Medical 3D Players: How Lima Puts Personalized Devices in Perpetual Motion

Pieter Slagmolen 00:00

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

Sebastian De Boodt 00:23

Hey Pieter.

Pieter Slagmolen 00:24

Today we are very excited to speak with Massimo Calafiore. Massimo has held various leadership positions in the healthcare industry in the past and is currently the CEO of Lima, a leading medical device company based in Italy. Lima has a long-standing history as an implant provider for the orthopaedic industry. And together with his team, Massimo aims to restore movement to patients, as he believes movement is one of life's greatest joys. This seems like a great focus for a company — the gift of movement — and also a wonderful reason to ask Massimo to be a guest on our podcast today and talk about the role that personalization can play in this mission. Welcome, Massimo.

Massimo Calafiore 00:57

Welcome. Thank you for having me. I'm happy to talk about a topic that is very dear to me. As you just said, it's easy to be identified with a company that, in the end, has a main aim to bring the eMotion of motion to patients around the world. So, I'm looking forward to this conversation.

Pieter Slagmolen 01:27

Wonderful. You actually started at Lima fairly recently. Can you tell us how you came to be the CEO of an Italian medical device company?

Massimo Calafiore 01:36

Yeah, interesting. I am an engineer by training and spent the majority of my work life in the United States. I was lucky enough to have a good overview of the entire musculoskeletal business. So, I did orthopaedics first, I moved into spine, I worked with one of the leading companies in the world NuVasive. And I think all these experiences that I had brought me to start at Lima given that, being Italian, it was easy for me to be associated with the leading local, Italian company in the orthopaedic space, a company that is based on innovation. They know that what we have on the technology side and on the manufacturing side is state-of-the-art. 

The company was founded in the late 1940s. So, we're talking about years and years and years of experience. And luckily for me, given it’s a global company, which, of course, is of interest to me, given that I had, for many years, a global role. Actually, for most of my career, I always had global roles, so I was lucky enough to be chosen to lead this organization with the plus of being in my mother country, Italy. So, happy to be at Lima and grateful for the experience that I had in the United States that brought me here.

Sebastian De Boodt 03:20

So it was a little homecoming in a number of ways. Massimo, if you would ask five customers of Lima to describe Lima. What would we hear them say?

Massimo Calafiore 03:29

Yeah, as I said before, Lima is right now a pretty good size to differentiate itself. One of the main things that the customers in the market appreciate is that, given our size, a customer is still a customer and not a number. So, a patient is still a patient; a customer is still a customer. We are lucky enough to bring not just technology, but also a service level and attention to the level of support that we give to everybody in the field. That makes us interesting. At the same time, it’s easier for us to talk about Lima as a company that is laser-focused on bringing technology forward. We are not playing just the numbers game, we are playing also a differentiation game which makes my life, and the lives of many people at Lima, very interesting.

Pieter Slagmolen 04:31

So focus on a good customer relationship and a passion for innovation. Okay, great to hear. So how do you apply this to personalization? And, maybe, how important is personalization for Lima?

Massimo Calafiore 04:45

Yeah, this is an excellent question. The connection between Lima and Materialise is that Lima is a leader, for sure, in terms of know-how around 3D printing. You know very well that Lima's been the first, if not the first or second company in the world to start laser sintering titanium. The machine that you guys have also in your manufacturing plant got designed many, many years ago between Lima and a leading market supplier for 3D printing.

So, personalization and customization is in the DNA of the company at the end. The idea of laser sintering came because there was this goal, this aim, to mimic the human bone structure. So that one was the first impulse that brought the creation of this technology. You combine this with the ability, as I said before this DNA of the organization to bring back motion, and to restore, let's say, a high quality of life with the patient. I think that creating implants that match, specifically, the bone void that is created by the specific disease, is the ultimate goal, the ultimate aim that we have to restore the anatomy of the patient. So, personalization, I think about patient-matching implants to become very natural for this organization, given that the entire thesis around the laser sintering was to mimic, again, bone morphology.

Sebastian De Boodt 06:30

And can you give one or two examples of applications or products where you have a strong focus on personalization that you think are noteworthy or that you're proud of at Lima?

