Transkrip penuh untuk Ep 308 - How Zimmer Biomet will use AI and robotics to lighten the load on orthopedic surgeons

I encourage you to listen back to the interview and look for your own surprise and delight moments. But before that conversation starts, I'm excited to bring you another episode of our FOMO series, Our Future of Medtech Opportunities. So I actually asked Karen Mills, medical device Sales Director for HID Global, to join me in the studio again. You probably heard that I interviewed Karen on the Women in Medtech podcast and Karen introduced RFID or radio frequency identification to me. And I felt like what would be really helpful would be a short sort of masterclass on what it really is and what does that mean for med tech and connected health and robotics. And boy, Karen absolutely delivered. So before we sit down with the keyNote interview with Dr. Jonathan Vedorczyka of Zimmer Biomint, I'm so pleased to introduce to you once again my friend and expert on rfid, Karen Moats. Welcome back to the future of MedTech opportunities. You. You may remember an interview I conducted for an episode of the Women in Medtech podcast where I was gifted my first lesson in RFID or radio frequency identification and its impact on MedTech. Well, since then I've been hooked and I even attended a webinar which did a technical deep dive into rfid. I learned so much that I had to bring back Karen Mills, medical device Sales Director at HID Global, back into the studio to give us a 10 minute masterclass on what we need to know about RFID now and and of course, the future. So with that, Karen Mills, welcome back to the podcast. 2 00:04:46.000 --> 00:04:50.000 Thank you so much, Kayleen. I'm so excited to be here again with you. 3 00:04:50.000 --> 00:05:20.000 Well, I can't wait. I will mention it again at the end, but I want to say at the beginning that I have dropped a link to our first interview together where I got to know you more and more about HID Global and then a link to that webinar for that technical deep dive. So for our audience, if you can't wait, pause the interview. Now, check those out and then come right back. All right, Karen, for those who can't wait, can you give us just a high level overview of what drew you specifically to rfid? And connected medical devices. 4 00:05:20.000 --> 00:06:47.000 Sure. I mean, I started in medical device sales and pharmaceuticals. I think I shared that with you on our first podcast. And you know, after I grew out of those, some of those roles, I worked for a startup RFID company and then I've been with HID now for five and a half years. And what drew me to RFID in the medical device space was realizing that RFID can do so much more than just tell you where something is. At its core, RFID connects physical medical product and its digital identity. The product could be a medical device, a surgical instrument like a robotic arm or instrument, an implantable device like a breast implant, any consumables like that razor, razor blade model, or another item that's moving through the healthcare ecosystem. So once you establish that digital identity, you start opening up so many more possibilities. You can potentially connect the product to the information through its whole life cycle, from manufacturing and distribution, through inventory management, and ultimately to the clinical environment. So that's where I think RFID becomes particularly interesting for medtech. You know, what it can do differently once I know exactly where that item is, is unbelievable. Right? So RFID is not just about tracking where something is. It's about giving the physical medical product a digital identity and asking what becomes possible once that identity is connected to the data. 5 00:06:47.000 --> 00:07:17.000 The digital identity is maybe what got me so hooked. You gave me a few illustrations in our first interview together. Again, that link is in the show notes here and I highly recommend our audience take a look at that. There was one about the breast implant and a recall and how having this digital identity could really be a game changer. I loved it so much. Let's talk about RFID and the principal challenges that's facing it today. And also data driven connected medical devices. 6 00:07:17.000 --> 00:08:59.000 Sure, I think the biggest challenge is that healthcare is filled with physical products and data. But those two words aren't always seamlessly connected. We have medical devices, surgical instruments, implants and consumables, like I mentioned a few minutes ago. But the the challenge is connecting the physical product to the right digital information in a practical and reliable way. That's where RFID has the advantage. Unlike technologies that require like direct visual presentation or visualization, RFID can support that automatic data capture and the information without requiring the same line of sight interaction. It also creates opportunities for identifying multiple tagged items within an appropriately engineered environment. So simply adding an RFID tag doesn't solve that business problem or the clinical problem. The entire solution has to work. The tag, the RFID reader, an antenna, software systems and data Infrastructure and then the product materials, the physical environment, and more importantly, the entire workflow. So that's especially important in healthcare. We shouldn't just give clinicians another technology that they have to manage. We should be looking for opportunities where RFID can remove the manual steps from their workflow. RFID by itself doesn't create patient safety, but better identification, better traceability, and better information at the right point in the workflow can support safer clinical processes, in turn creating better patient safety. So it's not just whether the RFID tag works. The question's whether the entire RFID enabled workflow delivers that better information with less effort. 7 00:08:59.000 --> 00:09:16.000 I think the fact that you have touched on workflow is so critical, so that the digital identity and the workflow were the two

