BackTable / ENT / Podcast / Transcript #84

Podcast Transcript: Your Implant Robot: The Future of Robotic Assisted Surgery

with iotaMotion Founders Dr. Marlan Hansen and Dr. Christopher Kaufmann

In this crossover episode of BackTable, Dr. Eric Gantwerker interviews Dr. Chris Kaufmann and Dr. Marlan Hansen from the University of Iowa about their startup company, iotaMotion, which has developed the first FDA-approved robotic cochlear implant insertion system. You can read the full transcript below and listen to this episode here on BackTable.com.

(1) Hearing Preservation: The Impetus to Develop iotaMotion

(2) Technology-based Solutions to Increase Cochlear Implant Uptake

(3) Moving Intellectual Property from the Operating Room to the Office

(4) Building the Team

(5) Staying Resilient in the Face of Challenges

(6) Inserting Cochlear Implants using iotaMotion

(7) Encouraging Surgeon Enthusiasm for iotaMotion

(8) Future Applications of Robotic Cochlear Implant Insertion

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[Dr. Eric Gantwerker]
Hello, everyone, and welcome back to the BackTable Podcast. You can find all previous episodes of our podcast on iTunes, Spotify, and at backtable.com. This is Eric Gantwerker as your host this week. We have the folks from iotaMotion here, Marlan and Chris. I wanted to start by asking you to introduce yourselves. Tell us a little bit about yourselves and how you came to be in the entrepreneurial innovation space.

[Dr. Marlan Hansen]
I'm Marlan Hansen. I'm a neurotologist, which means an inner ear and skull-based surgeon. I primarily practice out of the University of Iowa. We do a lot of work around inner ear and especially cochlear implants. That's what led us to this innovation is we were trying to develop ways to do better job with cochlear implants than currently. That's what led us to this.

[Dr. Eric Gantwerker]
Awesome. Chris?

[Dr. Chris Kaufmann]
Yes, I'm Chris Kaufmann. I guess I'm a clinician engineer scientist. I grew up in South Texas. I have a background in biomedical engineering, did business and undergrad as well as in biochemistry. A diverse background that led me through this path that I guess we'll get into here in a little bit. Went to medical school. Prior to that, I worked on drug-eluting stent development down in San Antonio, where they developed the first stent. Then went to medical school, did general surgery, and then I matched up into the University of Iowa and ENT.

I was in the T32 Research Resident Track. After a year of ENT, I got in the lab working with Marlan, and really University of Iowa was one of the top cochlear implant centers in the country, really the world. Marlan and Dr. Gantz, really having the clinical perspective saw a need. really, that's when Marlan and I got together and started developing it.

[Dr. Eric Gantwerker]
Awesome. Chris, obviously, you had the engineering background. I was also a biochem major, by the way. Lots of respect to you. Marlan, for you, did you have an entrepreneurial background or a business background, engineering background, or you really came from the clinical side?

[Dr. Marlan Hansen]
I have not a business background. I have engineering interest but no background. My background was really that I have a lab that does basic auditory neurobiology and regeneration, but also a lot of efforts to try and translate what we do to make cochlear implants and other therapies better. Had some ideas around how we might be able to do that, but really didn't have the expertise to do it or other people who had the expertise to work with until Chris showed up. Had some of these ideas way back, we dabbled in them but really didn't do anything.

Then when Chris came, it opened up the avenue that he had the time and the expertise to work on it. We started to work on it together.

[Dr. Eric Gantwerker]
Awesome. Chris, how did you come from a BME and biochem background and business to robotics and working with Marlan?

[Dr. Chris Kaufmann]
I think as part of NIH Fellowship, you have two years of really, like Marlan said, dedicated research, which is nice because I think it gives you the time away from the clinical activities, but you still bring the clinical perspective. Combined that with engineering a little bit of business that I've had. Previously, I think really what it came down to, like a lot of things, is funding. We got into the lab and Marlan had the idea. We just needed a way to get some funding to help develop early prototypes, start working with the cochlear implant companies.

It all started with an SBR grant. Really, we said, okay, it's something that can be potentially translated into a company because there's a lot of interest from the cochlear implant space. For one, just a very big clinical need is really what started it all. We applied for that first SBR grant through the NSF, the National Science Foundation. We got it our first try. We used those funds while I was a research resident to start developing robotic prototypes to address really the need of improving access to cochlear plants and really standardizing the insertion and minimizing trauma.

