BoneChat #107 - Open Discussion New Years Day 2026. There are no holidays for Entrepreneurs.

Tiger Buford hosts a roundtable with a distributor, Biotronik scientific affairs manager, engineer, and spine-device founder to discuss 2026 outlooks and med-device commercialization. They cover Arbutus Medical's traction kit, IDE/PMA pathways for cardiac devices, profitability pressures at Nova Perch Spine, and Tiger's new venture the Bone Factory for rapid prototyping of surgeon ideas.
Chapters
Well, this is an open discussion, Chris. So we're just talking about this coming year and, you know, anything you want to talk about, anything on your head, on your mind while you're driving.
Yeah, no, I'll jump in then. Is anybody else on yet?
Yeah, we've got two others. We got Vinay and Kyle.
Good.
Who? I have no idea. Show up.
I'll be interested in what people think and say. I mean, I, you know, it's definitely going to be an interesting year. I'm interested in seeing what some of the people think about. Like, I mean, I'd like to get Al's take on you know, what he's thinking as far as like small distributors, small OEMs and everything versus kind of the continual beat of, you know, bigger and bigger and bigger. So, so yeah.
Yeah, Al's not here yet. Hopefully he'll dial in, but yeah, the big guys kind of are, uh, like Arthrex or redefining sales. But, oh yeah, but the little, the little companies need independent, independent salespeople. And so as long as there's a crop, I'm just throwing my two cents, as long as there's a crop of, you know, hundreds of startups every year, I think, I think the independents are going to be fine.
Um, yeah, you know, I got your email on the, and I talked to Cope about it a bit. Um, couple months ago, but on the Arbus, uh, is it Arbus? It's the new trauma traction drill for EDs. Yep. Which I think is a great idea. So we kind of touched on that. I think things like that are going to continue to be, uh, being in and a way for, you know, the smaller guys to continue to, to make a difference. But, but yeah, I think that that's kind of where we're going to have to continue to do, um, our best to grow is with, you know, niche unique things like that.
So yeah, what Chris is talking about is Arbutus Medical. I, I love— this is my, my new favorite startup. Nobody's ever heard of them. They have, uh, they've gone from like $0 to $5 million overnight, and they, they're the— they, um, they enable surgery outside the operating room. So, uh, they have a monopoly. There's no— nobody in that space. If you just go to Arbutus— ARBU— I, I'll put it in the chat— but arbutusmedical.com. Um, I— they created a niche. They found a niche and they own it, and they're just getting started. I mean, they just got started. They have 16 employees, venture capital. They're in Canada, but they enable— Yeah, go ahead.
So what do you mean when you say they enable surgeries outside of OR?
So the, let me drop it in the chat. Good question. Let me drop in the chat real quick. Their website. So as it turns out, there's a lot of trauma that comes into emergency rooms that need instant traction, things like that, where you need a hip dislocation or femoral fracture or tibial fracture. It has to be put in traction immediately. And the old way of doing it is you run over to the Level 1 trauma center and you borrow some wrapped kits, sterile wrapped kits, and now you've just robbed a bunch of trays from the level 1 trauma center. Well, these guys invented a drill. It's an off-the-shelf drill at Home Depot that has a sterile connector and you, and a little pack, and they, you can drive sterile pins into a patient in, in a hallway anywhere. And I mean, it's just brilliant little kit, and if you go to their website, yeah, streamlining skeletal traction is kind of the— so anyway, they, you know, it's— and the way they're— the, um, the, um, conception story is fascinating because there are young people, there's young people in Canada, and they wanted to change the world, so they went to Africa and they were gonna find out how to help, how to help people do surgery in Africa. And they found out that the, the biggest problem is power. They don't have any power. And so they said, well, why don't we just use an off-the-shelf drill? And, you know, and they had patented this technology where you can have a, a non-sterile drill in your hand and deliver a sterile product. And then they quickly realized you can't make money selling anything in Africa. And so they, they're based in Vancouver. And so somehow Harborview in Seattle got wind of this and said, hey, we need a— can we buy a bunch of your kits? Because, you know, we got to— we got the emergency rooms departments got to put people in traction instantly. And we don't— we can't, you know, we're getting yelled at. From the Level 1 trauma center. And they said, sure. And then they realized, oh wow, maybe there's a business here. Anyway, no competition. They're the only ones enabling surgery outside the operating room. And that's what I love. I love startups that have, they define a brand new category that nobody else is playing in. So that's what Chris was talking about. What— so what's— Vinay or Kyle, let's talk about 2026. Big plans, changes?
Well, yeah, I, I have a— I can share a change. I joined recently, actually it's been now a couple of months, a company called Biotronik. They make pacemakers and, you know, CRM devices. Wow. And yeah, so it's, it's within their clinical organization. So that's a change for me.
So, so you're doing this is, this is an IDE, PMA.
So yes, there is an IDE as well. And then there are other studies, you know, which are kind of real-world evidence generation. As you know, CRM devices has a lot of software component to it, so, and home monitoring systems. So it generates a lot of data which can be used for real-world evidence.
Got it.
Did you listen to Bone Chat number 104? We had Laura Schoom on.
No, I have not. And I want to do that. So now I have, now that I'm back into the groove with you.
Yeah.
Lauren.
Yes.
You should go back and watch that.
Yes.
I mean, Mark Maloney said it was the best episode out of 100 so far. Awesome. I mean, she's so good. She's so smart and she's so good at converting clinical data into stories that are relatable. Man, yeah, I would listen to that. Listen to Laura.
Definitely would do that.
Cool. What kind of devices are there, Vinay?
So these are cardiac rhythm management devices like pacemakers and ICDs and cardiac monitors. Wow.
