For the latest episode of TCT Magazine's Innovator on Innovator series of Additive Insight podcasts, John Bohenick [JB] and Steve Zambrano [SZ] were the first pair of innovators to have their discussion in person since the series launched during the pandemic.
Bohenick is the R&D/ Engineering Manager at Osseus Fusion Systems, while Zambrano is the Director of Patient Specific Solutions at 4WEB Medical. Both are mid-sized companies operating out of the Dallas region of Texas and both are leveraging 3D printing technology to advance their medical implant products.
As a result, Bohenick and Zambrano have ran into many of the same challenges, enjoyed many of the same benefits, and have built up a friendly relationship. Throughout their conversation, they discuss the differences in development patient-specific and serialised devices; the key design considerations that need to be made for medical products; and the big opportunities in the implant space over the next ten years.
Below, we have the full transcript of the pair's exchange.
JB: I think it'd be interesting for us to talk about where's the additive manufacturing market right now in terms of suppliers? Like, for me, the biggest gap or biggest roadblock, I should say, that we're facing is post processing. It's a very, I'd say, pretty young... I mean, additive, obviously, has been around a long time, but I'd say additive within medical, really, what? 10 years? Maybe 15 years now if that. No, I mean, Zimmer [Biomet] was doing it back in the 80s.
SZ: Let's say the wider spread adoption, I would say for the past decade to two decades or so, we really started seeing that pick up. But in 2010s, we started seeing AM start going through. And now if you go to some of our trade shows, if you don't have an additive manufactured product, you're kind of behind, right? And I guess what you're asking here is, where's that industry headed to? And I obviously have some my own thoughts on that. As you already know, my role here is the Patient Specific Director. So I solely concentrate on patient specific devices and how to create these one offs for individual patients that don't have an off the shelf solution. But moreover, I see the vision of the medical device industry headed towards more bespoke products. But that's not a golden bullet as well. In order to be in this field, and in the role that I have, I need to go ahead and understand what the constraints and the pitfalls are of that. So while I do think that there are better outcomes for patient-specific devices, like potentially easier surgical operations for the clinical customer, I do know that along with that there goes increased cost because of the uniqueness of the devices. And then an almost entirely different supply chain is necessary to run a patient specific device compared to a serialised device. Now there is a good deal of overlap and the key is trying to figure out where you can overlap those and where you can't. And we're working on it now but I think there's still a lot of work to be had over the next coming years, not just in the design and manufacturing standpoint.
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There are a lot of design companies out there who are solely focused on some of these patients specifics. And in the manufacturing standpoint, there are suppliers who are starting to cater more towards these individuals and the advent of additive manufacturing lends itself very well to that. But also on the regulatory side, we see here in the United States with the FDA that 10 years ago, patient specific regulations wasn't really ubiquitous. There wasn't a really great standard to follow out there or regulation around it. But since 2014 and on, we've started to see more regulations coming around for that, and then vice versa, just in general for additive manufacturing as a whole. When I first started out, there was no 3D printed material ASTM standard, we in fact referenced out old standards of casting in order to go ahead and do some of our quality work. What's the experience been for you? And where do you think the industry is headed now?
JB: So, I actually want to potentially touch on or talk through the differences between doing a patient specific device versus a serialised device, because I'm just personally really interested in that, because that's a space that I don't have any sense of, but I'll just talk briefly to answer your question.
I mean, for me, I'm really a newcomer into this space, as many people are, but for me figuring out... so, I was previously working for Globus and now Osseus. And at Globus, they were just trying to get into working on their HEDRON system at the time. And so, it was a learning experience there, just kind of going on around me. For me, I was an associate engineer. And so I was working on kind of basic instrument stuff, and adjacent to me, there were engineers working on the additive manufacturing aspect of it, and I got to go into the prototype shop and see them kind of figuring stuff out, which was a great experience, but I wasn't actually knee deep in it until I got to Osseus. And so I had to really figure out, take what little knowledge I had from being in that environment, and then bringing it to Osseus, and had to really talk to a number of regulatory consultants, and trusting in our manufacturing partners, our suppliers, for what they had, but also just doing a lot of reading on my own, just like, trying to reach out to contacts in the industry, it'd be like, 'hey, what is the deal here?' Or, was there something that I can look at, reading, just like, 'hey, how does...?' I mean, it sounds very basic, but like, 'how does a direct metal laser sintering machine work?' You know, like, 'what even is that,' right? Because colloquially, we just call it 3D printing. And so it does sound perhaps basic for someone in the know for additive, but I mean a few years ago, I had to really kind of start from scratch and figure out what was the deal. I really liked, in concept, being able to design a device that didn't have the constraints of traditional subtractive manufacturing. Right, there are clearly advantages to that. And you guys take, I think, more advantage of that than most companies for sure. And in trying to be able to design features and optimise not necessarily - I say optimise, just take advantage of the ability to make some things additively that you wouldn't be able to subtractively, I think that that is a shortcoming of some company's additive devices, that they'll just take their subtractive manufacture device, and then say, oh, it's additive now [laughs] that's like... it is what it is.
