Episode#127 | Lean Compliance For Medical 3D Printing With Erik Boelen

We talk with Erik Boelen, founder of Qase3D, about how medical 3D printing went from a regulatory free-for-all to a world where hospital print labs function as medical device manufacturers. We break down MDR, CE marking, ISO 13485, and how to stay compliant with a lean system engineers will actually use. 
• The early “no rules” era and why proof of quality becomes unavoidable 
• How MDR and CE marking work for standard medical devices 
• Why custom-made devices can be CE-exempt yet still heavily regulated 
• ISO 13485 as a process-focused QMS and where it helps most 
• Building a lean, day-to-day QMS instead of a paperwork vault 
• The MDR Portal approach and the value of lawyer-backed interpretation 
• Practical triggers for when a growing lab should consider ISO 13485 certification  

00:00:00 - Welcome To The Regulatory Reality
00:03:10 - MDR, CE Mark, And ISO 13485
00:06:30 - Making Implants Before Clear Rules
00:08:33 - What Custom Made Really Means
00:10:20 - From Engineer To Quality Builder
00:12:12 - A Lean QMS People Actually Use
00:17:33 - The MDR Portal And Lawyer Support
00:26:45 - Scaling Compliance Without Bureaucracy
00:30:40 - The Future Of Hospital 3D Labs
00:41:05 - How To Contact Erik
00:43:15 - Disclaimer

Show notes: https://3dheals.com/episode-127-lean-compliance-for-medical-3d-printing-with-erik-boelen/

YouTube: https://youtu.be/wR7TVN4WGno?si=pvQ-Fl7VJNgNRq7F

Transcript

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Welcome To The Regulatory Reality

SPEAKER_01 0:00

Twenty years ago, medical 3D printing had almost no rules. Today, any hospital that prints an implant has quietly become a medical device manufacturer. My guest today, Eric Boland, has lived that entire arc. He founded Case3D. To make compliance lean, his take may surprise you. For a small hospital 3D lab, chasing ISO 13485 may not be the best goal. Let's dig into it. Please listen to the disclaimer at the end of this podcast. Hello, hello. Welcome to the pot. Today we have an industry veteran, Eric Bolan, to join us. Eric has been in the industry for more than 20 years. Am I correct?

SPEAKER_00 0:41

I am Doctor Correct, yes. In the medical 3D printing industry.

SPEAKER_01 0:46

Exactly. I would say you were in the industry in the wild days when there was absolutely zero regulation for US and you're in Europe located. And now you are so full of experiences that you founded your own company focusing on compliance called Quase 3D. Is that right?

SPEAKER_00 1:04

I pronounced it case 3D.

SPEAKER_01 1:06

I knew I was I was messing it up. Okay. Well, thanks for coming back to me. Well, why don't you tell me a little bit, what was it like when there was absolutely no regulation? Because you were with Zillok Medical for a decade or so, and then you move on to materialize. Both were very heavy in medical device manufacturing using 3D printing, but there wasn't very clear regulation back then. So what was that like?

SPEAKER_00 1:27

Well, actually, I started with materialize and later moved to Xiloq. Okay. But indeed, the time when I started at Xilock, there was no MDR. It was they call it the MDD. It was a directive. So it was not really a regulation. It wasn't, there wasn't a law. But that was introduced as I was there. So in the beginning, indeed, we were already making implants, cranial implants, going into patients, and we had zero proof, so to say, of our quality, of what we were doing. We might as well be making this in a dirty garage. Obviously, we were not. But in Europe, there was so we made custom-made devices. They are also under MDR, they were exempt from CE marking. And we had no quality system also in the beginning. Of course, you have a system, but not a documented QMS as we know it now. But we we noticed the first time that we needed something like that is when we were venturing outside of Europe, where people expect products to come from Europe to have a CE mark. And it's really difficult to convince someone that our products are exempt and we don't need a CE mark. So you have no real proof that you're selling a good product. And I guess the surgeons here in the Netherlands were just trusting our blue eyes, so to say. But that was for us the realization: okay, we need to be able to prove that our products are good. And the way we decided to them was a strategic decision is to certify the process rather than the product. If you can't certify the product, let us certify the process. And that's basically what you do with an ISO certification.

