Medical 3D Players: The Path to Payback for 3D Printing at Point-of-Care

Sebastian De Boodt 00:06 

Welcome to the 3D Players Podcast where we explore personalization and healthcare through advancements in 3D technology. We'll 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. Today's discussion will focus on 3D printing at the point-of-care. And we have Andy Christensen as our guest! Andy started his career in 3D printing in 1993, and after seven years, founded his own company Medical Modeling, which was acquired by 3D Systems in 2014. Since then, he has been instrumental in the community to drive the adoption of 3D printing and healthcare. And last year, he received the prestigious innovator awards of the additive manufacturing user group. He currently serves as the Chair of the RSNA 3D printing special interest group and holds the title of Adjunct Professor in the Department of Radiology at the University of Cincinnati. Welcome, Andy. 

Andy Christensen 01:06 

Thank you, Sebastian. Great to be with you. Hello, Peter.  

Sebastian De Boodt 01:10 

So, Andy, 30 years in medical 3D printing? How did you actually get started?  

Andy Christensen 01:17 

Yeah, gosh, 30 years goes by like a blink. Yeah, so my experience... I did, you mentioned starting medical modeling in 2000. But medical modeling had a little bit of a pre-start several years earlier. And I got into it through a family connection. My father was a surgeon, and an entrepreneurial guy, and he had a focus in oral surgery and became an investor in a company in Texas, actually, that would later go away. But that company invested in one of the earliest 3D printers, it was an SLA 250, something like that. But that 3D printer, its purpose was to produce models of anatomy. And back then it was hard, you know, you guys and Fried Vancraen (Founder of Materialise, ed.) definitely know how hard it was. But the purpose was to make models to help patients that had major issues in their temporomandibular joint area. And so that was kind of the initial emphasis when that company dissolved the technology and ended up coming to Colorado. And in 1996, I had a business degree and I was finishing school; I'd always had kind of an interest after seeing it years earlier, and kind of seeing what it could do. And so that became my kind of basis in running that little effort in 1996, that would eventually turn into medical modeling. I was able to buy the company and re-founded (it) in 2000 as medical modeling, and kind of built from there through to 2014 when it was sold to 3D Systems. So that's a little bit of how I got my first experience seeing the technology back in the 90s. 

Pieter Slagmolen  03:05 

Like a family history that you rolled into... 

Andy Christensen  03:09 

Yeah, the earliest was the Oral Surgery connection, because you know, oral and maxillofacial surgery around the world was really the first big adopter of these technologies for medicine. So, it wouldn’t surprise me that some of Materialise’s, earliest cases, too, were in oral maxillofacial surgery. Even I've enjoyed kind of going back to pre-3D printing to some of the earliest visualizations of CT scan data, and some of the folks in places like Kiel, Germany, and Vienna, Austria, where they were milling models out of foam from a medical imaging dataset. A lot of those early applications were also oral surgeons that were doing this work for jaw tumors and orthognathic surgery and other things. So interestingly, yeah, the Oral Surgery component just sort of fell into place and was a good place to start because those surgeons kind of got it.

Pieter Slagmolen  04:10 

Actually, in our introduction, we used the term 3D printing at the point-of-care, which I think is an oral surgery is also a big thing, maybe nowadays, so could you describe for our listeners what this entails–point-of-care–what it means for you? 

Andy Christensen  04:24 

Yeah, so you know, really, historically, the services were provided by companies to hospitals, you know, where a hospital or a surgeon would send out a dataset and a company, an industry, would make the model and send it back to the surgeon. What's happened over the last, I'll say 10 or 15 years, is there's been an effort to in-source some of the production of those models so you would find either surgeons or departments like the Department of Radiology, buying 3D printers and producing in-house inside of a hospital or a clinic or an office, the same model that they used to buy from industry. And I think what's led to it is kind of an interesting thing. How did that happen? I think you'll find in all areas, surgeons that are kind of tinkerers, that really liked the concept of playing with tools and data and, and it's not like that’s most of the surgeons, but a few surgeons, so you'd find those kind of early adopters that said, hey, I can now buy a 3D printer, most of those would probably have started with a filament based extrusion 3D printer maybe 10 years ago. And over the course of time, the quality of the lower cost printers, the lower cost stereolithography printers, for example, in the last 10 years, sometime, all of that's made it more accessible. So I think you'd find people that were like, “Hey, I've got some imaging expertise,” or “I've got surgical expertise.” And now I can go buy a couple of $1,000 3D printers and kind of put the two together. So I think that's kind of how it started. I think what's interesting to see is, over time, how it's kind of morphed. You now see in the US, for sure, if you had to pick one place in the hospital where you're seeing the most uptick to bring in a point-of-care solution, it's radiology. And radiology is a great fit, because of the fact that they own the imaging; they're experts at the imaging. They're also a service like a centralized service within the hospital. So, they are servicing every surgical specialty in the hospital. I think those two things combined to make radiology a good fit.  