But anyway. For me, though, I had to learn very quickly. And through that learning process, also, like I said, bring on new vendors and new trusted manufacturing partners, which I don't know, you'd have a better perspective on ballpark, but there are maybe only, like, two handfuls, I would say, maybe just one handful, of really reputable additive manufacturing vendors for medical specifically.
SZ: Yeah. I mean, certainly those who have been open longer than a decade or two decades or so, you know, yeah. It's very interesting that you brought up the topic about converting a conventionally manufactured, subtractive manufactured product, and then converting over to an additive manufactured product. That really, for me, has been one of the keystones of my career is being able to ask myself, is this a product that needs to be additive manufactured? And the answer is not always yes. Sometimes we have customers that will come to us and say, 'oh, well, I was in the surgery suite and I saw this product, and I really want you to manufacture it additively. And the question is, well, why? What do you believe is the benefit that you see there? Are you looking at lightweighting structures? Is there a different form factor that we can produce using a 3D printing process that we can't do in conventional manufacturing? What's the end goal there? And when you start to tease out some of those questions, the answer isn't always let's go the additive route. It may be let's keep it as is because here, I'm being charged 82 cents per part. And on an additive manufactured part, I'm charged two dollars. Now, it doesn't always work out that way but being able to answer those questions, I think is key to a successful career in people like our roles.
As the FDA are getting more of this test data, they're building a larger understanding of additive manufacturing devices.
SZ: What type of algorithm or thought process do you usually ask yourself when going through that process? Should this part be additive? Should it be conventional? Should it be a combination of both?
JB: Well, I would say it's definitely not an algorithm [laughs] I'm definitely not that sophisticated. But I wish.
SZ: Flowchart A…
JB: [Laughs] Yeah, right. If not, then alright, we go back to the beginning and now it’s additive again.
No, there's actually one device that we're looking at developing or starting development on this year. So I won't get into many details of it, but surprise, it's a spine device.
SZ: [Laughs]
JB: Yeah, but we are taking a look at just based on working with our surgeon design team on what are their goals? Right, obviously. And then being able to go from there, for example, a lot of them do like kind of the sexiness of additive manufacturing.
SZ: No, it’s definitely sexy.
JB: And in other industries, it may not be looked at as a tangible factor, you know, how many dollar signs do you get out of that sexiness factor, and it's, for sure, a thing in medical.
SZ: Of course.
JB: You know, look at the instruments, the feel. I mean, whenever we're developing something, it's all about does this have a premium feel, is this going to be differentiated from other products on the market? Even just from a look, right?
SZ: I mean, colour palette comes into our design.
JB: Absolutely.
SZ: How do we colourise this and then what’s the texture that we put on it to make it feel like it’s a premium product?
JB: It's funny you mention that. At Osseus it's a big deal, actually, to go with the high polish on every single product across the board to really make them shine. It's a thing.
SZ: And it can be costly.
JB: Absolutely, for sure.
SZ: I'm sure you guys have looked at the cost benefit there and found it, hey, that seems to work out for us.
