PODCAST
Medical 3D Players: Craftsmanship Meets Digital Precision to Scale Personalized Vascular Care (S2, Ep.01)
Discussing mass personalization in healthcare — because one size fits no one
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Uncover the latest medical advancements and challenges in 3D technology. Hosted by Pieter Slagmolen and Sebastian De Boodt from Materialise, this podcast examines key developments with experts in the healthcare industry.
In this episode, we dive deep into the world of custom-made vascular devices with Jamie McCarte, Head of Global Custom Devices at Terumo Aortic. Jamie shares his insights on how personalized solutions are transforming the treatment of aortic diseases, the collaboration between engineers and clinicians, and the role of cutting-edge technology in delivering tailored medical devices. Tune in to discover the future of vascular healthcare, where innovation meets precision in patient care.
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Read the full transcript
Sebastian De Boodt 00:00
Welcome to the 3D Players podcast, where we explore personalization in healthcare through advancements in 3D technology. We talk to leaders championing more predictable and sustainable patient care. I'm Sebastian De Boodt and I'm joined by my co-host, Pieter Slagmolen.
Pieter Slagmolen 00:23
Welcome to 3D Players! I'm here today with my co-host, Sebastian. Today, we're recording the episode in parallel with the Materialise Leading Minds conference in Leuven, which means that we're lucky enough to be able to welcome our guest today to the studio. We have with us Jamie McCarthy. Jamie is the Head of Global Custom Devices at Terumo Aortic, which is a leading medical device company that specializes in the design, development and manufacturing of vascular technologies. Jamie’s expertise lies in custom devices where he has been working for over 10 years in this field. And with this episode, we hope to discover why personalization matters in this field, how Terumo is contributing today, and what opportunities the future may bring. Jamie, welcome to the show.
Jamie McCarte 01:05
Thank you. Thanks for having me.
Pieter Slagmolen 01:08
Maybe as a starting point, can you tell us a bit more about Terumo Aortic? What is the company all about?
Jamie McCarte 01:12
Sure. So Terumo Aortic are part of the larger Terumo group, which is a Japanese-owned company, medical device company, and Terumo Aortic form, basically the vascular graft division of the Terumo Group. So essentially, we've been put together by Terumo to address the needs of patients and clinicians, basically provide treatment solutions for aortic disease, and we pride ourselves in having solutions straight from where the aorta connects to the heart right down to the LAX. So we'll get a variety of different solutions for treatment of the aortic disease throughout the whole aorta.
Pieter Slagmolen 01:50
So, you're specifically the Head of Global Custom Devices? How did you end up in this role? For somebody in that role, what does a typical day look like?
Jamie McCarte 01:58
So I started in the company maybe 13 – 14 years ago, and I'm from an engineering background, so I have a master's degree in engineering and started in R&D. And at that time, we were just a Glasgow-based company called Vascutec. And we just started looking at custom-made devices. So a small group of engineers who are taking these requests for custom devices from the field. And we would look at how we could develop and design products based on the core technologies they've already had to basically provide a solution for individual patients, where a clinician is common, there's nothing else available. And from that, the demand just grew for custom-made products. Different clinicians could see what the technology that we could offer as a business could do for them that off-the-shelf products couldn't, so different regulations and different standards to meet with every one of these devices. But yeah, we ended up evolving from my team of engineers and R&D, looking at one-off requests, to a dedicated team spanned over multiple sites. So again, this was back in 2010 – 2011 when we made the first custom-made device, and Vascutec, the company — over time Terumo — then acquired Bolton Medical and Sunrise Medical, Florida, and it's joining both the Medical and Vascutec, which made this global custom solutions entity. And I guess I've just stuck with it. So I've been there since the start and joining up the two companies, lots of opportunities for different development paths with different personnel within the team. And instead of just engineers, we have engineers who have clinical-orientated planners, we have dedicated case management staff, admin staff, who will just work dedicated to providing these custom solutions. I realize I'm kind of jumping all over the place here. So again, looking at a day-to-day, what we do is, essentially receive requests worldwide for these custom-made devices. And it's the job of the team to take the request and look at what a clinician wants and then provide an optimal solution, and we need to often do that in a fast turnaround.
