MedTech Expert Explains Hip Implants and Implant Design | Pressure Tested

Good morning. My name is Sharat Kusuma. I’m the president of an orthopedic device company, a global orthopedic device company called JointMedica. We have offices and manufacturing in the United Kingdom, not far from Peterborough here, and also in the United States. And so I’m here today to talk a little bit about orthopedic medical device and the med tech industry in general, and perhaps some topics about human anatomy and physiology. And so now I’m going to be pressure tested, so looking forward to that. I’m an orthopedic surgeon. I spent my first life, my first career as, you would call them, a consultant in the UK, doing hip and knee replacements. So I was trained as an orthopedic surgeon in the United States, and then about 10, 11 years ago, made a transition from being a clinical full-time surgeon to now being a med tech industry leader. And so I’ve enjoyed that transition quite a bit. And of course, in our medical training, we don’t learn much about all the testing and standardization and the regulatory process of getting implants approved. And so it’s been quite an education to learn the stuff that I spent half my career actually putting in people’s bodies, how they get manufactured, how they become approved, how they become tested and validated. And so it’s been a fun journey to learn that entire arc of a medical device.

What is a medical implant?

OK, I’ll contextualise what is an orthopedic implant. Implants, and I’ve got a couple here on the table, are mechanical devices that we put in people’s bodies when something is messed up or broken. So there are lots of examples. The med tech industry is a huge industry globally. I think the total industry size is something like $800 billion. And I guarantee you, everybody you know, somebody in your friends or family have had a medical device. And so an example is like a hip replacement. When your hip or the cartilage is worn down, you can get a hip replacement. A hundred years ago, when people had this problem, they essentially lived their final days of their lives bed-bound. They couldn’t do anything because the hip was so arthritic. And so there are hundreds, thousands of examples of medical devices, things like stents. We put in people’s hearts when they have a blockage. You can put in a heart valve. The heart, of course, has valves. And for those of you who are plumbers, the heart has valves that control the flow of blood in and out of the heart. We can now replace heart valves. And actually, for me, a medical device is pretty amazing because you can actually take an inanimate piece of metal or plastic or something and put it in somebody’s body, and it can restore their function. It’s pretty amazing. So at a top level, that’s what a medical implant or an orthopedic implant is. Of course, my expertise is in orthopedic implants for bone and joint problems.

What are the different parts of a hip implant?

Thankfully, orthopedics is for folks who don’t have a lot of intellectual agility. It’s a pretty simple device. The hip implant, the hip joint, is a ball and socket joint. And so, and I don’t have a model of a pelvis or a human hip with me, but essentially, you’ve got a socket and you’ve got a ball, and what ends up happening is the cartilage between the two wears out. And so I’ve got a couple of examples of hip implants here. And particularly my company, JointMedica, we’re focused on innovating in the hip implant space, and we’ll talk more about that. But so again, most hip implants have two pieces. They’ve got the ball that replaces the native ball that you were born with and grew up with, and they have a socket. And so you can imagine it’s pretty intuitive. You can imagine this type of hip implant. It’s called a hip replacement. And the way it works is you put this plastic inside the socket, and then you put this stem inside the thigh bone, which is known as the femur, and that becomes a new hip joint. And it may seem archaic, but it’s amazing how well it works. And if you think about some additional innovation, you may say, okay, if there’s a ball and socket, why could I not maybe just tap the ball instead of cutting the ball off and replacing it? So this would be called hip resurfacing. So these are two different varieties or flavours of hip implants. So those are examples, and my company is working on innovating in this space.

What are hip implants usually made from?

And this is a perfect segue into what this interview is about. Hip implants have gone through quite an evolution over the last 60, 70, 80 years, and they’ve been made of lots of different materials. Back in, early on, before we knew much, people tried to make– So surgeons and scientists tried to make hip implants from Teflon. They tried to make them from different– They used pig skin membranes and things. So, back early on, when initial pioneering surgeons, many from the UK actually, were trying to figure out how to treat hip arthritis, they made implants from different materials. And so they’ve been made out of cobalt chrome, they’ve been made out of titanium. So the materials can be quite variable. What’s going on now in the world, this is probably a fair summary, most hip implants are now made out of some kind of ultra-high molecular weight polyethylene. Of course, as you know, polyethylene is an organic kind of plastic-type compound that has excellent mechanical properties. And then usually the ball socket, the ball side of it, is made of some kind of ceramic or some kind of a very smooth bearing surface. And so when you put these two bearing surfaces together, what makes it work well is because it has excellent wear properties. Because if you think about a hip replacement, once I put it in somebody’s body, it’s not as if I can go into the shop every year like when I go to the car dealer and get a new set of tires. This thing has to last for 20 or 30 years, and so that’s the challenge we’re trying to achieve. So in this day and age, most hip implants are made of some type of ceramic and some are articulating in some kind of plastic. There are also some hip implants that are made of metal. This is a cobalt chrome head articulating against either, again, a ultra-high molecular weight polyethylene or against another cobalt chrome cup, and I don’t have an example of that with me today. And then finally, you could actually have sub-implant hip implants where you’ve got a ceramic ball head articulating into a ceramic socket as well. I don’t have an example with me today, but that’s a summary of what the materials are made from. So okay, next question.

