. So it's exciting where it's going. And the final thing is, because we have this repository of 3D cases, we can— and it's all in the cloud— we can create what we call community, which is a space where cases are shared. So on our interface, you just click on community, and what you find is all of our cases in 3D. And you can, you can scroll down and find what, what other surgeons like you are doing. You can filter by type of case. So in this, in this case, I want to filter by maxillofacial reconstruction implants. So here you find the case, you, you can like it, you can contact the surgeon who operated that case. Everything gets anonymized, and there's a, there's a consent from the surgeon and from the patient if they needed to, to share a case. But everything gets anonymized, and you can visualize an anonymized version of that case, of that patient's surgical report, and you can iterate with the 3D model, with the anonymized 3D model. And if you have a, if you have a question or a comment to that surgeon, you can always just click on, click on contact and it'll, it'll directly set a chat with, with you and that surgeon. So I feel like this is bringing all of the digital technologies available so we can know what we're doing in advance. And for, and the way I see it right now, most of what we do is virtual planning with Patient Matcher, custom implants and custom guides and the bells and whistles. Just because honestly that gets us the highest ASPs right now. And as a startup, it's good to get traction with high ASPs. But we see that our platform will allow us to grow even more. So the second one that we're shooting for is just, let's say, a high tibia osteotomy. You can use a standard plate for the osteotomy, you can plan it in 3D, we can AI design a guide for you, you can print it in your office and you can use a, an anatomic plate and a surgical guide to perform a more accurate high tibia osteotomy or distal radius osteotomy by using this. And then the next step is just, you know, just having a surgical plan, walking into a case knowing what length of screw to use is going to save you a lot of time. So, or knowing exactly what size of plate to use is going to save you a lot of time. So that's where we want to permeate and we see us as a as a platform technology rather than just an implant provider. So looking at how today works, at least in the patient match space, and defining the market for this is complicated. We see that we have two types of competitors. So one is the incumbent. So, you know, DeafYou Synthese has TrueMatch, KLS has their custom solutions, Stryker has their custom solutions, and they all have their custom solutions. They're basically— their model is what I call the concierge model where the rep gets the case, uploads the CD, then you set up a Zoom call with the doctor, you plan the case, you manufacture on order, you ship. And this is good, it's expensive, it's hard for them to make money on it just because of their cost structures and the way it's structured, but they are very good solutions. Their problem is surgeons need to give give away part of their productive time. Remember, a surgeon is only making money when they're cutting or when they're sitting— when they're in consult. A surgeon is not making money when they're sitting with an engineer planning a case, and a health system is not making money when their surgeon is with an engineer planning a case. So we need to be very mindful of that, and we need to make it as productive as possible for them. The other approach is, you know, bigger hospitals and Mayo started this trend, but now a lot of larger health systems are— they're buying 3D printers and they're buying software and they're hiring engineers. And this gives them the flexibility that maybe the companies can't give them, but they have a challenge. Now they're going to have to set up a QMS for that. They're going to have— if they're going to manufacture implants, it becomes a lot more complicated.. It also builds a silo, so the hospital has the data from them, but they're not interacting with other hospitals around the world, which for us— and then, yeah, you can print stuff in the point of care, but in reality, if you go into the places that make money by doing research and by getting a reputation, they all have a 3D printing lab. But if you go into the people who make money by treating patients into the hospitals, they're going to struggle to justify hiring a, you know, $150,000 engineer and buying a $500,000 3D printer to create anatomical models and to create surgical guides. So we feel like we can offer an end-to-end solution where, you know, we offer a point-of-care printer because we can actually fit them into our QMS and certify and validate their printer, and it's our printer, and we fit it inside our maintenance schedule, but it's located in the point of care. We can provide a flexible solution where surgeons can plan their cases whenever they want. And we have the ability to go up to the highest complexity if needed. So we can create custom PEEK implants, custom titanium implants, and we're clear to create those. So we can offer them the best of both worlds. This is our traction. We're still early, but this year we