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ECOSYSTEM: The Future of Enabling Tech in Spine

During the NASS 2021 meeting, Enhatch interviewed leaders working in top health tech companies about their work and how it impacts the Intelligent Surgery Ecosystem. In this interview Enhatch’s Senior Project Manager Morgan Continisio sat down with Orthopedic Spine Surgery Specialist Henry Fabian, MD. to discuss how technology is impacting spine and orthopedic surgeries. 

Fabian has practiced for more than 30 years as a private orthopedic spine surgeon. While he performs surgery daily, his background is different from his colleagues. Below is a Q&A conversation between Continisio and Fabian talking about NASS 2021, enabling technologies, and the future of spine orthopedics surgery. 

Morgan Continisio: So my name's Morgan Continisio. So I'm on our product management side, and am kind of our interface between engineering, marketing, and really trying to make sure that what the industry needs from our intelligent ecosystem gets translated to our engineering team and everything kind of continues to move forward.

Enhatch is a medical technology company and our software is kind of the foundation of running the Intelligent Surgery Ecosystem. We provide everything from preoperative planning to generating 3d workable models. From that, we can provide 3d cutting guides, patient specific cutting guides, implants for the knee or hip side. 

Now moving a little bit more into spine, but also with that, we work with companies to take their models and superimpose them into these 3d models, give you predictive placement of the implants, sizing, helps with inventory management and then kind of on the tail end, we also do kind of a postoperative learning. Using that AI to be able to build out profiles for our patients so that now the decisions are a little bit easier on surgeons like you. If 98% of your patients have received the same, similar prognosis, similar demographic, you have an idea of what sort of implants are going to be used with them. You know, but now the system's learning. We're powering the AI and the AI is kind of the foundation of the software.

So the reason why I asked you here today, and we're very thankful you were able to give us some time, is we want to have thought provoking conversations. We want to bring awareness to the intelligent surgery ecosystem and just kind of talk about the future of the medical device industry and where we're going. You see less and less mechanical companies. It's all about the tech now. Can you introduce yourself? 

Dr. Fabian: Yeah. So I've been practicing, I'm a 59 year old surgeon, so we're coming up on probably good 25 to 30 years in the business as a private orthopedic spine surgeon. My background is maybe a little more unique in that I have an engineering background and have done a lot of design work for spinal implants and actually ran a company, a young startup. So I've been through all the throws of how that develops and creates new technologies. And I've been a consultant throughout the years with several of the bigger names in the business and I continue to do that kind of consulting work. So I'm very much involved in the design phase and implementation phase. I've got eight patents to my name and they've all been basely generated off of this expandable, inner body technology. That's kind of where my area of expertise is. But that's kind of what I'm in. I'm still practicing. I do 350 to 400 cases a year. It's a high volume spine surgery practice. And that's where I'm coming from to get to this angle.

Morgan Continisio: You've been a busy man. I don't meet many surgeons who have an engineering background. And over my years of knowing you, you've always kind of been pushing new technology, especially expandable technology. And obviously now, you see it everywhere. What do you think was one of your greatest challenges as a surgeon or even a developer working with some of these smaller companies, getting products to market, especially expandable technology. Do you see any people struggling to... resistant to the change from static cages to expandable?

Dr. Fabian: Well, it's kind of curious, you mentioned that because we're finally here at this NASS in 2021 and basically seeing the development and the actual acceptance of expandable technology for the first time. And even there, it's still somewhat limited in that we're talking mostly about the height expansion or height expansion in the interspace. We're not talking about really, truly horizontal expansion. There's really only probably three or four companies that are actually delving into that.

You know, it's interesting, my biggest impediment to getting this technology accepted, getting some traction with it was actually with the large companies, who can be quite a roadblock in terms of that, because it's looked upon as being threatening. You know, we first rolled out an expandable at NASS in 2007. And we go through these phases in this industry where, in the early 2000's to 2007 range everything was about artificial disc, everything was about peak or the polyether, ether ketone type of platform to the point where you had people making edicts in 2007, that we would never do a lumbar fusion again, that lumbar fusion would become obsolete within the next 10 years. And we know how that played out. I mean, artificial disc technology still kind of struggles to find its place, at least lumbar spine. Expandable, we were just simply 10 years ahead of where it needed to be. Now people want the titanium, they want expansion, they want load sharing. I think the biggest thing, frustration as a surgeon designer is getting the industry to catch up. That the things have to mesh, right?

For instance, the osteo biologics have to make sense with the implant and the two of them together, which needs to be functionally integrated. That's my big buzzword here is functional integration between. We've got to have an implant that works. And the big thing here is we've got to get a fusion success or whatever we're accomplishing, but it should happen not in spite of the implants and the osteo biologics we're using, but because of them and those two things being integrated. Function integrated. And that's not really been happening. We're just beginning to see that now. You see guys' renewed interest in biologics, how am I going to mesh this with this implant? How's it going to work? And that'll be, of course, the evidence based medicine that we talk a lot about evidence-based medicine.

Morgan Continisio: Okay. So would you say that that's going to be the next expandable cage? Where is this industry going? What in 10 years, what is going to be everywhere at NASS?