MDR, CE Mark, And ISO 13485

SPEAKER_01 3:10

So Eric, before we dive too deep, we do have a very general public, and myself included. So, like you said, MDR didn't exist until 2017, right? So it was actually quite recent, these strict regulations from MDR. And I was looking up this morning uh in terms of the ISO 13485 certification. Also, it's pretty recent as well. It's like 2016, then the newest version. And then also, if you could just kind of describe the relationships of these concepts, it will probably help a lot of people. Is what are the relationships with CE mark, custom device, and then later on MDR and ISO certification? What are the relationships of these terms?

SPEAKER_00 4:05

Yeah. Okay. So if you're making and selling a medical device, you have to do that according to the applicable regulations. And here in Europe, that's the medical device regulation or MDR in short. And for most devices, standard devices, that means that you have to go to a notified body to get your product basically certified. You get a CE mark for it. And what that requires is that you adhere to the requirements of the MDR for your device. And for standard devices, um, that's all pretty clear. And one major requirement that the MDR has is that you produce your devices under a quality management system. So that's one of the big requirements. And most manufacturers, well, they don't know any different, and it's been like that for years. So ISO 1 has been around for years. It just I think five or ten years has to be a revision as a new version. I think this year they decided that we can go ahead with ISO 2016 version for another five years. ISO 13485 specifically is a standard, a quality standard specifically for medical devices. Now you also have ISO 9001, which is another quality standard most people know, but 13485 is specifically for companies who make medical devices. So that is a bit of a guidebook of what your company should be doing in order to make decent devices. So that is the relationship a little bit between ISO and the NDR.

SPEAKER_01 5:37

I think you unpacked the concepts pretty clearly. I think that really helped a lot. It's important to understand that ISO is more, like you said, a qualification. It's not a law. It's not like MDR, which is a legal process that you have to uh comply with to be able to sell. Yeah.

SPEAKER_00 5:55

Yeah, but they do that quite smartly. I mean, so the MDR requires a quality management system. Right. Specifically for medical advisors, there's basically only one standard, which is ISO method at least. Um we use in Europe, but also the ISO standard in one of the first paragraphs as a requirement says your company should adhere to the requirements in this standard and any applicable regulatory requirements. So the standard for quality management also points back to any regulatory requirement that may

Making Implants Before Clear Rules

SPEAKER_00 6:30

exist.

SPEAKER_01 6:30

So you mentioned that with Zello Medical, you guys produced a 3D printed mandable implant, and that was the first in the world.

SPEAKER_00 6:39

Well, the first complete mandable replacement where we really 3D printed an entire lower mandible in titanium, yes.

SPEAKER_01 6:47

And that was implanted into patient? And what year was that?

SPEAKER_00 6:50

I think 2011 or 12 or something.

SPEAKER_01 6:53

So way before 2017, when these how was that? I mean, you certainly were not printing these in the garage, like you said. So how do you regulate yourself?

SPEAKER_00 7:02

Well, basically, and that's what we decided as a company. I mean, because there was no real standards at the time, our philosophy was just like, okay, uh, we'll do our utmost best. And whenever something would happen, that at least we can justify to ourselves, we did everything we thought was best and what we needed to do, so that you can sleep well at night, at least. And that's also where it initiated this. Is and what I usually also on LinkedIn I say that a lot. That imagine that the device you're making is for a loved one, is for your partner or for your child. Would you still allow the surgeon to use it at that point? And that's a question you should be able to answer 100% yes immediately, because if you're not, then something is wrong. So that's that was our philosophy to just be able to produce decent devices. Yeah.

SPEAKER_01 7:55

Or or or a device made for yourself when you need it. Well, you put that in the body.

SPEAKER_00 8:06

That's true. I think a lot of manufacturers would say, yeah, for peak implants, I can use the industrial peak. So that's why I shifted it to loved ones.

SPEAKER_01 8:15

And uh I think the time 2017 is a very interesting time in our industry, medical 3D printing, because the MDR, because I remember at the time was pretty contentious or confusing. A lot of people uh were complaining about it uh back in 2017.

What Custom Made Really Means

SPEAKER_01 8:33

I think the the right the term that we uh forgot to talk about or unpack was custom device, the definition of custom device, because I think in the law they also made a distinction of mass-produced versus custom made device, and didn't really remember 3D printing can mass-produce personalized devices.