things that brought the importance of RFID to me at the forefront. Can you help me understand what technical advances and achievements are making this possible? 8 00:09:16.000 --> 00:10:28.000 Sure. This is where the story really gets exciting, because RFID itself has evolved considerably, but so has the technology around it. We've seen continued development in RFID tags, inlays, specialized form factors, miniaturizing these form factors. I mean, a glass tag is basically the size of a grain of rice at 1.25 by 8 millimeters. That's tiny. The reader infrastructures have improved antennas, software, AI, cloud connectivity, data platforms, and connected devices. So these advances expand the environments, the applications where RFID can be potentially considered. But I think one of the most important developments is actually broader than rfid. Now we have better ways of doing something useful with all the data that the RFID generates. Can you read the tag? What data driven workflow can I create because of automatically identifying this product? You have boundless opportunities. So in MedTech, the RFID read isn't the destination, it's the beginning of a connected data journey. 9 00:10:28.000 --> 00:10:34.000 I love that so much. So then, how do you see the industry's response? Changing innovation in the near future? 10 00:10:34.000 --> 00:11:24.000 That's a great question. The next several years, I think we're gonna see medtech companies moving from individual RFID use cases towards thinking more strategically about connected product identity. Today, a manufacturer might just start with one specific business problem. How do we improve inventory visibility? Or how do we identify an instrument? How do we authenticate that the product is our device? Or how do we improve traceability? But I think the next step is a bigger question. You know, if the product has an RFID enabled digital identity from the very beginning, what else can we do with that identity throughout its life cycle? That's a much more interesting conversation. And I Think that that's where we start designing the product, the identity, the data, the connectivity and the workflow altogether. 11 00:11:24.000 --> 00:11:44.000 Well, I love that so much. Okay, so then what about a decade from now? And I want you to think about the most hopeful expectation of what RFID can be. I won't hold you to it. I just want to know like, what it could be. So what is the future potential of RFID and in medical devices? 12 00:11:44.000 --> 00:13:14.000 Wow, that's a great question. I think 10 years from now, I think some of the most exciting RFID applications may be the ones that we are not even considering today. I can envision an increasingly connected healthcare environment where many medical products have a persistent digital identity that begins much earlier in their life cycle. It correlates with, you know, post market surveillance. It correlates with UDI information. Think about the possibilities if the

appropriate products can carry that identity from manufacturing, through distribution and inventory and eventually into the healthcare environment. Instead of repeatedly recreating information about this product or surgical instrument, the digital ecosystem could increasingly recognize what the product is. That can open up so many opportunities around traceability, inventory, visibility, authentication, that workflow. We were talking about automation and lifecycle management. So they shouldn't have to think, now I'm interacting with a connected device. The technology should simply help provide the right information about the right product at the right time. I think the future of RFID and MedTech isn't about putting more tags on more things. It's about creating an intelligent connection between the physical medical device, the data, and the people who depend on that information at the right time. 13 00:13:14.000 --> 00:13:29.000 Karen, I cannot thank you enough. I think our audience is pretty clear as to why I invited you back into the studio and why I got hooked. So, Karen Mills, Medical device Sales Director at HIV Global, thank you so much for joining us on the future of medtech opportunities. 14 00:13:29.000 --> 00:13:32.000 Thanks again so much, Kaylene. 15 00:13:32.000 --> 00:14:38.000 Now for my audience. Once again in the show notes, I have included that link to the Women in MedTech interview where I learned more about Karen. I learned more about HIV Global and that's actually where I got my first terrific overview about the power of rfid. So I can't, cannot encourage you to watch and listen to that interview more. It's fantastic. I also included the link to the technical deep dive webinar from MDO that I mentioned earlier. So make sure that you you check that out so you can dig into RFID further. And of course visit www.hidglobal.com to learn even more about how HIV Global works with medical device companies. I suspect that if you're not already hooked, you sure will be. Thanks again for listening. Karen always delivers. Thank you so much for joining me on the pod. And now we bring you our keynote interview. Connor Hale, senior editor for mass device, MDO and device talks, sits down with Dr. Jonathan Viktorchek, Chief science, technology and medical affairs officer at Zimmer Biomed. Enjoy. 16 00:14:38.000 --> 00:14:45.000 Hi. My guest here is Dr. Jonathan Vijorczyk, Chief science, technology and medical affairs officer at Zimmer Biomet. Welcome to the pod. 17 00:14:45.000 --> 00:14:48.000 Hey, thanks for having me. Looking forward to it. 18 00:14:48.000 --> 00:15:01.000 Absolutely. So one question we like to start out with here on Device Talks weekly is, you know, how did you get into this industry? Kind of, how did you start out in medtech? Can you kind of walk me through your steps to get here? 19 00:15:01.000 --> 00:15:59.000 Yeah, I took an unconventional path, I would say, to get into med tech. Yeah, I started on the surgeon side. So