Yes. It's all software and it's all numbers.
Yeah.
Yeah.
Yeah. Wow.
Definitely.
It's a different world from orthopedics. We don't have any numbers. Well, that's, that's fascinating. And bet the better product in cardio work is wins the day where that's not, not true in orthopedics either. Mm-hmm. Yeah. Bill Hunter's taught us that, you know, the, you, you do a big study, it works, everybody switches to that product. You know, it's data-driven.
Yeah, yeah.
Well, good luck.
Yeah, thank you. Yeah, it's been, it's been good so far, so enjoying the ride.
And what, what's your title?
It's a scientific affairs senior manager, scientific affairs. So I'm kind of responsible for, uh, data management, uh, group, the stats group, and the, uh, medical writing kind of group. Designing the studies and protocol writing and all that stuff.
That's a lot of— that's a lot of—
yeah, it's a— that's why I liked it, because it's actually, uh, you know, compared to my previous role at Edwards where I was kind of director of clinical program, my, my, my, uh, role is actually far more greater here. And, and far— I feel, I feel far more impactful because now that you can, you know, you have this, I guess, involvement with, with every, with the typical, you know, the critical pieces of, of generating the data and then reporting on it.
Right. You own kind of own the data.
Kind of own it.
Yes. Yes.
The whole spectrum.
Yeah, that's correct. Correct. Yeah.
Yeah.
I like that better.
Yeah.
Thank you. No kidding. You don't inherit other people's data and you say, why did you write the protocol like this?
Yes.
Seen that. Well, cool. Good luck, Kyle. What's, what's new? Are you going to tell us about your shoulder thing ever?
Uh, not a shoulder thing, but I'm not going to tell you about it yet.
But things are—
a project is still moving along, probably come to, come to fruition over the course of '26. Cool. And then as that takes more shape, I might kickstart a couple other things I'm looking into. A fractional CEO role with something else. So I don't know, the, the year so far hasn't come into clarity yet and may not for the duration of it, but a lot of, a lot of different things are in the mix.
Well, you got a lot of talent, so you can go a lot of different directions.
Well, thank you. Although you did have a perfect Freudian slip for me on my behalf. I, I am very tempted to get back into the shoulder game.
Hmm.
Well, you know a lot about shoulders. You probably know more about shoulders than probably 100 people in the country that know as much as you do.
Well, thank you. I'm not sure that's accurate, but I have been thinking about it pretty constantly for the better part of the past 15+ years. So I love it. It's an interesting space still, and I think there's a lot, a lot of cool stuff that can still happen there.
Cool. Kyle, whenever you reach the stage where you need help with clinical evidence, let me know. I would love to kind of, you know, support anything in any ways I can. You know, I would like to do some side consulting.
Sure, I will keep that in mind. Yeah, absolutely. Yeah, as a, as a general rule, most everybody in orthopedics tries to, you know, avoid clinical stuff like the plague. I'm sure you're aware.
Absolutely.
Yeah, but that does— that doesn't mean there isn't a space for where you need to think about it, not necessarily in the context of you are required to do a PMA and an IDE, but you need to think about what you're doing to create claims language for your product. So I may have reason to talk to you sooner rather than later.
Exactly. And you don't necessarily have to do clinical studies to generate data. You know, you can do some real-world evidence generation as well. You can work with your users directly. There are some cost-effective ways of collecting the data. Cool.
Yeah.
And Tiger, while I have the opportunity, I would like to introduce myself to Chris Jones. Hi, Chris. I, I see your posts regularly because some of the— I guess we have common connections like Kevin Brown and all. And, uh, I see your face a lot with the same picture that I see up here on the LinkedIn. So I just wanted to say hi to you.
Hey, good to meet you. Um, yeah, no, I appreciate it. Um, I try and be somewhat entertaining on LinkedIn, so Absolutely.
No, I, I, I love, I love that group. I get to learn a lot. I'm on the clinical side, so not on the commercial side, so, but I get to see that side of the picture and learn about all the pains and joys that are there. But just to give you a little background, I, I, I used to work with Smith Nephew and Zimmer Biomet before I moved over into the cardiac devices, so I I have that background in orthopedic space. So that's why I'm connected to a lot of people in that space as well.
Chris is the, Chris is in the field a lot, right? You're— Yes.
Yeah, he's— Yeah, I'm a distributor and for a couple companies and then for Shawbee Advanced Technologies, we're probably their longest distributor now from all their name changes. And then yeah, so I'm a large joint, so microport, Shelby, Link, um, all those are kind of my, my niche is kind of large joint is what I've done. Um, so yeah, it's funny, yeah, the, the comments about clinical and how we don't care about that as much and so forth is, you know, I've had some funny stories with my friends that work in cardiac and how seems a lot more detailed sometimes. So yeah, I mean, I appreciate all that. So no, I mean, yeah, yeah, I have much more to say other than that.
So he's also driving, so he probably—
yeah, no good to me.
Yeah, I'm driving, so I can't see anything. And then I don't want to like— I know my Bronco's got terrible road noise, so I'll, uh, try not to ruin the audio track as much.
So Well, you got to have a Bronco because you got to carry trays around, right?
Yeah. Yeah. You know, I mean, this is a complete side note. It's one of those things that I thought would be really fun to own and buy and then really kind of regretted about a month into, you know, a couple months into realizing that it's not as big as it needs to be. And then we really got into some recon, you know, revision, metal allergy stuff with, you know, multiple multiple trays and implant tubs and realized real quick that may not have been the funnest decision I've made. So, but now it's fun.