SPEAKER_00 8:54

That's what changed between the MDD and the MDR, that the definition of a custom made device indeed has changed slightly, including indeed that you're not allowed to use mass production to produce these devices, because then it wouldn't really be a mass-produced device. But indeed, that's what we forgot to unpack earlier. So one of the things in the in the MDR is that a custom-made device is exempt from a CE mark just because the product is always different, and then and there are other requirements for those, and one being again that you need to work under a quality management system. So, yeah, for custom made, there's no there's no notified body looking at your device unless you're making a class 3 device, which is the like the highest class um devices. You can you can basically deliver an implant without any kind of third-party review, and that's what makes it also a bit tricky. And I think the reason that they changed the definition is because there were a few companies who took advantage of that slight loophole by saying, Yeah, uh these are stories I heard. I don't know if it's really true, but they say uh a surgeon requested to put some kind of specific label on this generic scalpel or or scissors or something, which made it a custom-made device because it was prescribed by the surgeon, so it didn't need to go through CE marking, I think something like that.

From Engineer To Quality Builder

SPEAKER_01 10:20

That makes sense. So you were in the industry as an operator and engineer for decades before you now are fully embracing the regulatory side of the industry. What in what motivated you to do that?

SPEAKER_00 10:32

Yeah, that's it's strange how things can work out. I mean, I'm a biomedical engineer by training. I did my PhD in in biomaterials. I started it materialized as an application engineer, so really in a technical role. But already there I evolved into a more marketing role. So in the end, I was the marketing manager for their medical software. And then indeed I moved to Xillog. Yeah, I was the first real employee, so together with the founder, we built a whole company. And we when the point came that we wanted to implement a quality management system, I also became the quality manager. And how I got started is I started reading the standard really just as it is, and I fell asleep dozens of times and had to start over, and I just keep reading it, but then at some point it starts to make sense. And you read it, you read it again, you're thinking about how you do that in your company, you think, I'm already doing this in my company. So a lot of the things that are in there are actually quite logical, and you're probably doing them one way or another, but most companies just never documented it, and that's the thing. So over time, I think I learned to appreciate quality management. I also experienced that because I built this entire system from scratch and I tried to build it as lean as possible. So I realized it doesn't need to be this scary or or this big thing. I mean, if you're just starting, uh you have to build a QMS, you're really overwhelmed, you don't know where to start. And that's something that I want to help companies with to teach them that it's it's not that difficult, and probably you are already doing a lot of things right, and just need to document

A Lean QMS People Actually Use

SPEAKER_00 12:12

it properly.

SPEAKER_01 12:12

So tell me about case 3D. Did I say that right? Case 3D. Well, what kind of service do you provide and how do companies work with you or hospitals work with you?

SPEAKER_00 12:21

Yeah, so because I have gained all this hands-on experience with ISO 345, with building a QMS, this is the experience that I'm now using to help other small companies to set up their quality management system. But and I could do that for any kind of medical device, but I focus on the companies that use 3D printing to do so. Because that's where my experience is, that's where my passion is, that's what I want to do. I like the fact of using 3D printing in medical devices. I think it's a wonderful technology. So my focus, so to say, is helping clients who 3D print the medical device because that also has some of the challenges in its own way. So companies for one, but also more and more hospitals, because hospitals are also now embracing 3D printing more and more, becoming a manufacturer, and also need to have, yeah, as a manufacturer for the MDR, I need to have some kind of quality management system.

SPEAKER_01 13:18

So I'm trying to have a picture of what this quality management system looked like from and how you work with them. Is do you actually create a software for them, customized SaaS software, or do you just help them to create their own process, either paper or digital?