I am a practicing orthopedic surgeon at HSS in New York City, specializing in hip and knee replacement surgery. And around six months ago, I took a dive into the med tech world by transitioning from full time clinical practice to part time clinical practice and now full time as at Zimmer Biomet. So why did I do that? Well, I've always been involved in startup companies. I loved being on the consulting side and development panels for different technologies. I've used robotics and technology since day one out of fellowship training and really decided that the time was right, a great opportunity and an exciting time for Zimmer Biomet and to really change the future of what, what orthopedics looks like, you know, for the next 30 years. 20 00:15:59.000 --> 00:16:17.000 Let's dive into that a little bit more. Can you tell me about a time in your clinical practice, in your career where, you know, maybe you felt like you had the right team, maybe the right understanding of the disease, the right knowledge, but the technology, the robotics wasn't exactly where you wanted it to be or needed it to be. 21 00:16:17.000 --> 00:18:03.000 Yeah, it all started back in fellowship. We, we trained with a lot of different surgeons. Some used technology, some didn't. And after surgery, we would always have these case conferences looking at what we did throughout the day. How did all those 6, 7, 8 cases go? Are they successful? Did we like the X rays or not? And we noticed that every time we would do something with technology, the postoperative X ray was always perfect. It was just no variation. Boom, boom, boom, boom, X ray, X ray, X ray after X ray, always perfect. And then you would look at the manual surgeries and you'd say, oh, those Cups are a little bit different, the knees a little bit differently aligned and each one. And that was really the kind of light bulb moment that went off and said, hey, this was actually not that hard to do. And the X rays are much more reproducible. And now is it translating into clinical outcomes? So fast forward the next 10 years, right? Starting to use these technologies. X rays continue to stay perfect and. But now there's a variation in clinical outcomes. Why do some patients who have perfect X rays still don't do well after surgery? And right now the tools that we have really just allow us to execute a surgical plan, right? I want to cut this knee bone at zero degrees, okay, Perfect. The robot lets us do that. And it brings my variation down from, you know, a standard deviation of 3 degrees, ish, 5 degrees with manual instruments to really being able to hit the target. But we could never translate that into any type of clinical difference. Right. Why is that? That's what we really need to figure out. 22 00:18:03.000 --> 00:18:05.000 So how are you going about doing that? 23 00:18:05.000 --> 00:19:54.000 Well, it's really about combining everything that we do as a surgeon. My preparation for the operating room starts with reviewing the patient's chart that's in the electronic and medical record. Then I pull up their X rays, I check out their anatomy, make sure the diagnosis is the right one, that they need surgery, and then we start planning the operation, right? The preoperative planning piece, that's all done in my office or on some sort of PAC system. Then I need to figure out how to get that plan to the robot or the computer technology, execute that plan, and then the patient's released. And, you know, we don't really know what's going on with them until we see them back in the office at two weeks or six weeks after surgery. So the whole purpose and the whole vision of what we're trying to do here is connect the dots between all these different technologies. It's really how do we look at somebody's X rays beforehand and predict what's going to happen during the operation or predict any risk that they could have and then do something differently? How are we going to go execute that surgery to that pre operative plan? And then how are we going to track that patient's recovery to make sure that they're actually recovering well, they're not falling off the wagon and just forgetting to call. That's what we're trying to connect that entire ecosystem and then learn from it. Connor comes in. Connor is 64 years old. He's got knee arthritis. Well, we know that patients with the Bones like Connor, your age, your anatomy, the way, your activity level. We know how patients like you recover to the best of their ability. Let's learn from that and execute your surgery and the next one from those learnings and being able to inform the next preoperative plan. Right. That's the vision we're trying to create. 24 00:19:54.000 --> 00:20:08.000 Yeah, knock on wood. But are you seeing patient satisfaction kind of match up with what you're seeing with these post operative X rays when they come back in maybe a month later? 25 00:20:08.000 --> 00:21:05.000 Well, it's. The patient satisfaction piece is really right now we have to connect the dots between all these things, and that's not what's happening worldwide. Right. Some of these things are happening very independently from each other. There's not really a system that allows you to build on this type of framework. Which is why we created the surgeon guided autonomy category. Right. Surgeon guided autonomy is really stringing the pieces together, translating what the surgeon wants to do into action. Right. Predicting how they're going to do better, predicting that preoperative plan, executing the surgery, monitoring their recovery. Once you start putting all those pieces together, we absolutely see clinical outcomes differences. But you know, you got to remember, we're just launching this category now. The technology doesn't exist that strings it all together yet, but the framework, the building blocks behind it all show signal towards, yes, it's going to affect clinical care. 26 00:21:05.000 --> 00:21:17.000 The company's kind of