Sebastian De Boodt 04:12
We'd love to dive into the whole custom device process since this is the first time that we have somebody from the vascular space as a guest on the show. Can you first walk us through some of the basics first, if you talk about a general stent graft, when does the patient need a device like that? And how does such a device work?
Jamie McCarte 04:32
Sure. So, the company I am with, and Vascutec historically, the biggest volume products we make are open surgical grafts, and, again, they can be used for various different pathologies and for treating different areas of the aorta. And that's when you think about traditional open surgery. That's what happens to patients where new devices are sewn in place, and then over time, and what we customize most as endovascular solutions, and endovascular just refers to minimally invasive surgery. So this is where stent grafts come in. These are stent grafts, again, in basic terms of devices that are introduced through a specific delivery system, and the access point, usually in the groin, and the device is then advanced into the aorta and deployed whatever the area of disease is. And so traditionally, I mean, endovascular devices have been around a while. And standard repair using endovascular devices can be done with off-the-shelf devices. So the biggest kind of treatment, or the pathology that we treat, would be aortic aneurysms. An aneurysm is like a swelling, like a balloon in the blood vessel. And if that's left untreated, what can happen is the aortic wall thins, and the blood pressure can increase, the aortic wall can rupture. Putting a stent graft in place basically excludes the aneurysm, provides a new conduit for blood to flow. That's all just general background in treating the aortic disease, where custom-made devices come in is when off-the-shelf solutions are not going to be suitable or ideal to treat certain types of anatomy. And that's when clinicians tend to look at us and other companies to look for custom-made solutions
Sebastian De Boodt 06:19
Can you give us some more color on when the standard is not suited? Is it then to do with the geometry of the anatomy mostly, or are there other factors that play?
Jamie McCarte 06:27
Basically, the most common type of aneurysm would be an abdominal aortic aneurysm. And that's below the level of the renal arteries, so this big balloon-type phenomenon is happening under the level of the renal arteries, and what you need to do when you're planning these cases, is provide the sealing zone for the stent graft. And in a typical standard case off the shelf, there's a suitable landing zone underneath the renal arteries and the healthy aorta, so we need to land in a healthy aorta and need to basically exclude the aneurysm and when custom devices come into play is basically when we don’t have that healthy landing zone or the disease has progressed, in an abdominal case, usually higher, to the level of the renal arteries to the other visceral vessels, superior mesenteric artery, celiac trunk, and these are all key blood vessels that supply major organs in the body. So when the disease has progressed to those vessels, we have to provide a solution where the stent graft or the device can basically accommodate the other blood vessels. And we do that through different means, fenestrations in the stent graft, essentially, holes, which we can then deploy branches through and provide a new route for the blood to flow and obviously still have blood flow to all these major organs.
Sebastian De Boodt 07:47
How does that design then go about? Do you design the stents from the ground up? Or do you have like a standard device where you then make some adjustments to?
Jamie McCarte 07:58
Essentially, every request is an individual case in itself. They are all unique; they have to be unique by definition. So every device is designed for a specific patient. And that's basically following the regulations under MDR currently. We can only make one of these devices if we have a request from a clinician for a specific patient. So we have a lot of core technologies. We have different product families in that, so we categorize it in the company. I think where we've got an advantage over a lot of competitors in the market is we do have technologies in open surgeries as well as endovascular. And we also have hybrid technology where we have devices where we can combine endovascular and open surgical technology in one device. So yeah, we get a request in normally, we would have a CT scan accompanying the request, and our clinical team, along with the clinician and our clinical specialists in the field, would review that CT scan and assess what the actual requirements are for that patient. And it makes sure that the clinician is aligned and it's in line with how he wants to treat the patient.
Sebastian De Boodt 09:05
I was intrigued by the tagline on your website, which states Innovation Through Collaboration. Is that this collaboration that you just talked about? Is that what you mean with this tagline? Or can you give some examples of, how this typically goes about?