[Dr. Eric Gantwerker]
That's awesome. I think what you guys are doing is really definitely needed because having done these with actually Dr. Ravisami, an old Iowa alum, I know how traumatic it can be, especially when some people like me do it. What was the pain point that you were trying to solve for more specifically and how did you think that the robot was the best solution?

(1) Hearing Preservation: The Impetus to Develop iotaMotion

[Dr. Marlan Hansen]
The issue is you're putting in a pretty big piece of equipment into a very small, delicate space. It really has become quite evident that any trauma you cause has deleterious effects. It became even more heightened in the era now, for the past 20 years at Iowa, we have been working on this idea that it's better to preserve whatever residual hearing you have in the ear. It became almost imperative to come up with ways to be more smooth, more steady, less traumatic, more precise, and also to make that so that everybody could do it.

Because what I could see is that there were a handful of centers that would really try and do any structure or function preservation by putting in the cochlear implant. Most places wasn't even on their radar screen to do that. You had to have something that you could have every surgeon use and use at a high level. Then some of it actually has to do with what happens if the patient loses hearing or has a change in their hearing status after you put the implant in? Can you adapt it so that you can personalize where the electrode is to optimize it for that individual patient's hearing?

I think in a big scheme, to make it a short answer, one, better structure, better function, preservation, more consistent results, and more consistent results across a wide experience range of surgeons.

[Dr. Eric Gantwerker]
Absolutely. Obviously, this may go across to our ENT BackTable, but our BackTable Innovation audience isn't all ENTs. For those who aren't familiar, cochlear implants, obviously, are an implanted device that goes into the cochlea itself, but not all patients are completely deaf. Some have residual hearing and that's the population you're primarily talking about with the solution. Is that correct?

[Dr. Marlan Hansen]
We're talking about all patients who receive a cochlear implant because even those where there isn't measurable hearing, there's still structure and function in that cochlear that's important to preserve. There's lots of data now that show that if you damage those delicate little structures in the inner ear, you're probably not only causing scarring and fibrosis, but the nerve itself that you're trying to stimulate is injured and just the overall benefit from the electrode is diminished.

Anything we can do to mitigate or reduce damage, even on a micro-micro scale, is probably very helpful for the patient. Of course, if they have residual hearing function like you mentioned, Eric, but even if they don't have residual hearing function, even if it's a completely deaf ear, there's still stuff in there we need to preserve to help it to work best.

[Dr. Eric Gantwerker]
For sure. Typically, it's the surgeon who's actually inputting the array into the cochlea through a very small millimeter size hole and putting this small electrode in there, which can be quite difficult. You had an idea, you got some grant funding. That's very different from building a prototype and thinking about building some product to actually launching a company and raising funds and going that route as opposed to an institutional-based. Can you tell me a little bit about that journey?

(2) Technology-based Solutions to Increase Cochlear Implant Uptake

[Dr. Chris Kaufmann]
Yes, I think Marlan alluded to it. I think it comes down to de-risking a technology to a point where it's attractive to investment. It gives you a little bit of time to assess and iterate and test the market out. Really, we started, honestly, at this wild idea that Marlan alluded to the pie in the sky of, if we can develop a fully implantable robot, you implant with the cochlear implant itself, you can put the implant initially robotically in submicron precision and speeds.

Then if the patient's hearing loss declines or progresses, then the technology that we developed was you could transcutaneously access the implantable robotic system and advance the electric further so that the electric contacts are exactly where they need to be within the cochlea. Really, back to your question about the pain points, the main reason for this is there's a big fear of loss of residual hearing. In Iowa, it's always been at the cutting edge of hearing preservation, cochlear implants. This was a way to overcome that barrier of fear of hearing loss and help to preserve hearing.

You put the implant in a little bit of ways just where the patient needs electrical stimulation, but then they can also use a hearing aid to provide acoustic stimulation to the remaining parts of the cochlea, which is really the best hearing that you can have. Over time, the problem was that hearing loss can progress, which we know. We want to be able to progress that implant, advance it further and really electrically stimulate the structures that have been lost over time with noise or just as we age. That's really where we started with this fully implantable system that can adjust an implanted electrode array.

The goal really, I think for me when it started was just the low penetration rate of cochlear implant themselves. You probably know it. Less than 5% of people who are eligible actually get them, which just blew my mind as a resident and new to the field of ENT. I think it's just a matter of asking questions of why is that? As I dug deeper and deeper and deeper and looked at all the different barriers and all the different pain points. One was fear of hearing loss which we were addressing but really it was the standardization of the insertion process itself.