expect to do about 1,500 patients basically in Latin America, the Middle East, and the US. For the US, we actually signed a channel agreement with Acumed Osteomed for CMF, and they have been our partners in the go-to-market. We are working with Mayo Clinic. We actually patented a PICC sternum replacement and patient-specific, and we're working with Mayo Clinic into developing this. We've actually done 2 cases with them already under the custom device exemption, and the patients have been doing great. We've gotten 510 for custom plates, custom guides. Our software is 510 cleared. This is software as a medical device. And we manage point-of-care printers in multiple customers. And yeah, our patient database is growing. Now we're up to 4,000 and something patients in our database. So this is, this filed with our constant software development and algorithm development, it will will drive us. And this is where I want to drive this conversation. I'm going to be quick because for us, the biggest challenge with this has been the go-to-market. And the go-to-market for us is not the same go-to-market for everyone in this industry. And we've tried it and we've tried to, you know, use our distributors, reps, and go to doctors. And we've gotten some of our implants cleared by DACs and we've done We've gone the whole route and we've realized that this is not a productive way to do it. And Tiger has been my consultant in this because I've been, I bother him almost every week like, hey Tiger, I need to dial down the marketing. And we found a sweet spot of a surgeon and we found this, an oral surgeon who's a friend of mine showed this graph, this curve at a presentation and I I stole it from him. And he shows like the different profiles of surgeons. So he says up to when they graduate residency, there's not a lot of difference between surgeons, but then you get two types of surgeons. You get the competent surgeons, which, you know, they'll stick to what they know and they'll churn out a lot of cases, but they'll stick to what they know. And then you get the expert surgeons, which are the ones that iterate and get better every day. Technology like this is perfect for the expert surgeons. But if you catch them too late in their life cycle, well, first, they're not going to be as technologically savvy, so you'll have a challenge there. And second, they'll already have their workflow optimized with something out there. So they're going to be— it's going to be difficult for them to say, you know what, I want to put everything on its head. So we're focusing on the first 5 years after residency and targeting those potential those surgeons who want to be experts, who you can tell that they want to be experts, and then work with them to build their expertise and to build our algorithms and our expertise in parallel. And we've built some very strong relationships, but these surgeons are difficult to find and it's hard to get to them. And then the lessons that we've learned in the journey so far, Number 1 is that standard commercial tactics won't work. Like, I always make the joke because everybody has a former Striker refs, and Striker is a great school of refs, but they all want to out-Striker Striker, and unless you're a $7 billion a year company, you're not out-Strikering Striker. So, one of the things that for me is how developing the right tactics to go to market that are— you have to take bigger risks than a large company is willing to take and getting yourself out there. But how do you fight a guerrilla war instead of an all-out war? It's a lot harder than it seems when you start. I mean, I sit down and look back, we decided to spin Techfit out of San Pedro and do all of the software thing. In 2019. I moved it out of Colombia to the US. So I packed, I sold my car, sold my house, and got on a plane and never looked back. Landed in Daytona Beach, Florida. No points for guessing why I chose Daytona with my racing background. And we landed in Daytona, set everything up, but it's— and we've set everything up, set up a manufacturing site, got an FDA clearance, and It looks like we've done so much, but man, it's been hard. The second thing is to find a very narrow profile. What we've learned is find the people who really resonate with your concept and perfect it with them. And then from there, start growing. And it's always an experiment, go-to-market, product, everything is, it's always an experiment. And one thing that we've learned recently is be able to articulate the pain you're healing very, very well. So we used to, and when we got started, we were pitching the whole, yeah, your patients will be better. So mark your story and you can make your surgeons more accurate and we can increase your OR time productivity. And they're like, yeah, everybody says that. What is the real pain you're fixing and you're healing? And it took us a while to find out that the real pain we're healing is the surgeon productivity and the surgeon time. If you make it easy for the surgeon to be better without investing a lot of time, that's what they want. They want to improve their game, but they want to do it in the way that costs them the least amount of time possible. Time is their most precious resource.