Jamie McCarte 09:19
I think in the field of custom-made devices, it's critical; we have to collaborate with clinicians; we collaborate with their own field-based personnel to make sure that optimal designs are always realized. It depends on the clinician, depends on the personnel involved in each case, some clinicians want to be really heavily involved in every aspect of design, some want to give us a CT scan and have a solution out in the end quickly. But yeah, the solutions that we've implemented, the current systems and processes, and working with Materialise has helped us, using current technology, using cloud based system, to have that collaboration and have real-time updates on where each case is.
Pieter Slagmolen 09:59
Because it begs the question: One, these are, the way you describe it, relatively complicated patients, and thereby also complicated devices? Is this done by any vascular surgeon? Or is it a specific breed of surgeons that tackle these cases?
Jamie McCarte 10:14
Yeah, most of the procedures that are carried out with these devices are done by experienced clinicians. And again, in accordance with regulations, it has to be a request from a suitably qualified medical practitioner. So yeah, I mean, most of these clinicians are known worldwide, you go to congresses every year, you hear them talking about devices, talking about new ways of treating patients. But yeah, most of them are specialists in that area, and sometimes patients are referred to different centers, and then tell us to make sure that the ultimate treatments are performed.
Pieter Slagmolen 10:49
What I'm wondering is, how does the clinician provide his or her input to you guys? Is that the engineering team? Because you described at the beginning that you basically grew out of an engineering company that then has acquired clinical knowledge, and so on and so forth. Is it you, as an engineer at a more clinical engineering company, that drives the design and then asks for feedback from the clinician? Or is it the physician that provides you with very specific requirements based on the CT scan, for example, on what he's looking for and you then implement that? How does that work?
Jamie McCarte 11:18
Referring to regulations for providing custom devices, the request has got to come from a clinician, so there's no, aspect of us going out into the field and trying to push these devices. Clinicians are aware of the technology, and that's grown over time. And what we've done is we've tried to categorize and simplify how we can offer the different types of technology. And we categorize it by different product families. And we've created like a suite of request forms, based on each of the core product families, so the physicians know, depending on the anatomy that they want to treat, what type of product family is going to treat that and then we've tailored request forms to basically capture their requirements. And then the process works: they can submit that request form with a CT scan, or something without a scan if it's a relatively simple case. But the request captures all the parameters of what they want. And then other planners and engineers will look at that. There can be more collaboration and discussion, whether that is the optimal design from the start or whether we have to then develop something different.
Sebastian De Boodt 12:21
It seems like you have quite a broad spectrum of types of devices also, like different ways of collaborating depending on the preference of the surgeon. At the same time, it's a high-risk device. I mean, we had people from orthopaedics and CMF on the show. But when you talk about rupturing of an aorta, I mean, it's very high risk. How do you deal with the complexity, the variety of cases, while still making sure that the quality is ensured and that you're delivering something that's safe for the patient?
Jamie McCarte 12:53
That's a good question. Over time we've kind of evolved risk management systems within the business. So we have to do a risk assessment for every individual case. And when we get these requests in, we'll look at the scan, we'll look at the parameters of the request, engineers will assess it technically, our clinical planners will assess the element of clinical risk. Again, over the number of years we've been doing this we can use previous experience in what we've learned from previous cases in applying elements of risk. So when we send a design out, before we start manufacturing, the clinician has to essentially sign off a prescription for the device. So we create a form, which has all the key parameters and the final design, and included in that form are additional concerns, additional risks, that engineers may want to highlight related to the designs. Before the clinician is signing off and committing to having that made, they can assess what we've come up with and what we see are things to basically be aware of before they proceed.
Sebastian De Boodt 14:00
It does seem that as an engineer working on your team, you do need to have quite some specific and complicated knowledge, not just on the engineering, but also on the anatomy and pathology before you can actually do the job, let's say. Is that indeed true? What's the typical onboarding timeline for an engineer?