Yeah, that's cool. So Kyle, you, uh, you, you have endless curiosity and I, you'll be, I'm sure you'll be looking at a lot of things. One of the hardest things to do is to pick the right opportunities. Man, is that hard to do because I see things coming at me all the time and it's, oh, it's so hard to say no to things that look interesting, you know, but you got to say, man, you got to say no. One of my favorite books is called, it's called Hell Yes or No. And so basically it means if it's like If you're screaming yes, then that's a yes. Everything else is a no. You know, so, and you got to leave, you got to leave enough bandwidth open for the hell yes when you see it, you know, that's the other thing. Raymond, welcome aboard. We're just talking about the year forward and goals and what we're doing.
Um, well, sorry I'm late. I'm multitasking as I typically do. Um, right now I'm putting up a shower curtain. Um, anyway, um, I just finished the basketball goal, but I wanted to participate because I always enjoy— or I always pick up something. Um, and are we introducing ourselves or are we talking about what this year holds?
We're just talking about what your goals are this year and, you know, opportunities, pain points, you know, anything you want to talk about.
Um, so our first and foremost goal at Nova Perch Spine is— has never changed and it will always be to glorify God. Um, and so we do that with the way we handle things. At least we try to, we strive to do that. We're not perfect, um, and we're empowered and enabled by that belief with the support of what I call an upholder that lifts us up in prayer every, every day. So that's nothing new. What's kind of evolving— so last year was the year of establish a larger sales group, and we doubled our sales group and doubled our revenue. We now need to focus on continuing that growth while reaching or getting closer to profitability. And so it's, um, I think you made a comment about TikTok, Tiger, and there was a separate article I got— I get from something called Healthcare VC that said basically the same thing, that talks about because money is so tight and right now it's all about getting to profitability. So our focus is do more with less. How do we do that? Creatively, in a scrappy way like we always have. So that's my main overarching view. Of course, we want to continue serving our surgeons and distributors in ways that are better than how other people do it. I mean, it's a technology company, but it's also got to be service and operational efficiency. I don't know if that's a bunch of mom and apple pie, but that's kind of our focus this year.
No, that's great. I'll send you this article I wrote, uh, a while back. There's 12, uh, I'll see, anyway, it's like 10 ways to, to reach profitability.
Mhm.
And there's some things that you don't think about in there. I've, I've had looked at the article in a long time, but, um, you know, things like, you know, trying, dealing with your suppliers and trying to extend terms. Things like that.
You, you will know all these things, but yeah, it's good to have them all together.
Yeah, put them together and it's good, man. If you can reach breakeven, man, you control your destiny and so much better.
Well, that's our goal, uh, and you're right, that's what a lot of people are saying. The question is, will an acquirer, um, value that. And part of it, it's the challenge is our commission rates are so much higher than what potential acquirers' commission rates are. Of course, they would say their overhead is so much higher, but I mean, it's a— and then the whole back thing is the biggest headwinds that's so different than what the large, you know. So when you look at multiples as a function of revenue, it's crazy because it's apples and oranges. Yeah, but I don't need to say what's been said so many times. Certainly if we could improve upon our VAC lead time, that would go a long way because we have so much pent-up demand. And I'm not saying that to brag. If anything, I'm bragging on the development that we did, or our commercial officer did this past year, and that investment has, I think, increased, um, our potential. The problem is got to bring it up, you know, take it over the line. Anyway, I hope that was helpful.
I don't know if that's helpful. So I mean, it's a typical thing, startups, um, like Raymond's, you have to— the only way to get 1099 attention is to give them huge commissions, right?
Well, everybody else, it's fine, you know. The problem is the third tier Ankle biter companies all are doing it. So that's who you're trying to get mind time or whatever it's called, mind share. And so it's, everyone is playing chicken in a sense. Everyone I'm sure is in the same boat saying, well, when's somebody else gonna lower their commission?
Yeah, I'm not a sales guy. I don't pretend to be, but I've heard a lot of sales pros like, Chris, you know, say that the commission is just one thing. If you become a company that's easier to work with, that gives you an advantage. If the communication's clean and quick, if the product is well packaged and the training, you know, there's a lot of things you can do that are not just commission-based, that where you can really partner with the 1099s. And, you know, they'll carry your thing if you're 25% instead of 35% or whatever. It's hard. It's really hard. Sales, I, you know, it's sales is the hardest part now. I keep saying that. It's for startups. Because of all the VACs and the GPOs and the contracts.
It's just you get—
I'm sure Chris sees that you get aced out of a lot of hospitals, right, where you, you can't even play.
Yeah. I mean, so I can touch on that a little bit. I mean, I do agree. I mean, like, commission's important because that's how I live and how I pay my bills and send kids to college. But that's not all it's about. I mean, you hit on it. I mean, like, I mean, yeah. One product's the same as another product and we're talking about like, you know, commodities, then yeah, I'm going to look at commission a little bit more. You know, if A's the same as the other A, you know, that, that's one thing. But I mean, you get into some of these things where if, if I can reduce my headache with backorders and take less commission, I mean, that's something to definitely look at. But as far as the BACs now, and and all that, that, that's just an added headache that you have. And there's some companies that are better at that I deal with that are better at coming alongside you and helping you in that regard. So that, that's another way to look at that. If you've got a company that'll— I mean, we want to talk about a partnership. I mean, if they're willing to come in and help manage some of that and mitigate that and have a process, that, that's another thing to look at because that, that whole process can just be a huge mess anymore with some of these facilities, especially the larger healthcare facilities, um, for sure. So that's one thing that I would always look at when I'm dealing with companies or looking to partner with somebody new is, is how much are you really going to be a partner? I mean, 40% commission sounds great until basically there's significant backorder issue constantly, and then you're literally going to, you know, these meetings by yourself with no, you know, secondary help. So that's one thing I would always consider.
