Beyond the Byline: Smart knee implant tests uncharted territory


Alex Kacik: Hello, and thanks for joining us. Modern Healthcare’s Beyond the Byline here, where we offer a behind-the-scenes look into our recording. I’m Alex Kacik, senior operations reporter. I’m joined today by our technology reporter, Jessica Kim Cohen, to discuss the latest tech development in joint replacement surgeries. Thanks for joining me, Jessica.

Jessica Kim Cohen: Yeah, thanks for having me.

Alex Kacik: Jessica, you came out with a story recently about a “smart” knee implant. It’s the first of its kind, at least to be approved by the Food and Drug Administration. And it seems to be an embedded extension of remote monitoring. You know, we hear so much about internet connected things, especially in healthcare that are supposed to be making our lives easier, but let’s be real with me for a second. Are the robots taking over?

Jessica Kim Cohen: Yeah. Definitely sounds very futuristic to have a sensor inside of the human body that is tracking various metrics. Yeah. One thing that’s kind of interesting about this is that it feels like a bunch of things that were already out in the world being put together to create this new thing, not to oversimplify. But existing knee implant from Zimmer Biomet, which is now outfitted with a sensor created from another company called Canary Medical being brought together to create this first smart knee implant to be cleared by the FDA.

Alex Kacik: So it’s the first of its kind. It kind of sounds like a Fitbit for your knee. It tracks your movement and, you know, how good you’re walking around and how your flexibility is. But tell me a little bit about how it works and what the potential use of this technology is.

Jessica Kim Cohen: Yeah, definitely. So like I mentioned, it’s a knee implant that is used for knee replacement procedures. There’s a sensor inside of it that collects various metrics, collects steps walked, gait, things like that. The thing to keep in mind right now is in terms of its FDA clearance, it’s been cleared insofar as it’s safe to use with patients, it is effective at counting the various metrics that it advertises. But so far, there’s a warning with the smart knee implant on the Zimmer Biomet page even that says that it’s not meant to be used for clinical decision making, it hasn’t been proved to have a clinical benefit yet. So there’s a lot of exciting things that people are talking about the potential for. Once we see some research, potentially it could be used to detect problems, inpatient recovery, if a patient isn’t up and moving around and walking as expected, potentially could be used to tailor treatment plans more, but that’s things that we will potentially be seeing down the line.

Alex Kacik: On that note, you talked to an analyst who said that the potential is significant, but it’ll take large research studies to prove the value to payers and providers. So let’s unpack that a bit.

So this probably costs more than the typical implant, which insurers have shown generally they’re going to be more skeptical about. They have to make sure that it’s worth their investment in reimbursement. So how could we potentially determine its value? I imagine you’d look at potentially how long it lasts, if it helps prevent readmission rates once you’re able to gauge how well a patient’s moving around. Many joint replacement patients have chronic conditions. So maybe they could see if it helps them manage weight, glucose levels, etc. What do you think about just how we’re determining whether it’s a successful product or not?

Jessica Kim Cohen: Yeah, so talking to Zimmer Biomet, which was the device company behind this smart implant, something they spoke to is that in other areas of medicine, having this type of device inside the human body is not unheard of. There’s cardiac devices, in diabetes there’s continuous glucose monitoring. So they see this as kind of the first step of bringing that into orthopedics.

Of course, right now we are at the stage where we’re hoping to see some research on whether this does improve patient outcomes, cut costs. Some of the ways that orthopedic surgeons that I spoke to are thinking about this, they said they were hoping to see whether data from this implant can be used to detect patients who aren’t recovering as expected, and if so, whether there are interventions that can be done that make it so that the patient gets back on track, that you don’t have to reoperate, you don’t have to readmit them.

Those kinds of things could potentially cut costs in the long run. But that is something that still would need to be proven, would need to be borne out. It’s something that a few orthopedic surgeons I talked to talked about, not necessarily specifically with this smart implant, but with sensor connected implants in general, could they be used to detect if an implant is deteriorating or loosening? Could a smart implant detect if there is an infection at the joint? A lot of different ways that this technology could potentially be used to reduce readmissions and things like that, which have been a particular area of interest, as we’ve been talking more about value-based care.