describing it as a new category of intelligent surgery. You talked a little bit about it, but kind of walk me through the details. What does it look like in the room? What are some real examples of how it's going to work? 27 00:21:17.000 --> 00:22:57.000 Well, it really goes back to those three pillars, right. Predict, perform and recover. So the predict piece, what kind of information can I get from the patient's record, from the information that I can predict what kind of risk that person's going to have. I can predict what kind of outcome they're going to have after surgery using all the available information from all the previous cases. How can I make the best surgical plan for this particular patient? Then you bring it to the operating room and it's connected to the robot. So the robot will then know that surgical plan. And with the robotics technology, you can execute that surgical plan with precision and accuracy. And then when they go home, we can monitor their recovery. Whether it's a smart implant, whether it's a connected app, whether it's a smartwatch that we can link into. We know exactly how that person is doing from the moment they leave the hospital to the moment we see them back in the office. And sometimes we need to intervene early. You may fall off the wagon there, not do your physical therapy. And I'm going to realize it. A smart, connected ecosystem is going to tell me that my office will reach out, whether it's through AI or a real person, and say, hey, hey, Connor, why aren't you doing your exercises? Why aren't you walking? Well, is it because you have too much pain? We can fix that. Is it because your knee doesn't bend? Well, maybe we need to see you earlier than six weeks. Maybe there's some signal there that shows us you're having an infection and we need to see it back in the office immediately. All these connected smart ecosystems you can see the world just starts to expand as soon as you start connecting the dots here. 28 00:22:57.000 --> 00:23:13.000 Yeah. So a lot of these technologies you've been mentioning have been on the market for a couple of years now, or at least been developing them for a couple of years. What are the missing pieces that kind of kept all of these systems from connecting together in the way you're describing until now? 29 00:23:13.000 --> 00:25:54.000 Yeah. You know, you bring up a really interesting point that a lot of these pieces are out there today, but none of them are connected. Right. There's startups that do one piece here, one piece there. There are some of the larger med tech companies that have a robot, but nobody's ever connected the dots between them all. It's actually just commercial execution. How do you go and link all these pieces together? And it takes a lot of effort to get the best predict information. You really need access to the electronic medical record. You need the images there. You need all the data from previous cases that you can reference and see in these types

of patients what's done well in the past. It's not just about a single robot either. Right. The robot is just an execution device for a surgical plan. So how do we string together that preoperative plan to the intraoperative part where you execute the plan and then how are we connecting that to the recovery piece? How did those patients recover? Unless you connect that whole ecosystem, you need to know who the patient is, what do their bones look like? How is the surgery actually executed? Not just looking at some X ray. With X ray, how is the surgery actually performed and then how do they actually recover after surgery? Right now we look at all these different randomized control trials, robots versus no robots, technology versus no technology, no differences. We have no idea what kind of patients came in. We don't know what those knee phenotypes look like. We don't know how they walked before surgery. All we have is a piece of paper prom score. Then we don't really have any idea how that surgery was executed. Maybe we know what angles those bones were cut, but we certainly don't have what balance that knee was put in at. What's the ligament laxity of that profile of that patient. And then we definitely don't know how they're recovered based on anything more than another questionnaire on can you walk upstairs? How you feeling today? How's your pain? You really need objective data about who was that patient going into surgery, Objective data on how you executed the surgery, then objective data on how they did after the operation. And only then can you feed it back and say, in these types of patients, this is what has done well in the past. You should probably think about executing your plan like this. You know, obviously keeping the physician in the center of all to make to use their clinical judgment. But you can start augmenting that physician information. 30 00:25:54.000 --> 00:26:21.000 Another part of how Zimmer is describing this intelligent surgery category is that it relieves a lot of the burden from, or at least some of the burden from the surgeon. You know, you've talked a lot about how all these different systems present information to the surgeon, who is then, you know, doing all of the reasoning, the thinking, the kind of the mental planning. How does the system kind of ease that mental workload? 31 00:26:21.000 --> 00:27:44.000 That's a really good point that you're making there. It's not only thinking about it from the patient outcome perspective, but really what's the burden on the surgeon right now. Like I told you prior to surgery, I need to spend 45 minutes to an hour planning all my cases for the day. There's a time burden there, there's a mental energy burden there. There's absolutely no reason why in the time of AI, we can't automate the majority of that surgical plan where it comes to me 99% baked. I check and double check everything. Then in surgery you got you have to preoperative plan again and then execute the surgery.