What does an orthopedic surgeon actually do?

As orthopedic surgeons, we are trained on the entire musculoskeletal system, is perhaps a technical term. So you think of any bone, any joint, any cartilage, any ligament, orthopedic surgeons address all those things. And so, as an example, a lot of you are probably sports fans who watch football or tennis or something like that. You probably have heard of the ACL, anterior cruciate ligament injury, which is one of the more common sports injuries. One of the more sort of well-known things that we as orthopedic surgeons do, we would fix the ACL ligament. We’d either repair it or reconstruct it, and so that’s one example of what we do. Other very common examples, we’ve all probably had a friend or family member who’s been in a car accident or a biking accident and broken a bone or something. We would be the person that fixes the bone and puts a plate on it, puts a bunch of screws or something. That’s another example. Another example, and this is sort of what I did in my career for a while, I specialised in when people have destroyed shoulder, hip, or knee joints, we would implant these implants, these hip or knee replacements into the joint. So those are examples of things that orthopedic surgeons would do. Other examples, when people have bad spine problems, like a lot of you probably have friends or family who have spine problems. Who have spine arthritis. We would do the back surgery of some kind. We would do what’s called a fusion, where you actually fuse the vertebra, or we would do something called a decompression. So again, to summarize, anything related to bones, joints, ligaments, tendons, muscles, orthopedic surgeons do. And what makes it hard, and orthopedic surgeons often get made fun of, being called dumb carpenters or something, but it’s a little unfair because we have to know the anatomy of the entire body. We have to know the anatomy of the whole arm, the whole chest, the whole hip and knee and feet and foot and ankle. So it’s quite a large body of knowledge to have. And so in most countries, our training is somewhere between, if you leave out the medical school component It’s easily six, seven years of training to become an orthopedic surgeon before you’re, we’d say, qualified as a consultant.

What goes wrong inside a hip joint that means someone might need surgery?

I addressed this in one of the previous questions, but I’ll review it again. So our joints are these wonderfully engineered, by nature and by evolution, bearing surfaces. We walk miles over a lifetime. We walk thousands and thousands of miles, and we go up and down stairs, and we don’t ever get a chance, like most mechanical devices, to go into the shop to get a set of tire changes. So in most of our joints, in particular our hip, we have what’s called cartilage. And cartilage is this amazing engineering marvel of nature that we’ve still not been able to recreate in a lab, even after 100 years of trying. And so what happens when a hip needs a replacement is the cartilage eventually wears out, the same way a tire may wear out on a car. And so what we do is we have to figure out a way to reproduce that smooth bearing surface. And so what happens, when the cartilage wears out, it becomes incredibly painful to walk. And again, I’m sure a lot of the viewers have had a friend or a family member who’ve had a bad hip joint, and it is debilitating. And like I mentioned previously, when someone has a bad hip joint, 100 years ago, they had to just sit in their wheelchair and become more and more immobile. And so now we’ve got these amazing technologies. We can go in and actually replace or resurface the damaged cartilage and give people back their function as if they never even had a hip replacement in the first place. And so that’s part of what our company does. We are innovating in that space. And so that’s why people need hip replacements. It’s very similar in the knee as well and in the shoulder. Now any other of the major joints in the body, when the cartilage breaks down between the two surfaces, when that cushion breaks down, that’s the problem. And so we have to go in and replace that cushion. And so we can do shoulder replacements, we can do hip replacements, we can do knee replacements, we can do ankle replacements. We can even do replacements in the small joints of the hand. So every joint in your body, more or less, has similar cartilage that allows you to move millions and millions of times a year. It’s a pretty amazing marvel of nature, actually.

Hip replacement surgery in a nutshell: what actually happens?