Dr. Fabian: I think you're going to be seeing, at least for those cases that are still in need of a fusion, you're going to be seeing what I'll call functional integration again. You're going to see an osteo biologic that either works with, enhances or is somehow part of the same ecosystem, if you want to call it, as the implant. For example, we've seen a lot done with silicone nitride ceramics. I mean, we have known them for a long time. It's a perfect osteo conductive material. Now we have data that might show it to be osteo inductive. So if you're marrying and if you can morph an implant after you've put it in and have it accomplish its goal of a solid fusion, I think that's where we're going to go with this.

Morgan Continisio: Interesting. What do you think about like, less on the implant side, enabling tech, where do you see navigation, robotics, AR. These are all what we're starting to hear a lot more of that was nonexistent a couple years ago.

Dr. Fabian: I'm a little bit skeptical about robotics and image navigation, because I think we're going to be facing financial constraints from the insurance industry in terms of how we pay for that. If we clearly have documented evidence based research that will show in the future that the robotic placement was more accurate, was safer, but faster and more economical than you get it. But all four of those points have to be hit. If it's only that it's marginally safer than open technology, and it's more costly, like we see with the robotic type applications, I think we're going to run into trouble there and you're going to have to marry those two things together there too. I mean, a robot sounds sexy, sounds sleek, but what are you really accomplishing here? I mean, if it takes the surgeon three times as long, it increases his complication rate because of infection, soft tissue problems. I mean, what are we really accomplishing? So I think you'll face those challenges with that as we move forward.

Morgan Continisio: Based on my experience, I feel as though it's very situational. You're not going to break out a robot for a one or two level case, but maybe for these high, high curvature deformity and scoliosis cases, they make sense. But this is a major investment that these hospitals are having to make and everyone's making the shift towards ASCs and we need to be able to match that pricing, so I completely agree.

Dr. Fabian: I think with the ASC migration again there too, we'll see what happens coming up in 2022, right? I mean, CMS is supposed to come out saying that they're pulling something like 71 or 77 procedures back off the outpatient list to only in-patient surgeries. Again, there was a lot of lobbying in Washington by hospitals and hospital systems that don't want to lose that business to ASCs. So you're going to see this back and forth there for a while. It could be kind of challenging. You're going to see the challenge of smaller companies not being able to compete, and I think our ability to innovate is going to be hindered by that. If we don't really promote incubation in smaller companies, things like that. Computer wise, I think inventory and things like that. I think surgeons and companies will need a lot of help with that.

Morgan Continisio: And we're seeing a bit of a shift there. So one thing that Enhatch is actually doing is helping on the inventory management side. And there's so many companies represented in each hospital. Instrumentation just ends up getting lost in the back central sterile. So I think that that's also going to be a big thing, moving forward. A lot of these bigger companies are trying to address that issue as well.

 

And some hospitals are trying to limit the number of companies in the hospital. They're only allowing companies that have the full offering, the full portfolio, which is one thing that I actually wanted to touch on with you where Enhatch kind of steps in. This is where smaller companies can kind of band together and enter into a hospital because all together, we can offer a full portfolio. If we enter under an umbrella and we have the technology aspect, we have the implants we have the full offering, I think that could be a great solution for some of the smaller companies struggling to get into hospitals, as well.

Dr. Fabian: Yeah, I think, there too. I mean, you're going to squash innovation if we don't do that, right? Because the smaller companies are far more nimble and to think outside the box, if you get too corporatized, you get too rigid in your thinking. You know, we have multiple products on the market right now that never would've come to fruition, if we were dominated by let's say two or three players, I mean the idea of the hospital or hospital system.

So some of the university based systems are notorious for this. If they go with a single sourcing contract this is most convenient because we all become a giant Cardinal health or a giant McKesson or a Striker or a Medtronic where we're going to supply you, your pacemaker. We're going to supply your drapes. We're going to supply your orthopedic equipment, your spinal equipment, your booms. I mean, it gets to a point where they won't have to innovate anymore. There'll be no need to. There's no incentive for a large company to innovate. If they're in that position, if they're in the driver's seat.

Morgan Continisio: You're very right. And this is something that's a little close to my heart. It's interesting because these bigger companies are spending money on the technology aspect. They're innovating, they're creating new robotics, new imaging systems, new navigation, but sometimes what's falling short are the implants. So now companies are being... if they want to use that enabling technology, they also need to use sometimes outdated or bulky implants. And I think this is where having the full ecosystem and having all these nimble innovative companies brought together is going to provide surgeons with the best of both worlds. Bringing together the best in robotics, the best in navigation and all the best implants. Some of these companies have been hyper focused on a niche product for years, and to be able to provide them with maybe the preoperative planning, the navigation, without them having to be swallowed up by the bigger companies, I think that's what we need to do or else it's going to be three booths here in a couple years.

Dr. Fabian: Yeah, if that. There might be two booths here. Yeah.

Morgan Continisio: I guess if there's any, as kind of a closing question, just want to hear, I guess, what you have going on. What's something exciting in your world or anything that you wanted to just share?

Dr. Fabian: Well, again, my implant system is coming to the market and going to finally see its light of day in terms of surgeon training and adoption. I think you'll see those expandable implants and hopefully some really critical thinking about why we do certain things we do and what the performance metrics of these implants are going to be. I mean, we haven't really demanded a lot out of implants. They've been kind of this static, you know, we've had this industry standard oblong cage for 10, 20 years now, and nothing's really changed. It's really a really poor implant all said and done in terms of biomechanics, in terms of the osteo biologics that integrate with it. So I'm looking forward to seeing that get developed and training surgeons in that.