Mauricio, here, highlight the amount of time it takes TechFit surgeon to plan a case versus a— let's just pick on Stryker.

Yeah, so Your normal case, probably 25 to 40 minutes of surgeon time with a standard meeting, because you have to set up a call, you have to tell someone what to do, which is always slower than actually doing it. In TechFit, you can get, you can get a case done within 5 minutes or 6 minutes because you just log in, upload your case, and you upload your case, takes 2 minutes. Then you log in again. If you like what you see, you click approve, 8 minutes, you're done. You'll get your case in a— if it's a custom implant, you'll have your implant in the mail in a couple of weeks, or our rep will have it ready for you in a couple of weeks. If it's something that you print in the point of care like we do with Puerto Rico and the Middle East, the printer in your hospital will start printing immediately after you approve, and when you get to the office, the parts will be done. So that's what we think it's It's the biggest difference and the biggest differentiator that we have compared to the market. So now, yeah, I took half of the time. It was a little long, but now I want to hear from you guys and get your feedback and questions and everything.

Here, Asher's got a comment already.

Sorry, I might have missed this in the beginning because I had to step away for a second. Can you clarify what types of patient-specific or patient-matched devices you can make?

So right now, uh, we do oral and maxillofacial surgery reconstruction, and that's what we're— that's what we're focused on. That we, we saw that as our first, like, beachhead. But at OUS, we're doing a lot of extremity osteotomy patients, joint replacement patients. But, but our focus right now is cranio-maxillofacial.

And you do anything in spine, just out of curiosity?

We have done a couple of cases where you— where we guide the pedicle screws, but it's been, it's been very early. It's been a surgeon that calls us, hey, can you guys help me with this? But we don't have any like research on it. Got it. But we'd be, we'd be willing to, to explore it.

Yeah.

Mark, so you mentioned the HTO. Uh, my experience in the HTO for the last 25 years is that it's a great, it's a great surgery. It is hugely underestimated because of the 360-degree complexity of the, of the cut. And so you can solve that and use a standard implant, is what I heard you say.

Yeah, so we actually— that, that's where surgical guides really excel. We, we actually did a study. I did— we did it for distal radius, but it applies for, for every bone. Where surgical guides excel is rotation. So the, the good thing is, because what we do is we we, we perform the osteotomy virtually, we correct it, we place the plate, we drill the screws, then we bring it back and we create a guide that tells you where to cut and it tells you where to drill. So you cut according to the guide and then the plate, by indirect reduction, it'll position the distal fragment with respect to the proximal fragment very accurate. And we—

the only people I've seen do HTOs successfully that lasted a long time like they should are those that are using computer navigation. Or are using a computer, I mean, are using a custom implant like a Bodycad. So if with your system, do you think you could plan the surgery and use a standard implant for, say, a lot less than a regular custom implant?

Yeah, I would say, I would say so, because then you only need the planning and the printed surgical guide. We actually did a study with the distal radius osteotomy And this was a really cool study because we had— we printed a malunited radii with the ulna, and then we print— we create a mold and we created sawbones out of those. And then we had 20 and 20. So 20 we gave to a hand surgeon that had probably 30 years experience. He's the guy who's like the president of the Federation, of the Colombian Federation. He's a top-notch KOL, AO instructor, you name it. And then the other— and those ones, we told him, do it, do them freehand. And then we gave the other half to our first-year resident with a surgical guide. And the surgeon was 85% accurate in rotation. The resident was 99% accurate in rotation.