Massimo Calafiore 06:44

Yeah, I can think of two. We can divide it into twofold right now, I think there's going to be threefold in the future. So, you have this, let's say universal patient, let's say a cancer patient, that has the need to grow a very severe bone resection. With this patient, where the doctor doesn't have access to off-the-shelf implants that can replicate and can actually recreate the bone loss that you have, because of the very big resection. So, we have a team that focuses themselves on helping the patient with such a big bone loss to regain some kind of normal quality of life. You have this first universal patient. The second universal patients are the patients that go through revisions. So again, a failed implant, a bone loss that is so severe that an off-the-shelf implant cannot support the doctor to make the best procedure for the patient. So then, we intervene with this kind of product. And in the future, we are working to address even less severe situations to make this personalization easier to access for the doctor and for the patient. Even for cases where, yes, you could adapt the off-the-shelf implant, but I use the word adapt. Our goal at the end of the day is to match the bone loss.

There is a main example that I'm proud of, actually. We had a celebration a few months ago with the anniversary of the manufacturing site where everything around Lima trabecular titanium started. And we had a patient talking, and it was actually about a very severe pelvic reconstruction where we matched different technologies. So we had, on one hand, our product working to restore that bone defect and the ability to connect all of this with a pedicle screw system from another company. So, you see a patient that was bound to be in a wheelchair, that actually, because of the combination of technology, was able to regain some kind of functionality. At the end, the situation that's happening in the world is where all of this technology comes alive.

Pieter Slagmolen 09:15

Yeah, thanks for giving us the examples. It's interesting to describe that the ones that you're tackling today are still very high-end, complex use cases. And that you have the intention to also move that into the less complex patients. We actually did a survey not that long ago asking where people saw personalization grow into and whether it would become more common, which was apparently the general belief of the audience that we inquired. How do you, looking forward, see the relationship between personalization and the sustainability of healthcare?

Massimo Calafiore 09:46

Yeah, then I'm sure at the end, you used the right word. I think that there are other companies that even a few years ago went through this path, I think that they are not gaining enough traction because as you said, the pricing is still much higher than an off-the-shelf implant. So now, you have two competing technologies. On one hand, there are two competing macro factors that are dumping, let's say, the ability to full personalization one, as I said before, is pricing. And second, now you compete with the robotic application that, in theory, can increase the outcome or procedure, which is the same thesis that you have with a personalized implant. 

So, I think that’s how you’re going to win, for me, you're going to win, A, if you can manufacture and deliver a product that is personalized at a price that is competitive. Because, again, the study and the effort that you need to make in order to show that you improve outcomes with personalization is not sustainable for any company right now. So, be price competitive. And B, I think, really focused on this niche, or not this niche, this market segment where you are borderline between a straight procedure and something that is a little bit more difficult. But it is interesting to me to see the dynamic today. If you think about 10 years ago, you start to invest in personalization, and boom, there was very high growth of all these organizations that started to fade away, because at the end, you need to clearly show that there is a premium and also an outcome.

Sebastian De Boodt 11:36

You talk about manufacturing at a competitive price, which of course, it's a unique device that is definitely not straightforward as compared to the high volumes of standard implants. And that’s one of the topics throughout our also podcast series... around the scalability of personalization. According to you, what is actually needed to make personalized approaches more scalable, or more competitive, in terms of costs, as compared to a more standard alternative?

Massimo Calafiore 12:04

Yeah, that's a good question. So, we are already testing the water for that. I think we already have a foundation, which is at the point of care inside the hospital, we have a point of care inside HSS. So, let's say, so we have the infrastructure. Now, in order to support the thesis that the model is financially viable is going to be what I said before, figure out how to increase the market that you can address with this market segment of cases that are borderline. So, I think that the point of care is the way to, in theory, diminish the cost. But we need to demonstrate the thesis when we're going to have a throughput and a turnaround of a device that is going to be large enough to see if the investment is going to pay off. But my gut feeling is to really to validate the ability to manufacture inside a hospital.

Pieter Slagmolen 13:09

Very interesting perspective that you believe that would drive down cost. What would be the main drivers, then, to be cheaper when you manufacture at the point of care versus at a medical device company? Because you maybe have fewer economies of scale to leverage somehow?

Massimo Calafiore 13:24

Yeah, but at the same time this is why I said we need to see the volume, because yes, the amount of people that you use is much less; the space that you use is much smaller. So, you already have some savings because the box is very confined. You save all of the back-and-forth costs from point A to point B, so everything is at the point of care. Now, the proof is in the pudding, we need to figure out now, is the volume that you can have at specifically the point of care, with the investment made, if the math is working to make it sustainable. This is why, let's say the thesis we have is that you have this box, very confined box, where you make two specific investments with a few people that are ready to manufacture. Now we need to see the throughput that you can bring to the site. If you can do that, I think that is sustainable. Of course, if not, the thesis is not going to support itself.