I covered this in a couple other questions, but to review, what we’re essentially doing, the goal of the surgery is to take– Again, if you imagine there’s a ball and a socket. The ball had cartilage on it. The socket had cartilage on it. The goal of the hip replacement surgery is to replace or resurface and put a new bearing surface on there so the bearing can move again smoothly and to eliminate the pain that the patient experiences. And so there are two different flavors, in general, of hip replacements. One is, again, we call this a total hip replacement. And the principle is that if you imagine you’ve got a ball, you have a socket. With a regular hip replacement, what you’re doing is you’re essentially taking a saw, and you’re removing the top end or the ball. And you can imagine, everyone knows we have a thigh bone that you walk on. You insert the stem into the thigh bone, and this becomes the new ball. And then on the socket side, what you’re doing is, again, you’ll take some kind of what we call a reamer, where it looks like a cheese grater, actually, and you ream away the damaged cartilage. Then you put a new socket in there. And so then this new articulating surface becomes the new hip joint. And again, believe it or not, it works unbelievably well. When people get this operation, their pain relief is improved, or often eliminated, have complete pain relief in a lot of times. They have improved function. They can get back at doing the things they love and being mobile. And, of course, as we’ve learned over the last 50, 30 years or so, when people become sedentary, their health goes down. And so while hip arthritis is not something that’s ever going to kill a patient, the lack of mobility that happens when people develop arthritis can be quite detrimental. So now we know that when people have hip arthritis or knee arthritis and their mobility has gone down, replacing that joint or doing a surgery is actually very beneficial for their health because it restores their mobility and helps– Mobility is, of course, key to aging in a more healthy way. So that’s how hip replacement works. I should share, there’s one other type flavor of hip replacement, and my company’s actually innovating in both varieties of hip replacements. The second one is called a hip resurfacing. And with this one, what we do, and it’s pretty intuitive if you put these side by side. With a standard hip replacement, like I mentioned, again, you imagine the ball and the socket. You would remove the ball, and you put this large stem in the body. And that may seem a bit invasive, but again, it does work very well. The next generation of hip replacements, we’re trying to be a little more even bone conserving, where we’re not removing that whole ball. So this is called a hip resurfacing, and this operation’s been around for a few years as well, and my company is working on innovating in the space. And so with this one, it’s again, pretty intuitive if you put them side by side. You can see with the hip resurfacing, what we’re doing, instead of removing the ball, we’re just shaving off the top of the ball, and then we’re capping it. Perhaps you can consider the same way with the way you cap a tooth. If you have a bad tooth, sometimes you go to the dentist. You can either extract the tooth completely and put a new implant, like a new prosthetic tooth in there, or you can try to fix the tooth and put a cap on it. So you can consider the tooth replacement where you extract the whole tooth from the gum and from the bone and put an implant in there. Whereas a resurfacing would be– And that’s kind of like a hip replacement. A resurfacing would be more akin to just capping the tooth, would be less invasive, and would even allow patients even more function. And one interesting note, there are a lot of famous athletes over the years that have had hip problems, and so this hip resurfacing operation, and there’s some published literature on this, has allowed some of the athletes to actually return to professional-level sport. And so if you want to look it up, you can look. There are famous surgeons at different hospitals around the world that have done hip resurfacings on professional athletes, and they’ve been able to get back to professional-level sports. Which if you can get your head around that, it’s pretty amazing to think that someone can have a hip replacement, and they can have enough functional level to go back to compete at a professional level. So that’s part of what my company’s doing. We’re innovating in that space and trying to develop hip replacements that allow

What does a healthy hip look like?

If you open up a healthy– Normally, you would have no reason to open up a healthy hip joint and damage it because it’s healthy. But if you open up a hip joint and looked at it, it would look like a shiny– The ball would be like a beautiful, shiny, reflective surface with cartilage. And the cartilage actually has a little bit of rebound cushioning on it. And then on the socket side, very similar, you would see a very beautiful– I’m trying to think how to describe it, like a reflective– It almost looks like ivory, like shiny ivory. It’s soft. And so you’d have cartilage on both sides. And then, of course, around the hip joint, there’s what we call a labrum. And the best way I can describe a labrum, it’s like a gasket. Like a gasket that sort of holds the ball in place. And so that’s what a healthy hip joint looks like. And of course, it’s surrounded by muscles and tissues and ligaments that hold the hip joint in place. And so again, it’s a beautiful structure if you get to see it in an anatomy lab or something like we do in medical school.