Interesting. Or if, or if the market is so small that you're seeing it once or twice a year, or if the product just isn't quite there and you're, you're potentially risking your reputation every time you bring it up. Yes, those are, those are headaches for sure.
Yeah, Chris, how do you judge a new company to work with, a startup? What are your criteria?
I mean, so that's a lot of give and take. It's not— I mean, some of it's just really a gut feel once you meet with, you know, the leadership and all that. I mean, some of that I always have to look at is, you know, like, where's that going to fit in our in our portfolio? And then do I have surgeons that are gonna look at it? So, you know, as a small distributor and, you know, you go to your guys that you currently work with, or maybe it's something that, you know, a new guy might really be interested in, he's expressed interest. And so you have a conversation with them because I'm not one of those people who want to waste a company's time either. I mean, everybody's time's valuable. I mean, that sounds like a cliché, but You know, then I'll, I'll present that, you know, most recently, I mean, I had an opportunity presented to me. I knew a guy was looking for an opportunity for himself, a surgeon, you know, I showed it to him. He was like, yeah, this seems worthwhile. And, you know, I made a phone call and had those people come into town to kind of give their spill, so to speak, to this guy. And I mean, and it worked out well. I mean, it's going to be a great opportunity for me, a great opportunity opportunity for him. Great. I mean, you know, I mean, sound like an office nerd. It's, you know, win-win-win-win kind of deal for everybody. And so, I mean, that, that's, that's really how I gauge stuff. I mean, and then sometimes you start doing something with somebody and you realize, uh, this isn't gonna work, you know, for me, for you, however. And so you— I mean, the respectful thing in my opinion is to bow out and say, hey, you know, there might be somebody better in the territory that can, you know, help you out with this. So that's kind of how I go about it.
Yeah, that kind of echoes what Brett Holmes said on Bone Shot last year was you have to partner even though you're hiring a 1099 with a contract. It's a partnership, you know, and you got to treat them like they're a partner. And it's hard to do because a lot of small companies want to say, okay, Phoenix, I got a guy in Phoenix, ship him the inventory. I never want to see him again. But that doesn't work because you're in it together. Raymond, if you're still there, what's your average vac process? I know it probably varies like crazy, but Sorry about that.
Lead time can last from 2 days to 2 years. How's that for a range? And the average is 6 months, maybe 10 months.
Okay. It's probably beating the average because I, I'm hearing 12, 9 to 12 months average. Surgeon says, I wanna buy your product, you gotta talk to these guys, and then 9 to 12 months.
So I'd be curious to understand, I don't know how many people are on this call.
Um, there's 5 right now.
I, I would be curious to understand how many other companies provide some type of compensation to sales or distributors that succeed in getting a first case, meaning the VAC has approved, you know, working in conjunction with us, because it is a process that requires frequently the efforts of both sales and the corporate. And so I'm curious to what extent are other companies providing some type of compensation for the successful VAC approval?
I have no idea. I just sent Mark Copeland a note. Maybe he can jump on. He's our expert.
So, good question to Raymond. Are you talking about like a bonus for like to— for on top of commission for getting through the committee? I mean, is that what— Yes, exactly. I don't have anybody that's done that. That's an interesting thought process for sure. Are you doing that currently with your distributors?
Yes. And it's because they do have to navigate that or help us navigate it. And that, you know, but, you know, I don't know, you said you're in joints and it could be a difference in the market, you know, joints versus spine. I don't know. Or maybe I'm too generous. I don't know.
Everything's regional-based too. So, um, And so like going into like, I'm sure that the East and West Coast are far more difficult than probably the Midwest and the South in my experience. I can understand your thought process on that though, as far as like offering. I mean, that's a lengthy process when you're talking about, I mean, I think you're right, 2 days to 2 years. I mean, that sounds funny, but I mean, that's a genuine thing that I've seen. I mean, I had something recently where I called up and, you know, it was approved within, you know, 48, 72 hours. I mean, it was a— it's a small orthopedic hospital. They've got multiple facilities. But, but yeah, no, that, that's an interesting compensation to do. I mean, because that is a lot of work, the possibility of it not ever panning out.
So Do you, Raymond, have you ever talked with Mark Copeland or used his services?
Uh, no, but I need to get around to it.
Yeah, I, I'm just— in big picture, it's probably— you'd probably better served in taking that, that SPIFF money and just giving it to Mark because he's, he's really good at shortening those, those lead times. And it's not because he's a genius. He's just really good at the messaging for the hospital. You know, he, he can create the business case for you really well. And the clinical case and basically give them a reason to say yes faster. And he's done it with, you know, all over the country with different, he's got so much experience. Anyway, that, that's it. Kyle, what's going on, uh, with you and Priority? You guys have a lot of projects going on.
I'm not working with Priority anymore. I'm just working on my other stuff.
Oh, I didn't know that. Oh, I did not know that. Okay, when did you leave?
It's been a couple months.
Oh wow, congratulations. I mean Oh, that's great. We ought to talk some more. Um, yep. Because I see— I get so many things that come at me, you know, and I—
yeah, you know, priorities. Priority was awesome. Uh, awesome folks, spectacular, great to help build it, but it was time for me to get back into design and not just engineering services and leading, leading, bringing products to market. That is my sweet spot. That's my passion. And, uh, well, it's fun to build a company. I need to I wanna also be building a company that's doing things that fit my, my passion, my skillset, my history in the, in this industry. So yeah, if you wanna chat, I'd be glad to.