But what's happened, what I find interesting, and kind of fascinating today, is once you put the printer and the technology in the hospital, and you say, “I'm going to service orthopedic surgery,” you know, they easily need bone models. But all of a sudden, you get this kind of creep in other areas. And so you'd find places like the Mayo Clinic that are one of the leaders in doing this work, they now have like 20 surgical specialties ordering models for cases. From an industry standpoint  it would be hard to imagine you could do that, you know, but once it's there, and the tools are in-house, anybody and everybody can see it and try to utilize it. 

Pieter Slagmolen  07:17 

I think you would describe quite well, how the technology became accessible and where it's been going. One thing that's not entirely clear is the why. Why do they want to do it within the hospital? Because if they had a reliable service they could get from companies, why did they want to insource this? 

Andy Christensen  07:32 

Yeah, it's a good question. I think the answer is probably multifactorial. I'd think that time and cost probably plays some role, maybe for certain things. You know, a lot of this technology has been expensive forever. So when industry sells a model to a hospital or a surgeon, it's not like it's a couple hundred dollars. I think the fact that the price tag is fairly high, combined with if people kind of say “Well, we're used to paying $2,000 for a model and here we know, we can buy a printer for $3,000.” When somebody's got the time to spend two hours doing image processing, they can potentially justify in their minds and say, “Look, we think we can do it cheaper.” I'm not totally sure that's accurate. When you look at the whole picture, can you actually be any cheaper doing it in house? If you're a high volume center of one thing, I think that that potentially makes sense. You'd find others talking about turnaround time. And turnaround time for things models is fairly routinely done all over the world. And it's probably not taking a lot of time. I mean, even in my own experience, we could turn models around in a day, to a week was probably pretty typical. I'm not sure turnaround time, but I know facilities talk about turnaround time. The third part, I think is interesting, and especially as you get this kind of scope creep beyond just making models of bony anatomy, which is where a lot of it started was just models of bones. And it turns out making models of bones is probably the easiest thing you could do imaging and segmentation wise… bony anatomy is pretty easy to pull out. What gets more interesting and complicated, though, is looking at different pathologies and tumors and problems. When you start thinking about the different areas of the body–say you've got something in the pancreas or something in the liver–and you need to determine what's normal versus abnormal anatomy...The accuracy is kind of an issue that some would point to and say, “Look, industry doesn't know the pancreas very well. It isn't an application.” So here, if we're going to model the vasculature and a tumor mass and the pancreas itself, we need to have that expertise as radiologists or surgeons. Industry doesn't have it and thus accuracy becomes a big piece...I think those are a couple of reasons; I'm not sure what the maybe the biggest reason would be. 

Sebastian De Boodt  10:07 

It makes a lot of sense. Maybe personally—because you come from a service bureau, a service company—what sparked you to go into that direction? 

Andy Christensen  10:17 

Yeah, I was thinking of that, too, even today, I kind of say I have an academic hat. And I have kind of a non-academic hat. I think going back, I mean, my whole history is in running a company up to 2014. My bit was: I am a company owner, trying to sell services to help surgeons help patients by selling services around this personalization area, and that included models and guides and implants. I sold the business to 3D Systems in 2014; I had a plan to stay on for several years. But as many of these things go, I left after 11 months, because I just could kind of see that I wanted to be doing other things. And it wasn't for me, may be the perfect fit. I'm very happy for the company in the technology and the employees. I'm very happy that you know, the fits there. And they've continued to do to do well to grow and expand and stay in a leading position. For me, after leaving, I kind of had a choice. What do I do next? And so, right around the same time, the Radiological Society of North America and The Radiologist, which is a large radiology group...and I'm privileged to be chair of the special interest group this year on 3D printing. But that group in general was starting to see a lot of interest in the radiology field in 3D printing. Over the years, my home clinically for myself, it would have been in areas like oral and maxillofacial surgery and craniofacial surgery and orthopedic surgery, kind of going forward, I saw, you know, just an opportunity to play a role in what was going on in radiology as they tried to do basically what we did in the industry, it was kind of like taking me back 10 years prior, 15 years prior, they were trying to do that. So, I think how I got there is just by, you know, being out there and listening and seeing what's going on. I do feel very privileged to kind of be contributing. And what's next ... Because some of it was old hat, I knew imaging and image segmentation and different modeling techniques and virtual surgical planning and templating... these things, what's interesting. So hospitals and radiology needed to kind of figure that out. What's interesting is moving beyond the practical tools and workflows to “How do you make a business of this in a hospital environment?” And specifically, the concept of kind of sustainability. So today, my own feeling for where we need to go, and what the future holds is trying to move to reimbursement being a more common practice for these procedures performed in a hospital environment. 

