Medical 3D Players: Expanding the Reach of Personalized Care

Sebastian De Boodt  00:06 

Welcome to the 3D Players Podcast, where we explore personalization in healthcare through advancements in 3D technology. We talk to leaders championing more predictable and sustainable patient care. I'm Sebastian De Boodt, and I'm joined by my co-host, Pieter Slagmolen. 

 

Sebastian De Boodt 00:26

Hey, Pieter.

Pieter Slagmolen  00:27

Hey, Sebastian. 

 

Sebastian De Boodt  00:28 

“At restor3d, we have it in our mission to expand the reach of personalized musculoskeletal care with additive manufacturing. Our solutions are as unique as the patients and surgeons we aim to assist because one size doesn't fit all.” When a medtech startup puts that, on its website, you can expect an invitation from the 3D Players podcast. And so, we're very excited to have received a positive response from Cambre Kelly, the Chief Technical Officer of restor3d to be our guest today. We're keen to understand her view on personalization and the impact startups are making to shake up the market. Welcome, Cambre. 

 

Cambre Kelly  01:04 

Thanks for having me. Happy to be here. 

 

Sebastian De Boodt  01:06 

Cambre, restor3d is still a bit of a new kid on the block. Can you tell us about the company? What should we know about restor3d? 

 

Cambre Kelly  01:13 

So yeah, I think we're kind of a relatively small player in the space but providing some very unique personalized solutions. The company was started in 2017 as a spin-out of technology being researched at Duke University — we're based here in Durham, North Carolina and still, stay very close to research efforts at Duke and other academic institutions. I think what makes us very unique for a business of our size is our ability to go end-to-end. For us, that means from preoperative CT scan, all the way through final finished parts, both instruments and implants, and sometimes also anatomic models for a personalized solution for a given case. And so for us, as a small business, very early on that was part of our ethos to in-source and own a lot of the design, and the manufacturing processes in-house within the four walls of our production facility. 

 

Pieter Slagmolen  02:08

You talk about your PhD and your background at that university. Can you tell us a bit more about that specific research and how your academic career then evolved into the creation of the company? 

 

Cambre Kelly  02:19

Yeah, absolutely. Like I mentioned, some of the core technology at the business, what we call our “TIDAL technology,” which is our 3D-printed porous lattice structure was part of my doctoral research at Duke University. Since then it's been continued by more students in that research group, which is the Gall Research Group at Duke. But that's part of the core of our business is being very scientifically driven and evidence-based as an organization. We really wanted to understand from the very onset, what the clinical problems were that the orthopaedic surgeons that we were partnering with were seeing in the clinic. Where were the gaps in their toolkit? And their ability to deliver good outcomes for their patients? And where could we plug in the scientific side, bring good basic research to the table and understand the manufacturing process, the design processes to be able to partner with them to provide these unique personalized solutions for each of their patients? That's something that we're very proud of as a business. We continue to do work on an academic collaboration level with Duke University. We also partner with Drexel University on biomechanics research at Soren Siegler's lab. And then we also do a lot of work with animal models with both Colorado State University and the University of New South Wales to study our materials in vivo, in preclinical models. It's something that as a business, we continue to invest time and resources to be able to publish data and be thought leaders on the scientific side. And it's something we're very proud of. 

 

Pieter Slagmolen  03:54

Both me and Sebastian we actually have a research background ourselves, but we never experienced the “Aha moment” to realize that our research actually also had commercial value. Did you experience that Aha moment? Identifying that this really has value outside of the academic world? 

 

Cambre Kelly  04:12

Yeah, that's a great question. A little bit of my background that might shed some light there. I'm a biomedical engineer by training. I studied at Georgia Tech for undergrad and worked at a couple med device startups in the Atlanta area when I was there, and that was my first exposure to orthopaedics and medical device development. I was always very interested in the translational opportunity — academic, research, materials-based technologies to commercial products — for better clinical solutions. And so when I joined the research group at Duke, that was the intention from the onset. The idea of doing research — not just for the sake of publishing and advancing one niche space of the field — but for thinking broader about the applications, and that's really what our research group strives to do. 