Also unnecessary to go through a learning curve to have to know how to exactly the most efficient way to cut the bones and to use the robot. All that can be pre programmed into an autonomous robot and then postoperatively. Why do I need to hire one or two FTEs to call patients, monitor everything when an app can easily track their recovery? So we've taken a lot of the burden from what the surgeon needs to do and eliminated every pain point and delivered information just in time when they need it alerts if the patients are not doing well, and then really strengthening that and let the surgeon operate to the maximum end of their license or other training, not doing administrative paperwork. 32 00:27:44.000 --> 00:27:53.000 It does sound like this program does go beyond simply bundling the robot and the implants and the analytics in a single commercial sale. 33 00:27:53.000 --> 00:30:22.000 Absolutely. I mean, we're trying to really keep the surgeon in the center of this by eliminating the burden from them and really preserving their judgments and control. So everything that can be automated around the surgeon's experience is ultimately going to help them. We want them doing more cases per day. Maybe if you can do the surgery more efficiently, we want you to be done after the end of your day and go home to your family, not completely mentally exhausted. Right. It's kind of interesting. Even things as simple as your surgical team, if you do five or six operations with a surgical team you've never worked with, you notice that mental energy that's been expended. As soon as you start standardizing how you do the operation, where you're not asking for every single instrument or you're not thinking about every case, just a double, triple, quadruple check to make sure you did it right. Once you start trusting in that efficiency in those steps and trusting in the technology that it's helping you, you go to double checking, knowing that you've got 99% chance that you're going to do it right. It takes away a lot of that mental energy. And that burden on the surgeon ultimately translates into good outcomes. You hope. And one thing we do know is that, and this goes back to one of your earlier questions about why did I get into this? How did I notice the technology was helping or not helping? 50% of the revisions that we do are completely avoidable. That's 55, 0. Completely avoidable. If the first surgery was done better, what's that mean, done better? Surgery planned better. So identifying some sort of risk where you could change your, change what you're doing during surgery, let's call it 80 year old female, really poor bone, you probably should use cement. Right. If you don't, she's going to have a fracture, the stem's going to subside, she's going to be back in the operating room. Right. So how do you plan surgery better and then how do you execute to that plan better to avoid that risk? So putting it all together, that's how we're really going to attack the

patient outcomes realm too. How do you prevent those avoidable complications? It's no different than what we Treat in nuclear facilities, in the airline industry, about being high reliable organizations. Right. Avoid preventable problems. 34 00:30:22.000 --> 00:30:44.000 I want to talk a little bit more about the individual pieces of this system, starting with outcomes. Maybe you can give us a little bit of background on the Persona IQ Smart knee with its sensor built into the stem. The company's working with, worked with Canary Medical to develop that. Picked up the de novo clearance, I believe, five years ago. Tell us a little bit more about that, how it kind of fits into the broader picture. 35 00:30:44.000 --> 00:33:44.000 Yeah. So that broader picture of predicting, perform the surgery and then recover, Persona IQ fits into both the recover phase. We now have objective data exactly how the patient's doing after surgery. And then that feeds back into the predict part. Right. If we connect all the dots, we know who the patient is, we know how the surgery was performed, we know how they recovered. And then we can do the surgery differently in that group of patients next time if we need to. So Persona iq, a lot of the activity monitors after surgery are based around your smartwatch or your smartphone. This thing is an implant, a smart implant that's inside your tibia. So it's attached to the tibial component of the knee replacement. It's actually an implant that's inside the tibia. So the patient signs up for this, they sign a data privacy agreement, a data sharing agreement with us, but the patient retains the rights to their data, and we can track the recovery. There's an app that they have access to so they can log into it every day. They can see how they're doing compared to thousands of other patients that have had a knee replacement. From the patient side, number one thing that they care about is, am I doing okay? How am I doing compared to everybody else? So now you can take thousands of patients recovery and compare this particular patient to how those other thousands of patients with similar profiles are doing. And it really gives a lot of peace and comfort to the patient knowing that they're recovering on track. Now, conversely, right. If they're not recovering well, the surgeon's got to know about it. And the surgeon's office, the surgeon needs to intervene. Why are they not doing well? Do they have an infection? Too much pain? Not doing their physical therapy exercises really opens up to the realm of what you can do on the recovery phase. Now, if you use this right, which we try to do, you can decrease cost of care. And not every patient postoperatively needs physical therapy. Not every patient postoperatively might need an ER visit when they just don't think they're doing well. Or they notice a little redness on their wound that's completely normal. Right. If they can't get an answer from the office, they're going to show up in an emergency room somewhere. You know what happens when they show up in