Sebastian De Boodt  13:04 

I think it's interesting to hear about getting involved in radiology. I assume that's like the early days, when the seeds were planted for what's now the special interest group. And I've seen you, within this group, really breaking down barriers for 3D printing. Looking back or even towards the future, what do you consider is the biggest barrier when it comes to hospitals that want to do 3D printing in-house? 

Andy Christensen  13:31 

I think the biggest barrier to 3D printing work is probably the financial side of it, and not just finding enough money to buy a printer, whether it's a $3,000 printer or $100,000 printer, but really creating the infrastructure and having the right people—and having full-time people dedicated to an area, which for hospitals is challenging, to just take on a new project. So, let's say this is kind of a new technology and to have that not really have an income source. Today, hospitals that have implemented these technologies in house are doing it mostly because they feel like it's better for patient care. That's the reason that hospitals are doing this work. It helps the surgeons provide better care for the patients. What it doesn't have associated with it, though, is a kind of standard reimbursement, which in the US is guided by some coding nomenclature that's then tied to a value. That value (that the CMS and the Medicare system set) that many of the private pay insurers in the US would take and pay based on these values and forever 3D printing enabled technologies for personalization of surgery have not had these codes and any associated value. What it means is hospitals, purchasing equipment and setting up shop to make 3D printed parts means doing it without any reimbursement, generally speaking. I think that's one of the big barriers because it hasn't stopped a lot of people from doing it, the benefit of the patient is great enough that these people are doing it anyway, even without money associated with it. But sustainably? I don't think it's sustainable to not have it. You know, it needs reimbursement to kind of be sustainable for the long term. 

Sebastian De Boodt  15:23 

The reimbursement, how close, or how far, are we?  

Andy Christensen  15:27 

Let’s say we're on a path. People used to ask me, you know, what are you doing? And whenever I say, “Well, I'm a guy on a path,” you know, moving forward. From a reimbursement standpoint, we're kind of on a trajectory now, that I think is going to be successful, and it has been successful. So, the general premise, I guess, if we rewind about four years ago, maybe even five years ago now is that the RSNA, was interested in trying to establish what are called CPT codes. The American Medical Association sets out the nomenclature for physician-provided services. And that is called Current Procedural Technology, CPT. They're the ones to kind of set the nomenclature and so, you first have to go petition them to just set codes. And there's several different types of codes. The ones that are primarily known by people are what are called Category One CPT codes. And these are for technologies that are kind of established with an established kind of value proposition for why they should actually be paid. The RSNA group collaborated with the American College of Radiology. So ACR, and ACR does a lot of this work, and is very active, and obviously in radiology as a kind of major stakeholder for the financial aspects of what goes on in radiology. Between the RSNA and the ACR, they decided that we didn't yet have enough data out there in the world to prove that we knew exactly what kind of a code we wanted and how it should be reimbursed. So, we went down a different pathway. And we went through the AMA (American Medical Association, ed), but we got what are called Category Three CPT codes. So the process was, you have to petition, go before a panel, the panel has to vote on whether they think this is worthwhile, and whether it's necessary. And so that happens circa—I'm gonna lose track of the dates here a little bit—but let's say 2017. That happened. And in 2018, roughly maybe a year later, the codes were approved. And this is the first time that codes have been established for any of this work.  

And the code said, anatomic models, there are two codes for anatomic models and two codes for what are called, in this nomenclature, anatomic guides, which would be the surgical guides and templates and other things, just getting these Category Three codes established was a major win. This is something I tried in industry for years to do back in the mid-2000s. And failed! I had three attempts at establishing codes and all of them failed for numerous reasons. But personally, I was very excited to see these codes get established. The Category Three codes are called temporary codes, the so-called “T Codes.” Their purpose is to collect data. They're good in that they set nomenclature; they aren't as good because they don't have a value associated with them, yet. And so, we're working now to collect data to progress to a Category One CPT code application, which likely happens in the next two years. We make that move after there's a process that still involves a couple of years. Probably on the whole continuum, we've got four or five years potentially before Category One CPT codes for some of this work are in effect and live. So, it's quite a process!  