I love it. That's a great, that's a great use case. Also, you know, distal tibia, Pilon repairs, things like that would be also really good. So, uh, the— you have the 4,000 cases that you have. If you're interested, uh, the— I have a, an associate that has a UC Berkeley, uh, created, uh, software that de-identifies, completely sanitizes any surgical information or PHI at the point of origin. So you don't have to do it manually. So if you're interested in an automated system on that, I'll introduce you to her.

I would be very interested in that introduction. Yeah, definitely.

I will do that. Is your agreement with Acumen exclusive? No.

Smart. So what? So Mauricio's got a better mousetrap. There's no question about it. It's a self-planning tool. It's fast, faster than anything on the market. So, how does he get— how does he get— how does he attack these surgeons that are doing CMF cases? They're probably between 35 and 45 years old. They grew up on video games. It's a perfect fit. How does he find these? Let's just throw out the marketing question. Go ahead, Cope.

At first blush, these folks all come out of fellowship, right? Um, can't you just target the fellowships and target the fellows and, and pick your 3 biggest academic facilities, or, or however you would define your best 3? And there's probably like 3 fellows I would think in each place, 2 or 3 in that CMF. I mean, I would be— I would have like a new tech— I don't know much about that. I was just telling Tiger, this is really cool, I've never seen this before. I'd have like a new technology dinner once in November and once in April and say, we want to show this to you guys and catch them before they're downstream a little bit and You, you plant seeds. I think they— I think at least a third of them would say, the heck is this? And I can do it in 8 minutes, and I can do it on my desktop, and tell me more about this. And it's the, it's the best marketing money I think you tend to spend because you're capturing them right before they hit the market. And I'm sure Maloney's done it. Like, you tell guys coming out of fellowship that are coming into your territory or going somewhere like, hey, listen, you're not going to be any sexier than you are right now. The hospital or health system is going to give you pretty much whatever you want within reason. And it's a good time to ask for this kind of thing when you go land at your place next year. I don't know. I mean, I just think like if you're a small group and you don't have like a big sales force, I don't know what Striker would do. I could tell you what Copeland and Mauricio would do. We'd go like, let's just go spend some money at dinner and let's go grip and grin and kiss some babies, um, who are fellows. And I'll bet we catch a couple. Um, usually what you just showed I thought was really cool. I've never seen that stuff before. I don't know. I'm sure there's somebody with a much smarter, more sophisticated answer, but at worst, that's what I would do.

That's, that's actually very insightful. And that's actually what we've been trying to do this year. And it's been where we've hit the— like we offer every time we offer them a Sawbones lab and a dinner and we share the technology with them. We're hitting 100 right now. Like every time we walk out with someone that wants to use it.

Wow, excellent. Dennis?

Dennis, I think you're muted.

He's not muted, but it's— we can't hear him. All right, cool. Come back, we'll come back to Dennis.

I, I bet he had the best insight and now I'm gonna miss it.

Well, he'll come back. Where— Maloney's up next.

All right, so basically my whole career has been based on early adopters, and it would— I don't think it's ever been easier in the sense of with a tool like AcuityMD or ZoomInfo you know, finding those that are time-wise that are in that 5 years, you know, you got to skip past that first year, obviously. But, you know, in that 1 to 5 years and then using, using LinkedIn or getting their cell phone and just calling them and just have an immediate 30-second pitch, you know, do you want to be part of the Stryker ARTHREX Army or do you want to be a SEAL Team 6 guy in the tech world? You know, you got to— every, every early adopter team I ever built was built from advice I got from Tony Russell 25 years, 30 years ago. And that basically doctors sell doctors in the sense of I would use a doctor's name on that first conversation and I would find out guys that want to be famous. I would find guys that want to be ambitious, that are ambitious. They want to make a name for themselves. Nothing drives a young early adopter more than the desire for recognition. Not money, nothing else, just recognition. So anyway, that— you got a great, great goal ahead of you. But, you know, it just starts with a message and a target list. And with— and I— my call— my next call is with the best LinkedIn guru on the planet., a Ukrainian guy who does it faster and cheaper than anybody. So that's another introduction I'll give you if you want.