One of the great things about Duke and other universities that have large medical centers attached to them is that there's great collaboration between the clinical side and the engineering side. And so that was something that we benefited from very early on. Dr. Samual Adams, who's a foot and ankle specialist at Duke University was actually on my thesis committee, so we had that clinical perspective represented in the research from the very beginning, and that was something that was hugely valuable. I think the “Aha moment” maybe came for us when we started looking at all of the different lattice structures that we could print with laser powder bed fusion. At the time, one of the first objectives in my research was to try to print all the lattices that we could, and see, to start, what was actually printable, what worked, and then start to narrow the funnel from there, and look at mechanical properties in static compression, static tension, just the basic characterization work that really wasn't very robust in the literature at the time. 

That was where we started looking at the gyroid structure, which is part of the triply periodic minimal surface family of architectures. First of all, they look really cool and different than strut-based or truss-based lattice structures. And so, from the very beginning, they're very appealing to the eye, or just look unique, with the sheet-based architecture that they are. But then looking at the mechanical data, just in static properties, we started being very interested in how they had higher performance for a given porosity relative to the other architectures that we were looking at as well. And then we moved into characterization in fatigue. That's when the sheet-based architectures really pulled away as far as performance, given their ability for homogenized loads and bear cyclic repetitive loading, as compared to truss-based architectures that are inherently flawed and have stress concentrations and don't stand up in fatigue in the same way. So that's where we started getting really excited. And that was probably where the “Aha moment” came to us, pretty early on in the research, really. 

 

Sebastian De Boodt  07:12 

The title technology is really built around the metal 3D printing side and porous structures, as you explained now, within restor3d. You chose to apply this not just to any medical devices, but to personalized care. Where does that belief in the future of personalization come from? 

 

Cambre Kelly  07:30

Oftentimes, when we talk about the advantages of 3D printing in our space in medical and orthopaedics specifically, we start out with two basic advantages, right? One is the ability to create complex porous architectures. Ours is title technology. We have great data that shows that, like I talked about, we have superior mechanical performance, but also superior bony ingrowth in those animal models that I mentioned. And then the second is the ability to create personalized devices using preoperative CT imaging to create a 3D model of the patient's anatomy and then work hand-in-glove with the surgeon to decide what's the correct surgical approach, what are the goals of the surgery for the patient, and to design a unique solution, which for us includes both implants and instrumentation for a given patient. So, marrying those two advantages of being able to create that personalized design not only to match the anatomy of the geometry, but then the surgeon and engineer being able to decide 'we want to have a porous and growth region here,' or 'an articulating region to maintain motion here,' is really one of the great advantages of the 3D design tools and then the 3D manufacturing processes that we have capabilities for. 

So, it's something that we get really excited about as an organization. One of the great things about the title technology being a sheet-based architecture is that it's both bulk and surface isotropy. And so when we apply it to the organic surface of an anatomically matched geometry, we can apply it and then cut the structure conformal to the surface, which is awesome, because it gives us unlimited design freedom — whereas other strut-based architectures, you have to play around with the nodes and make sure they all end at the right places if you've got a curved anatomically matched surface. So for us, that's been a great benefit of the architecture because the engineers have unlimited design freedom when they're working with the surgeons to plan what's right for each patient. 

 

Pieter Slagmolen  09:39 

Does that translate mostly into operational gains for your engineering team? Or is there also a benefit in the end for the patient? 

 

Cambre Kelly  09:46

I think it's a little bit of both. As we talk about personalization, I think one of the things we'll probably get into is the ability to make it scalable. And I think we're not the only ones in the industry thinking about that, but certainly, it's helpful when the engineers can decide for the surgeons where they want to put a porous architecture. They don't have to think too much about going back and closing off those nodes or making sure there aren't hanging struts or anything. It's something that it's just routine at that point — but certainly provides efficiency on the design side. And on the manufacturing side as well, where we don't have to think about different support structures or orientations or anything like that with the architecture. But then I think it does have an inherent benefit for the patient, right? Because we can be creative as we want to be with the design. We're not limited to some artificial design envelope based on the manufacturer ability. I think that that's mutually beneficial downstream, all the way to the patient, as well. 

 

Sebastian De Boodt  10:42

So you describe how your technology has some unique benefits. At the same time, you're looking to solve real clinical problems. How does that work? Where do you go and look for those clinical indications? How does this process work for you?