Jamie McCarte 14:18
Yeah. It's a good question again. And I started this in this industry without any medical device experience. And coming into a company like this, you can quickly pick up the nature of the products and learn about the anatomy. And that's what we do as part of onboarding for anything. So nowadays, we do tend to recruit biomedical engineers, they seem to be the most suited to the role. And we're lucky to have two big universities in Glasgow nearby that have biomedical engineering degrees. So we have a lot of interests whenever we have vacancies, but we do still have quite a diverse range of backgrounds within the group. And I think that's important as well. From mechanical material science backgrounds, and so on, that study product design, which is elements of mechanical, electrical engineering, and just having those different perspectives can be good when we look to develop products and processes as well. But anyone starting, we obviously buddy up with experienced engineers, and we use our clinical teams as well as to make sure everyone's fully aware of what they're doing and the nature of the anatomy and types of devices on that they are working on.
Pieter Slagmolen 15:33
You describe the process of a clinician getting to a prescription and then essentially giving the go for for manufacturing of the device. A lot of our guests in this space use 3D printing as a technology to manufacture the devices. How does that work for the types of devices that you make? Do you use 3D printing, for example?
Jamie McCarte 15:51
When we first started making custom devices and making custom fenestrated devices, so fenestrated devices for endovascular aneurysm repair or FEVAR as it's known. And we had a platform that we felt was really well suited to FEVAR, and we could treat a lot of complex anatomies. And to verify these different designs and to test and develop designs, we used 3D printing a lot, especially in the early days. What we did is take CT scans from the patient anatomy, convert that CT scan, and, as is well known in Materialise, create models to basically then test prototype devices. We still do that now, more for complex cases and modular designs where we want to connect different components together, and so on. So we use 3D-printed, usually hard plastic anatomy models work better for what we need. So we need a transparent model that's tested repeatedly. And this has been really useful. In the early days, clinicians, we used to offer what we call a case rehearsal service. So our engineers would basically make these anatomy models, deploy prototypes, and that gave them data, as we talked about, for risk assessment and to mitigate certain risks related to using that design. But then, we could reload the prototype device and send that out to the clinician in advance of the case with the model and they could then deploy devices and the 3D models and see for themselves and especially for complex anatomies people that are less familiar with the technology, give them more hands-on experience and then reassurance that things will go well.
Pieter Slagmolen 17:30
The way I understand is the 3D-printed models are there for like templating and for testing and for validating and for reviewing the device itself in the end but the device itself is not created using 3D printing. So you see it as an add-on somehow to help you in the manufacturing, right?
Jamie McCarte 17:47
For those, the 3D printing was more to create replica anatomy models that let us then deploy prototype devices and then look at that so that the devices themselves are all not 3D printed. We've looked at different automated technologies for manufacturing, but mostly devices are still quite labor-intensive and hands-on.
Pieter Slagmolen 18:06
And is that because there's an enabling technology on the 3D printing side still lacking to, for example...because I'm assuming the devices are nitinol, right? That technology still needs to be developed, perhaps before he can even consider thinking about directly printing the devices?
Jamie McCarte 18:20
I think so yeah. And we have definite stent technologies within the business as well. So we have a ring stent technology, we have Z stent technology, and we have different methods of manufacturing, different suppliers involved in that as well. So yeah, I think, to do that and replicate that, and validate that, with 3D printing, we might still have a bit to go. But for what we do, we also have, we use fabric and we make the fabric in-house as well in Glasgow. And that's a big part of it, is combining this stent technology with the fabric. And that's the most labor-intensive. Not really the production of the stents. It's the sewing of the stents onto the fabric.
Pieter Slagmolen 19:04
You've been doing this for a while, these custom devices, and you describe the process of using 3D-printed support accessories and then the manufacturing of the devices with nitinol and then in combination with fabric and so on. Have you seen the operational management of these devices? Have you seen that change substantially from how it was done maybe 10 – 15 years ago to how you do it today? Have there been operational gains that you were able to achieve that make it more scalable, for example, to bring these devices to more patients?