Yeah, I'd appreciate it.

All right, back to Dennis. Let's try the audio. Nope, not working. All right, never mind. Yeah, so Mauricio, do you have those lists? Of the fellows that are graduating?

So we have a database of residents, fellows, and attendings in every academic institution. We acquired that. I have to test its accuracy, but yeah, we do have a list that we can start targeting. I'll start reaching out to them.

Is there anything you can give to one surgeon that they can show to another surgeon? Along Mark's point, you know, where they can be the hero and say, hey, look at this technology I'm using to plan my cases in 8 minutes.

Yeah, so one thing that we were discussing just yesterday is how do we enable surgeons to share their cases? So right now they can share their cases on our internal community. How about we give them an automatic social media post that they can export and that gives them a landing page? So they look at this case I just did and have a couple of screenshots., and then just like log in, sign in so you can see the case, so you can watch it, so you can see the complete case in our healthcare provider community. That way we can have them like whatever they do that they operate on a patient that they're proud of, we can give them a way to show off a little bit, to show it off to their colleagues. And because we find as well, we do a couple of, I wouldn't call them courses, but a couple of symposia every year. We bring a few surgeons over to Daytona. We actually have one in September where we're bringing 15 surgeons and they just share, each one shares a case they did. And then we create like a roundtable where they discuss different cases they have, where they have used this. And we used to have a curated list of speakers and we saw that when we curated the list of speakers, we lost attendance. So we told everyone, if you want to share, share, and then we'll give each one a 15-minute turn to share their cases, and 100% of them share their cases. They all want to— they don't want to just learn, they want to teach. So finding a way to do this digitally, I think, could be a very interesting approach.

I like that. Have you ever filmed a surgeon, like, planning a case, like, just over their shoulder with a video?

We haven't, but we can do that very quickly.

Yeah, because that could, you, it would be anonymous because, uh, you'd just see the back of the head of the surgeon, but you'd see them, you know, planning a case on an iPad or somewhere. And then, and you could have a little clock in the corner that shows, okay, here's been 3 minutes, it's been 5 minutes. Okay, we're done. We're finished. I think that would be powerful. And then other surgeons will see, the other surgeons will see that and say, I wanna, where do I get that tool? And, and, and is, um, the Disrupt software is free, is that right, Mauricio? And the, the charge is the implant right now?

So right now we charge, we have a small fee for uploading a case, and then we have a charge for downloading devices. Or so if you, if you— so I call it downloading, but you, you upload a case, you pay a fee, and then you, if you, if you need a custom implant, you pay. If you need a splint, you pay. If you need a guide, you pay. So we have, you pay for what to download, basically.

Interesting. Asher, you think this would be something that spine surgeons would use if they have like weird anatomy and they have to build their own guide or build their own implant?

Yeah, absolutely. I mean, there's already two companies, uh, Muddy Oak Medical and then Medacta, where I actually used to work, um, that have patient-specific drill guides for a variety of degenerative deformity applications. It's— their turnaround time, I think, is typically in the span of several weeks because you're not just making one guide, you're making, you know, multiple guides for level that you're operating on. I was more asking for, uh, like patient-specific implants, um, but those are, you know, titanium and that's a slightly different market. So that's why I was kind of curious what you're, you know, specializing in.

Yeah, so I, I think looking back, I think we've done a couple of, uh, cervic— like of cages, of 3D-printed cages that are patient-matched. The, the problem there is getting the height right, and— but, but there's a— there, there are ways to do it. And then we've done the guides for the pedicle. But, and one thing that we are doing with Mayo in our chest wall peak reconstruction is we're doing for rib tumors where there's a costovertebral joint compromise, we're building a peak implant that fixates on the spine and then replaces the rib.

Wow.