Sebastian De Boodt 14:28

You are referring to the collaboration that you have with the Hospital of Special Surgery, where you have the on-site location, which is indeed I think one of the things that we, and I guess everybody in the industry, has noticed. Okay, it's an interesting experiment. I also always saw this as a way to collaborate with the surgeons at the HSS. And maybe more also, in terms of some R&D efforts. Was that also important? Or is it really as a kind of template and an experiment for more scalability?

Massimo Calafiore 14:58

I think that it's more of a template for scalability and on creating lots of solutions that are fully personalized. Because if you think about if this is work, this is the ultimate case to show a feasibility model because, in theory, you can be a surgeon that sees a patient, spends three minutes to walk to another room, sits with an engineer, designs the implant, comes back and after a couple of weeks, you have everything there.

Sebastian De Boodt 15:30

Okay, it's very interesting to hear from you.

Pieter Slagmolen 15:32

You refer to the engineer on site, so it's not only point-of-care manufacturing, as in 3D printers in hospital, but it's also all engineering teams and infrastructure around that to make that happen if I understand you correctly...

Massimo Calafiore 15:45

Yeah, because they do other stuff, but yes, you have a full support staff. Now, you can 3D print the plastic, so, you can do the size of some sort; you can do bone models. Especially, when you start to go through the most difficult cases, I think the surgeon likes to see a 3D-printed replication of the anatomy. So, there is a service that you give.

Sebastian De Boodt 16:09

We mostly have been talking about patient-specific implants so far, and indeed the expertise that Lima has in metal 3D printing is quite astonishing. You also have some patient-specific surgical guides to help in correct positioning of the implants. Can you explain also a little bit there, how do you see the importance for Lima?

Massimo Calafiore 16:29

Yeah, right now I think that this is improving navigation at the end, the PSI is linked to a plan; we are partnering right now together in what is the easiest way to deliver some kind of guidance inside the OR. So for us, the leap from 3D printing to plastic 3D printing has been pretty easy. Also, for us, compared, for instance, to a company like Materialise, where I see a lot of know-how on the software side, instrumentation devices are what we do every day. So, I think that this has not been too difficult, let's say to go from metal to plastic.

Pieter Slagmolen 17:09

It's interesting that you mentioned software, as well, actually, we see a lot of companies now invest more in software platforms to support personalized devices and services. How do you think that these software platforms will contribute to the scaling of personalization?

Massimo Calafiore 17:24

At the one end you have on the hardware side, let's see on the metal side over time you start to see less and less differentiation in terms of functions. I think that there are a lot of similarities between the systems out there. Like everything in our world, I think that if a planning system is the utilization of software, to optimize, and then speed up everything related to diagnosis and everything related to the type of implant that the patient needs. 

In the end, the main link between the patient, the surgeon, and the manufacturer is going to be the software solution. So, the more accurate the software solution, the more accurate the planning, the segmentation that you do, the faster and better the outcome is going to be. It doesn't surprise me also, that there is an expectation that in the future, the entire game is going to be a data game. So, look, it's a fun part right now to be in the space, because if you see you're doing a real transition from what this was before, a real focus on metal, to really start to play another game where you combine software technology with the hardware technology, to help the surgeon to have a better outcome in the OR.

Sebastian De Boodt 18:45

Can you share with us some examples of what Lima is doing as part of this transition?

Massimo Calafiore 18:49

Yeah, so we’re already for a few years investing in the space, so with some specific technology that we're developing in-house. Actually, on the planning side right now, we are laser-focused on developing a relationship with you guys. And where we are switching is literally to owning the OR with a navigation system that is going to be connected with the planning. So given the size of our organization, it’s difficult for us to do ten different actions. When I was innovating, I had a much larger budget and amount for people to invest in different segments. For us, I think that being an implant manufacturer, it is important to own the OR. So now we're focusing on all of the technologies that you can use in the OR and finding a partner, like you, to work on all of the enablers, all of the technology where they can enable you to be successful inside the OR.

Pieter Slagmolen 19:49

We see that reality as well. Not every company can cover the entire space with the limited capabilities they have. That probably leads at least today to the reality that physicians are maybe using multiple software platforms to get the job done with the patients. Do you consider that to be problematic for them?