Sebastian De Boodt 19:32
And then specifically as you grow into a more global company?
Jamie McCarte 19:36
In the production side of things?
Pieter Slagmolen 19:37
In general, I would say, the production side is only one of the aspects, but if you look at the entire chain, I mean, are there aspects that you say, Okay, if you look at how we do this, now, compared to how we did 10 years ago, it's vastly different.
Jamie McCarte 19:48
Yeah. So, from my perspective, we used to manage everything through various different spreadsheets. And that was all okay in the earlier days when we had a small number of cases. And now, with having lots more cases, and to scale the business up, we had to look at different solutions. That's where we started looking at, we now have Mimics Flow and, previously SurgiCase, We joined up with Bolton Medical, and that gave us an identity as Terumo Aortic. Previously, there's two different companies through a different identity. So having that single online solution gave us a consistent format and a platform to build from that give both our engineers planners and all the staff working on the devices internally, but also the clinicians in the field a consistent user experience and something that we could build up and scale easily. So again, it was a big exercise, change management to basically point people away from using uncontrolled spreadsheets and look at handling data better, and we have different internal systems that link up to Mimics Flow, but what we have now is a much more scalable system where it's the same consistent process, case by case. And that has just let us do a lot more cases and get the solutions out to a lot more patients.
Sebastian De Boodt 21:08
I can imagine because it's quite a big change, and change is always difficult. How did you manage that change from, let's say, more ad hoc emails and so on, to forcing a bigger organization to really consistently use more of a platform?
Jamie McCarte 21:24
It's still an ongoing challenge, and different people have got different ways of working, especially with things like email that's commonly used, we've just tried to proceduralize it basically. Any correspondence and any communications related to custom cases are all done through this system, this online collaboration system, so that it's audit traceable, and we can see a complete record of all the correspondence design decisions made throughout the case. So we've formalized through the quality system, that's part of a process now so any emails that are sent we can then upload and we can refer to on the system as well. And over time, the field personnel as well as clinicians and all the team working on these devices have seen the benefits and they fully believe that's the way forward.
Sebastian De Boodt 22:09
Great to see that. And is that platform then now also used in a customer-facing way? Because you mentioned creating a consistent experience for the clinicians. So they are directly also interacting with it?
Jamie McCarte 22:20
Yeah, not every clinician wants to have to log into something and use a system. And then, some do. Again, as I said before, it just depends on the personnel involved. And it's all part of providing that sort of personalized service, we're trying to give a product and a service that's suited to exactly what the clinician wants. So we do it, if clinicians want to use the system, we can give them an account, we can do one-on-one training. And again, it's relatively straightforward. I think, using a system like this, it's been a good analogy we've used this is like internet banking. Once you're logged in, you can see where everything is and how it works, it's not difficult to understand. And we have some kind of different spectrum of experience in the clinical community. Some like technology and want to use it, some don't. Some just want somebody else to give them what they need. And they can have some design. And so over time, we've seen more clinicians using it, and again, the direct benefits for us are engineers having direct contact with physicians in getting these design decisions quickly. It's good, then we can get other feedback and ideas for future development as well through that.
Sebastian De Boodt 23:26
And I think it's something that does come back, when you try to scale a personalized approach that, at some point, this platform becomes something practical that you need, but then also quickly turns into an added value for the clinicians because they like it, and it gives them visibility and so on. It seems to play a more and more important role in the scaling of personalization. Do you think medical device companies are becoming more and more software companies? Or is that something that you would rather stay away from? What's your perspective there?
Jamie McCarte 24:00
No, I think it's really important to embrace technology like this. And we would be going almost backwards, I think, if we were trying to stick to more manual-based, paper-based systems, even using spreadsheets, using email for every email chain, there's multiple people involved and communication gets lost, people miss things. So yeah, I think for medical device companies going towards a more, you're still going to have products but having a more service-orientated and patient-centric approach, I think, through the application of these technologies is critical.