SPEAKER_00 13:34

Well, uh it's a fun question because when when I started building this QMS at Xilock, we have been looking long and hard for what system to use. And you see a lot of people who are still using paper-based, and it's awful. And I also think that with a paper-based system, well, I don't think it really adheres to the requirements around document control in the new ISO standard. So we we investigated tons of QMS systems, document management systems, and well, we realized more and more that such a dedicated QMS system, it's basically nothing more than a file vault. So you have your documented procedures, you put them in the vault, uh, you lock them away so no one can change or edit or anything except the quality manager. And when he does, he has to check it out, he has to change it, he has to have signatures to prove that it's approved, and then lock it back in the vault. And we're thinking like, well, as a small company, we wanted a system that actually supported our engineers during their day-to-day operations rather than having some documents behind a thick wall that no one ever looks at except the quality manager three weeks before an audit is due, because then you have to get your paperwork in order. And we really wanted something that supported our engineers, that they know where to find the right instructions at the right point in their workflow. Um, so therefore, we had to look a little bit further, and we ended up with some kind of yeah, it's like a Wikipedia sort of system. So basically, we started using our internal company Wikipedia. We built our QMS in there, including well, the necessary document review and everything. And we use it for much other things as well. So we we documented everything we knew about biomaterials, about the peak that we use, titanium, about 3D printing technologies, and we use it to plan our next company barbecue. So it became so much more than just our QMS. People use it every day, and I actually loved using it because it and that's what an auditor also really appreciates that people use it and they know where to find stuff, and they use it on a day-to-day basis. And that's what you see in a lot of companies now, is that people complain about quality management. Uh, they say it's bureaucracy and it's paperwork and they hate it. And yes, there is, it is necessary to record a lot of stuff, so there is some level of bureaucracy always needed. But if you make it easy and accessible, then it doesn't feel so if you really need to go to some kind of folder and and find the right form to fill out, yeah, then it becomes a hassle. But if that form is offered to you at the right time of the process and it's just easy to fill in, that changes a lot, I think, in the perception also of the people on the workflow.

SPEAKER_01 16:34

Yeah, no, that sounds reasonable. And uh, and I'm just curious, does that mean that when an engineer is designing a device, for example, in a design process or design for manufacturing process, and suddenly a prompt will show up and say, Hey, you need to document this for future reference?

SPEAKER_00 16:50

Or how does that work to engage not it's not really like that? So you document certain steps in your workflow and you just record after a step and you say what you've been doing, who approved it, maybe take some pictures or something like that. But also, and the your QMS basically describes what it is that you're doing, so you don't need to read it all the time. Uh, you will probably also have some instructions in there, but if you do the same design every day, you're not looking at the instructions anymore. That's true. So you know what to do. It only becomes important when you want to change the instructions so that other people also know that they have changed and that you have a different approach. Other than that, you're not looking at these instructions every day.

SPEAKER_01 17:30

And you mentioned you want to make the process easy for

The MDR Portal And Lawyer Support

SPEAKER_01 17:33

people. So you lately have pushed out a new service with case 3D. Can you expand on that a little bit?

SPEAKER_00 17:39

Yeah, you're probably referring to the MDR portal. Yes. Yeah, so while I was working with hospitals on building their quality management system, as I mentioned before, I focus on ISO 1345 because that's the only standard for medical devices. Um but it's also it's quite I don't know how to say it, heavy. It's it's it's ominous, it's a big system. And ISO 1345 focuses very much on business processes, on what to do in your business. Whereas if you are talking to a small hospital facility who use 3D printing to help patients, yeah, it's it's it's usually a small team and maybe one or two engineers or something. And then ISO becomes this really massive thing, which I didn't think made a lot of sense. There were a lot of requirements that might be overkill, I don't know if you say that that way. And then I realized that actually building the quality management system is not really the goal. And the hospitals just want to reach compliance and they want to help patients, but they also want to adhere to the law. Um, and the law has very different requirements, or at least some overlap, but also different requirements. Um, so I was thinking, okay, how do we how do we help them adhere to the law rather than to this quality standard? Whereas if you implemented that, you still have other requirements from the law to adhere to as well. Um, so I started initially with making like a ISO 1345 light version, so a reduced version, where I skipped a number of the requirements that I thought were not really necessary for a small lab. But then I got in touch with actually a lawyer firm, and they had already developed some kind of platform specifically for custom-made devices that was being used here in the Netherlands by virtually all the podiatrists because a podiatrist is also making a class one custom-made medical device. So it's also a manufacturer, needs to adhere to the MDR. And yeah, and so the lawyers I met, they're really into keeping things really simple and making the law, taking the law and making it simple to adhere to. And uh, so we got to talking, and I say, can't we? Well, basically rework this a little bit to also make it available to hospitals so that they really know what requirements in the MDR to adhere to for custom-made devices. Because yeah, you see a lot of people trying to interpret, and we're all engineers, we're all smart people, but the law is really difficult to read and even harder to interpret. And yeah, and and the way if you talk to these lawyers, then that for them it's not it's not a gray area. For them, it's black and white. They say, no, this is what the law wants, and this is what the law does not want from you. So I worked with them. We we create well, we reworked the platform specifically for custom-made device manufacturers, and so that's what I'm offering now is basically a compliance platform that doesn't look at ISO 13.5, that purely looks at the requirements in the MDR. And it's a it's a license-based fee, a yearly license, because our philosophy is also like okay, compliance doesn't stop when you completed everything, it's it's an ongoing effort. Yeah, and the and the platform costs just sort of uh yeah, it's like 990 euros per year. So I think I always told the lawyers I think it's it's almost too cheap, but that's it's their decision.