Alex Kacik: There’s a couple things I want to hit on there, one of which is this push to bring more hospital services to the home through remote monitoring and other types of interventions. So you have health systems, big ones like Mayo and Kaiser and others that are investing in these hospital at-home programs. They’re getting the technology set up at people’s homes and the right staff and personnel pathways, coming to treat them in person and then also consult with them virtually in order to help ease any access issues because it’s easier for folks to stay in their homes. Generally they’re more, they’re happier, which can help with health outcomes. So, you know, I imagine, you know like you said, there are a lot of other devices that can monitor things like glucose levels and things related to heartbeats and other elements, other patient characteristics. So how does this coincide with the movement to bring more acute services into people’s homes?

Jessica Kim Cohen: Off the bat I would say bringing this type of data tracking and patient monitoring into the home is one piece of this. The fact that basically the implant that’s inside of the knee is collecting patient data on a daily basis, which is being sent to the patient’s orthopedic surgeon who has the opportunity to review that data. So there’s more monitoring going on than would typically happen after a joint replacement. The way that this kind of intersects with some of this talk of home-based care and hospital-at-home, again, hasn’t been proven in the research yet. But one potential idea is if it’s shown that this type of sensor can be trusted to track patient progress and how they’re doing, potentially patients who are recovering really well could stay home and maybe have more telemedicine-based visits rather than having to go into the hospital for regular checkups after the procedure. Maybe those in-person visits could be reserved for the patients who aren’t recovering as expected. So that’s one potential idea that’s been thrown out of how these types of smart implants could change the care models that we’re using today.

Alex Kacik: And if it’s part of the bundled payment models where we see orthopedics, hip and joint replacements, being pretty popular avenues for a type of reimbursement where providers get a lump sum to treat a patient. And then, you know, if they are able to save money through smarter or fewer interventions or the site of service could be a big factor too, where a patient’s able to recover at home where it’s cheaper and you don’t have that overhead associated with, let’s say, a skilled nursing facility where they’re watched by someone in person more regularly and it just comes with, you know, a different cost profiles. So I imagine if they’re able to glean savings by treating folks at the home, that could bolster their pursuits of these bundled payment models and this could be popular in that avenue.

Jessica Kim Cohen: Yeah, definitely. That is one area that folks are really interested in. Those types of programs tend to want to make sure that there aren’t unexpected readmissions or a need to reoperate or anything like that. So having something that can potentially flag problems that are happening earlier than you might otherwise be able to or ideally maybe even predict whether a patient is heading towards being at risk for a certain problem, definitely something really important.

One question that came up a few times when I was speaking with orthopedic surgeons about this is a lot of those bundled payment programs, value-based care programs, cover a specific period of time after the operation. This smart implant tracks patient data for 10 years after the operation so there’s a long time where there’s the potential that the smart implant is sending data to a physician, that, that physician’s reviewing that data. And just some questions about how frequently the physician would be reviewing that data, how they would be reimbursed for that time, of course. Throughout the healthcare industry there’s questions about reimbursement for telemedicine services. So this definitely intersects with that conversation. Depending on the patient’s insurance, whether they’ll be charged copays for that, which again would be for multiple years after they’ve had this joint replacement done. So that’s another open question right now when it comes to cost.

Alex Kacik: Interesting. And when, you know, when it comes to 10 years of gathering some of these data points, you and I have talked a lot about privacy concerns as more big tech is getting involved in analyzing healthcare data. We’ve seen them try to synthesize and make sense of these massive amount of EMR data from these big health systems. So I’m wondering if there are any privacy concerns here. I understand the patient signs up for this, but is there any way the device maker could use or glean more data than the patient expected? Did you talk with any of the, with Zimmer or any of the other legal experts related to any potential liability concerns where if this data, if there’s any breaches or if the data’s used for some malicious or unintended purposes, what that looks like?