One of the things I'll point out is that supports that effort, is the RSNA 3D printing special interest group and the ACR establishing what's called a registry. This is another I think, great step for the industry. A registry was established to collect data from institutions that are doing this work internally. And so ACR has several registries in the imaging field that are set up over the past years and they run and effectively gather like millions of data points for some of these registries. So ACR knows registries and helped us set up a 3D printing registry so that hospitals can join and submit data on how they're using 3D printing, what they're doing with it, what tools they're using, and all that. This is an important data point for us going forward because it'll help show what's called widespread adoption or widespread use of these tools through different institutions. 

Pieter Slagmolen  20:07 

I've always wondered, and I don't get the answer entirely from your story, is how will reimbursement cope with wide differences in value for what 3D printing is going to deliver? I mean, if you place a hip implant, it is pretty straightforward; it's probably very similar in value for all patients. But if you're talking about 3D printing, and you're going to be creating a bone model for a fracture versus doing a big anatomical model for conjoined twin surgery, for example, the value and cost are both very diverse. So how do you see that being handled in that reimbursement pathway? 

Andy Christensen  20:40 

Part of the answer comes from the registry. I think what people will want to know is how much time–let me back up–cost, in general, could be equated to a few different pieces of the puzzle. One of those is specific for CPT. These are things that have physician time associated with them. So, one of the reasons why CPT is appropriate here is that these models are being made in a hospital environment with the oversight of physicians, and they could be surgeons, radiologists, and others. So, we're looking at cost, we're trying to break down how much physician time is involved, because there's a physician component of the reimbursement. And then there's also what's called the technical component of the reimbursement, and the tactical component could include things like the 3D printers and the materials and the software. It also would include the technologist or engineer time used for segmentation, you know, somebody that is not a physician, but is skilled to do this work. All of the technical side. So part of “the why the registry exists” is to collect that data to say that the physician time for these cases on average is 30 minutes or an hour, or whatever it is, and the technical time and cost equals x. Looking at that will give data; it won't be the total picture, but will be some good data points about what's realistic in the field and what tools people are using.  

The other piece that ties into how much could be paid, and what procedures could be paid, ties into this concept of clinical appropriateness. You can imagine somebody goes and breaks their arm or stubs their toe or whatever kind of medical issue, you can imagine that making a model for some of those things, or for all of those things, isn't necessary. And we would all say that's silly, like that's a waste of money, it's not even going to help the field. Generally, there's this concept of clinical appropriateness, and it falls to two groups. The RSNA, and specifically in this area, the RSNA special interest group on 3D printing has published and will continue to update guidelines for clinical appropriateness for models. The way it works is that you break it into different categories of cases. There will be cardiac modeling, and that might even be broken into pediatric versus adult; you'd have cranial maxillofacial; you'd have neurosurgery; you'd have GU and other areas. These areas, specifically, we would kind of dive into and look at diagnoses for medical conditions. When either diagnoses for medical conditions and or surgical procedures. And then you'd start to review of the literature, the scientific literature plus expert opinion, you would go through and start to kind of create a ranking scale. And the way we've done it, is a one-to-nine scale: one being not very appropriate and nine being really appropriate. And you spend time going through all of these diagnoses and procedures, and you end up creating a list that's backed by science. Like you want to have evidence, but it says that, for a simple face fracture, this might be rated a three, not very appropriate, not totally inappropriate, but not very appropriate. But for a complex fracture, the face maybe takes it up to a seven or eight, making it definitely appropriate. It's a long- winded answer your question by talking about why something would be paid, and how much we'd be paid for it. I think there's a couple of pieces that go in and, and both the time element and the cost, plus what isn't clinically appropriate for a specific case will both hopefully eventually equal value. There's another kind of concept here that gets a little complicated, but when those CPT codes are established in a Category One CPT code, they also go to another group before they're released that actually does the valuing. And this group is a bunch of physician groups that each have a member of their group that comes and sits in a in a panel. Maybe, I think it's 20 or 24 physicians. This panel is called The Rock. It's developing, it puts a number on it, that's called a relative value unit. And RVU is established for each of these codes. And interestingly, if we want to get a code established for making a model, and it's going to be 1000, reimbursed to the $1,000; it means that around that table of these 24 physicians, which are all different groups, all different areas of specialty, somebody's going to have to give up $1,000 for the $1,000 to be allocated to the 3D printing part. So, it's just kind of a zero-sum aspect of this, which I find quite interesting. When it gets to that point, there's a lot of discussion about what things are going away and what things should be invested into the future. 