SPEAKER_01 21:22

Now, I remember the VIN diar diagram you sent us. I think that's a really good demonstration of what you're envisioned here with this new product, which I think is refreshing. And I will share that with our audience, which is the MDR and the ISO 134A5, they intersect a little bit in the middle. And that's where the little lab from hospital point of care medical device printing is located. Can you expand on that? I mean, who would qualify as a small lab?

SPEAKER_00 21:50

Let me correct you there. You're referring to the two two circles. Yeah. That I try to visualize very basically, graphically, indeed, how. The requirements in the MDR and in ISO 13485, how they overlap, but also how they differ. And so there's a little overlap, but the other part of the MDR that is not overlap, that's still the part that you need to adhere to. The portal really focuses on the MDR requirements. Should you decide to also at some point go for ISO 13485 certification, which I recommend doing if you are becoming a bigger lab, if you're also supplying to other hospitals, for example, and then you also have these other requirements in ISO 13485 to adhere to. And that's the part that I was already doing, so to say.

SPEAKER_01 22:41

Right. And what's the part that's not covered in the middle? Like the MDR part that you think the hospital labs should also include in their compliance process. That's not part of the intersection.

SPEAKER_00 22:53

Yeah. So that was what triggered me from the beginning is that okay, I'm helping them with this ISO 13485 QMS, and yeah, it's nice and you can get it certified. But after that, you still need to look at the MDR and look at the additional requirements that are there. And I didn't feel really comfortable helping them there because I see myself as a quality specialist, not so much as a regulatory specialist. And I see that also a lot in consulting, that yeah, you don't want to be held liable for wrong advice, so to say. So I if I tell them I think this is what the MDR wants from you, and in the end it turns out that I was wrong, then what are the ramifications then? So that's why I didn't want that kind of responsibility. That's also why I'm happy with working together with a bunch of lawyers, so to say. So there are requirements around management commitment, uh, around human resources and and and those kind of things. Yeah, a small lab, the human resources probably arrange higher up in the hospital, and it's not part of their day-to-day job. So why should they need a procedure around human resources? And so and the requirements in ISO are much more on a company level, on company processes, whereas the requirements in the MDR are around product safety and performance. I mean, yeah, one of the biggest things in the MDR is the first Onex, which is the general safety and performance requirements that are always applicable. And so the MDR really is focused on is this device safe and does it perform? Um, whereas ISO is more on how is your company organized so you can guarantee ongoing continuous quality of the devices that you produce. So I think that's the big difference. Uh the product focus versus the process focus.

SPEAKER_01 25:06

Okay. You mentioned that your newer lean MDR product is better for small labs. Can you just expand now who qualifies as a small lab, any hospital, or only the community rural hospitals or one-person lab qualify?

SPEAKER_00 25:22

Well, for sure, the smaller labs, you see labs that are indeed are just two persons or something, they for sure, because then it's more manageable to reach compliance. You don't have to spend time trying to understand or interpret the MDR yourself. But for the bigger labs, especially if you become a really serious manufacturer, I would recommend also to look at ISO 13.5 for sure, to keep your processes in order, but they also still need to adhere to the MDR, and so they can still benefit from having this online platform that just tells them what the MDR wants. So it's it's a synergy, yeah, they work together. Because if you start with just an ISO system, then it doesn't automatically lead to compliance. For that, you still need the MDR. So that's why I think this is a nice addition also to already existing quality management systems, because you, as a company, you should also be able to demonstrate proof how you stay on top of regulations and of changing regulations. And if you are if you have a license for this platform, yeah, there's a team of lawyers that monitors the regulations for you and should ever whenever anything changes, then the platform is updated, and we tell you if you need to do additional things. But yeah, if you're just working day-to-day in a hospital, you're not really focused on, yeah, oh, did something change in the regulations?