Yeah, I was actually going to ask about that because in terms of marketing, you know, I've kind of done a similar type of product exclusively focused on spine. And one of the problems we ran into was just trying to convince surgeons and distributors to carry this. I think because you've got that partnership with Mayo, going to all these other academic institutions or even community facilities or ASCs that, that don't have that infrastructure in place and saying that you can be basically the external wing that facilitates what Mayo's already doing, but unique to them. So now all these community facilities, all these ASCs can basically offer what Mayo's offering, but they can outsource all that infrastructure to you and then have them kind of go to their surgeons and be like a partner for you to kind of leverage that relationship. And that way you can kind of get scale a little bit more efficiently. You don't have to go surgeon by surgeon, you're more going facility to facility, and then you kind of get a good culture feel of where are the best surgeon customers based on what facilities are actually interested in doing this?

That's actually a very good insight.

All right.

Let me— we can give you Mayo's resources as a service.

Yeah, exactly. You're selling the surgical planning system that's world-class, used at Mayo.

Unless that idea doesn't work and then I was never the one to propose it.

Hey, you're, you're on video now.

We'll call it the Asher proposal. Uh, all right, Mark.

So the best marketing programs that I ever did involved bringing the surgeons to Road Atlanta and letting them drive a car for 20 minutes. And then I did that with Audi and with Porsche. I did one at the Atlanta racetrack, and they were both hugely successful with great participation. And you've got that background. And although that would be very expensive in your budget, you know, to do that very often, you could replicate that as a preparatory for like a 1-year out just using video games. And this age group that you're going after probably played video games their entire life. And so that would be just kind of an interesting angle, and you've got it in your background. And the last thing is your reference to time saving. That is the one thing that is the most powerful, you know, tool— time saving time. Denis, are you back?

I am back. Can you hear me?

Yeah.

Yes.

Yeah.

Sorry about that, guys. Actually, this is a great technology. We had— I ran into a similar situation where we were getting no uptake and it was a technology that required a lot of education and where you needed a lot of KOLs. So Mauricio, if you want my cell phone number is 609- 744-7506. I'm done right after this. But I agree with what everybody said on the panel except for one thing. I think you need, need to be very disciplined about the fellowship programs you're gonna go after and how you're gonna go after 'em. And the reason I say that is you, you've gotta get, you know, if you got Mayo, you have a couple options. You, you, you try to find out who from Mayo has connections to other CMF players that, that would— you go to them and you say, who are the earlier adopters in the other fellowship programs? And you build out a network. We did a scoring system of early adopters based on their publications, based on their adoption of new technologies. So you can actually— there's a science to this and you can narrow it down to 40, 50 people. And I mean, I can show you how to do this. So there is a whole scoring system out there that will get your number down from let's say 400 or 500 down to the top 50. And really hone it in based on their publications, based on their podium presence, based on, you know, what they've done in their fellowship. So I wouldn't just blanket it. And I do agree, I think it was, I couldn't hear, but the, the whole spine thing. We did this in spine because we had a terrible uptake in spine and we tried for like 5 years to get adoption and within 18 to 24 months we almost became gold standard when we, when we switched to this program and we only had, we, we couldn't get, we got nowhere with the distributors. We only picked like 3 to 5 people that did it. And then the other thing I would suggest is that you only look at meetings or doing things where they have a fellowship component where the fellows are not just the guys that are in the fellowship, but where the, the whole fellowship is gonna be there. You know, you'll get, you'll find the right people and I can give you a bunch of those in different, in different specialties cuz that's where your niche is.

Yeah, you see, he had something very, very valuable to say. Thank you, thank you very much, Dennis. I'll call you right after, we can have a chat. I would really appreciate your help.

Yeah, I had to do it. It was— I, I had to, I had to actually sell my company on doing this. It was cheaper and more effective, and they couldn't believe it would work. So I don't know if that helped anybody.