When you put a hip implant in the body, how does it actually stay in place?

this is interesting. And so if you look very closely at these implants, you can see that what we call the femoral component, or the part that goes in the thigh bone, has this white surface. This is called hydroxyapatite. Hydroxyapatite is a mineralised calcium molecule that is very bone-friendly. So what happens is you put this inside the bone, and then over the first six to 12 weeks, and believe it or not, the patient’s bone actually grows onto the stem and holds it in place. And then if you look very closely at this socket here, you can see that the inside of it is the plastic, what we call the ultra-high molecular weight polyethylene. This back surface, if you look, is a titanium coating. So again, the same thing. We use a cheese grater reamer, and we sort of clear out the damaged cartilage, and then we put this into the bone. And you don’t need screws or anything, believe it or not. These pegs offer some stability. And then believe it or not, the human body, the bone loves titanium because titanium is a molecule that has what’s called a lot of osteoconductivity. What that means is that bone cells, our bones are made of tiny little cells that are called osteocytes. And so those osteocytes can actually grow and attach to the titanium. So essentially, the answer to the question is, what holds it for most modern hip replacements in the body is actually the body doing its own thing, where the bone goes onto the implant and holds the implants in place. So it’s very fascinating. Now, sometimes there’s another way we can put these implants in place. Sometimes what we’ll do is we’ll put what’s called bone cement. And the way to think about bone cement is kind of like a grout. So if any of you ever do any tiling work in your bathroom or something, you know when you have tiles in the bathroom, you put grout between the tiles, so the tiles don’t fall in together. We use, believe it or not, a similar substance sometimes. So you’d pour bone cement in here, and then you put it on the top of the femur, and then that would hold it in place, and it could last for years and years. There are varieties of stems, unlike this one. Again, where you can actually put cement in the thigh bone, and then you put the stem in there, and of course, the cement can hold it in place. So the top-level answer is, there are generally two ways to hold joint replacement components in place. Method one is what I described earlier, where you actually have a surface on the implant that is a bone-friendly surface, where over the first 6 to 12, 18 weeks, the bone actually grows onto the surface and holds it in place for 10, 20 years. Option two is you can actually have a special bone cement that you can put on the implant that holds it in place and functions like a grout between the bone and the implant. So those are the general two ways that hip implants are held in place.

How long should a hip implant last, and what determines whether it lasts longer or fails earlier?

And so one of the holy grails of this space is to do two things. Number one is to design a hip implant that can last the entire life of a patient. Now, the problem is, if you have a young patient who’s 35 years old or 40 years old, when they have their hip replacement, that hip may have to last for 50 years. And that’s a lot, if you think about it. Think it, name for me a device in your house, a refrigerator, a car, any mechanical device that would last that long. So you can imagine what an engineering challenge it is to try to design. And also, there’s another challenge here. As I mentioned earlier, when you put a hip implant in somebody, you can’t go to the car auto body shop and open somebody up and change out the parts, because of course, that would be another surgery and has a lot of risk to it. So you get one shot to put hip implants in place and have it last for 30 or 40 years. So the holy grail of joint replacement surgery in general is to find a set of materials that you can put it in one time, independent of how old the patient is, and it will last the rest of their life. And so when you think about how long should it last, it’s a bit of a loaded question. Nowadays, we can safely say that with modern materials, a hip replacement should last 15, 20 years. But again, there are a lot of variables beyond just the materials. The other thing, and you can think about it. Imagine if you have a car, and you’ve got the most advanced set of tires on the car, but if the tires are malaligned, and they’re not perfectly aligned on the road, and you drive 10,000 miles in the car, and the tires are aligned incorrectly, the tires will wear out quickly no matter what they’re made out of. And so a hip replacement is very similar. You’ve got to orient the parts perfectly where they fit together. They’re not too big. They’re not too small. And you can even imagine, if you’ve got a hip replacement, and you put the pieces in where this cup is too vertical and the ball is maybe only touching the top, this would be like a malaligned tire versus having it perfectly aligned where it moves that way. So the point is, there are a lot of factors that determine how long a hip replacement device will last, and I would say it’s the materials, it’s the age and the activity level of the patient, and then, of course, it’s the quality of the surgery that the surgeon does to align the pieces. And so those are the three factors that determine. But to answer the question at a top level, I would say 15 to 20 years is how long a good hip replacement lasts. Now, that being said, we have promise that with some of these new materials that we’ve engineered, which may be beyond the scope of today’s discussion, we may be able to get even farther, maybe 20, 25 years, and so that’s obviously the next

How do surgeons and engineers work together to design an implant?