Massimo Calafiore 20:07

My hope and my bet, and this is why we're betting also on Materialise, is that over time, the entire planning, for instance, just to use it as example, is going to become a more valuable staple in the OR. And as you saw in other technologies, the standardization is going to be very important. I don't think that moving forward, a surgeon is going to be happy to move from one system to the other. So, I hope and I bet on the fact that this is going to be a system or two systems that are going to emerge to become more the standard. I think that that entire conversation is going to be always on the ownership of the data. So, I think that whoever wants to become the leader also needs to give up something that is going to be the data, otherwise you force companies to have closed systems.

Sebastian De Boodt 21:12

The infrastructure might be standardized, but the data should be owned by different companies, and you can still create your own IP and develop different, say, basically...

Pieter Slagmolen 21:24

That's clear. And it would be a bit different from how we see consumer platforms evolve like the Amazons and Googles of this world who own the platform, but they also own the data on the platform. You envisage clearly that that's different in healthcare...

Massimo Calafiore 21:36

Yeah. But the challenge that you have is that you need to think about the conversation that we're having today. If I want to use Materialise, and I want to also provide personalized surgery, I need to have your data of the things that I plan with Materialise. Otherwise, how can I provide the care? Also about Amazon and the others, I don't think that they own 100% of the data because they also help the vendors to do some specific analytics. Google has the Google Analytics tool. So yes, they own the data, but you have access to your own data. It’s a very fine line where we are. But a company like you, I think, yes, that is a value. But if you don't give value to your specific user, it's going to be difficult to extract even more value.

Pieter Slagmolen 22:31

One of the bigger trends that we're seeing impact our business over the past years, I would say, is the rise of the medical device regulation, MDR. How do you see that impacting personalized medical devices? And do you consider it to be a threat or more of an opportunity for your business?

Massimo Calafiore 22:47

But I think that now, I want to see this more on a macro level. I think that MDR is going to be challenging for all the countries that are going to apply MDR, so mostly Europe as healthcare economics is a reality. So MDR creates a level of complexity to clear anything new, which may create a barrier to entry, but not a barrier to entry to market to companies. I think this is gonna create a barrier to entry for surgeons, for a patient to have the latest and greatest technology. 

I think, over time, if I have my crystal ball, we may see a decrease in the quality of healthcare in Europe compared to other countries around the world. So as everything in life, I wouldn't be surprised if right now we're investing millions and millions of euros to comply with EU MDR. And one day, the legislator is gonna realize that maybe they went too far, which is already happening. You read I'm sure, that Switzerland is starting to consider the utilization also of 510k. We’re starting to see what Great Britain is going to do. It’s pretty clear that many legislators are coming to the realization that MDR is too costly for companies to support innovation in Europe. But for me, I don't see it as a threat or opportunity for anybody. I see a threat to access technology for the patient and the surgeon.

Sebastian De Boodt 24:10

And there used to be a time for innovations, you would first go to Europe because that was easier, and then you would go to the US. I think maybe it's flipped too far to the other side now, but we'll see. Hopefully not. As we're on the topic of innovation, we do see that the rate of technology and innovation in healthcare is increasing spectacularly if you just look at the past ten years. Looking ahead, are there any specific innovations that you are thinking about that will help create sustainable advantage in relation to personalization?

Massimo Calafiore 24:41

At the end, it's going to be what we said before, it’s the economic sustainability of the model and speed. I think that if you can find the right balance between the first few manufacturers’ distribution for the surgeon, then you can match this with a competitive price, if you think about it even logically, why should you not have the personalized implant?

Sebastian De Boodt 25:02

If we think about personalization in a broader sense that we briefly touched upon: robotics. One of the things you now see more and more is augmented reality as potentially an alternative technology for surgical guides or for robotics to execute a planning, curious to hear your thoughts on that.

Massimo Calafiore 25:21

That one I think that...Okay, I will give you a two-fold answer. If you think about that, to get the economics. Yes, I think that I don't know how sustainable the robotic platform is going to be as they are today because they are very capital intensive. So I'm very curious to see how everything is going to evolve. But remember, a robot doesn't give you a personalized surgery. At the end, the robot helps the surgeon to achieve a clear and predefined surgical plan. So the surgical plan is kind of quote-unquote, personalized. But it's not personalized surgery; that's two different things. You may have the ultimate customization if we have a patient-matching implant that is used through a navigation system of a robot, so you match an implant and a surgical plan. But by itself, it’s just the matching of a surgical plan within the OR.