an emergency room somewhere? They get blood work, they get an ekg, they get a CT scan, they got an orthopedic consult, and you've just blown your entire bundle. If that patient's in a bundled care environment, all on a very simple, you know, take a picture of your wound, send it to the office and say, yep, that looks fine. Completely normal. You know, how are you doing? In some pain. Let's change up your pain meds. Go on with your day. Right. There is a lot of that that's going on out there because the majority of patients are just sent off into the wild. 36 00:33:44.000 --> 00:34:07.000 Yeah. So this implant tracks range of motion. It tracks step count, walking speed. In terms of the data that we were talking about, when it comes to, like the FDA label, the indication that kind of data is still the clinical usage of that is still limited. Right. So what's Zimmer Biomet doing to bolster its clinical use? 37 00:34:07.000 --> 00:36:12.000 Well, it's really about the full ecosystem again. Right. If the patient allows to share the data and they participate with the my mobility app, that allows them to do virtual physical therapy so we can track exactly what exercises they're doing. We can track their exact range of motion and step count so we know exactly how their recovery is doing. So it's really part of that entire complex. Just wearing, you know, just having a smart implant in their bone is a glorified pedometer. But once you look at all the different types of gait data you can get, you can get signals of this patient was doing well and now they're not. What happened? We published a few papers and some abstracts that have been presented recently showing that you can prevent or predict somebody going onto an infection because they were doing well, well, well, and then boop. Their step count and pain score. Step count drops off. Pain scores go up through the app, you know, to reach out something's going wrong, or maybe they've had a fall at things like that. So in isolation, the smart implant alone doesn't do much. And once you connect it to the rest of the mind mobility app, which is the recover pillar, then you can really start unlocking clinical data. You can unlock preventing problems before they start and to hopefully help in that entire connected care ecosystem. What might be the most important thing to know about Persona IQ is that it's not really about the smart implant that connects the recovery piece. The smart implant is a piece of it. However, it's actually the whole ecosystem around it. You don't need a smart implant to achieve the surgeon guided autonomy. If you know how the patient is before surgery, you know how the surgery was executed and then you know how they're recovering, you can use any sorts of technology to monitor their recovery. Whether it's your phone, whether it's a smartwatch, any type of device that's giving data. It's not really about the smart

implant. It's about the whole connected ecosystem. 38 00:36:12.000 --> 00:36:22.000 Let's talk a little bit more about what's happening in the operating room. There's been recent advancements in robotics, but with handheld form factor. Can you tell me more about that? 39 00:36:22.000 --> 00:39:11.000 Robots have always been thought of. These big apparatus take up a lot of space in the operating room. Clunky, difficult to use. That's all historical now. So two companies. One is Think Surgical and they came up with a T mini device and we have a exclusive partnership with them for our Persona implants. And then recently Stryker came out with their handheld version, the rps. And these are designed for. The best way to explain this is really the majority of surgeons don't use anything in the operating room other than manual instruments. So taking a full leap to a robot maybe was too big of a leap for them. So could there be some cheaper, lower cost option that they could use in their ASC as almost a gateway drug for lack of a better term too full robotics, you could still get the accuracy you want. Maybe there's less steps in the operation than the full blown robot and you could have this intermediary step. And that's been the strategy around that and really taken off in terms of adoption. Smaller footprint, easier to use, great for ASCs, especially as we migrate more surgery to the ASCs, which has rapidly accelerated after Covid and will continue to rapidly accelerate with CJRX coming for the inpatient stays. Maybe there's a role in the marketplace for the small form factor. Well, we want to give the surgeon options. Sometimes you want a CT scan, sometimes you want all the bells and whistles, 3D planning and robotics to help you with the different boundaries to help do the surgery. Other times you just want to go through efficiently and do as many cases as you can safely. Right. Then you can use a smaller handheld robotic platform. Different options, different ways surgeons look at these things. In my view, once you get efficient with a large robot, it's equally as efficient as a Small, handheld. It's really just about your workflow, surgical team workflow. And that's where medical education comes in. How do surgeons go visit other surgeons who are utilizing these technologies to the fullest? How do we create courses where we can not only just certify them for use, but teach them the best in class techniques to get everything out of it without overburdening it? And that's where the surgeon guided autonomy comes in again, Right? How do you not overburden the surgeon? How do you give them all the information that they need so that they can perform the surgery safely, translate their clinical intent into action? It's really, it's bigger than just any robot platform, right? You can't, it can't just be tied to the robot. 40 00:39:11.000 --> 00:39:36.000 On that note, you're rolling out this surgeon guided autonomy category at a symposium at the American association of Hip and Knee Surgeons meeting in Dallas. Its title describes intelligent surgery as kind of the next step after kinematic alignment. Can you walk me through the relatively recent rise of kinematic alignment versus mechanical alignment in knee replacements? 