 

Cambre Kelly  10:55

I mentioned that part of working at Duke University gave us access to surgeons who are really on the cutting edge. And one of those is Sam Adams. And at the time, he was treating a lot of lower limb reconstruction cases and limb salvage cases. And he was one of the early adopters of 3D printing and was using some other solutions at the time and partnered with us to advance what he could provide for his patients. So he and some other early adopters were the ones that came to us and said, “Here are the places where I don't have any good solutions for my patients.” Oftentimes, especially in the lower extremity where we started out exploring solutions, it was: 'these are our limb salvage cases and the alternative is below-the-knee amputation.'

The ability to bring innovation there and try something new is oftentimes what thought-leading surgeons are looking for. Their patients are willing to explore a new technology with them because they want to salvage and keep their limb. Those were really, really hard complex reconstruction cases that we started out with in the lower extremity. And then, as we got the design platforms and the manufacturing platforms established, it expanded into other areas of indication, some complex reconstruction in the lower extremity, like I mentioned, as well as upper extremity, some trauma indications, pelvis reconstruction for orthopaedic oncology, cutting up all across the body. We've seen a lot of opportunity to, again, provide solutions where surgeons are lacking good options for these patients that have difficult pathologies and anatomies to provide good solutions for.

 

Pieter Slagmolen  12:46 

One of the observations that we have from looking at your portfolio is that rather than focus on the more high-volume, very large joint applications, you're looking more at smaller indications like spine, maybe extremities, or ankle. Why did you make that choice? 

 

Cambre Kelly  13:02 

Yeah, it's a good question. Starting in the lower extremity again was really driven by the clinical need and some experience that our founding team had from other businesses working in that space — the surgeon network that we weren't familiar with at the time. Really it was just being drawn in by the ability to provide solutions where surgeons returned to allograft or worst case to PKAs (partial knee arthroplasty). And then we've seen these other niche opportunities, upper extremity, for example, and other complex reconstructions; we have really been able to deliver a unique solution where there aren't others in the market. So for us, that's been, as a small business, a really good opportunity to play in the extremities space or other places where there isn't a lot of entrenched competition. I think the large joint space, hips, and knees, has definitely seen some benefit to personalization. But where you have a lot of large volume, you also have a lot of competition in the landscape and pricing pressure, at least here in the US to continue to drive down costs in that space. We feel very excited about continuing to develop out and scale our platform and our capabilities in the extremity space, and some of the other smaller markets, before trying to jump into some of the large joint spaces. 

 

Sebastian De Boodt  14:28 

Makes a lot of sense. I think this also explains, I guess, you recently received FDA clearance for patient-specific resection guides to use with a total ankle system. Can you explain a bit more about this product and how it came about? 

 

Cambre Kelly  14:43 

Yeah, absolutely. So a little bit of background to set that up. We acquired a business called Kinos Medical back in 2021. That business had developed the Kinos axiom total ankle replacement system, which is a unique total ankle replacement in that it allows for range of motion in all three anatomic planes. A more natural kinematic total ankle. And so we were excited about that technology when we acquired it. That team, the basic research came out of an elite biomechanic research group at Drexel University and was very well studied and understood. That was part of the attraction there and that they had great basic science foundation that paralleled with our thoughts in that space. 

At the time, when we purchased the company, that system was traditionally manufactured with a plasma spray-coated implant. The thesis behind bringing the Kinos system into restor3d was to apply their biomechanical technology and articulating surface, and then layer that in with our additive manufacturing capabilities and our title technology to bring a 3D-printed implant to market. We have brought the 3D-printed tibial and tailored components to market with title technology. And then, like you mentioned, we recently received FDA clearance for our patient-specific resection guide, which is a patient-specific cutting guide — cut-through guide — that is an all-metal guide for surgeons to place onto the bone and guides them to make their sawblade resection on both the tibial side and the tailor-side of the ankle joint complex, and then use the rest of the traditional instrumentation to proceed with the surgery. So again, that starts with preoperative planning, based on CT from every patient, and then the surgeon — working hand-in-glove with our engineers — to decide what they want to achieve for the patient. If there's a lot of correction that needs to be made due to deformity or other considerations, they work through that all together to provide the best possible outcome for the patient. 