That's awesome, that's awesome. Yeah. So Mauricio and I have talked about turning, you know, slow— this, this is a, it's a patient-specific 3D printed company today, but it's really a software planning company in the future. And we've gotta change the marketing brand to, you know, it's, it's the operating system that makes a difference. I mean, we all have a phone, we all have an iPhone or an Android phone, and we didn't pick the phone, we picked the operating system, right? So surgeons in the future will pick for their cases, for their strange cases, they'll pick the operating system, not, not the implant company, I think.

Well, I think you're making a good point there. The, the issue is they've been so used to buying a commodity or a box that whatever operating system comes with it comes with it, right? And now you're at the point where you can say, oh, wait a second, I can put whatever operating system I want on my phone? That, that's a revolutionary thing.

Interesting.

And I think it's a smart thing.

Yeah, it's, I mean, it's kinda like Amazon, you know, we all, we all use Amazon and we, we don't use it because they have better products. We use Amazon 'cause it's, they read your mind and they ship it to you the next day.

It's easy. Like, like he said.

Yeah. So TechFit's got a chance of being the Amazon for patient-specific anything. What, what other markets do you think, uh, they should look at other than— so CMF is a very specialized area, right? Uh, you get into foot and ankle or spine or trauma, it's completely different world. What, what's the next, what's the next piece of low-hanging fruit?

Asher, I don't have the specific answer, but what I would do is I would go look at all the elective procedures. Sure, I would avoid trauma just because of the timeline and the turnaround. And, you know, if you run into manufacturing delays, you miss the case. I would prioritize the highest profit margin elective surgeries and just go after those. I don't know, have the answer to that, but, you know, having been in this patient-specific drill guide world, like, you want to avoid anything trauma, you want to avoid anything that's time-sensitive where you run into manufacturing issues, and then anything where you have to charge a premium for your guides or planning software. You want to make sure there's enough profit margin already in that case to, you know, justify for the hospital.

What's— Asher, what's Carl's Med doing? Because I know they're kind of in this space.

Yeah, they do patient-specific implants. But the main obstacle for Carl's Med is that they're only economically viable because they have a special code called an NTAP code. It's a new technology add-on payment code that allows the hospital to get additional reimbursement above and beyond the DRG codes that Medicare or private insurance would, would cover. As soon as they lose that code, because I think it only lasts for another maybe year or two, um, they run into a situation where the price point that they want to sell their implants at isn't economically viable. And so they've been burning a ton of money just to get market share and implants sold with the hope that, you know, at scale Medtronic or somebody acquires it and brings down the cost of goods and brings everything in-house. Um, and that's why, like, I, I would avoid implants just because, at least in spine, it's, it's a gigantic infrastructure nightmare to kind of set that up, especially when you've got a competitor with such a huge head start.

Interesting.

I'd go after HTO. It's a— it's a very specific procedure for a very specific purpose. It saves— it saves a patient from having to get a total joint or a uni. It can add years to a knee function. It's, it's a cross between sports and recon. And it's, you know, you got companies like BodyCAD that are creating big custom implants, which really work great. But there's a new French company that's making a reentry to the United States. And their super specialty overseas is the, the HT. I mean, they do a lot of sports medicine, but one of their products is the HTO and these very precision, uh, synthetic wedges. Oh, I, that would be, well, that would be around my recommendation.

Yeah. I, I know a lot about HTOs, haven't worked in these forever. Uh, you know, HTOs are very popular in Europe because they actually treat the patient, you know, they're trying to delay total knees or unis, but in here in the US, they just tend to, It, not many people are trained on HTOs. It's kind of a lost art. Right. Yeah.

Why? Because they were, because they were really hard to do right. And so they stopped doing 'em because they didn't, they didn't get good results for the same reason that orthopedic surgeons stopped doing bunions a long time ago. 'Cause they got crappy results. That tell, until Tries came along.

Yeah. That's a really good point. Maybe this could be a resurgence. To HTOs in the US. Um, it materializes in the US with, uh, creating guides for HTOs, I believe, right?