Yeah, we could talk about that. So one of, one of my little side ventures is called the Bone Factory where we, we help surgeons take an idea and quickly figure out if it's got legs or not, you know, with early design and prototyping and, and, you know, spin it out in a company, into a company at some point. And we just, we just, we officially created it. We incorporated the business. I've got a partner, Chris Runnels, who's a VC guy. He's great. He's the CEO of The Bone Factory. And we just incorporated and we're trying to raise $2 or $3 million to give us some product development capital, basically. 'Cause the, the easy part is, it turns out, is I can find, I could find 10 surgeons this month that have ideas for products. That's, that's the easy side. The hard part is the surgeons don't wanna spend money on their, on their idea.
And so we are not, we are not distanced far enough from the current Sergeant Poole, their mentors, and even the mentors before them, there's still a legacy of, if I have an idea and draw it on a napkin, money starts falling from heaven. And that expectation is going to take some time to get shaken out. Now that— I'm glad to hear you say that you could find— I bet you, you could find hundreds, every surgeon said they got an idea, that these guys are carpenters, they're fixers, they're problem solvers, they're going to have ideas. All of them want to do it without having to put necessarily any capital into it, which is a big challenge. The other challenge comes into having them understand the expectations of this is going to take a minute. It's not just about an idea, it's about execution. You got to understand the marketplace. What does the competition look like? Where can you find your, your space in there? So yeah, it's a, it's an interesting piece to navigate. The other challenge, of course, is that you probably have to— and maybe, maybe you experienced this firsthand— because so many surgeons can have ideas, wading through the sea of copycats or ideas that really are unlikely to ever take shape, or it's too complicated, or it's too similar to something that's out there. Having to filter through that is complicated too.
Yeah, yeah, we did, we did that last year. We went through about 5 projects. It's kind of a trial. And we, I mean, we, we found an arthrodesis nail that, you know, wanted to use remote control to compress and extend, you know, grow, grow the length of the ankle back. And it was, it was way too complicated. And we just said, no, this is, this is, this is a science project. It's not a business. And, you know, but, and then we've, and then we've, we worked with a couple of podiatrists that had a really good idea and we, we developed their product pretty far along. Yeah, there's a, there's a need for that. You know, I see, I wrote about this. I mean, there's 1,000 really good ideas for ortho, for orthopedic innovation in the United States right now. There's 1,000 that nobody can work on. Because it's in a surgeon's head somewhere and there's no funding. They can't take it to Zimmer or Smith Nephew 'cause they don't know what to, they, you know, they don't innovate anymore.
And, or even sometimes the surgeon doesn't have the idea in their head, but they can clearly articulate the problem.
Problem.
And then now, now combine that, the understanding of that with some people that understand, that, that can, that can collaborate to come up with an actual solution. That can be really powerful. There's a lot of opportunity out there with that.
Yeah, that's a really good point. The other thing is a lot of people only have one worldview. So orthopedics only. I mean, Raymond is the greatest example. I love to tell his story. I mean, he was, he was head of R&D at Exactech and he basically said, hey, I, you know, I'm, there's, we're running out of ideas. So I'm gonna start going to medical conferences that aren't hopefully I'm doing this right, Raymond, that aren't orthopedics. And so he went to an endosurgery meeting and they were doing surgery through the belly button, which is considered an open orifice. There's no wound issues. And then he said, well gee, why can't you fuse S1-L5 through the belly button? And he patented it. And so you gotta go outside the industry. I mean, look at Bill Hunter, you know, he brought a pacemaker and basically put it in the total knee, you know, Kaifan, you know, Kaifan took something out, it took a balloon and they put it in a bone to make a space. I mean, you gotta go outside the industry for a lot of ideas. And that, that's where a lot of people, orthopedists are just doing carpentry all day and they can't see things that aren't orthopedics. I mean, the magic rods when I was at Ellipse, you know, we put in, we put a tiny motor inside a nail with rare earth magnets and we were spinning the rare earth magnets from outside the body. I mean, just because the engineers there were geniuses before I got there and they were aerospace engineers, you know. So, some people call this idea sex where you have, you get two ideas and you put it together and it makes a third great idea. Yeah, there's just, so anyway, going back, there's thousands of great problems that are people aren't working on, like you said, and there's thousands of ideas that aren't being executed on. So man, there's—
Well, and, and it, while that exists, the most common function in, especially in orthopedics, and I suspect it's the same as you branch out into other med devices, it's just a copycat world, right? What has happened over the past 10 years in foot and ankle I mean, once Tres pushed something, then everybody came out with their own jig and then things started to get into the distal osteotomy and then everybody else has their own version. And it's just always these cycles of once something hits, somebody has, somebody starts with an idea and then everybody else copies it. Now sometimes there's an advantage of not being the first mover, but usually there's some, there's some opportunity there to be the first one to get it. And because especially any company over mid-size, they're busy hearing from the field all the time. Well, if I only had this, I could sell more of that. Or if you only gave me this, then I could land this surgeon. And big companies aren't very good at parsing through those opportunities, and so they end up in this, well, we're going to make a Splined Stem, and now we're going to make an Actis knockoff, and now we're going to offer a big, big ceramic head, and then now it's going to be an anti-infective coating, and okay, we need to do a robot now. And all of it is so reactive that, you know, there's just endless opportunity for startups to be ahead of that, looking at the next thing and the next thing after that, instead of the endless copycat cycle.
Yeah. This SI bone taught everybody that there's a new place you can fuse and now there's 50 SI fusion companies. And Mako taught everybody that you could actually sell a robot that did part of a surgery in orthopedics. And then everybody copied Mako. I mean, Therese told everybody the bunion market's bigger than you think. Everybody copied It's just crazy.