Like you said, it's a very complex, very-- We probably picked the most challenging procedure to apply robotics to, but there was your micron-level insertion. The structures are sub-millimeter. It's beyond the abilities of what a surgeon, the human can do. That's where I put the two together and said this is where robotics really has a true clinical benefit in robotics with the true need here, that surgeons can't go submicron speeds. They can't go submicron precision, but let's make something that fits in the current approach, doesn't add cost, doesn't add significant time.

It's compatible with multiple different electrode arrays across the different implant manufacturers so that we provide access to the most number of patients and potentially improve that penetration rate so we can treat a big public health problem of hearing loss with cochlear implants.

[Dr. Eric Gantwerker]
When you went through this process, obviously cochlear implants from a company standpoint, from a total addressable market, is a really small market. As you started to enter into the conversation of, "Hey, this is a great idea, this is a great product, let's create a company," did you do market research? Did you see what competitors were in this space? Did you think about monetization, how you're going to grow a company based on a small population basically as compared to something in the other spaces that are more consumer-focused or larger populations?

[Dr. Marlan Hansen]
I would say yes and no. We certainly looked at those things, but primarily our motivation was to try and develop something that was going to help and benefit people and say, "This is really a need and this is something we think we can develop something that's going to--" We feel like it's really going to move the needle in a lot of ways. That was our primary motivation. I don't know that we were initially in particular that concerned with exactly the market size. We were more concerned about is this going to work, and can it work, and how does it help, and what's the benefit, and what's the outcome.

Obviously, as you move down the path, you need to have something that is-- You can't just build something and not have it go through an industry phase and get it into the hands of all the patients and all the surgeons that need to do it. Those are other things that we have been addressing those other issues. Fortunately, it's looked quite favorable for things. To say that that was the fore of what we were doing from the beginning, it certainly wasn't for me. Maybe Chris can tell you what his thoughts are on it too.

[Dr. Chris Kaufmann]
I know. I think just as clinicians and surgeons with that mindset, you're wanting the best for your patients. You're wanting to improve outcomes and improve healthcare. I think we did look at those factors, obviously the cochlear implant industry is a multi-billion dollar market, so that checks that box. If you look at the low penetration rate of 5%, if you look at the missed revenue opportunities, if you increase the penetration rate by 1% or 2%, that equates a multi-billion dollar missed revenue opportunity.

I think almost it's an orphan drug mentality of there's an opportunity here, but we're overall from, even a public health perspective missing it both on the public health side as well as the commercial side as well.

[Dr. Eric Gantwerker]
Got it. As you went through that commercialization process, did you have any pushback from investors? I know you've gone through several rounds of investors and raising money, which is fantastic, and obviously a lot of grant funding as well. Has there been any skeptics who said, "It's a great idea, a great mission. We're not sure about this as a business"?

[Dr. Marlan Hansen]
I don't think anyone's really pushed to say this is a bad business idea. I don't think we've heard those. I think there's probably a little different ideas about how big of a business it might be. I think almost everybody who looks at it says, "Look, there's a need here. This fills a need." The way we design this is to really integrate into the natural flow of surgery. We're not talking about something that's this huge multimillion-dollar investment of a hospital system to get into the hands of surgeons to do just one specific surgery.

This is really something that takes the most crucial part of this procedure that's very difficult for human kinetics to accomplish and takes over that part of the procedure or complements the surgeon in that part of the procedure. It doesn't contemplate, it isn't designed to be some big behemoth machine-type thing that takes over. It turns out that the economics are actually quite favorable. I don't think we've had a lot of pushback on-- There's disagreements about what size of market it might be, but everyone I think who looks at it says it's a very favorable market.

(3) Moving Intellectual Property from the Operating Room to the Office

[Dr. Eric Gantwerker]
The other thing is obviously starting this type of idea and working through at a university level, how did you manage the intellectual property working with-- I don't know if there's an innovation arm to University of Iowa or a commercialization or tech transfer. How did that process go for you and how did that negotiations or how did those conversations with the University of Iowa go?

[Dr. Marlan Hansen]
Yes, there is. That's a very good question. The initial IP that went in on this was filed by the university as is university policy. We filed it through the university, and then they strongly recommended and we agreed that that was a good strategy is to form a small startup company and license that IP from them. In fact, that's one of the main reasons to do it, is the university's not going to commercialize a robotic device. If they want to see the IP move forward, if we want to see the IP move forward, it really does require commercialization-type effort.

We negotiated the licensing agreement for the IP through the university's foundation. That's basically how it happened, is they filed some of the initial IP. We negotiated with them what the terms of the licensing agreement for that IP would be. They still have a little bit of say in how the company goes and a little bit of stuff. They have a percentage of the company as a consequence of that.