41 00:39:36.000 --> 00:40:55.000 So mechanical alignment is the way we've been doing knee replacements since the 1970s. And the fundamental premise is that it's targeting zero, zero for everybody. Everybody gets a perfectly straight leg. And when I say zero, zero means zero degrees on the femur, zero degrees on the tibia, make the leg exactly straight. Now if you walk around the street, walk around the airport, you can see that not everybody's leg is perfectly straight. Some people have some bowing, some people are knock kneed, some people are bow legged. That's where the fundamental philosophy around kinematic alignment comes in. It has to do with understanding the person's bone and cutting the bone in the angle of that particular bone for that particular patient. In effect, not selecting 0, 0 for everybody, but thinking about how is that person's bone, is it 2 or 3 degrees, 5 degrees this way, 2 degrees that way, and respecting that anatomy? Because when you respect the anatomy, the ligaments of the knee are happy as well. That's the fundamental thought around kinematic alignment. It's just turning a knee replacement procedure into resurfacing the knee, respecting what's there, just feeling, putting that knee back to how it started, how it began its life. 42 00:40:55.000 --> 00:41:02.000 How much of this shift is really being enabled by these new medical technologies that are coming on the scene? 43 00:41:02.000 --> 00:43:04.000 Yeah, absolutely. So kinematic alignment is not new. It was first described by Stephen Howell around 2008, maybe even 2006. And Persona was actually the first total knee arthroplasty. Component or implant that was cleared for use with the kinematic alignment technique. So it's been around for quite a while. But to your point, are these techniques now enabled because of the technology? I think the one thing Stephen Howell did wrong was he showed these really crooked tibia X rays and said, look what I can do. This patient's doing amazing and scared people. The reality is, 95% of the time, maybe even 98% of the time, kinematic alignment is plus or minus 5 degrees. There's only 2% outliers that are going to be weird based on some weird Boeing, some weird deformities. So what is kinematic alignment? It's really understanding how to understand the patient's knee anatomy and say your particular knee's got 3 degrees of valgus in your femur, 5 degrees of eris in your tibia. And how do I execute that surgical plan now, doing that manually with a plus or minus 5 degree opportunity, you're going to make some mistakes. Technology now allows you to very accurately execute that one or two or three degree difference in your surgical plan. So that you can now connect

the dots there. Right? It all goes back to the same thing. Understand the patient's anatomy. You've got a joint line that looks like this. Somebody else has a joint line that looks flat. Somebody else has a joint line that looks this way. Understand that anatomy beforehand. Go execute that surgery to the best of your ability and then see how they do. 44 00:43:04.000 --> 00:43:10.000 So it's really fitting into even more broadly across medicine, a shift towards personalized medicine. Right? 45 00:43:10.000 --> 00:45:17.000 I mean, kinematic alignments, it was personalized medicine before that term existed, Right? That's really what Stephen Howell was doing. He was taking, I am removing this many millimeters of bone from this medial side. I'm going to put back this many millimeters of metal from this side. And we tried this Even in the 90s, in the 1990s, they came up with these anatomic reconstructions. However, they went with three degrees and three degrees for everybody. So no matter what you looked like, you got a 3 degrees valgus on your femur, 3 degree varus on your tibia. And the same thing happened as in implants. Right. There are certain implants out there that do the same thing. Three degrees, three degrees for everybody. Kinematic alignment now is understanding every single patient is different to the millimeter, to the degree different. So how do we execute that particular plan? There's different techniques to do it. You can do it manually with a caliper but you have to really measure. You got to take into account cartilage soft thickness, or you can use technology and robotics to do it. It's all in the way to simply say, what's the preoperative anatomy look like? How do you execute the plan? Right. And then connect it with the third pillar. How's that patient recovering afterwards? Right. Is there truth to what Dr. Howell told us? KA patients do better if you really talk to him. Every single patient for a long time got a postoperative ct, and he had a spreadsheet tracking every single alignment that he did. And he tracked every single outcomes measure on those patients postoperatively. So to be honest, like, back in 2008, he was doing the same thing. Understanding the patient's preoperative anatomy, executing the surgery with maniacal detail, measuring every single millimeter, every single cut, knowing if he made an error or not, and then tracking postoperatively what he did. Right. It was. It's that same thing now we're putting together with technology, with surgeon guided autonomy. 46 00:45:17.000 --> 00:45:22.000 That's fascinating. So it really just sound like a. Sounds like a natural evolution of it. 47 00:45:22.000 --> 00:45:27.000 Yeah. And it's. It's an exact natural evolution to that personalized medicine piece. Right. 48 00:45:27.000 --> 00:46:06.000 This kind of makes me think about how, if you look back on the history of the 20th century in oncology and cancer treatments, there was a time where radical surgeries were the norm. Today we have, of course, laparoscopic procedures, targeted therapies, combination regimens. One of the things I like about covering the medtech industry in particular is you get to see technologies come along that make clinicians say, oh, I can't believe we used to treat this disease any other way. Right. What have you seen in orthopedics that has made you say that? And what do you think will make people say that in the future? 