Yeah. Well, and you, you can keep going backwards. Keep going. That's how the volar plate went for wrists. And once the volar plate started, right? The reverse shoulder falls into that category. It was ceramic on polyethylene and then it was ceramic on ceramic and then it was metal on metal and now we're back to ceramic on polyethylene. It was the same tidal wave of crosslink polyethylene as, as it worked its way through the system. Anatomic versus mechanical axis in the knee. Like, it's all, it's all the same. It's all the same dynamic. Once it hits the marketplace, then everybody has to play catch up.
Yeah.
And the patents all expire and, you know, you know, there's no, the moat goes away. Yeah. Yeah. Wow. The medial pivot. Are people copying the medial pivot from Wright when we were there?
Who has their own version of that?
Is it somebody?
Everybody's trying to do medial congruent knee for sure right now. I mean, it's not a medial pivot, but they wanna call them, call it that, but everybody's racing to have their own MC now.
I mean, yeah, wow.
Yeah, although I, I— what surprised me, and maybe Chris, you know more about this because I've been in more trauma and extremities for the past couple of years, but I don't see everybody racing to try and get to a cementless uni. And a couple of those have hit, and I'd expect there to be a flurry, but there hasn't been.
Uh, some— so I'm on a dirt road now, sorry if it's rough. But no, I don't— you know, that's interesting. So like, there was one that came out before the ox, you know, before ZB did Oxford, and I can't remember the company. I think Smith Nephew bought them, but then I haven't seen anything from that. So yeah, I mean, realistically, I think— and I could be wrong— that I think Oxford's the only one with a truly cementless uni right now. And there's some guys that are screaming about that online, that that's not the smartest thing right now. From things they're seeing. But I mean, everybody has their opinion. But yeah, they're right now, they're the only ones pushing that. And I think part of that's just because, you know, uni is such a small market and you have the guys that really believe in it and then you have the guys that don't. And so it's pretty niche. But I agree. I mean, my question, what you guys were talking about is, is how do you know, like when you see a product on a napkin, that that's the next thing that you want to pursue and invest time and money in? Where it's not just going to be, well, you don't, you don't, you never know on the napkin.
You never know. You have to, you just have to.
I mean, I guess my question is, you know, like, to be sound like a dork, but how do you know? I mean, so you don't know that it's going to be the Yeti of 2026 or the, the Hydro Flask of 2025. You never know that when you're starting out. I mean, it's just let's play this out and see, you know, where it goes.
Yeah, well, there's layers to that, Kristen. Um, I guess, Tiger, you're welcome to jump in there, but no, go ahead.
This isn't—
this is an area that's probably been more of my specialty, um, if I had to pick one in the past 15 or 20 years, is doing that phase zero preliminary stuff, like finding out if we had a bad idea or a good idea as quickly as possible. Uh, one, because that keeps you from spending money too fast, but also because that helps you figure out if you got a winner, and then you can try and, you know, light the rocket ship. So understanding what the predicate looks like, understanding what the mechanical testing requirements might be, looking at the competition, uh, looking at what intellectual property landscape there is, and then a truly deep dive, horrendously vetted market analysis. If you've got an idea and you've drawn something on a market, on a napkin, and you've talked about, okay, here's this idea we have, if you understand that there exists an actual problem that it solves, then The very next thing you need to do before you put any time, effort, and energy, money into it is to dig into those other elements of does the market exist? What is the competition out there? How difficult could you get into the marketplace? And for someone like myself, I've been in R&D for 20+ years at this point. That's all kind of old hat for me. That stuff haunts my dreams. I can't get away from it. But most companies don't do a great job with that because they're typically bad at upstream planning and marketing. They're more reactive to the marketplace. Oh, ZB just got a cementless uni, then we got to do a cementless uni and it's going to have two pegs instead of one peg because two pegs are better than one. But that's not really an iterative, collaborative, innovative thing on the front end. It's just a reaction to the marketplace.
Yeah, well said. But the key is you have to— once you pass those first hurdles, Chris, like, is the market big enough? Can you sell it? Reimbursement codes, all that stuff, patents. You have to iterate quickly. So you have to get in the lab and you gotta, you gotta prototype, test, prototype, test, and figure out if it's a, if it's doable or not.
Yep. There's also ways to do that that are bite-sized to keep the complexity and cost down too. Right? So, yeah, that's a, it's a great point, Tiger. Once you've got some, some tailwinds to tell you this might be a good idea, you gotta get a basic proof of concept and that might be a 3D printed thing that's made outta plastic that costs nothing. But you might also, you know, decide, well, hey, we've got this widget that has all these complicated features. I'm just going to make one of them and see if I can get that one piece to do what it's supposed to do and prove that, yes, that's, that's an element of this that we want to contain. Just because, you know, you can turn— you can destroy $30,000 in prototypes in the blink of an eye pretty quickly when you start ordering parts, you know, one or two at a time.
Yeah, you're exactly right. The first Genesis knee we made, we made all of the revision modules that fit inside the femur. We made them out of cardboard and straws, you know, and in one day. I got so many, I got so many examples like that. Yep. And then, and I can't overemphasize, you gotta find a market that nobody's playing in. I mean, I'm really big on monopolies. You know, you just gotta find something that nobody is really addressing. I mean, like Chris Hughes's business, that's a great example. You know, the, the two-stage peri-prosthetic infection market for knees and hips is, was a disaster until OsteoRemedies kind of picked it and innovated it. I mean, you, Chris, you go to infected knee and hip stuff where they rip out the old thing and then they mix a big batch of cement with tobramycin and they jam it in the hole and then the patient walks on that for a few months and then you do the real revision surgery later. I mean, that's like barbaric. It's like the 1950s.