JB: When a nurse or scrub tech, you're set open, and they're like, 'oh, wow', you know that you've done something significant, right? And it ends up being worthwhile, you know, or at least you remember it if nothing else, which is saying something as a smaller player in this industry, but going into that flow, where they might say, 'hey, I really like the thought or the theory behind, let's say, distributing surface load across the end plate, right, and being able to have continuous end plate contact.' Great, but we also want to have a big graft window, or we really want to have... it's like, alright, okay, we got to compromise these things. I mean, you guys obviously have your solution, right? So I got to do it a little differently. But there's that piece to it and then also, there's a piece of okay, is this thing going to expand? Is this thing going to do this? And then when you add..., anytime you add moving parts, it just complicates.
SZ: It just increases the order of magnitude of difficulty.
JB: Absolutely and I think that’s something that’s under-appreciated, but at the same time, they want it to be pretty radiolucent. And you’re just like, ‘oh God [Laughs] how do I fit all this stuff in here?’.
SZ: [Laughs], yeah where is this magical material, right?’
JB: And then you have to bring it back to how much can we sell this thing for?
SZ: You're bringing up a couple of other points about factors that go into design. One factor that I think is often overlooked in the design standpoint is regulatory and/or quality inspection. How do you advise some of your team on, I guess, the quality input that is needed for design?
JB: Oh yeah, that is a whole topic.
SZ: [Laughs] yeah, do we have enough time?
JB: I would just say that for me, really, I've only been waist deep in this and maybe even head deep, I guess, kind of more recently, in additive over the last three years, right. And I've even seen a progression over the last three years in terms of how much knowledge different regulatory consultants or agencies have with additive specifically right. And same thing with the FDA. We had a conversation about is the HIP process - hot isostatic pressing. Is that really applicable? And it's items like that, that I think people are maybe only just starting to question, but at the same time, there are a number of agencies in industry that don't even know what that is. You know what I mean? Like, they're just like, 'oh, a part comes off the printer, it's done,' right? And they have really limited knowledge of manufacturing. I think that a number of conventional manufacturing, traditional manufacturing items have been taken for granted because they've been around so long and because we have all these standards, that now with additive, it's like, oh, we actually have to think,' [laughs] and you have to be knowledgeable about this space in order to intelligently regulate it, control it, come up with your PPQ because it's not the same, right. It's not necessarily equivalent. And there are multiple parameters that you want to be setting. I know for certain that the validation that any number of companies did back over 10 years ago had some gaps, allowed a little bit too much variation.
SZ: Yeah, and frankly, our validation process has evolved over the last decade. You know, when you're mentioning HIP, when we started out producing additive manufacturing products, here at 4WEB, there was no standard for additive manufactured products. So what we did is we utilised the standards that were available in the closest fit, and at that time, it was casting for titanium and casting for titanium had a hot isostatic pressing process put into it. That was to allow for some of the closure of some voids that might have been produced in a casted product. Now, since then, and we figured, well, that's also applicable for 3D printing, or this additive manufacturing when we do powder based either EBM or laser. But since then, we've progressed the technology, and now we're getting 99% densification on an additive manufactured part. And then we need to ask ourselves, well, is this type of process necessary anymore? And if it's not necessary, how do we go ahead and alter the precedent that we've already set as an industry? And what information is enough to go ahead and provide to show that we're still producing safe and effective devices? And we as an industry need to be able to critically think about that problem, right? Well, you know, is this HIPing process having an effect on our parts? Is it technology dependent? Is it part dependent? What are the factors that we're going in? I personally believe that it is dependent and in some cases, it may be necessary. In some cases, it may not be, and in some, you may need a different type of heat treatment altogether, that could potentially save you time and money. But we, as people in the industry, need to question the process that we've implemented from decades past and see, are they still relevant?
JB: Because really, I think I pretty much agree, really all you need is an annealing process. That's really all that is necessary. But how long is it going to take us to undo that precedent?
SZ: What's the level of evidence that we need to provide in order to go ahead and push back that precedent that we've already set?
JB: And same thing with passivation?
SZ: Yeah.
JB: It's like titanium automatically it oxidises, right, it creates that oxide layer. Does passivating titanium really makes sense? And it's something that we haven't done on traditionally manufactured products, right? Maybe someone can dunk it just to for good measure, but you really don't need to do it. Whereas it has become the standard for additively manufactured products.