Pieter Slagmolen 24:35
Obviously, your focus is on personalized devices. Can you maybe illustrate how big the impact of those are in the vascular space as a whole? So, how many devices there are at this point in time, personalized versus still standard, and do you see that evolve substantially in the future?
Jamie McCarte 24:55
I think there are only a few big companies involved in providing custom endovascular or open, more hybrid solutions, but custom solutions in the aortic space. And I think what we've seen over time is the demand for these products has grown as clinicians get more comfortable with using that type of technology. So certainly, within our business, we've seen the demand for custom devices increase a lot. And we add a lot of value to these devices to get a lot of the tension off. And it's quite labor intensive, we still have to design things, we still have to consult with various different people. We add a lot of value, the products are obviously more profitable as well. So it has formed quite a big part of our business. The core business is obviously still off-the-shelf products and open surgical devices are still growing as well. But what I do see is just more clinicians seeing the benefits of having that type of service available. And alongside, it's difficult. As it scales up, we've got to make sure that the production capabilities are there to keep up and we can turn devices around fast enough.
Sebastian De Boodt 26:07
What would you say is the biggest challenge that you have in front of you when it comes to further scaling or accelerating the adoption of personalized devices?
Jamie McCarte 26:16
For me, it's just what I said, I guess. We now have really robust systems and processes to receive requests and for the teams working on the design and planning and so on, to progress them is then getting that through this to the business where there's other priorities and other focus areas. So I’m just dedicated on custom devices and as a small part of a really big business. But as that grows, it's difficult to balance the demand and the priorities for custom-made solutions along with all the targets for standard products, particularly through production.
Pieter Slagmolen 26:51
When you talk about fast enough lead time in this specific space, because we have seen people here in the orthopaedic surgery space, we have had people in the cardiovascular space and so on, or even in the oncology space, what does a fast enough lead time mean for you? Because typically, that's a very important driver for being able to choose, even for personalized approach, somehow. So what does that mean in the vascular space?
Jamie McCarte 27:10
Typically, the industry standard, that's banded around this, to have a solution available to implant, usually three to four weeks after the clinician has approved the design. And that's typically the case, depending on the complexity of the case, too. A CT scan can come in, and there can be a lot of discussion, a lot of collaboration before we get to a final design, and that can go up to six, seven weeks. But usually we get a request, then everything's relatively straightforward and agreed straightaway. Clinician signs it, and then it's getting that, when they sign it, there's a deadline, there's an expectation, and an implant date, so we work towards that. And we prioritize the cases based on what the field needs and based on clinical urgency as well.
Sebastian De Boodt 27:59
Today, it seems like there's still a lot of knowledge and, well, craftsmanship for every single patient. We've also had guests on the show with more high volume, more orthopaedic applications, for example, where AI and automation is a big driver to further scale. How do you see that for your type of application? Do you see a lot of the manual engineering work getting replaced by AI or is that still far away in the future?
Jamie McCarte 28:24
We've looked at different technologies as they are introduced. It's one of the benefits of working on custom devices. We can, as long as we can look at the element of risk involved, we can look to try new things and experiment with different solutions and different processes. I don't see AI replacing the need for planners and engineers case by case based on the current type of products that we do and the complexity involved. But yeah, I certainly think as time passes and technology progresses, it's going to be more and more important. And we can see benefits, particularly on the case management side and how things are processed and how we present and report on data. But looking at KPIs and performance of the team, we can use certain aspects of AI to take data and assess where we are strong or weak or where we need to improve. But also look at the types of requests that we get, look at the parameters that come in from the field, what final designs we put out, how many times we have changed designs, what geographies request certain things, and I think there's technology out there that we're already using to an extent, but that's making it a lot easier to dice and assess that data.
Sebastian De Boodt 29:34
But the personal interaction between the engineer and the clinician is still remaining an important factor I can imagine.
Jamie McCarte 29:41
Yeah, I would say so. And I think that it's also something we have become a bit sort of known for in the field as having that personalized service. There's aspects of that you can't get away from. It takes time to have these discussions and have that collaboration. And the systems and the collaboration we can have through the online system and real-time tracking and so on, helps with that. But yeah, I think that still really has a lot of value and an aspect that we wouldn't want to lose.