 

Pieter Slagmolen  17:05

We'll talk about scalability in a second on that ankle system. You mentioned already, your guide is printed in metal, not in plastic, which is probably more typical for guide systems. So why did your team choose metal in this case, which may be more difficult to scale, 

 

Cambre Kelly  17:19

It probably seems like a nonobvious choice. But for us, it's something that we're very excited about to have a differentiated offering on the market. Like you said, most of the guides for total ankle replacement systems are polymer patient-specific guides, and most of them are printed using SLS technologies. What we understood from speaking with those thought-leading surgeons that had some experience using other systems was that those polymer guides had a lot of issues related to rigidity and that they weren't registering in the best way. For all their cases, there was a lot of variability in whether or not that patient-specific service would actually match, click on (for lack of a better word) to the anatomy with a high level of confidence. And then also that the polymer guides just aren't rigid. And so when they started to cut through them or proceed with a surgery, they would flex and maybe not provide the most accurate cuts. For us, we wanted to deliver something that had a higher level of confidence — not only from the registration of the guide — but also from the ability to be confident that the cut that you're making is the cut that you want to be making. So metal was the right option. Given our in-source capabilities, we've developed  a streamlined process to deliver those guides in a quick turnaround time — and hopefully be able to scale them up, as the demand for that offering increases as we get into full launch in the summer.

 

Sebastian De Boodt  18:51

Right, makes much more sense now. It really comes from a clinical or mechanical need, so makes a lot of sense. Let's switch gears to scalability, as we previously already alluded to. Maybe first from your portfolio perspective: which of the products that you have today do you think has the biggest potential to scale? 

 

Cambre Kelly  19:11 

Yeah, it's a great question. A little bit about our portfolio. I mentioned that Kinos total ankle replacement system that we're very excited about, and I've done a lot of work collaboratively in our team to convert the traditionally manufactured implants to 3D printed to provide the patient's specific resection guide, which is a really valuable tool for the surgeons intraoperatively. We're very excited about that product portfolio and the ability for, not only great clinical outcomes, but the ability for it to become a flagship product and scale with the organization. 

I think about the other products in our lower extremities portfolio, and we're trying to build out a bag of products that offer a continuum of care for these patients. So, when you think about primary total ankle replacement, all the way through in-stage limb salvage procedures that I've mentioned a couple times. And so there's some great products in the pipeline that will offer that continuum of care, depending on where the patient is. We get very excited about that. We do have some products in the spine space. I think 3D printing was quickly adopted and spine (if you think of all the different markets) and orthopaedic spine was one of the early adopters of printing technology. And I think that's something where our title technology is a differentiated solution. But we also offer 3D-printed disposable single-use instrument kits for spine, which I think is something that is becoming more and more of an opportunity, particularly in the ASC market [Ambulatory Surgery Center] for spine. 

Our interbody solution for cervicals and accompanying single-use instrument packs. I think that's something that will unlock the ability to scale those procedures to higher volumes in those ASC settings. And that's something that we're excited about with our cervical solution, and soon, our lumbar solution, as well. So yeah, I think we're pretty excited overall. We're not going to be predisposed to trying to scale any one vertical. One of the great things about owning everything from end-to-end is that we can scale up where we're seeing the market pull — as opposed to trying to push our technology onto the market. And that's something that has been beneficial for us that we'll continue to look at that over the next few years. 

 

Sebastian De Boodt  21:29 

All right, so there's clearly a very nice pipeline of interesting products to scale. Now, from your experience, so far, what has been the biggest blocker for the adoption of personalized medical devices? 

 

Cambre Kelly  21:40 

There are probably a couple things that I can point to, some related to technology readiness. And some of that has been things that we've felt here in the organization as we've been trying to stand up our production facility — maybe a misconception of those that are not super familiar in operating the metal printers in the space is that they're a plug and play. And that's certainly not the case! We did a ton of work to develop the parameter sets and the process that we use to print our titanium and our cobalt chrome products. And then there was a lot of effort to optimize that for our given applications. And so that certainly was something that we had to figure out from a very early standpoint. There's a lot of questions around quality systems and traceability, and other sorts of things related to personalized implants, which is something that most medical device manufacturers are not really set up to do lots with a batch size of one, or one or two or three, right? If you're going to provide a couple in the OR as backup. And so that's something that we've spent a ton of time thinking through very carefully: to set up a process not only on the design and the manufacturing side, but also on the documentation side to support the traceability of these parts and produce good quality parts through our system. 