SZ: You then go back and ask yourself, well if it's not actually passivating this particular alloy that I'm working with, what is it actually doing? And then one of the things that I've looked at is, well, when I passivated, I'm potentially removing manufacturing residuals. So it's basically not having the original intended function, but one of the byproducts of it is potentially helping us because well, I know that I have manufacturing residuals, I do some conventional machining and there may be some coolant on there and a passivation process tends to remove that.
JB: And does it help with loose particulate inside, now that we're getting into these complex mesh structures, I'd say that's a piece of it. Basically, is a thorough ultrasonic cleaning process going to be doing more of that than the passivation? I would think so, right. But yeah, it would be interesting to take a look at how much the passivation actually does help in that regard.
SZ: And that goes back to adequate controls on your cleaning validations. And ISO 10993. And what that battery of testing there is, which I think, we know those problems intimately, because we've been in industry and been designing some of these products for several years now. But as we tried to go ahead and bring up the next vanguard of engineers, that's tribal knowledge that we need to go ahead and impart.
JB: Right now, if you want to call it that, in the additive space within medical orthopaedic specifically, we're kind of all, I think, acting on tribal knowledge, because none of it is standardised [laughs]. None of it is standardised...
SZ: Yeah.
JB: or very limited amounts of it are standardised and what the FDA has indicated to us is extremely vague. And if we're trying to validate multiple vendors, if we were doing that from a traditional manufactured approach, it's like, kay, maybe we'll do a PPQ validation, manufacturing validation, on a couple vendors, well, what does that mean? Okay, we'll do 100% inspection on the part, alright, the material certs good, the hardness, okay. All right, great. You know, it means you're up and running, right, this is this is a quality product, we'll be good. As long as you have the right ISO certification, we're good to go. With additive, I feel more comfortable actually doing mechanical testing on the parts, when I'm validating a new vendor, which is something that really, I'd say, generally is not done with traditionally manufactured parts. I wonder, I mean, I would think at some point, the FDA will add some type of requirement for that. But at this point, there's no standard for trying to validate multiple vendors, and certainly not multiple machines with different parameter sets.
SZ: Yeah, there's some rough guidance that's been put out there, that we tend to go ahead and follow, but it doesn't paint a complete picture. And I think one of the things that I feel strongly about is, I obviously have some alliances to certain companies out in the industry, but what I want to ask my peers in industry, and what I love having these types of conversations with is, we as an industry need to go ahead and devote ourselves to taking more active role in developing these standards, working with our regulators, and trying to go ahead and impart our knowledge that we've learned through these tribal means through doing, so that way, we can help shape the next decades of additive manufacturing. And I would love to go ahead and say that you and I will take that on, but we already have a full work load on our plates [laughs].
JB: [Laughs] That’s true. How do I put this, we acting on new devices, us acting on new devices and developing new devices, I feel like that is us already kind of doing that right.
SZ: Right, of course.
JB: When we're putting out more test data at the FDA, that's what we've talked about, with the FDA, is that as they're getting more of this test data, they're building a larger understanding of additive manufacturing devices and from different manufacturers. I mean, they may start asking - in fact, I know, for a fact, they are - asking kind of where the parts are being made and what machines they're being made on, so that they can gather a better knowledge base to then be able to produce some type of standard so we are doing it just indirectly I think. But what I would hope for is on the comment of shaping the next decades of additively, manufactured orthopaedic implants to make sure that the standard doesn't necessarily constrict, because, for example, any number of - whether using Haas or whatever machinery you're using - you're able to determine, a vendor or manufacturer is able to determine tool speeds, feed rates, different tool choices, different fixturing, there's a lot of options for how you can potentially manufacture a part, right. And similarly, in additive, I want still folks to be able to have that freedom, for those who understand it, right, we just got to make sure that everything is tested and evaluated before it goes in a patient. Because I would hate for a standard or specified criteria to be administered or controlled such that you wouldn't be able to... it would limit like your parameter set for, I don't know, let's say a 3D Systems DMP 350, or whatever. FDA says you can only use this laser intensity for this and whatever and you're like..
SZ: Don’t get to that level of scrutiny.
JB: I would want to make sure that we don't get to that level. And so it really just comes down to making sure that the manufacturer - us really being the manufacturer - and the supplier work together to make sure that parts are properly evaluated throughout that process.
That's something that is never taught in university: how do you go ahead and tease out all of those stakeholder needs and convert them into design inputs, and specifications?