I have a bias, and I’ll answer this question with my bias. I think that right now in the medical device industry, surgeons and engineers actually don’t work closely together enough to design implants. And we can talk about why that is. Engineers come at the problem from a very engineering standpoint, what they learn in school, they learn biomechanics, and they learn mechanical engineering, they learn the mathematics and how engineering works. But of course, in the human body, there’s a biological overlay on top of any kind of– So again, when you build a bridge, or you build a tree house or something, you can do all the measurements, and you can go, and you can put the tree house together, and you can figure out, okay, I need pylons, or I need stabilisers that are this size, this dimension, and if I build them, that will exceed the force that I’ll ever see, and the tree house could last even many years. In the human body, it’s different because, again, the human body has the ability to sort of regenerate. So, for example, if a bone wears out, the body has an amazing ability, when you fracture a bone, the bone can heal. And so to answer the question, how do surgeon engineers work together? I’ll give a general answer of how they work together. Generally, what we do is the following. A surgeon will come to an implant company and say, “Hey, I’ve got an idea for a device, and here’s why I need this device. Because the current state-of-the-art in hip replacements or knee replacements is not working, and I’ve done 10,000 hip replacements, and I have an idea for a new implant design.” And that’s actually how our company was started, is some surgeon had some great ideas of how to develop a better mouse trap. I’ll talk about that in a minute. And then what will happen is then the surgeon and engineer will sit down, and they’ll design, again, the dimensions of the implant. Well, okay, let’s figure out how thick it should be. Let’s figure out should it be a full hemisphere, or should it be part of the hemisphere? Let’s figure out should it be a cap or a stem. Let’s figure out what materials it should be made of. And so then the surgeon and engineers get together, and they’ll mock up an initial design. And then what they’ll do is they’ll go to what’s called a cadaver lab, where they take some initial prototypes of the implant, and we open up– A cadaver is obviously a preserved human body that some generous human being has donated their body to science to allow us to innovate. And so then we go to the cadaver lab, and we take these prototype implants that the engineers make, and then we’ll put them in the body, and then we’ll figure out how they fit and how they work. Now, beyond that, what we described sort of generally the implant design, if you think about it, if you’re a carpenter, when you build a table, you don’t just go chop a tree down with a saw and then put the table together. You have a lot of instruments and tools that you use to assemble the table. And I’m not a carpenter, so I’ll try to do my best. But you’ll have like a band saw, where you cut the saw, and then you’ll have a drill where you drill holes in the table, and you assemble the table with screws. Just like that, and I wish I had some examples today, maybe another episode I could show this. We have very sophisticated instruments that are metal instruments that we use that help us make the bone cuts, that help us prepare the bone surfaces. And so as important as the implants is the surgeons and engineers working together to develop instruments that help me prepare the bones in the body to receive the implants. Again, I mentioned when you do a hip replacement, you cut off the top of the femur. And so when I cut that off, I have to have a special saw that helps me make the cut perfectly. So in addition to designing the implant itself and the materials and the dimensions and the sizes, we’ve got to work together as surgeons and engineers to develop instruments that help me put the implant in perfectly. Now, here’s the other challenge. The tree house example I gave you, or even putting a car together, I can take the car apart and put it back together. In the human body, I can’t do that. I have to make an incision, and I can’t damage anything around the hip. And of course, surrounding the hip, there are nerves and blood vessels and big muscles and very important structures that I can’t damage. So we’ve got to develop instruments that that allow the surgeon to very carefully, precisely implant the hip joint without damaging the outside, the structures around it. That’s a pretty challenging thing to do. So in summary, the way we work together as engineers and surgeons is we develop the implant design, we test the implant design in cadavers, we then develop instruments, and we make sure we have the whole package that allows the surgeon to implant the device. And the way this all comes together, we have to, of course, work with regulatory, with the FDA in America. In the UK, we work with the MHRA. In the EU, we work with European Medicines Agency, the EMA, and the notified bodies. And so we have to develop these implants, develop the instruments, and then we have to have the regulatory bodies approve the entire package that they then deem is safe to use in humans. So it’s actually a pretty complex process, and this is where companies like Tess Labs come into place. They help us do the testing and the validations and things on the instruments, and even the implants, to make sure they’re safe to implant in the body. So that’s how the two groups work together. It’s actually a very complex process, and so that’s how they work together.