And— Yeah, OsteoRemedies did a great job stepping into that. I mean, I didn't have that product It got sucked up by somebody else in town, but I recommended that to every one of my surgeons after I first saw it. So yeah, absolutely.
Yeah, they, they said, why can't you make a knee and spacers, temporary spacers that looks like a knee and a, and, you know, tibia and a femur and, and fits the patient, comes in different sizes, eludes the, the antibiotics at just the perfect rate. And they went from 0% to 50% of the market in a couple years. And now I think they ended up with 80%, 90% of the market because the DePews and Smith Nephews can't do it. And I mean, they own that market and that's been bouncing around for decades. I remember going to those revision cases in the '80s and nobody thought there was a better way. So that's, I think that's the hard part is identifying You know, isn't there a better way of doing this when you, when you go to surgery and it just looks clumsy? You know, interesting. So Kyle, you're talking to a lot of different people right now, surgeons or, or companies or both?
Little bit of all things, including scoping the opportunity to just start more things of my own.
Yeah.
Yeah.
Well, you could start. Now, I tell a lot of people this that are capable and they've been in the industry for 20 years plus is don't underestimate your ability just to start a company. If you find the right idea, the right problem, and you can raise angel money is not hard to raise still. Seed money, angel money, and go get a co-partner. And man, be the CEO. I mean, Raymond did that. He came right out of a medium to big-sized company and just jumped in. And you're never going to know enough to be CEO. That's the other thing. CEOs don't know everything. They're just willing to take on the responsibility. The reason they're the CEO.
That's right. Yeah, that's right.
So yeah, don't, don't be shy about it. If you see something really good, Kyle, just say, hey, I want to own this.
Thank you.
I will, I will be keeping that in mind. That is certainly stuff that's on my radar.
If I could add one other point that kind of fits in this, uh, discussion. If you're— if you have that idea find a college engineer who knows nothing about orthopedics and assign the problem to some bright mechanical engineer who doesn't know he can't solve the problem that he ends up solving. And it's all about thinking— somebody that focuses more on problem solving instead of of saying all the reasons why it can't be solved. So it's, it's out of the box thinking. I think Tiger, you touched on that relative to a magic and, um, I forget what the other example, the balloon hypoplasty. It, you gotta approach it as with zero baggage, I guess is the way I'd put it.
So that's my only other addition, which is maybe obvious to a lot of people, but you gotta find people that Yeah, baggage is a good way to do it. That's a good way to refer to it. And I've, I'm certainly, I've been guilty of it at times and will continue to fail there. That's a great suggestion to talk with some college kids. The other thing that's interesting is marketing people can be the worst about getting captured in that, like, well, we're not doing it that way because it's never been done that way, or none of our competitors do it that way. And that could be really frustrating if you're trying to be a creative engineer.
Agreed, 100%.
Yeah, you're— what you're both talking about is prejudging. So a lot of people, they prejudge the idea. Well, we— that's been done before, we can't do it, or that's impossible, we'll never get a patent on that. And so that's a little— that's the reason a lot of ideas just die on the vine. People prejudge them. The, the Ellipse story is amazing. I mean, I, I, I don't know if I've told you guys the whole background, but they start off as a bariatric control company, and with aerospace engineers. So they, they were trying to create a hose clamp that went around the stomach and had little spinning magnets so you could close and open the clamp. Okay. Pretty simple. And they, they developed it. They could spin the magnets and they could make a dog or pig gain weight or lose weight all day long. And it was like, and this was 2019. And then the board got nervous because they said, okay, class 3, this looks like a class 3. We got some patent issues. There's other people in the bariatric, in the remote control bariatric space that we didn't see before. And so they literally called timeout and they sent all the engineers to other companies and they left one guy and they said, what else can you do with remote control implants?, and the guy came back with scoliosis rods and limb lengthening nails. And then the, the board said, okay, let's do that. And they started, they brought the engineers back. They brought, they had like 3 people, 4 people, and they started working. They didn't know anything about orthopedics. They literally had to Google, where are the orthopedic conferences? And they started going to those and they didn't know anything about spine. And it's incredible. I mean, they, so they didn't prejudge, they were fearless. They did not prejudge anything. That, I guess that's my point. That's why the big companies can't do anything. 'Cause you have, it's designed by committee and every time there's an idea, somebody in regulatory or quality says, well, you can't do that. You know, yeah, that's right. Well, that's fascinating. Maybe, Kyle, we'll talk to you one day, maybe at the bone factory, because you, you may be able to help us with some projects.
Yeah, be glad to talk.
But you're right about surgeons don't understand all the work in the background. They have no idea. Were you, Kyle, were you at, were you at Wright when we did the micro nail? Which was, uh, yes. Yeah.
Okay.
So that was Mark Wahlberg. And, uh, we just, I found the patent on my one day on a patent search, you know, IM nail for radial fracture, distal radial fracture. Eh, kind of interesting. We were, so I flew up to see the guy and he showed me his, and I said, have you developed this? He goes, no, not really. I said, well, we wanna buy your patent. And so I came back and I said, I want to buy this guy's patent. And so he said, well, figure out what he wants for it. So I call him up and I said, Mark, we want to buy your patent, you know, how much? And he goes, well, man, I've got like $20,000 in this thing, you know, all my, for years, you know, work on this patent that's issued. He goes, if you could just write me a check for $20,000, he goes, that would be great. And so we, we paid him $20,000 and I said, okay, you know, and then he calls me the next week and says, when can I start putting these in? Yeah, that's right. Yeah. And I had to explain, you know, quality, product development, FDA, and you're gonna, you're gonna get to be a part of all these cadaver labs and you, Oh my, but they, you know, the surgeons are so used to saying, I need this in surgery and then somebody magically produces it a few weeks later. Right, right, Chris. Yep.