And again, that's something that I think is not universal. Everyone's trying to figure this out in their own isolated vacuum. So that's on the technology side, and maybe a quality system side. And then I think we just need better overall collaboration between industry and academics and the regulatory agencies. Some of that's being facilitated through some of the standards organizations right now. I'm part of ASTM's F42 subcommittee for medical device. And so, working directly with Matthew Di Prima from the FDA and others to try to provide more clarity on what the expectations are and more standardization around these kinds of products and processes to bring more innovation to the market as quickly as we can. 

 

Sebastian De Boodt  23:54

All right. You talk a lot about some of the internal challenges with scaling this up, and first of all, developing a qualitative personalized product and bring this to the market. Anything to add maybe from the surgeon’s perspective, if he has the choice between ordering a standard device versus anything patient specific. Are there any challenges related to that? 

 

Cambre Kelly  24:14

Yeah, that's a great question. I think probably the biggest one is just education on the technology for surgeons that haven't been exposed to it, trying to educate them on what the technology is and how that works. And one of our favorite things to do is to bring surgeons to our facility and walk them through the production process, and when they see the printers and see the lasers going into layers going one over the other, it almost becomes an aha moment where they think, “Oh, wow, there really is this unlimited design freedom.” And that's when the surgeon and the engineer collaborating get super excited and creative. But obviously, that's a very tough thing to scale up. Trying to provide just more education around working with the KOLs that have been early adopters of the technology to publish their clinical data to be on the podium, sharing their experience with the design process, and the products and their patients with their peers, has been the best way that we've seen to be able to unlock the educational aspect, as well.

 

Pieter Slagmolen  25:24 

You're obviously a startup and a lot of companies driving personalization in the market are also startups and smaller companies. How do you convince physicians to choose your products over those of much more known, established market players that are out there? 

 

Cambre Kelly  25:39

I think when they're scratching their head and wanting better solutions for their patients, it's not too hard of a sell. We've been very lucky to have a lot of market pull and like I said a lot of this peer-to-peer education, where one surgeon who's worked with us will refer us to their partner or their peer in the space that's also struggling to come up with solutions. And I think for surgeons, like I said, it's that educational piece getting through the first case where they learn a lot, and maybe takes a little bit more time on their first design call with the engineer to understand the 3D model and talk through what they want to do. But then, after they get through the first repetition of a case, they think, “Okay, I learned a little bit, I did the surgery, what I thought was going to work didn't quite work,” or “I learned something new,” and then they come back to the engineer. Then it becomes this great virtuous loop where the surgeon is bringing a great clinical perspective and the engineers bring great design perspective, and then they've snowballed to these great solutions. We've been very lucky to have a lot of market pull because we've worked in these spaces where there aren't a lot of solutions and some of the larger players in the space aren't really offering products for the indications that we're working on. 

 

Pieter Slagmolen  27:02

It seems like you're delivering fun, as well, to the physician the way you just described it. 

 

Cambre Kelly  27:06

Yeah, I think it's a really awesome collaboration for the surgeon and some of our engineering team. I think they get along really well, and bounce ideas off of each other. It's been a really awesome opportunity for us to connect with those surgeons and have a lot of really great conversations from both sides. 

 

Pieter Slagmolen  27:25

Is that also how you tackle the variety in customers that you have as a company? Because you have a quite broad portfolio... is it the combination of science and basically, mouth-to-mouth or word-to-word? Or how do you describe that? Marketing and sales? Is that what allows you to tackle such a broad variety of customers? 

 

Cambre Kelly  27:42

Yeah, I mean, we have a great commercial team. They're pretty small, but mighty. But yeah, we've benefited a lot from their expertise — but also from this peer-to-peer aspect of it. And I think as the 3D printing technology is percolated through lower extremity, and now upper extremity and other spaces — it's a hot buzz topic at the large orthopaedic meetings — it’s something that people are looking for: the right first case. If they're interested in the technology, as they're going through their clinic thinking, “Is there a patient out there in my practice that is the right patient to try out the technology on?” That's been very exciting as we've seen more organic adoption of the technology all across the portfolio. 