JB: Before we finish up here, though, I do want to touch on where you are in the patient specific implant space. And I'm curious, you mentioned before where you're making a decision between what's additive versus subtractive, do you end up making subtractively manufactured patient specific implants?
SZ: No, at this point where all of our patient specific devices are additive manufactured, but there is certain processes that have conventional processes built into that.
JB: Sure, different machining processes.
SZ: Correct, yeah. And so the base volume or so in all of our patient specific devices right now are 3D printed, but then we go through several processes of finishing [that are] necessary there. You know, there are many different types of patient specific devices out there. And one of the things that I feel that regulation has started to catch up on is, what is the difference between a custom-made device? What is the difference between a patient match device? And why is there a difference and whatnot? In our industry right now, those terms are probably interchangeable.
JB: Yeah, colloquially for sure.
SZ: Yeah. And really, when you start getting into the regulation, you then start to understand, 'well there is a difference between these and there are different regulations that I need to abide by.' And, for us, in design and manufacturing, we need to go ahead and understand those regulations to make sure that we're producing products that are meeting all the appropriate compliance.
JB: Do you mind walking through what that process looks like in comparison to a serialised additive manufactured implant? I’m just curious about that because it’s not a space I deal with.
SZ: Yeah, for sure. To me, I see. It kind of three tranches of product right now. A serialised manufactured device is something common to what we've been doing for the last...
JB: Where you'd have let's say, different sizes, maybe millimetre increment heights, right?
SZ: And you might have a bit of a boundary dimension for producing these SKUs. On the far side of that, there's what we call a custom made device. And a custom made device is something that essentially doesn't exist until there's a need for it. Let's say you have a patient who has a sufficient sufficiently rare disease or diagnosis, and there's nothing off the shelf to go ahead and treat that. I think of someone who, maybe the seven year old who got into a motor vehicle accident and is missing 50% of their femur. I bring that up because that's a very real case that I had earlier this year. And there's just nothing off the shelf that's going to go ahead and treat that. And so I am allowed through regulations to make a particular custom made device for that. But then there's, in the middle, what we call a patient match device, and a patient match device still has that bounding box of serialised dimensions or serialised products. But within that particular bounding box, you're allowed to go ahead and edit particular variables that you've laid out in your market submission to fit the patient individually, so I see it as a blend between those serialised production devices and those custom made devices which are diametrically opposed at opposite ends of the spectrum and a patient matched device is somewhere in the middle.
I believe that that is where our industry is headed over the next 5-10 years. And there are a lot of great companies out there who are concentrating on software for creating some of these and making the workflows a little bit better, ourselves included, and we have some proprietary software that we utilise. There are other industries that are concentrating on how to set up these manufacturing cells for making these more personalised devices. And then, as I mentioned, FDA is doing a better job at providing regulations around some of these devices. And I feel strongly that that is where our industry is headed. And I welcome the challenge because there are a lot of unanswered questions. But I feel that if we really ask ourselves the critical questions, then we can go ahead and get to that point and potentially get better outcomes for the end patient.
JB: Yeah, if you don't mind just touching on how your design process between those diametrically opposed types of devices differ. So, for example, with a serialised, I know that I've got a design team, I'm going through, like we talked about earlier, going through that design process and trying to evaluate the device, optimise for DFM and all this, and then end up finally producing a range of sizes that we think are appropriate for majority of the market. Right, we go through that entire design process, we touched on some manufacturing, I guess, challenges along the way, certainly a lot of manufacturing challenges, whether it's post processing or what have you, and then the quality space, the regulatory space. How does that differ, or maybe pick out a couple specific items how that differs for a patient specific device?
SZ: Well, I see them operating in two different ways when you do a more serialised device, for me, you start off with a concept that you internally already developed. And then you present that out to the, let's say, clinical customer. For a patient specific device, I don't start the design until the clinical customer comes to me and says, 'hey, this is what we have going on' and I'm designing it for an individualised person. So once I have that data, then I have my main design input, right?
JB: Are you getting a CT? Are you getting MRI?
SZ: I get CT. We can also work with MRI, but CT is the industry standard right now for getting that done. Whereas in the serialised production, you're taking the 95th percentile, right? You're trying to go ahead and find the object that fits 95%. Whereas in a patient specific device, you're trying to find the product that fits that one individual.