49 00:46:06.000 --> 00:47:19.000 In orthopedics, a lot of things. For knee replacement, we used to cut everybody at zero. Zero. And how do we cut everybody at zero? We literally looked across the wall and lined up your finger and said, yep, that looks like a right angle. Even before that, they used to look at the tiles on the wall. The tiles on the wall you hope were right angles to each other and line up a knee cut to that. It's kind of crazy to me that that's how we did surgery on humans even today. I mean, in real life. What kind of things in real life do we do that? Looking back, manually executing something is completely crazy. Even the guys who are building our houses using lasers to level walls, airplane Pilots using technology for flying, for landing and takeoff, they used to fly that manually. That's the same place we are in orthopedics. It's kind of shocking to think that we're okay with all that stuff in our cars, but we're not okay with that. With our surgeons in the operating room operating on humans, that's kind of the mind blowing thing, is how slow as an industry we are to uptake technology. 50 00:47:19.000 --> 00:47:22.000 Why do you think that is? Well, why is it so slow? 51 00:47:22.000 --> 00:48:58.000 Regulatory burden is one piece of it. Right. The product life cycle is several years. So you can have an interesting idea today and it won't hit a patient until 2030, probably depending on how fast we can get the R and D done and then the regulatory piece done. And surgeons are just resistant to change. Right. There's been this hubris of I don't need tech, I'm good enough, my patients do well enough. Yeah. I've never been under the mentality that a person could do well enough. Right. Why are we not striving every day to make the surgery as perfect as possible to understand who the patient is, how you do the surgery, and how they're doing afterwards? You should always be on a continuous search for how to do things better in orthopedics, in life, and everything that you do, that's kind of the quest that we're on. So I don't know, I think about it a lot. The rate of technology adoption in orthopedics lags behind every under industry. Automotive, airlines, everything. We're operating on human beings. Right. Take it back to the principle. 50% of complications completely avoidable if you do the first one correctly. 50%. We have technology today. We've had it for 10 years. That allows you to do the surgery correctly. Right. This is how we're. We're now getting to the realm of understanding how to do the

surgery, not just precision. Now we're not just hitting targets. We're understanding what targets are needed for the particular patients. 52 00:48:58.000 --> 00:49:02.000 Well, thanks very much for taking the time. I really appreciate you joining us here. 53 00:49:02.000 --> 00:49:10.000 Thanks for having us and looking forward to launching this category. And we'll keep you updated on. On how everything's going. 54 00:49:10.000 --> 00:52:12.000 And that's a wrap. On another episode of the Device Talks weekly podcast. I am so beyond please that I asked Connor Hale, our senior editor for mass device and medical design and outsourcing and of course, device Talks, to do today's keynote interview. Connor had grace and elegance, and I think he guided the conversation in a way that made me so so proud and I actually learned a lot from his own interview style. Thank you so much to Zimmer Biomet, to Dr. Jonathan Viktor check for sharing your time and your insights with us. And of course, thank you so much to my FOMO guest Karen Mills, Medical Device Sales Director at HID Global, for giving me and us a masterclass in rfid. I hope you've enjoyed that topic as much as I have. We will continue to bring you these FOMO interviews as part of our Device Talks Weekly podcast that will come to you every Friday. Except we're going on a winter break next week. November 20th will be the final episode of Device Talks Weekly for the 2026 calendar year. And why is that? I won't be here. I am actually taking medical leave for myself second foot surgery. So if you've listened to me on the Women in Medtech podcast, I had my right foot done. I had a bunionectomy. I officially have a medical device in my body. I liked it so much I wanted to make a matching pair. So I will be out for all of December so that I can recover from my left foot bunionectomy. But never fear. I promise that we will be back starting January with an uninterrupted cadence for Device Talks Weekly. It will come to your favorite podcast player every single Friday. I'm going all in on the weekly podcast here and I'll be back. I'll be healthier. We'll bring even more voices on the pod. We'll keep expanding it. So I hope that you continue to join us. Once again. I'm Kayleen Brown. I have. I've enjoyed every second of the podcast, of being on stage, of doing the webinars. I absolutely have the best job in the world and I'm so grateful that you're listening. I'm so grateful for your support. Support. Speaking of being grateful for support, thank you so much to HID Global for sponsoring this episode of Device Talks Weekly. To learn more about radio frequency identification and how HID Global works with medical device companies, please visit their website@hidglobal.com and make sure to check out that October webinar from Medical Design and Outsourcing. Please make sure to jump on LinkedIn. Follow me Kayleen Brown Follow Device Talks and follow our guests Karen Mills, Dr. Jonathan Vic Dorchak, our senior editor, Connor Hale. If you haven't already, follow Device Talks on your favorite podcast player. Don't miss next Friday's episode. It's going to be the final episode, but I'm doing the keynote interview with Olympus So that'd be a great ending to the season. Thank you. Thank you. Thank you for listening.