Scaling Compliance Without Bureaucracy

SPEAKER_00 26:45

Yeah, that's something you don't I think you shouldn't be bothered with. You should focus on doing what you do best, and that's making perfect personalized products.

SPEAKER_01 26:54

So somebody is basically monitoring for these small labs on ongoing changes in the law and perhaps the work of the lawyers, I would say. I hope so. And so for the newer leaned down version, do you have a ballpark estimate of cost reduction for these smaller labs? You know, what they have to do before, which is the full ISO compliance, and now they just have to do the MDR part mostly.

SPEAKER_00 27:18

Yeah, well, I think the the main gain is in the time spent. I mean, everyone is doing this, redoing the same exercise, is having to look at the MDR, probably doing control find through the text to find any of the requirements related to custom made. But even there, there are requirements that don't mention the word custom made but are still applicable. The danger is that you miss certain requirements. I think the time spent in trying to figure everything out is a major saving factor. Other than that, I think that that's the majority actually.

SPEAKER_01 27:54

Time is money, in my opinion. Yeah, that's why. Now, we we talk about these like one or two people, small app in the hospitals, but do we have any other definitions to say, you know, now is time to stop being lean and to go for full ISO? So let's say the product that you're making now stop being the anatomical models only and now going into implants or any kind of wearables like prosthetics. Would that elevate their needs for compliance and standardization?

SPEAKER_00 28:24

Not per se. I mean, you can make a customate implant if you follow the requirements in the portal because they apply also to implants. The only change is that as I mentioned slightly before, is that if you reach a class three device, then it needs to pass a notified body, and they have to look at your uh yeah, what you did to to show the safety and efficacy of the device, and they look at your quality management system. But still, I I I would recommend if you're getting serious as a manufacturer and I would call manufacturing of implants quite serious, yeah. Then at least look seriously at ISO 13485 as a yeah, as a system that will help you to manage your processes. As a company, you keep improving and that you have consistent high quality coming out. So yeah, and you said before that when it stops being lean, but I don't think it should stop being lean. Okay. Because that's the point where people start to hate quality management. Um, I think it has to keep being lean, but yeah, one of the important things in a QMS remains documentation. And you might have heard it before that most auditors will say if it's not documented, it never happened. Um so you need to be able to prove that yeah, you did what you say that you're doing. So, in your, for example, you say in your quality system, every device that we make is checked for dimensions with a caliper. Then the auditor will pick one device and saying, Show me the recorded dimensions that you made. And so you should be able to show that, huh? Because you said it in your system, you have to also do it. And that's also something that is easily going wrong, where people are thinking too strict and they document things the way they want to work, but not the way they actually work. So then they document, they think, yeah, this is the way we should be working, and if that's documented, but it's not happening, then you also have an unconformity. So I'm just a fan of doing it very lean and making quality management easy for the people who actually have to use it. And if you allow me, I have a very short story on

The Future Of Hospital 3D Labs

SPEAKER_00 30:40

that topic. I was working for another startup two years ago as a quality manager, where I helped them to build also their quality management system. And they also hired a more experienced uh woman near the end of her career who spent her entire career in quality and regulatory and everything. And when she looked at my system in the beginning, she was really skeptical. She thought it was it was too dynamic, so to say, and she thought, yeah, it needs to be more rigid because that was what she was used to. But after a few months, she completely turned around 180 degrees. She uh she really appreciated the system that I built and how easy it is to use. And she wrote me a very nice review on my LinkedIn page, just saying just that.

SPEAKER_01 31:29

Yes, yeah. Well, conversion is always really a validation to your thesis. Now, just a little bit about the growth of the market, because I almost think that people who need compliance standardization products is a proxy, you know, how many people are needing it? The growth of that is a proxy of the growth of the industry. How what is your observation right now of people who are trying to reach out to you to get compliance and regulatory advice? Is that growing and how how do you see the future?