How do we know an implant is safe before it goes into a person?

a fascinating question. So like I mentioned, 60, 70 years ago, when we didn’t know anything, surgeons tried all kinds of different materials, and this holds for knee replacements and for hip replacements, because we didn’t know what worked. We had materials that worked outside the body. We had Teflon, we had latex, we had organic membranes from different animals and things that we tried to put in between the damaged cartilage to see if it worked. And so the answer, as crazy as this may sound, trial and error. Over the last 60 or 70 years, we’ve learned through trial and error that some metals and some plastics and some surfaces, the bearing surface, work well together. And it truly has been a trial-and-error process over the last 60 or 70 years. And I had a question a few questions ago, where it said: well, what are the common implant materials? So the way we’ve learned what’s safe is over the last 50 or 60 years, by trying all different kinds of materials. We’ve learned that some materials do very well in the body and don’t cause problems. And I’ll give you an example, an interesting example. 40, let’s say 50 years ago, we used a particular type of plastic inside the hip joint that we thought worked well, and then we put it in the body. What we ended up finding is that once somebody walked on it, the plastic would shed little particles, small, microscopic little plastic particles, and those little plastic particles would actually activate the body’s immune system. Because what would happen is, when the body saw these little pieces of plastic, we have an immune system that is designed to eliminate foreign bodies that are inside our body. Our immune system helps us shield, protect us from viruses and bacteria and parasites. All these foreign body diseases and things. Well, in the same way, our body’s designed to eliminate foreign materials as well. And so again, 50 years ago, we tried certain types of plastics. When we put them in the body, we found that what would happen, these small plastic particles, the body’s immune cells would come in, and they would eat, actually literally eat the plastic particles and then try to excrete them, in your stool or in your urine or something, or in your kidneys or something. What would also happen while they were eating the plastic, it would actually eat the bone as well, if you can believe that. So what we’ve learned over time, that different kinds of plastics and metals can actually sit inside the body and function without any kind of damage to the body, and we call those, those are biologically inert materials. And so it’s a fascinating, very complicated area of science. But what I’ve got here on the table today, we’ve now generally found that titanium, which the stem is made out of, ceramic, which this ball is made out of, and ultra-high-molecular-weight polyethylene, which this bearing surface is made out of, and the titanium, this material coupling actually works very well in general and is pretty safe and does not really cause any reactions in the body. So again, it’s been a long process of trial and error over many, many years that has resulted in us learning what materials work well.

Are hip implants one size fits all?

And the answer is absolutely not. It could not be farther from the answer. Because again, if you think about it, human beings come in all different shapes and sizes. Some people are petite, some people are 6’10”, some people are a little bit wider, some people are very narrow. And so just like that, the hip joint, even though it’s basically a ball and socket joint, comes in an infinite number of sizes. And so as a company, you can imagine what we’re trying to do, we’re trying to develop hip implants that function just like the native hip joint that somebody had. And so the reason I have these three examples of implants here, I’m going to show you the evolution of what we’re trying to accomplish at JointMedica as a company. So what I’ve got in my hand here is what I call a traditional hip replacement. And the way this one works is, you can see there’s a titanium socket, a shell here. And so the way a traditional hip replacement would work is, you’d open up the hip, you’d chop off the ball head with a saw. Then, like I mentioned, you’d use that cheese grater, reamer, and you would ream the bone inside the socket. Then you’d implant this metal shell as sort of the base or the foundation, kind of like the foundation of a house. Then you would snap this plastic, and I showed you this plastic liner. You would snap this into the titanium socket, and that becomes the new socket. But you can see there’s an engineering problem here. Because what I’ve done, I have replaced the thickness of the cartilage with a shell and then another shell. And so you can see this hip replacement for a reasonable-sized socket actually has a very small ball head. And that’s the engineering compromise that traditional hip replacements require, is that because they’re designed to be a shell, a shell within a shell, you lose a lot of the head size. And so what ends up happening, if I use this traditional hip replacement in an average patient, I end up putting a ball in there that’s actually smaller than the native ball that they had, that they lived with. And so what we’re trying to do at JointMedica, and this will be pretty obvious when I show you the comparison. You can see this socket here, this is a single-piece socket. There’s no what we call modularity. I’m not taking a metal shell and implanting another shell inside it. You can see that I’ve affixed this coating directly to the plastic, whereas in this one, the coating is affixed to a titanium shell, which then has a snap-on plastic liner in it. You can see fundamentally, for a similar-sized socket with the traditional hip replacement, I get a very small ball. With our JointMedica implant, this is the innovation that we’re trying to develop. I have a much, much bigger hip ball head, a ball. And so you can see if I put these two side by side, it’s pretty obvious even to the layperson which hip would you rather have. You’d rather have the one with the bigger ball head, because the bigger ball head gives you a bigger range of motion you can see. And if I put the stem on there, you can see this would be the position where a patient doing a split. This would be a patient doing a roundhouse kick if they’re a judo boxer. With the smaller hip replacement, the traditional one, if the patient does too much range of motion, you can see the hip is going to pop out a socket. Because what will happen with the smaller ball head, you can see the stem will hit the edge and the ball will pop out. So you can see, even from a layperson standpoint, there are a lot of advantages to having a larger ball in the same size socket. So that is some of the innovation that we’re developing and we’re trying to advance the hip replacement field. And believe it or not, it’s quite difficult to innovate from going from this type of hip to this type of hip. Because for the last 30 years in the industry, most of the regulatory bodies, most of the testing shops like Tess Labs, have been used to demonstrating the safety and the equivalence, if you will, of hips that are just like this one. So bringing to market a novel new hip replacement that doesn’t have a locking mechanism, where there’s not a socket within a socket, is quite difficult. And so this is one of the reasons why innovation has been so difficult in hip replacements is because Most regulatory bodies and most testing shops are used to taking the existing standards, the existing testing standards, the existing regulations, and just iterating in a very incremental way, which when you’re trying to do a fairly disruptive innovation and have an entirely new type of construct– But again, back to answering the question, the reason we’re doing this innovation is because we’re trying to make hip replacements that function more like the native hip that you had. So I think the example I gave pretty obviously shows why a larger ball head is better. Now, if we take the evolution even one more place farther, you asked if all hip replacements come in the same size? Well, you can imagine if I have a hip replacement of a ball and socket like this, and I chop off– Every body, every human being, has a different shape of the top of their femur, right? Some people’s is more bent this way, some people’s is more straight, some people’s is bent backwards, some people bent forward. So when I cut this off and I take a stem like this, I would have to have an infinite number of stems to perfectly match all the geometry of somebody’s hip replacement. So the next evolution we’re trying to work on, and this will hopefully make intuitive sense, instead of chopping the ball off, if I can just perfectly put a cap on the top of the ball, I’m maintaining all the different angles of the person’s bone, right? And so this is our next generation hip implant. It’s a hip resurfacing. We’re trying to create a hip that actually perfectly fits and perfectly reproduces the anatomy of the patient. If you follow my explanation, you can probably understand the less bone I take away, and if I can approach a hip replacement where I’m removing minimal bone and simply resurfacing the surfaces, that allows me to match the anatomy perfectly. So back to coming full circle, hip implants do not come in one size fits all, and really the holy grail of hips is to try to develop a hip that lasts forever, that doesn’t cause any reactions in the body, and which also nearly perfectly reproduces the anatomy of the patient. And that’s what JointMedica is all about as a company. We’re trying to develop hip replacements that match the anatomy of the human being, of the patient, better than traditional hip replacements. That’s what our company is all about. And again, the industry, it is challenging to innovate, like I explained before, because most regulatory bodies and testing shops are used to just seeing implants that look like this, and so when you’re trying to bring a new implant to market, it is challenging. So it’s great to have partners like test labs that can help us think through how to develop tests and standards that can prove to the regulators that our innovative implants on the right side of my table here are safe and effective for patients.