Sebastian De Boodt  25:44 

Sounds like quite an intricate puzzle that you're laying out there on your path, but certainly valuable. The appropriateness criteria, I assume that it creates value for hospitals who still are at the start of their 3D printing activities to kind of immediately work on and identify what are the most useful, valuable cases to work on? 

Andy Christensen  26:05 

Yeah, I like that idea. I think if you were starting out and didn't know anything, but said, “Hey, I've got some interest in this area. And where do I start in a hospital?” I would go pull those appropriateness documents and start looking for everything that's a seven or eight or nine. They're really highly appropriate things and say, “let's forget everything that's low.” But let's shoot for the high end, the very appropriate work. 

Sebastian De Boodt  26:30 

Yeah, great tip for some of our listeners who might be starting. 

Andy Christensen  26:34 

Yeah, there's still a lot to do. These documents are living; they need to be updated every year to three years. Because with time there is more literature and some things that maybe we thought were really appropriate, maybe now aren't so appropriate, for some reason. So, ratings could change the literature. The body of literature, hopefully will keep increasing; the literature will prove something's more appropriate and probably prove something's less appropriate. 

Sebastian De Boodt  26:59 

Yeah, exactly. One of the other important pieces of the puzzle that we haven't laid in this episode, is the regulatory piece for companies who want to put a medical device in the market and offer this in hospitals; they need to go through a very stringent process to make sure that whatever they sell is safe for patients and works effectively. Now that hospitals are starting to produce basically their own medical devices, how does the FDA, for example, look at that? Are they getting nervous? Are they an ally along your path? How does that go? 

Andy Christensen  27:37 

It's clear that in the future, some of the work that's done at the point-of-care will have direct oversight by the FDA, if we back up. So I'm trying to think of where to start on the timeline, we go back some of these tools for models that are maybe moderate-to-low risk devices have been made for years by companies like Materialise, and medical modeling and others, followed regulations. And like you say, for industry to sell these services to hospitals, they need to go through certain regulatory pathways over time. That's gotten clearer and clearer as to what those pathways are, for things like anatomic models and surgical guides that are tied to a surgical plan. Those things in the US are Class 2 devices that would require a 510K to be submitted prior to marketing those devices. If you're a company, and you want to sell something to a hospital, it seems pretty clear. You know, it's only been, I'm trying to think of all the steps...the first 3D printed implants that were cleared by the FDA was in 2010. We were privileged to play a role in those first clearances there, but that's not that long ago. It's only a dozen years ago, when before that, there were zero 3D printed implants cleared in the US. I think the FDA has been a great collaborator in this area. Many people historically would say the FDA has kind of stood in the way of innovation, in some way, by putting up barriers. The barriers they put up, if you call them “barriers,” again, in air quotes, they really are focused on patient safety. These are barriers that have a very good reason for existing. It's about you and me walking into a surgeon's office and knowing that what he's going to do for us is safe and effective for we're going to do. Over time, the FDA has held a couple of different important meetings starting back in 2014. There was a great workshop the FDA put on that had about 500 people and wherever it was in the DC area. This led to the FDA creating a guidance document specifically for additive manufactured medical devices. This was really targeted at medical device companies and not so much at point-of-care installations. But you could tell as things were moving and as people were talking more about point-of-care, say from 2015. And forward, the FDA was increasingly interested in trying to address this area and what it meant. Because you're right. Historically, if industry is selling these products to the hospitals, FDA regulates the industry, they don't regulate the users.  