SPEAKER_00 32:00

Yeah, well, I think that personalized devices are are gaining traction. And yeah, when we started Xillog in 2011, it we were very early, maybe one of the first to do to do only make custom-made devices as a as a company. And our philosophy was that every patient deserves a personalized implant, but it was in the beginning uh actually a hard sell. It was difficult to get the sales going. But now I see that, well, I we already noticed in during the 10 years I was there that the bigger companies started to look into that, started to offer it as well, and and really embrace it. So as an I don't know if you can call it an industry, but as an industry, I think personalized, becoming bigger and bigger. And parallel to that is yeah, the raise of the of the 3D labs in the hospitals. That hospitals are starting to become manufacturers in their own right. They make surgical plannings based on the CT data from a certain person. That's a really personalized surgical plan assisted by anatomical models, which is nice. Yeah, you you don't need an expensive 3D printer. They're all very accessible, affordable, desktop models. So it really made it easy to bring manufacturing in-house, and that is just that is just growing and growing, and every every one of these manufacturers and labs will face the does face the MDR. So yeah, I expect that I won't be out of a job anytime soon.

SPEAKER_01 33:37

Well, uh in that case, how many hospitals are there now using your products? And how many do you wish there are that are going to reach out to you?

SPEAKER_00 33:46

Not yet enough. No, yeah. Well, uh there are now, yeah, I don't really want to name numbers, but there are several out there using it, and I hope that to to much satisfaction. So I hope that it speaks around and it goes from one to the other. Because yeah, as I mentioned, I think it it's really a growing market. There's a lot of hospitals, at least looking already at this kind of technology already, maybe a bit scared about the MDR to really start. But if we can lower that threshold, that would probably get them started. And probably it also has to do with reimbursement schemes. So once this gets it's easier to reimburse a personalized product, then it will take off for sure.

SPEAKER_01 34:29

I'm surprised some hospitals, I mean, the ones that who don't use your product, do they have their own QMS system then?

SPEAKER_00 34:37

Well, I hope so. Well, yeah, I know that a number of hospitals they already started before I offered the system. They already built a quality management system. Yeah, some of the bigger ones based on ISOM345, uh, the smaller ones may have looked to the MDR and yeah, interpreted them themselves. And and of course, there's a community and people talk to each other. But yeah, when my fear is a little bit, and that's what I also always try to advocate on on LinkedIn is that so we interpret the MDR, but is that really the case? Is that really true? What do you think? So I'd rather put my eggs in the basket of the lawyer. Well, basically translating the MDR rather than interpreting, because in the end, you're you're making a medical device that goes into a patient and to someone's loved one, who I do hope that everyone has a good quality management system and adheres to the law. And then another, I don't I wouldn't call it fear, but at this point, because the MDR is just into effect for several years, all the notified bodies, all the local authorities are very busy. So there's not any inspections really going. So there haven't been any slap on the wrist, but at some point they could even give penalties for not adhering to the law, and that's something that you probably want to avoid at all costs. And that's something that that scares me sometimes. The accessibility of 3D printing made it so easy that people rush ahead and making medical devices, yeah. Please be careful. And uh the law is there for a reason, and it's not to to make your life harder, it's just to ensure that patients get safe and effective devices.

SPEAKER_01 36:22

Yeah, you mentioned that you partner with legal experts in this, which I absolutely agree. Now, how do you how do you know that this particular group of lawyers are more trustworthy than the other? Um I'm sure there are other law firms who want to get into the space too.

SPEAKER_00 36:36

Well, I in a way I don't. Yeah, they're lawyers, so I somehow trust that this is their expertise and the fact that they were in this space already. As I mentioned, they were offering this already to podiatrists. So they had already a number of years of experience. And they also they not only focus look at the MDR, they in their platform they also offer other regulations, so to say. I think there are abbreviations in there that I don't even know. But the GDPR for one, so the privacy regulation in Europe, that is also one that they offer. And I think for personalized devices also quite relevant because most of the times you really get the name of the patient, the date of birth, all their DICOM imaging, which is data that you're processing and that has a privacy impact. But coming back to your question, they are lawyers and they are experienced and they need to be able to do that.

SPEAKER_01 37:32

In other words, if if you want them to regulate devices made for your wife and children, you would trust them.

SPEAKER_00 37:38

Yeah, 100%. No, well, not to make the no not to make the device, but to not make the device tell me what I need to do to make a proper device and to adhere to the law.