Has the industry ever got hip implants badly wrong?

The answer is unfortunately, yes, they have. And I gave some examples of this. About 15, 18 years ago, there was a very public example, and I won’t name the company, but you can look this up on your own, where a few companies developed hip implants that were made of cobalt chrome metal on cobalt chrome metal, and roughly around the world, maybe a million people got this implant. And what ended up happening, I mentioned to you earlier, about 50 years ago, we had a situation where the plastic particles were shedding from the implant, and the immune system was eating the plastic in the bone. Well, the same thing happened with these metal-metal hips. You can actually have metal debris that’s created as well when you have a metal ball and a metal socket. So about 18 years ago, these metal-metal hip replacements came to the market, and they produced billions and billions of tiny little metal particles, and the same thing happened. The immune system recognised these particles, started trying to ingest and eat them and get them out of the body because the immune system recognised them as a foreign body, and they ended up eating the bones and the muscles, the immune cells around the tissues and caused a lot of damage. So there have been many, not many, but several fairly public, fairly catastrophic examples where hip implants have gone wrong. So that’s why I think it’s important that regulators and surgeons and engineers and test shops work very closely together to test implants, test the biocompatibility, test the bioreactivity of these implants, and make sure they’re safe. And of course, that process takes a really intense and purposeful partnership between surgeons who are putting in the implants, following patients, seeing how they’re doing, looking for any signals that there may be some problems, and then the surgeons have to report that back to the implant company and to the regulators. So there’s a partnership between testing shops, surgeons, implant companies, and the regulators, and of course, the patients, is very, very important as a way to prevent having other episodes like this.

Have failures in the past made the industry afraid to innovate?