 

Sebastian De Boodt  28:29

You really nicely described the importance of this synergy between the engineers and the physicians, and the collaboration for finding a good solution for patients. At the same time, you, as a company, also recently launched an online platform for, you know, I guess ordering your products and devices. How should we look at those next to each other? You have the personal interaction, but then also the digital interaction to streamline things. How do you look at that in combination? 

 

Cambre Kelly  28:58

Yeah, for sure. So, our platform is called r3id. We launched that last fall. It's essentially a surgeon-facing platform, both web-based and then also iOS and Android apps, for a surgeon to track and manage their cases through our process. So it goes hand-in-hand with that very personalized experience between the surgeon and the engineer that I described. But it is a tool that allows for direct and secure upload of the preoperative imaging data, and any other information that we need to initiate a case and get started. That helps them schedule their design call, provide comments or feedback, look at the design plan that we provide, and then move through that patient-specific process that we facilitate in a platform that, you know, it's all right there. And so for surgeons that do a lot of work with us, and that have multiple cases in flight at any given time, they can see what cases and which part of the status, and they get notified when we need information from them. Or when the ball is in our court, and things like that. And then, the other major benefit that we've seen is that it’s now acting as an archive for surgeons. They can go back and look at their past cases, whether they just want to refer back to it as they're thinking about maybe a next patient that might be a candidate for something similar, or when they're thinking about pulling together a case series or putting a presentation, or something like that, together... all the information for the cases that they've done with us are all right there and accessible to them at any time. That's been a huge benefit and something that surgeons have been very excited about with the platform rolling out. 

 

Sebastian De Boodt  30:42

One of the things you mentioned as what makes your company unique, is the fact that you own the entire process end-to-end — which is fantastic. Can you explain what benefit does this provide? And why is this relevant? 

 

Cambre Kelly  30:57

For us, we think about a couple of things, as it relates to owning the process end-to-end. One of those is the ability to move quickly for any given case. And so we have control over the cues, more or less, and so whether that's the inbound cue of converting the CT to the 3D model so we can just start the design plan, working through the design with the surgeon, and moving as quickly as they want to move through the design but then also the manufacturing processes, as well. We endeavor to hold lead time, somewhere around six to eight weeks for most cases, and then depending on complexity, or urgency, speed up or sometimes slow down if we need to do something for more complex reconstruction. 

That gives us a lot of flexibility and agility on the process side, and that also allows us to control costs in a way that is very important for us as a small business. I think the other, probably softer, aspect of it is that having the manufacturing process and the design process all in-house enables our engineering team and our operations team to work very closely together. And for the engineers that are designing parts, to be able to turn to their colleagues on the manufacturing side, and bounce ideas off of each other. We benefit a lot from doing R&D work on the same systems that we're doing production runs on. And so we see a lot of — very early on as we iterate through design — the ability to move more quickly through design iterations. And for again, that tribal knowledge in the team to benefit, the design is we're making personalized products and thinking through support strategy and orientation, and design for additive manufacturing, internally. So that's something that I think has been hugely beneficial to us. 

 

Pieter Slagmolen  32:54

You mentioned speed a number of times and the ability to change. You talk about agility at one point in time. How important is that agility for a startup company? 

 

Cambre Kelly  33:04

It's hugely important. I think, for us, one of the great things that we've been able to offer to our surgeon customers is the ability to move relatively quickly compared to some of the other lead times in the industry. And that's something that is tough as we scale up and has certainly been a growing pain that we're experiencing now and continuing to work through and endeavoring to be better and faster every day. But the ability to be able to be not only reactive to changing priorities, but sometimes being proactive where we can, and remaining agile around what we have going on any given week is hugely important to us as a business. 

 

Sebastian De Boodt  33:46

Let's maybe look forward. If you project yourself five years into the future, what do you expect will be the two trends, or two or three, trends that you believe will have the biggest impact on personalization? 

 

Cambre Kelly  33:57

I think one thing that we've thought a lot about as a business, and we've talked a little bit about here, is scalability. And I think that that's probably one of the trends that we're going to start to see. I'm really going to pressure test — it's going to be make or break — can we do this in a scalable way, in a cost-effective way? I think that's one of the things that, not only here at restor3d but others in the industry are thinking about, and we're going to have to solve those problems industry-wide.  