Hospitals and surgeons aren't under the auspices of the FDA. I think what's seen to be different is that now you could buy a 3D printer. And you could make all kinds of things in a hospital environment. And we're talking here about models and guides primarily, but you also see, and I think we'll see some more hospitals talking about metal implants and actually making implants inside the hospital. It seems easy to think that these are permanent devices in a moderate-to-high risk level, that are going to be in the body, they've got all kinds of different considerations for strength and biocompatibility. Whatever, the FDA isn’t going to care if those devices are now made in the hospital, as much as they care that the devices that are made by industry. So, the RSNA held a meeting with the FDA in 2017. At that meeting, they talked a lot about anatomic models, and maybe a little bit about surgical guides. During that meeting, the talk was about the model itself and what are called “diagnostic-use anatomic models,” which are kind of, you know, if you're going to make a model, and it's going to be used for patient care, the FDA says that is a diagnostic-use part. If you're going to sell diagnostic-use or make a diagnostic-use part, the FDA said here's the pathway. And they laid out a new pathway that...actually Materialise was the first to go down this pathway of clearance for a product which was the Mimics inPrint software... in 2017, the FDA (so this is how you should do it) in early 2018, Materialise gets clearance for Mimics inPrint, which is a system that includes the software to do the image processing, as well as validated hardware and material components. It said that you could make a model in a hospital using a XYZ printer with XYZ materials for XYZ application, say hearts or craniomaxillofacial. And that those parts that came out of that printer would be diagnostic-use anatomic models, which was pretty cool and kind of laid out a framework for I think more of what we'll see in the future. There's still a lot of ambiguity in this area. So over time, hopefully the gray areas are getting less gray. But what happened after that is that the FDA has since had held several discussions over the last few years that led to a discussion paper being introduced in December of 2021. The FDA put out a discussion paper on 3D printing at the point-of-care. This is a long-winded answer to your question. But it's important I think, to the future, this paper laid out three scenarios of how the regulatory aspect of this whole equation could work. The first one is hospitals using a tool, that industry has created, as a system. And they use a term that is coming from kind of an international group consortium of regulatory bodies called “medical device production system” or MPDS. The concept of an MPDS is that it's a system that industry would put together that includes hardware, software, materials, know-how and documentation. And this system would be cleared by industry and sold to a hospital. Its purpose would be to allow hospitals to take data in and output something that again is a diagnostic-use part. The FDA says if you're using an MPDS and you're a hospital, you have no regulatory burden, or the regulatory burden is on the company that clears the MPDS. So that was Scenario One. Scenario Two was this concept of co-locating a manufacturer, a medical device company at the point-of-care. Here you'd actually have a company put a satellite facility, or a facility next to or inside of a hospital. In the past, this area the FDA has pointed to a collaboration between the Hospital for Special Surgery in New York and a company called Lima Corporate from Italy. And Lima is placing its manufacturing, I'm gonna call it a cell within the Hospital for Special Surgery, and it's co-located. You've obviously now have a good ability to cross-collaborate between the groups. And the regulatory burden there falls to the company—not to the hospital. The company clears products has its own FDA registration and all of that, and they function that way co-located. The third area, which is interesting, is that the hospital (if there aren't products that are out there that they can use), they want to develop their own thing. And it's a certain risk level. The hospital would become the medical device company, and submit for registration and listing, and submit pre-market clearances, as needed, for products they want to sell. This would make the hospital take on all of the responsibility of a traditional medical device manufacturer. I think, you know, the future will be interesting. Where all that's leading over the next, I'll say a year to two years...we should see a guidance document come out from the FDA about point-of-care 3D printing, and what it means, and who has responsibility for what, but a lot of interesting moving parts. 

Sebastian De Boodt  35:58 

I think it's probably very comforting to know that the regulators are very much involved. When I hear you talk, it feels like they are an ally, so that as a patient, we also don't need to be too worried. I think that's probably a good thing. I was triggered by the fact that you mentioned some hospitals are looking into metal printing, where today it's mostly models being printed at the hospital. How far do you see these go in the future? You believe, for example, that printing metal implants in the hospital is actually a good idea? 

Andy Christensen  36:30 

I think it's sort of inevitable that it will happen some. The kind of the question is, how often will it happen? We've been to a couple of institutions in the US, and I know around the world, where there’s talk about implementing metal 3D printing inside the hospital. The question is whether it's a good idea or not, is actually a good one. I don't have a pat answer. But I would say that in my own experience, metal 3D printing has a level of complexity that's quite a bit higher than any of these other 3D printing technologies. The machines are more complicated; the safety measures surrounding the stuff are more complicated. The kind of pre- and post- processing steps needed are definitely more complicated. You think of what you need for a metal 3D printed part with things that are stress relieving, you know, different types of heat treatments and stress relieving, and things like hipping. And then further, the machining of components, which many 3D printed implants get machined to some degree, after they're printed, as well for meeting tolerances and whatnot.  