Sebastian De Boodt 30:10
And I guess you've captured a lot of, you know, innovative ideas as well, through those discussions on maybe new products you might want to develop.
Jamie McCarte 30:19
And that can also help drive product development and the direction that our R&D teams may want to look at and how they're going to develop standard products as well.
Pieter Slagmolen 30:30
The devices that you're making are obviously very high risk. You already described the approach where you're basically driven by prescription, by the physician, to actually go into the manufacturing and so on. Have there been substantial changes, for example, on the regulatory side or what was important for you to bring and keep these devices on the market over the past decade.
Jamie McCarte 30:50
The big change was the introduction of the MDR in recent times. To be honest, with custom-made devices, it changed things a bit. But in general, the regulation has a set of essential requirements that have to be met. And that's our responsibility as our business to make sure that we're providing something that meets those requirements. And where there's something that's not meeting the requirements stated that we are addressing and communicating the risk associated with that, because, for these devices, a lot of the times it's the last resort for patients and clinicians to treat them. So, basically ensuring compliance with that. But we do have, obviously, a regulatory affairs team that will keep on top of any changes to the regulations. And we have dedicated people within our team that’ll keep us right with what we need to do.
Sebastian De Boodt 31:36
All right. I am curious how you look at the future, and maybe specifically are there certain innovations that you are specifically looking forward to new enabling technologies in your field that you think will have an impact on the next generation of products in your field?
Jamie McCarte 31:51
There are a few things that we're working on as a business, and as the custom side of the business grows, we've seen more opportunities to take development that R&D are working on and then introduce that through a custom platform because clinicians have expressed that kind of interest. They've been involved in the design process and they want to be able to apply those technologies now to be able to treat patients. And as long as we can have sufficient design verification done and risk mitigated, we can take that new technology, and put it through the custom program and do that. So some recent developments with some of our hybrid products, where we have located a unique type of device that's used for treating thoracoabdominal, complex abdominal aneurysms where we combined open surgical techniques with endovascular. That's only to specialist clinicians and specialist centers. But through that development process, working with our R&D teams, we've been able to do a number of those types of cases in recent years. In the last couple years just, and we've seen a big positive response from the clinical community.
Sebastian De Boodt 33:03
So what I hear you say is that having this custom process in place also allows you to accelerate the innovation even more? Also, maybe on what will ultimately maybe be used in standard grafts because you have more flexibility?
Jamie McCarte 33:18
We do have flexibility. We can use the technologies that we have available to make optimal solutions, and, by definition, custom products aren't CE marked, the standard products are. So we're providing something that's it's not off-label; it's designed for a specific patient. And it's to prevent clinicians maybe taking something off the shelf, and then using an off label and using it against the IFU. So it does also give us clinical experience for if we do cases like this with devices, with these parameters, we can see the clinical outcomes. We can see, over time, there's various studies done and lots of things published on all the devices we make, even custom-made devices that we can then use to help drive future development as well. The clinical experiences is a big thing to actually see successful implants done with different types of technology, it can definitely help drive future development.
Sebastian De Boodt 34:17
And it goes full circle again to your “Innovation Through Collaboration tagline”. Nice.
Pieter Slagmolen 34:26
One aspect that we haven't touched on is, you mentioned it in the beginning, you're actually based in Glasgow and you were acquired by a Japanese company. Japanese companies have been quite instrumental in the past in establishing, in other industries at least, a few manufacturing practices like Kanban or just-in-time and these kind of things. Have you seen elements in the way of working that that you adopted or were able to adopt from your Japanese mother company and bring into the Scottish environment and do you see some of these aspects being relevant also for other companies?