Jessica Kim Cohen: Definitely an important question whenever it comes to a device that’s connected to the internet. So many cyber attacks in healthcare, as we know. When I spoke to Zimmer Biomet, something that they emphasized, which I do think is important, is thinking about the type of data that the device collects. There’s step count, there’s gait, but there’s no location tracking or anything like that, which I know is a concern that I had heard a few people wondering about when the announcement first came out. So it’s not tracking super sensitive data that could be used against a patient in that way. There’s no GPS component. They also spoke to the fact that like with other information systems that are being used that involve patient data, they do sign HIPAA business associates agreements with the providers that they work with. So they’re complying with HIPAA. But yeah, definitely whenever it comes to anything connected to the internet, there are concerns.

One area that folks I spoke to kind of questioned was there’s the smart implant itself which is sending data, but Zimmer Biomet is also kind of building a digital ecosystem around that, where it would be sending this data to an app that includes different patient data, preoperative, postoperative. There’s a dashboard that’s used by physicians. There’s an app that’s used by patients. And just in general, any time you’re connecting a new system to other systems, that kind of increases the attack vectors or the places that a cyber criminal could enter a system and potentially be lurking around to try to infiltrate other areas or to get patient data. So that’s one concern.

And then the other concern is just of course, patient perception of privacy. Will patients be comfortable with the idea of a sensor being in their body for 10 years? What if they are comfortable right now, and then five years later, they change their mind? In which case there is the possibility of they can, not necessarily remove the sensor itself, but they could turn off the base station in their home that’s being used to transmit the data. So definitely a lot of questions and things that both Zimmer Biomet and the physicians who are potentially suggesting this device to patients would need to be able to explain so that folks are getting an informed choice on this.

Not a Modern Healthcare subscriber? Sign up today.

Alex Kacik: So when you’re trying to figure out the potential market for this and who’s interested and what it could be used for on these smart devices, what did you find out from the other device makers that you talked to? Generally, what do they think the ceiling is for a product like this and how widely it could potentially be used?

Jessica Kim Cohen: Yeah, it does sound like there’s some interest around this. Not just necessarily in terms of sensors being embedded in the body, but in general. Zimmer Biomet, in addition to this smart knee implant that it made with Canary Medical, it also has a partnership with Apple where it has an app that can do some remote monitoring. I know there’s been research done on whether Fitbits or other wearable devices that also have sensors can be used to track metrics that help with patient recovery. So that in general has been an area of conversation for a while.

I spoke with DePuy Synthes, the Johnson & Johnson company, who also spoke to the fact that they have a research and development group focused on sensors, looking at things like wearables and also implantable devices. They said that it was an area for research. They haven’t launched any smart implants yet. They said that they were waiting to be able to launch something that they had evidence behind and that they could show had a clinical benefit, which of course right now is something that people are questioning about the Zimmer Biomet release. The fact that they were first to market with this FDA clearance, but they haven’t proven kind of a clinical or financial benefit quite yet.

Then on the flip side, there’s also other companies like Stryker, for example. Earlier this year, towards the beginning of 2021, they acquired a company called Orthosensor, which developed sensors for total joint replacements. At the time I looked at their press release and in the press release Stryker said that, that could potentially support work towards smart implants in its joint replacement business. I did reach out to Stryker to ask if we could discuss that in more detail. They declined to be interviewed.

I reached out to a lot of medical device companies who are in the orthopedic business. Aside from DePuy Synthes, didn’t hear back or was declined an interview request from the others. So seems like even though this is an area a lot of folks seem to be talking about, seems like a lot of companies aren’t ready to necessarily discuss exactly what they’re working on.

Alex Kacik: Well, we shall see. This has been a great primer, Jess. Thank you for breaking it down for us and sharing with us about this latest technology when it comes to implantable devices.

Jessica Kim Cohen: Definitely. Thanks so much.

Alex Kacik: All right. Thank you all for listening. If you’d like to subscribe and support our work, there’s a link in the show notes. You could subscribe to Beyond the Byline on Spotify or wherever you listen to your podcasts. You can stay connected with our work by following Jessica and I at Modern Healthcare on Twitter and LinkedIn. We appreciate your support.



Source link