Pieter Slagmolen 26:21

Yeah, it's definitely a different degree of personalization in between using these assisted tools versus having a personalized implant. One of the other enabling technologies that we're seeing have a big impact is just artificial intelligence and any kind of machine learning that's impacting the data processing. You talked about speed, as a very important differentiator to being able to drive personalization forward. How do you see the relation between the role of AI and speed as a company, you make that link...

Massimo Calafiore 26:50

You are like the master at the end, to do additional AI, to segment, and start to create the ability to give surgeons a predefined plan. It’s foundational for the success and the speed of every planning and every device that we manufacture in the future. If the system is intelligent enough to start to diminish the amount of iteration you need to go through an implant, of course you are going to have speed. So machine learning is the foundation for the ability to support what we're talking about today.

Pieter Slagmolen 27:29

I don't want to trigger people with ideas here. But you see, in the general consumer world to see this anti-AI movement also appearing now just because of the speed, the rate of innovation that's happening there. Do you think that in healthcare, we should be concerned about that? Will AI replace the physician or become a threat at one point in time?

Massimo Calafiore 27:50

I think it is different like apples and oranges because in the end, with AI, we don't have a self-working robot where it does procedures by itself. I think we are like tens and tens of years away from anything like that. So, in the end, AI is a positive action in our industry because, if you think about it, it’s just the tools that can read much quicker images. You can train an AI model to identify specific kinds of target markers that maybe you can miss with the naked eye, that can help to give a surgeon a specific diagnosis that the surgeon can start to review and decide if it makes sense or not. I think that AI in healthcare, I believe, from my vantage point, is much more valuable, but a different value than what you can see over AI for standard consumers where you can be fooled as a person from AI.

Pieter Slagmolen 28:54

I'm glad that you're on my side and that we probably shouldn't start the anti-movement at this point in time and we see more advantages in the operational side of things.

Massimo Calafiore 29:01

For us it’s different. I think that in the end, whoever performs the surgery is always going to be a doctor. So, the ultimate decision-maker is pretty clear. I think AI is scary right now because people start to defy the ultimate decision-maker being a computer, which is not the case for us.

Sebastian De Boodt 29:20

And likely, maybe not even in ten years. Let's see where that goes. Looking ten years into the future, if it's not the AI taking over the decision-making powers of the surgeon yet. If you would project yourself in ten years, and we would be sitting here again, in the next podcast episode, what are some of the major achievements that you hope you will be able to share with us in ten years?

Massimo Calafiore 29:43

Yeah, I think that everybody's going to plan, I think that I hope that everybody's going to have a patient-specific implant, and everybody is going to be able to navigate successfully and very precisely in the OR. At the end, everything that we do is just to increase the outcome. So, I hope that the combination of technology and hardware, in a sustainable way, is going to make sure that you see the medium outcome from a surgeon is going to keep increasing, especially in pathology like knee replacement where we still see a lot of discrepancies between outcomes. So, I think that if I was projecting myself 10 years from now, I wish that we're going to have a pretty standardized outcome, independent of where you go to get operated.

Sebastian De Boodt 30:35

Yeah, I think that's a nice goal, that we're all very hopeful for and working hard on every day. Thanks so much for joining us, Massimo, I learned a lot of things.

I think it was a really interesting episode with three key takeaways for myself, things that I'll remember for a long time. First of all, for personalization to become sustainable, we need to make sure we can manufacture it at a competitive price but also focus on segments where a standard device is starting to have its limitations in terms of the impact on patient outcomes. The second thing is the way that Lima is playing a pioneering role with manufacturing at the point of care and trying out if this is also a way to make personalization more scalable. And we're very eager to see what conclusions you will come to because I think everybody in the industry will be happy to learn how that's going. And then lastly, I would say the discussion we had on the software platform where we probably need some kind of standardization and to not overwhelm our physicians, as well. And if we can find a way to do that in such a way that each company still has access to its own data, and can use that for innovation and to keep differentiating. That would be a win-win for everybody.

Massimo Calafiore 31:49

I'm very curious to see what's going to happen ten years from now.

Pieter Slagmolen 31:52

All of us, I guess.

Sebastian De Boodt 31:53

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