Jamie McCarte 34:56
Yeah to an extent. Terumo, they don’t directly influence how we manage the Terumo Aortic business, so we've not really seen anything enforced, and it's consistent across all different Terumo entities, I think. They are all still treated as different business entities. But yeah, in the team I've been in, I've seen different practices employed and some successful, some not. And that's how we learn and grow as a business. But, yeah, I think there's always something that's evolving, and, in particular, what we do with custom stuff is seeking continuous improvement all the time in all areas. But where I'm focused is more on the process of receiving the devices and providing that service to the field, to the clinicians. And in working with internal stakeholders, so it's a balancing act because it's a different — the same personnel can be involved in making custom devices or standard devices. But when a customer's request comes in we have to often jump them to the top of the queue. And it's like that just-in-time, and it's managing that type of process alongside the other standard business processes that's the ongoing challenge.
Pieter Slagmolen 36:06
And on the geographical aspect as well, obviously, you're a global company, you mentioned MDR already and the custom device pathway in Europe. Are there substantial differences in the major regions in the world to how such personalized devices are perceived and how the market looks at these kinds of technologies?
Jamie McCarte 36:24
I think across Europe, obviously, that's where we're doing the majority of the custom business. Just now, we have some made cases in South America, Middle East. We've done a few in Australia, and so on. And our regulatory department makes sure everything's aligned. Most of the requirements are similar from different markets. The big difference is the US where we don't provide custom solutions currently. We do provide other off-the-shelf products in the US. And there's different avenues and different routes to get some of our technology in there. It's not essentially classed as a custom-made product, but we're currently involved in a various number of initiatives to basically use the same type of product that we can offer in Europe as a custom-made device and offer that technology to the US market as well. Again, it's just meeting the FDA requirements and whatever clinical trials and clinical studies are needed to get there.
Pieter Slagmolen 37:19
So there are regulatory differences, but essentially, the market demand for these types of devices and the patients — you see them across the world. And it's about figuring out how to manage the different regulatory environments to be able to also offer them.
Jamie McCarte 37:30
Yeah, exactly.
Pieter Slagmolen 37:32
It was a very interesting conversation, Jamie. thanks a lot. My main takeaway, perhaps of this conversation is that while there is a lot of demand for a specific group of patients for these highly complex, personalized devices, the process to get there is still a combination of, on the one hand, quite craftsmanship in the manufacturing of the device, but then complemented with some relatively advanced digital technologies that allow to streamline the operations in the communication, which makes it handable to also scale that already to some extent, which I find interesting, because in a lot of other conversations we have, you see a bit of a different mix there. But the role of that digital platform and the impact they can have do seem to come back somehow.
Sebastian De Boodt 38:15
I agree with that takeaway also. I've written down that the systems and the technologies are there, still in support of the engineer and the condition not to replace anybody in that, but just to allow them to focus more of their time on the actual collaboration. Another thing that I found interesting was how once you have your custom platform and processes in place, how it also just allows you to tap into new needs more easily. And, therefore, as your custom department that can also really drive the innovation in the company as a whole. And I think it's also a nice way of contributing to the bigger organization and also to accelerate how we treat those patients.
Pieter Slagmolen 38:53
A foundation for the future as well. Jamie, would you agree with that?
Jamie McCarte 38:56
Yeah, I think that was a good summary. Basically, I see that these type of systems — it's just been an excellent way for us to be able to get these solutions in the technology to treat more patients. Yeah.
Pieter Slagmolen 39:07
It was an absolute pleasure having you with us today. Thanks for shedding some light on the vascular space and how you guys are operating in it and how personalization works in there. Yeah so thanks a lot for this conversation.
Jamie McCarte 39:17
Likewise, thanks for having me.
Pieter Slagmolen 39:19
That's a wrap for this episode of the 3D Players podcast. We appreciate you tuning in to explore how 3D technology is revolutionizing personalized healthcare. Don't forget to subscribe and join us next time for more conversations with pioneers in the field. This is Pieter Slagmolen and Sebastian De Boodt signing off.
Featuring

Jamie McCarte
Head of Global Custom Devices, Terumo Aortic
About your hosts

Pieter Slagmolen
Innovation Manager

Sebastian De Boodt
Market Director, Materialise
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