The answer is absolutely yes. Anytime you get very public failures like this, everybody reacts. It’s human nature to react and maybe even overreact and say, “Oh, gosh, we had this very public implant failure of metal-metal implants. We should not innovate.” And this is an appropriate response because, again, we want to make sure public safety and patient safety is preserved. But when we’ve had these, every 10 or 15 years, there’s some very public failure, whether it’s breast implants, whether it’s hip implants, whether it’s cardiology devices or something. There are always going to be failures. And so when those happen, there definitely is a correction that happens where the regulators, the surgeons, the developers of implants, they become a little more conservative. And like a lot of things in business, these go through cycles. At some points, the industry is very innovative, and regulators are very innovative, and then there’s a problem, and then they become more conservative. And this cycle is a perpetual cycle that goes on, and it’s probably appropriate that it happens that way because that’s how innovation has to happen. There’s no way to innovate without having sometimes there may be innovations that don’t work very well. Again, I think the key is having a tight partnership between the surgeons putting the devices in, the implant companies, and this is something as a company we do, we’re intense about it. We make sure we keep in touch with our surgeons regularly, on a monthly basis, checking on our patients, making sure how they’re doing, and if there’s even a slight whiff of a safety signal, we come back and make sure and say, okay, is this safety signal something related to the design or the instruments or the materials? And I think that tight partnership can help prevent having future problems. One final interesting question here.

Where do you think the next real breakthrough in hip implants will come from?

And again, I’ll give a biased answer here. I think it’s going to come from JointMedica, and I explained this in one of the previous questions. Again, hip implants have not had a lot of innovation over the last 20 years, and there are a lot of different reasons why that is. Primarily, number one, innovation is hard because if you’ve got something that works pretty well, you have to prove the next innovation is as good or better, and that’s a high bar. Every time we innovate something that’s better, the next innovation becomes even harder. But I think for us, what we believe at JointMedica is the next cataclysmic innovation or the next disruptive innovation, as I explained earlier, this hip replacement here is a socket within a socket. I chop off the top of the femur, and I prepare the patient’s socket with a cheese grater, and I implant this, again, what I call a foundation, like the foundation of a house. Then I snap this liner in there. But you can see the downside of that design is that I lose a lot. I have a very small ball. So at JointMedica, what we’re all about as a company in one sentence, we’re trying to be a bone-preserving company where we develop implants that do not have these modular junctions and where I can have a single-piece implant where I can accommodate a thick enough plastic that will last a long time. But again, you can see if you compare this hip to this hip, this hip in my right hand has a much bigger ball for the same size socket versus the traditional hip replacement in my left hand. So we think this kind of innovation is going to be a pretty big innovation. Then moving to even further, we think that innovating even further, where we’re getting rid of the stem altogether and putting a cap on the femur, this type of hip resurfacing is yet another innovation that has all the safety benefits of a plastic surface that we know works well with a metal ball head. And then again, an implant like this, you can see pretty intuitively, avoids putting a big stem in the thigh bone. So we think this portfolio that we have of our product here on my right side of the table are going to be pretty disruptive innovations, and we’re right now going through the challenging regulatory process. And so we’re very optimistic that once we get these approved worldwide, that they’ll help a lot of patients return to even more activity than they can do with traditional hip replacements.

All right. So again, this is Sharat Kusuma here from JointMedica, and that’s me having pressure tested. And so in summary, what I would say is a couple things. Number one, being in the medical device industry, I believe, is really a privilege. And I mentioned my first career, I used to implant this stuff in people, and I had the benefit of seeing– And I’ll give some personal stories. I have people who are groomsmen in my wedding whose parents I put hip replacements in 18 years ago, and they are still functioning perfectly. And it’s quite a gratifying thing to have had the privilege of spending part of my career implanting the devices and seeing what impact they have. And now in the second half of my career, I now have the privilege of working with the great team at JointMedica, and my colleagues at JointMedica, and developing new implants. And it’s just so gratifying to be able to develop widgets or parts or things that actually make a human’s life fundamentally better. And so the reason I value the opportunity to do things like this pressure tested exercise and work with test shops like Test Labs is because the only way we’re going to continue to innovate and make these implants better and improve the lives of people even more is by helping prove the safety of the implants before we launch them to the market. And the only way to do that is to have test shops and a tight partnership between companies like JointMedica and testing shops like Test Labs, and developing tests that definitively prove the safety of the implants, so then we know that when we go to market launch. And of course, we have to prove the safety to regulators. And if we can continue to do that faster, we can innovate faster, and we can then bring new implants to the market faster, which ultimately helps patients. And so what we’re passionate about here is our partnership with test shops like Test Labs that work with us closely and help us develop the tests that prove the safety and efficacy of the devices. And so it’s really a privilege to work in this industry, and so I appreciate the opportunity to be pressure tested.