Yeah.
Magically.
Yeah.
Hey Tiger, I, I wanted to ask a question about a, a product idea and just wanted to see the thoughts of everyone here. What do they think about it? So I was speaking to one of the, like, I think he's a knee surgeon, or he does both hip and knees. And he mentioned that there is a need for a, like, a needle or injection kind of system to introduce, to deliver antibiotics into the knee compartment, you know, for knee, during the knee replacement surgeries. Is that really a need? Because they, he said that they use all kinds of off-the-shelf products to kind of inject or deliver the antibiotics.
Is this post-op or?
No, it's intra.
Intra. Well, it's an open procedure, so I would think they could just use a syringe or anything they wanted. Nothing, not a needle.
Yeah, and they use, so they use any of the existing, I guess, off-the-shelf syringes, But, uh, so I don't know why he was mentioning that as if this was a, a need.
Was he talking about interosseous, you know, introduction to like the canal?
Yes.
Yeah, so that's— I mean, there's been a couple of things that have come out in the last few weeks online about guys talking about varying ways to do that and like introducing like TXA, transexamic acid, into the canal. Um, So that might be what that particular physician's talking about, is like a kit to basically do a tap and do that. Um, I've seen a bunch of different ways guys do that actually.
So, so what, what would be the purpose? Is it like before you open up the knee, you just want to kind of introduce the antibiotics there to kind of create a—
yeah, that might be what they're talking about. So the idea that this guy was doing that specifically talking about was he was in total knees. He'd bone plug the distal femur for the IM canal, and then he was going in and using— I can't remember what needle he was using, but they were introducing the TXA into the femoral canal. And so you get faster uptake of it technically. And so that's what this guy's discussion was. I don't, I don't even know if there was a paper about it. Brian Fuller may have been the person that posted about it. I can go back and look and see, it may have been something that he was talking about, but I've seen a couple different guys do that, um, in varying ways. I work with a guy that does makos, and he, he does that through the mako, like, guide, um, points. And so he uses a pretty good-sized needle and does it through one of those. So, um, that might have been what they're talking about, but without knowing fully what he was trying to do. That, that's, you know, you know, interosteous, you know, uptake of things is way faster than, you know, just injecting it into the, you know, um, op site. So that may be what they're talking about is the kit to do that.
So yeah, I mean, given that now these—
they have, I believe they have brought down the infection rates to really low percentages like 1 or 2%, how, how much more scope is there That's the challenge with most innovations in the knee, in the knee realm especially where, you know, whether it's valid or not, the pushback you get on any new technology is, well, it's got 97% survivorship at 10 years or 95% at 20. How much better are you gonna make it? Which is, that's a bit of a smokescreen because you can always make things better and that you're not always capturing all the right outcomes there. But I mean, Chris, I'm sure you've seen that when it comes to robotics or, you know, anytime you're trying to charge more, bring something else in there or new technology, you know, the, this is good enough. Yeah.
Oh, there's a lot of good enough anymore.
Well, maybe, I mean, if there's a product that makes those existing 95% people feel even better, then that would be disruptive.
Well, there's probably a different approach to it that comes into play for something like that. And what I mean by that is, if you go to a doctor, and you say, well, here's this thing that I have that's going to solve all these problems that you have, their response is always gonna be, well, I don't have those problems, other people do.
Right?
So this, that directive approach is not necessarily where it lands. And I, I once had a surgeon who was really struggled with his hands as a trauma doctor, and his comment was, I've never seen a failure like that. Well, we looked back through like his patient records and all his patients that didn't do well went to other doctors because he didn't do well enough for them to want to come and see him again. So, you know, his, his perspective may have been valid that he didn't have patients that had problems. He's like, well, yeah, because they're not your patients anymore, they went to somebody else. So you know, with an opportunity like that, you would want to, you would want to really, you'd want to really vet the, the indirect route instead of going to a surgeon and say you need to inject something into the canal. It's some other pathway for that that is, you know, establishes the market opportunity.
Good question. Yeah, we have terrible records in the US because patients just go somewhere else. But like, you know, the UK, they've got national registries, and Sweden, you know, and they, they they can tell you exact revision percentages. You know, it's just terrible in the US.
Yeah, except those registries internationally are not— I mean, they're, they're large joints is about as far as you can get with it. It's not great with trauma, it's not great with extremities, and it leaves a lot, leaves a lot to be, um, desired for sure.
Yeah, good point. Well, we're hitting the top of the hour. Anything else? This has been interesting. I love the open discussions better than the speakers.
Yeah.
Open mic, always an hour disappears very quickly.
Yeah, it's great.
So yeah, go ahead, Tiger. Where are you at this week, uh, this coming week?
I'm in Texas.
Yeah, Tex, not Hilton Head?
No, I'm in Austin. So I moved this year, I moved from Hilton Head to Austin.
Okay, all right, very good.
Yeah, are you going to be up, you're going to be in—
Yeah.
Oh yeah. Oh man, I'm that way. Yeah, darn. Well, enjoy it. It's pretty. You'll enjoy it. Bring your golf clubs.
Well, working from Hilton Head.
How's that? Okay, got it. We're all working all the time.
That's a long story.
Life of a CEO. All right guys, thanks. Happy, happy New Year. Next week, next week we're talking about how to get the most of a medical conference. And I think we got 4 BoneChat members that stepped up to kind of be on a panel, so that'll be good.
All right, thanks.
Thank you.
Happy New Year.
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