I think all that is to say, it's not a little thing for a hospital to get involved and say, “We want to do metal 3D printing.” They've got to have a really good reason to do it and know that it's probably a multimillion-dollar commitment. As opposed to saying, “Well, we're gonna buy something for 50 grand in terms of the kit here.” They're biting off a lot. I think, given the complexity, I don't think we're going to see a lot of places do it. Because it is complex, it is difficult, I believe that the FDA is making that pretty clear. I mean, that's probably the clearest area that if you're going to do titanium 3D printing for implants—inside of a hospital—you need to be thinking of yourself as a medical device manufacturer with a full-fledged QMS and all the product clearances that you'd need, the good and the bad. I mean, the way the US regulatory system works, product clearances are in these kind of silos under indications. Depending on your indication, whether it's for... even if you made a bone plate that was the same bone plate for a fracture in the jaw versus a fracture in the hand versus a fracture in the lower leg. All of those typically require separate clearances from the FDA. That means there's a lot of regulatory work that goes behind trying to set up something that you could use in a hospital for more than a couple of things. All that said, I think we're seeing people try to do it.  

I'm sure there will be some interesting use cases that come up. But my guess is based on the complexity. The regulatory complexity probably keeps people away from doing this often in the hospital. Interestingly, one other piece that sort of ties in this concept of some kind of a hybrid approach, where you've got hospitals playing more of a role, and maybe design a part. Then instead of having all that technology in-house to output that part—let's talk about implants again—maybe there's a way where industry and the facility at the hospital are kind of working together in a way that allows for design to happen at the hospital and production to happen in industry, which historically isn't the way. The regulatory system isn't set up really for doing that much. Most of it, the design and the production are kind of coupled together and the medical device company houses and owns all of that, but you could see maybe some hybrid component coming about where you can see the hospital playing a role where it's useful, and still not having to implement all these things in-house. 

Pieter Slagmolen  40:12 

In one of our previous conversations, we talked about 3D printing in a more regenerative medicine context? And I remember you said, well, one, it's far out. But on the other hand, you also said point-of-care will play a crucial role in them. And I didn't really fully capture, why? Why is point-of-care going to play a crucial role when we do 3D printing in regenerative medicine? 

Andy Christensen  40:33 

I think first off 3D printing is a key manufacturing technology for the regenerative medicine applications, you know, kind of the ability to put certain materials or cells or growth factors in specific places you can think of, like Voxels and Acube, and putting cells, tissues structures and tissue types and growth factors in specific places. 3D printing will be an excellent tool, and already, I think, it’s a workhorse tool in development of what's going on today. So that seems clear why point-of-care will be interesting. You know, my own view is that some of those things won't likely travel well; part of it may have to do with just the transport of things. I think a lot of these things in the future, you could see using the patient's cells to somehow seed these components, whether that's taking a scaffold and seeding it or whether that's actually directly depositing patient cells into a 3D printed part that may be incubated and matured before they can put it into the patient...a few of those reasons. To me, it seems a lot like stem cell work when today some of the stem cell therapies, for say, osteoarthritis, where you would go and have some of your cells harvested, and these would be multiplied, duplicated physically over the course of some period of time before they're then put back into your body. To me, that seems like there will be a play for point-of-care to be quite actively involved. What that looks like, I'm not sure even in the FDA’s most recent discussion paper and some of the work that the FDA has been talking about in the last couple of months, they have definitely said that all they're looking at right now are things that are medical device related, and not some of these other biologic areas, which are handled typically in a different part of the FDA than deals with some of the implant devices. So, I'm very proud. I'm definitely bullish on regenerative medicine and the impact it'll play over the next decades in reconstruction of the body and all kinds of different ways. I think that it'll have a big impact. 

Sebastian De Boodt  42:48 

For the point-of-care transition, a lot of that was driven by the hospitals motivated to do that. How do medical device companies actually react to the strengths? Do they see this as a threat or as an opportunity? How should they react?  

Andy Christensen  43:03 

Yeah, it's interesting to kind of watch the different stakeholders in this area, because you can imagine that traditional medical device manufacturers are somewhat interested in what's going on and sort of feel like, even today, that things like anatomic models and surgical guides, hospitals could be making these things for their own use without any regulatory oversight from the FDA, for instance, and in the US, maybe everywhere, but in the US for sure. This concept of the practice of medicine is very clear. Basically, what it says is that a surgeon or a physician can provide health care for the patient in any way they see fit. If the surgeon or physician have appropriate training and appropriate credentialing from a facility like a hospital where they can provide care, they can provide care for the patient any way they see fit. This is why you'd find surgeons deciding to use certain devices off label because they the FDA clears things and gives the company an indication that says you can use this product for this reason. But the surgeon, you know, if that product is legally marketed, that surgeon can actually take and use that product. However, he could use it for something else, too. Say it's again, the bone plate example. And it's a plate for the face. And he's working on somebody's hand and knows that it's going to work perfectly. He could use that plate and he could use it in an off-label way from a medical device standpoint, but doing his or her work under the practice of medicine.  