JB: Yeah. So on that note, how does your actual engineering process - I mean, I know you said you have proprietary software - but when you have that CT, like for example, with the femur right, you have to come up with an implant that replaces half a femur. And you said it was for a seven year old? My goodness, I mean, how does that scale? I mean, we can get into that in a second, but I mean, you're you're coming up with where a bone would be, right? I mean, are you considering bone density at all? Are you considering where you're loading? I mean, what are those considerations? Because, especially when you're doing it for a one off, I mean, that's tough.
SZ: 100%. In some instances, for me, the customer requirements are easier on a patient specific device, because I have that one stakeholder who's the patient, I have that one stakeholder who's the clinical surgeon, and I can go ahead and focus all that. But we do a pretty deep dive into what are the patient needs, we take age, weight, bone density into factor, we started looking at DEXA scans to look at bone density there, a region of interest. So, that way we can figure out what are the appropriate loading conditions there. I mentioned age, that particular patient is still growing, what do we need to do there? And then, in addition to that, what is the surgeon's operative approach? How do we make this device such that it's easier for the surgeon to implant it and get a more successful clinical outcome? And then we look at some of the third party components that are going into that.
One key thing that we've needed to do or that we do on the far end of the spectrum of custom-made devices is we find that there's a device, but we also need to figure out supplemental fixation as well. And it's not all one company that can do it all, right? We partner out with other individuals, other organisations, I should say, to figure out total solutions for this one surgery. Whereas in a serialised device, you're expected to go ahead and have that all figured out already for the 95th percentile, you're expected to know well, here's the supplemental fixation that you're going to use and by the way, we've already provided it to you. Whereas on a custom made device, you may not necessarily have that, or you may have a surgeon who just prefers to use some different type of supplemental fixation. And you need to lay out all of those type of customer requirements in the span of 30 minutes, which can be daunting for someone who's trying to do this for the first time. Over many, many years of trial and error, I feel like we've developed a good process. But that's something that is never taught in university, how do you go ahead and tease out all of those stakeholder needs and convert them into design inputs, and specifications, right? And being able to do that is going to be an essential aspect of how we transition to some of these more patient specific devices in the future, and I think is going to be a critical, a crux, if you will, or a particular focal point for the adoption of this type of thought process or technology if we do intend as an industry to go towards these personalised devices. As I mentioned at the beginning of this conversation this is not a golden bullet, much like additive manufacturing, there is a decision algorithm that you need to make between a conventional manufactured product and an additive manufactured product. If you're making a screw, I'm going to make it on a Swiss machine all day, every day because I get them for pennies on the dollar. The same thing is true for these personalised devices, is a SKU of 64 vertebral body devices good enough to go ahead and treat this individual patient? Sometimes it depends on the patient, right? What's their ideology? How are they presenting to the surgeon? What is the overall situation that we're intending to concentrate on here? And if the answer is it's a general routine surgery, answer is you're probably better off with those 64 SKUs, because of turnaround time and cost to the hospital, which we didn't get to touch on, but to me, that's one of my major stakeholders. But if it's a complex and rare disease state, and you're looking at maybe an NBA player who has come down with a cancerous tumour, then absolutely personalised device is necessary there, because the off the shelf devices don't meet that particular need. So, I think we need to go ahead and critically think about our decision processes and say is additive necessary in this particular application? And for the future, is a personalised device necessary for this application? And the answer is not always yes, the answer is not always no. It depends.
JB: It seems to me from a design standpoint, with everything going on, for a serialised product comparing it to something that is individual, it's like taking that timeline and putting it in like a hyper chamber [laughs]. That's what it sounds like to me.
SZ: Yeah and we still meet many of, if not all of, the requirements for a serialised device. I mean, I'm still going through a design controls process, I'm still going through ISO 10993, mechanical testing, powder handling, all of those things that you would see in the serialised device, but I've done it in such a way that we've compacted that process, right?
JB: Do you end up going through a [inaudible] processors or do you just rely mostly on FEA?
SZ: So a combination of both, it depends on the individual product. If it's something that is more routine, and I hate to use the word routine, but...
JB: Sure. In terms of loading conditions?