SPEAKER_01 37:49

So we have been actually, I think, our cross path in the past, Eric, I think you've appeared in one of the point of care 3D printing webinars that we hosted. Um, but now obviously you're in a different space. You're providing the service to a lot of these point of care hospitals, labs. What do you think the industry is going? Do you think do you think this will be a standard in every hospital in Europe?

SPEAKER_00 38:11

Yes, I firmly believe so. I mean, I already believed it in 2011 that personalized is what's going to happen. And now it's moving into the hospitals, which I think is is is the logical choice because when we were a commercial company and we were talking to surgeons because we needed their input and their prescription on the device that we were making, but they don't have time, they never have time, they're always busy. So whenever we wanted to discuss an implant design and we had to set up an online meeting, which was challenging in his own right, but usually it was at 10 in the evening because that's when they are at home and have some time for other stuff rather than surgery or something. So we had a lot of late-night discussions with surgeons. Whereas if you bring that closer to them, so in a hospital, they can, in between surgeries, they can just go to the 3D lab, say to the to the engineer, Oh, can we review that case real quickly? And then you open that case and you get his feedback and his input, and then you can proceed. It just needs a little bit of his time or her time, and just because the proximity and because it's in the hospital, that makes it just so much more powerful. So that's why I think this 3D lab has a kind of uh existence right. No, I don't know how to say that properly, but it's like in the imaging department. So they make CT and MR images that has gained place in the hospital. Uh yeah, you can't imagine hospital without it anymore. So yeah, I do believe that every hospital in the future will have a department of 3D technology. That's the way we call it right now.

SPEAKER_01 39:54

So and from a regulatory perspective, since you're expert in the field, like what is your number one wish that the EU can, you know, create this one law that will make things much easier for these point of care services?

SPEAKER_00 40:09

That to no, I mean, I'm not a lawmaker. As I said, the MDR is there to protect patients and everyone has to adhere to it who makes medical devices, so commercial manufacturers, but also 3D labs. The thing is in terms of size, you might want to look at things differently, but usually there is room in the regulations as well. If you're smaller, that you are somehow have to adhere to other requirements or smaller requirements, but in the end it goes about the safety of the device, so you there's not really much way to deviate from it. But you have to realize you're becoming a manufacturer, and that was before that was exclusive to to commercial companies, and now hospital is becoming a manufacturer bit by bit, and that is just something that they have to do right, also. I mean, by all means make ho uh

How To Contact Erik

SPEAKER_00 41:05

make devices in-house, but make sure that you uh that you do it properly and and to level the playing field with a commercial manufacturer, same rights, the same regulations should apply. Because otherwise, why would a hospital not start making standard knee implants? Because it's cheaper to do in-house and you don't have to adhere to any heavy regulations. Why not actually?

SPEAKER_01 41:28

Why can't they? I mean, they have all the machines and technology and and probably talents. One day I can see that happen in the hospital.

SPEAKER_00 41:37

Maybe one day, but at this moment, most are not experienced manufacturers. And if you look at the industry, um, and that is also something that I noticed during the last five years as a consultant, the requirements for industry with the ISO 13545, they're quite heavy. And if you then see hospitals doing more or less the same, but much getting into the surgery much faster and easier, uh, that feels it might feel a little bit unfair. But for a commercial company, there's just no avoiding it. So they all accept it. They know they need to go to a notified body, get their QMS certified and everything. So that somehow also needs to happen if a hospital starts manufacturing things.

SPEAKER_01 42:23

Yeah, I agree. Well, thank you, Eric. We have reached the end of this interview. Thanks so much for spending time with us. How do people get in touch with you and when they when should they reach out to you?

SPEAKER_00 42:33

Well, uh, you they can have a look at my website. It's uh case3d. It starts with a Q QASE3D.com. And if you have any questions on quality management and compliance, if you're working with 3D printing in a medical space, if you're making medical devices, then let's talk and see if I can help you. And if I can't help you, I'll try to point you in the right direction. But if they want a lean system, it's easy to use, it's compliant, or still also good for ISO. I would gladly help them. Awesome.

SPEAKER_01 43:10

Well, thank you, Eric. I'll see you next time.

SPEAKER_00 43:12

All right. Thank you so much, Annie. See you next time.

Disclaimer

SPEAKER_01 43:15

This podcast is for educational and informational purposes only. The views expressed do not constitute medical or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case, but always consult with a licensed professional.