So today, that work goes on and if industry wanted to sell a model or a guide to a hospital, they would have to get a 510K as it's laid out today. But if a hospital just wants to do that themselves, they don't really have to; they don't have to do anything. Already you could tell industry was like, “Well, that doesn't seem quite fair.” There's a fairness aspect. There's also patients’ safety and all aspects to going through those FDA submissions, makes you really lock down on processes and have really robust protocols in place for making a safe device, which you wouldn't necessarily. Those just don't happen, in a hospital environment, those just don't happen.  

I think looking forward, let's see, what would I say, again, back to this FDA discussion paper from December of 2021. They opened it up for public comment. You can actually go find the paper online to download that same place, you can go look at public comments that have been pushed out there, which there's something like 40 public comments (that period closed in February). But over a couple of months, they collected comments. Several of those are from medical device companies, traditional medical device companies, and/or advocacy groups. And you definitely get that same flavor, that they're interested to see that the playing field is level, and that they want to be playing at the same level as the hospital—or the hospital can do something and skirt regulatory implications. That doesn't seem fair.  

Interestingly, the FDA is in looking at patient safety, they want a patient to be able to walk into a medical facility, get care, and not have to worry about whether the care they're going to get was made there. Let's say they're going to go for a shoulder implant, they don't want the patients have to worry about whether that implant was made on-site or whether that implant was bought from industry. And to me, the industry rightly pointed out that same issue that, from a safety standpoint, they have to go through all kinds of hoops, and that hospitals, if they're doing the same work, should go through those same set of procedures. I think there are lots of different viewpoints. I think some of that is maybe looking ahead to implants, which I think is really somewhat far ahead. I don't think there's a whole lot of fear about hospitals making a bunch of their own implants. But I do think the area of kind of personalized surgery—where you've got either models or surgical guides and templates which are very commonly used these days—that there is this concept that the medical device companies want to continue to remain prominent in this area and want to make sure that the playing field is level. 

Sebastian De Boodt  47:25 

It’s all very interesting, a lot of interesting evolutions in the coming years, in the field of the surgical guides and these things are obviously where Materialise is also very, very curious to see where the needle will go. Final question to you Andy: you had already quite an interesting journey into 3D printing. Looking ahead, what does the future bring for you? 

Andy Christensen  47:53 

I hope to continue to contribute. I definitely kind of enjoy seeing where things are going and trying to play some role in putting pieces together to push it forward. I'd say for me, I'm very interested in academically helping move forward the concept of reimbursement for these types of products in the US. To me, it's important that we're now on a path, I'd love to see it, progressed to something positive at the end of that path. The other part of me today is kind of advising and helping mostly small companies, many of them in the 3D printing space, trying to see these companies reach potential as well. I enjoy being a strategic team member, helping companies navigate the regulatory side of things, or just business trying to figure out how to get products out to market and how to compete effectively. That to me, I think, is where I will be spending more time. I sit on a few boards, and I enjoy that work. I do some investing and enjoy seeing other people with passion. If I think of myself and energy, passionate energy from, say, 30 years ago, people that are really passionate about doing something and changing the world, being able to contribute to seeing those dreams manifest is exciting.  

I've definitely enjoyed the last few years having more time to spend with my family and I got a son who's now 17 and his first 10 years was challenging running a business and growing an enterprise... challenging to be all that I wanted to be from a father standpoint, as well. I feel like I was given a gift of being able to spend more time personally with family during this last few years. It's a long game. I mean, it's interesting to see how all these things tie together. Thinking back to, I think, we all stand on the shoulders of giants. One of those giants for me, for sure, is Fried Vancraen, Materialise’s founder who, in 1990 or thereabouts, really did things and created software tools that enabled the rest of us to do what we did. I think, for me, it's great to see Fried and Materialise playing such a leading role still and kind of pushing forward these topics and not just thinking about customization for a couple of people, but thinking about it for the masses, what's holding us back from offering these tools to lots and lots more people. So exciting things. 

Pieter Slagmolen  50:30 

I think we learned a whole lot of things. Maybe to recap a few, I think for me, it was very insightful to think about history and how 3D printing became more accessible, and that if it also became available at the point-of-care. I think you described that quite well. Also today, how we're handling reimbursement as a way to make it sustainable in the longer term and bring it to more patients, as well. And then also thinking about the future about where the next generation of, whether it's metal printing or regenerative medicine, 3D printing will play a role and how it will contribute. So, all that was, I think, pretty exciting to talk about. 

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