SZ: Yeah, then we'll go ahead and just rely on our computer aided design and manufacturing softwares, but if it is something that's a little bit more out there, undoubtedly, that prototyping is helpful, not just for us who are designing and manufacturing it, but also providing that to our clinical team who are going to be utilising it to make sure that they understand what the free space is and the intended use of that device in the OR, so not only do we produce the implant, but we also produce the anatomic model and ancillary devices to go with that. So that way a surgeon can utilise that in the OR, for pre planning if you need it.
JB: Yeah, it feels like, where I, for example, have been able to learn throughout the process of developing additively manufactured devices, I wouldn't be able to do that if I was doing something patient specific, right? So I have to have all this knowledge base beforehand, going into that, I feel like there's a much smaller range of error.
SZ: Oh, absolutely.
JB: So, that's another thing. It's like you take a serialised device development cycle, and then you put it through a HIPing process [laughs] put that and then some extra pressure in there. But I'm really interested in that process, we can keep talking about this forever. But I do think, we can finish up here in closing that, there are different manufacturing regulatory considerations that need to be taken when we're thinking about - certainly cost considerations that we need to be thinking about - making something more specific. And I think that it's a cool, I think, how do I put it? It is very cool, but I think it's a cool idea to have perhaps an additive manufacturing machine of some kind, whether it's DMLS or Ebeam, adjacent to the OR, and like, oh, you could pop something out, and process it right there on the spot. But it's just, for a number of reasons, I think, unrealistic, and maybe not even worthwhile, I think from a cost standpoint.
SZ: Oh yeah, and what you're touching on there is the point of care push, which I think has been another hot topic in our industry is, how do we get manufacturing at the point of care facilities? And this is another one that I could talk for hours on, but one thing that I feel that a lot of people miss is, OR space, hospital space, is some of the most expensive footprints from a square foot perspective, we'd be talking about hundreds, if not thousands of dollars per square foot of office space. And when I can go ahead and potentially set up a manufacturing facility, probably about 10 miles away, and provide that same output. And that needs to be the cost benefit that as we kind of go through is, while I do think there is some validity in point of care manufacturing, the question is, what type of point of care manufacturing? Is it rapid prototyping for polymer devices? Potentially. Is it a class three device, fully implantable? Not likely at this point, you know, because there's a lot of relation that maybe some of these point of care facilities haven't, - or health care facilities - haven't thought of just yet, and we haven't developed regulation for it. And we're still off, right? That then asks the question, who is the manufacturer of record at that point? And how do we handle that as we go through? I think there is some type of middle ground but it's not as easy as setting up a 3D printer, having an engineer there who designs something for you, and then boom, you pop it into the 3D printer, and then within an hour, put it into a patient.
We can't, at this moment, produce safe and effective devices but with people who lead the industry, and concentrate on those questions, I think there can be something that is attainable. Now, who knows if it's now - we know that there are some companies out there who have set up facilities - or if it's 5, 10, or 20 years from now? It depends on the product that you're intending to produce.
JB: So in closing, then, if you don't think that's necessarily the direction for orthopaedic implants, where do you think they're going? I mean, you just hit on the hybrid between serialised and patient specific, but where do you think? Just take take a stab in the dark, Steve. Where are we 10 years from now?
SZ: [Laughs] That’s a lofty question. I've fully invested myself in patient specifics, you know, so, if I were a gambling man, I'd go ahead and put it there. You may argue that there's some other people who are going to say it's point of care. And then you may argue with some other people that would say it's going to be robotics, or AI, trying to go ahead and overlay computer models into the surgery suite. And I think all of those avenues have validity to them, but it just depends on... money is king, really, right? What can you make for the least amount that will give the most benefit to the customer, that will get the highest adoption rate. And for me, things like robotics and AI are high cost, which maybe not all facilities can afford. Now, we've seen huge advances in robotics that have been instrumental in improving the quality of care. But not all facilities can adopt that. Maybe something that is a little bit lower bar, like patient specific cutting guides or so, we've started to see those emerge a lot more. And that potentially can be coupled with a point of care thought process, because those could be considered maybe class one, class two devices, with a lower risk profile to the patient that potentially could be controlled at a healthcare facility. What are your thoughts?