 

I think the other thing that we're very excited about and have been doing a lot of work, thinking through here, is how do you connect more directly to the patient? I think that it's something that has always seemed a little bit funny to us, where we're creating these incredibly personalized solutions, and the engineer and the surgeon have a great collaboration, but ultimately, the end customer is the patient, and in orthopaedics, we're in a patient satisfaction business, right? We're trying to improve pain, improve function; that's really, ultimately the goal: patient satisfaction at the end of the day, postoperatively. And so, we have some early-stage projects that we're very excited about to be able to connect directly to the patient, educate them on the technology and the procedure that they're going to receive, but then also be able to track outcomes from the baseline preoperatively, through postoperative follow-up to understand, How are they doing? Are they satisfied with the procedure? Has their pain been reduced? Has their function improved? And really understand the outcomes related to these devices, which is something that's unique to do in the personalized space, where inherently, every device is different. And in so doing, robust clinical research becomes a little bit more nuanced in this space. But I think that that direct patient interaction is something that we're going to see more and more companies be interested in. Here at restor3d, we're pretty excited about that opportunity to do that with our patients. 

 

Sebastian De Boodt  35:56

And how are the patients reacting to this?

 

Cambre Kelly  35:59

Yeah, we haven't gotten all the way to MVP level or anything like that. But from what we understand of what's going on in some of the other large joints markets and things like that, there's a lot of opportunity to provide patients with more, and empower them with, more information, whether that's education around what's happening preoperatively for their surgery, but then also what's happening postoperatively. How are they recovering relative to other patients that have received the same procedure in the same cohort more or less? 

When I think about, if I needed to have an orthopaedic procedure, I'm a pretty competitive person, I would want to make sure that I'm recovering as well as some other people that are similar to me — if not better, right? I think that's only going to inherently drive better postoperative protocols, and hopefully better recovery outcomes for patients long term. But again, I think that that's something that, as an industry, we're going to start to see more of and figure out where to provide the most value to patients as the end customer. 

 

Sebastian De Boodt  37:00 

Absolutely. As a closing remark, you know, we should be grateful that startup companies as yours are bringing new innovations that can positively disrupt the medical device industry. Do you have any advice for people who might want to start to innovate in the market? 

 

Cambre Kelly  37:15

For us, and something that I've always thought through is to start with a clinical problem. And I think one of the most important things is to have a clinical perspective and a team of key opinion leaders from early on in the process. Having market pull from solving the clinical problem with your unique innovative solution is very important. And I think that that's probably more important than having some huge total addressable market, or a ton of IP or anything else — you really have to be able to find a problem that you can solve and have surgeons that are excited about the solution and want to develop it with you. And I think that, from my experience, has been the most fruitful, as opposed to developing the technology in isolation on the benchtop and then trying to explain to a surgeon why the technology is so much better than what they're currently using. That's a harder sell, oftentimes to convert them from something that they're generally already happy with. But if you can find the pain points in the places where they're pulling their hair out, and they're frustrated, and then provide a solution to that — that's the easy sell normally where they get very excited to work with small companies like ours. So yeah, I think that that would be my big overall suggestion. 

 

Pieter Slagmolen  38:36

That's a wonderful closing remark. Thanks a lot for joining us, Cambre. It was an absolute pleasure to talk to you. 

 

Cambre Kelly  38:43 

Thanks for having me. Really, really enjoyed it too. 

 

Pieter Slagmolen  38:46

Our three key takeaways from this conversation today are first, personalized products when they deliver value: they sell themselves, especially to surgeons who are pulling their hair out with a problem they're facing. Second, if you start your company with a clinical end in mind and work very closely with the clinicians on delivering value, that's a great starting point. And third, invest in-house in capabilities end to end because that will allow you to scale up in a natural way as your company grows and your products reach the market in a broader fashion. 

We appreciate you sharing your insights with us on 3D Players, a podcast where we explore trends, insights, and innovations in personalized and sustainable healthcare. We are your hosts, Pieter Slagmolen and Sebastian De Boodt. Thank you for listening, and join us for the next edition.