I think materialize— yeah, because materialize, they— for CMF, so they're the backend for Depucinti CMF patient matched. So everything that Depucinti sells is materialized. They have an agreement. But for Ortho, I think they're independent. And materialize, I know Materialise sells this to other device companies and to hospitals, but it's the traditional model where you upload your CT, you have a Zoom call, they create your guide. I think we can have something, because we can have something where if you have a point-of-care printer, you upload your CT scan, we compare it to contralateral, you approve a surgical plan, you tell us what plate you want to use, you have your guides the next day printed in your office. I think that's something that can be a very interesting value proposition.

It, when I used to go to HTO cases in Europe, I, they, if it was a standard HTO where the varus deformity was 15, 20 degrees, no big deal. They could do it by hand. But it was the severe HTO cases where maybe the, the val, the varus or valgus was, you know, 30, 40 degrees, which was really weird anatomy. They always use Materialize to plan those cases.

And, and I think that the big, the big angles and the rotations— rotations is where, like, when a patient has a big rotational deformity, that's where they start getting into X-fix territory. And, you know, we can replace an X-fix with a plastic guide and a standard plate.

That's a really good point. Yeah, it's a three-dimensional problem. That's a really good point.

That's the hard part.

Yeah, but this is fascinating. Well, um, any other comments, questions? We're hit the top of the hour. Pretty quiet. Eric, you got anything? Mateus? Oh, can't hear you, Eric.

Sorry about that, I was double muted, um, and it worked. Just did it. Um, I, I, I was curious about regulatory implications. Um, you know, in the world that I've, I've always operated in, you know, we, we, we've had to have certain strength parameters that, that, that we had to meet on, on our implants. And, you know, I can, I can design the weakest implant— yeah, there is out of some of the strongest material possible. So I'm wondering, you know, with these patient-specific implants, are there, you know, guide rails that prevent you from, you know, making something that has too small of a radius, such that you have, you know, poor fracture resistance, you know, in the corner or something like that?

Yeah, so there's two regulatory pathways for this. In the US at least, first you have a 510, and in the 510, what you do is you do an envelope. So basically you parameterize your design and it'll tell you like your plate has a maximum thickness of this, a minimum thickness of this, a maximum radius of this, a minimum radius of this, and if you design within those parameters, you're good within the 510. And that's when you do the higher volume. So everything you want to get high volume, that's the pathway. Then if you have a low-volume thing that's very rare that, you know, they do 1, 2 a year, there's nothing available in the market, you always have the custom device exemption. And there's a lot more freedom, but you're still not exempt from having design controls on it. So you have basically your design controls are auditable, but you don't have to submit them prior to making the device, and you're limited to 5 devices a year per indication.

Very, very interesting. And do you have a new 510s for each application? You know, we were talking about the HTOs and then the, the maxillofacial plates, and that— are they each separate?

Yeah, we would have to get a separate— so we have, we have right now, we have a 510 for maxillofacial plates, we have a 510 for our software, and we have a 510 for anatomical models for diagnostic use, which gives us a little bit of an extra because it's, it's, it's, it's cleared for diagnostic use, so they can They can bill it. There's a few codes for diagnostic models. They're still experimental. They're CAT 3, but you can still try to get reimbursement in those. But yeah, so if we're gonna do HTO, it's not like we can just go out of US. Yeah, in Europe and actually Latin America, most countries, if the doctor signs a prescription, they assume responsibility. They call it practice of medicine, and we can do HTOs, and that's where we've done the osteotomy cases and the, the things we've done. If we want, if we wanted to bring it to market in the US, we'd need to get a 510.

Great. Thank you.

Makes sense. All right, let's— that's a wrap. Great call. I think all of our— we saw something new today that we've never seen before, and we're— everybody's thinking All right, great stuff, Mauricio. Good luck.

Thank you all very much.

All right, see you next week.

See you.