JB: Yeah. So I think that just touching on that great point that you brought up, I completely agree that I think custom, if you will, instrumentation, for sure I think we're gonna see more of that, I think we're gonna see more additively manufactured instruments
SZ: AM just lends itself to that, right?
JB: It really does. And we can get into, how accurate is it? But we're, for sure, on the scale now, where we can produce accurate enough, plus or minus - we're getting the plus or minus less than a millimetre, you're certainly going to be more accurate in that case than, I would say, the accuracy of most surgeons. And so that I think is gonna be very effective, maybe not the implants because maybe the efficacy isn't there relative to the costs, but certainly, I think from an instrumentation standpoint, that I definitely think we'll be seeing more of. I think that generally, we're seeing it certainly already, I think we're feeling it, personally, that the consolidation, where you have more, you've got larger and larger hospital systems controlling more hospitals, you have parring down to individual vendors, the cost for, or rather, the price that different hospital systems are willing to pay for products, it just keeps going lower and lower and lower and lower. Right now, it's cost effective enough for companies like 4WEB and Osseus and other, I would say, mid sized, I think is fair, companies to exist within this space. But I think we're moving in the direction where it's going to continue to consolidate within the larger companies and I think we're going to be moving toward where most of the market just ends up going the route and we're really mostly there already where, what, majority of implants are still just PEEK, it's still just plastic, they're just serialised, plastic implants, does the job, vast majority of the time, and I think we'll just keep heading in that direction when it comes to devices across the board. And then there will be a very secluded specific space that I think is just going to be intensified, where, like you said, we'll be getting closer and closer to the patient specific devices, frequently within a small population. I think it's going to be really a kind of maybe getting into haves and have nots, there, but I think that's where it's gonna go. And there are already, I think, a select few folks who do what we do, and I think it's going to become even smaller.
SZ: Right, we're a very incestuous group here in the orthopaedic medical devices.
JB: Yeah, that's what I think. It is possible to expedite the timeline down a little bit. But I think with patient specific devices, at a certain point, there's only so fast things can go and how fast you want them to go in terms of a turnaround. I mean, what's the the average turnaround, or not even average. Like, what is an example of a turnaround for a patient specific device?
SZ: Yeah, I mean, we're down to about three to four weeks, three to five weeks, depending on the design complexity, but always at the forefront of that timeline is, 'am I still producing safe and effective devices?' And, for me, that is an unmovable goal that I cannot sacrifice, right? I will not push out a device that I do not believe is safe and effective. And we're always trying to play that balancing game. How do we go ahead and take turnaround time, and take safety and efficacy, and pull the levers and push the button, so that way, we get the optimal balance of them? Which, by the way, there's also the third corner of that little triangle, which is cost, you know?
JB: The big corner.
SZ: [Laughs] The big corner. And that triangle balances that out, right? Cost, turnaround time, and quality of a device.
JB: So I took the very, I think, easy, if you will, route in terms of shooting a projection because like, 'oh, yeah, that's a great trend to pick', it's an easy one. So I'll I'll shoot a shot. I think that - and this one, I guess, is probably is going to be along the same line, but a little bit more - I think that we're going to be moving more into robotics and navigation, right? Because we already are. But to the point where - and I know, other other folks have talked about this - where you can have a surgeon in Miami operating a machine in California, or something like that, I think we're going to be doing that. And in having - I don't know, other than, I guess, like we talked about - where you have additively manufactured instruments potentially playing a role there where additive plays apart, but I would say that, that would be kind of my shot, and that kind of goes into the specialisation of everything else. I mean, surgeons are very specialised, certainly. But I think we're going to get to a point where, it's like everything is going to end up consolidating, right? You end up having your very, very skilled and specific surgeons, and then you're gonna have surgeons that are able to operate in a different capacity, let's say, where they're reliant on a patient specific instrument that guides them in or that combines with a robot and navigation, and then they can potentially operate from their couch or something like that, I could definitely see us moving in that direction. So that's what I think.
SZ: And just this last topic. I think, in order for engineers and moreover than that, organisations to survive in our current industry, we need to have a level of flexibility and adoption, that is at the forefront of what we do and how we operate to keep up with these types of technologies. Because otherwise we may not be here in the coming decades. But I look forward to the challenge.