[Dr. Eric Gantwerker]
I'm sure. How about as the company has grown and your role within the company versus as a clinician? I myself, am a part-time clinician. I'm 60% clinical and 40% working for a technology company, and that's a constant battle of trying to divide myself 30 times into multiple areas. How have you managed working with a company as well as practicing and active clinician?

[Dr. Marlan Hansen]
The university has really strong guidance around this. We have a conflict of interest policies and things that we do, and we truly try to make sure it's clean between-- The university is very supportive. Our initial office for the little small startup company was actually in university space for these little incubator-type scenarios. We started there and we just keep it separate. I make sure that my time is separate. We try and make sure that-- in fact, all the way through we have made sure that university work is done with university things and resources and time and iotaMotion work and resources are used to develop iotaMotion things.

[Dr. Eric Gantwerker]
Totally understand. You're still full-time clinical, right?

[Dr. Marlan Hansen]
Yes, clinical/administrative/research.

[Dr. Eric Gantwerker]
Sure.

[Dr. Marlan Hansen]
I have several research grants that are devoted to things that are not robotic, have a clinical and surgical practice, and then also I'm the department chair, so I have an administrative role within the department as well.

(4) Building the Team

[Dr. Eric Gantwerker]
Keeps you really busy. I don't know where you'd produce time, but I'd like to find out. The other question I had was that as you grew the company, obviously you had to onboard members to the company. Obviously, you had Chris and yourself, but how did you start to build out that team? I guess, how do you plan to continue to do that?

[Dr. Marlan Hansen]
The first person we hired was actually an engineer who Chris knew very well. It's one of Chris's colleagues from back there. The way we set it up is really through the SBIR where he would function as a PI on the SBIR. That's how we got the initial support. Then through grant funding and through investor funding, we started to grow and add an employee here and an employee there, depending on what the needs were. We worked with a guy named Derek Timko who came out of the orthopedic robotic space.

He took over as our chairman and has helped a lot with the fundraising and he had the context that he could go to to get some of the initial fundraising that we needed to do to keep things moving forward. Obviously, we have a lot of people who are not just employees but are consultants. We use FDA consultants and all kinds of different people. It's growing. It's now becoming a much larger operation than this, me and Chris and a bag of ideas.

[Dr. Chris Kaufmann]
I think the key is to run it efficiently. We tried to keep it as lean as possible, leverage our grant funding with the private investment with Eric's help bring that in. With that, I think we really will be very efficient about it and de-risk it to the different gated phases where now it's a very attractive point for investment in a scalable, can I hit the gas and I want you to de-risk it to that point. I think the big key for us obviously is being the first FDA-approved robotic-assisted cochlear insertion system. Now we're at a point where it becomes a scaling and really commercialization phase.

[Dr. Eric Gantwerker]
That's fantastic.

[Dr. Marlan Hansen]
Chris was really good in this and we had milestones and we just really like Chris mentioned, I think being small, we were nimble, very efficient, and made really good use of grant funding as well as the other investor funding that we had. I think all of those things were very helpful to us.

[Dr. Chris Kaufmann]
I think it helped us in a way. The fact that we were able to do what we have done with the resource we have really, getting through COVID with a lot of unexpected, obviously global pandemic, the complete clinical study and submit to the FDA during that time. It was hard for a lot of startups. Markets were shutting down and things, hospitals were closing and so from med tech perspective, we were prepared for that because of the way we were already set up with these phase-gated milestones.

Really phase 1, 2, 3, and stick to the plan and execute accordingly. Time the incoming funding with the next milestones.

[Dr. Eric Gantwerker]
Yes, you brought up the big gorilla in the room and FDA I knew a lot of people who've gone through this process and they're just afraid of going through the FDA process. It sounds like for you guys it actually was pretty straightforward and simple even though it was during COVID.

[Dr. Marlan Hansen]
Straightforward, yes and no.

[Dr. Chris Kaufmann]
Straightforward, on a circuitous route, exactly.

[Dr. Marlan Hansen]
It's straightforward once you're on the backside of it.

[Dr. Eric Gantwerker]
Yes, exactly.

[Dr. Marlan Hansen]
It went well. I think the FDA, they saw the value and I think they saw we have the data and that's a critical thing is if you have data to support it and if you can show it and then I think they were pretty enthusiastic.

[Dr. Chris Kaufmann]
Yes, we had a good team of consultants so I think that was the other way we were able to-- Obviously a small team but surrounded by some of the top consultants in the industry. I think that helps – surrounding yourself with some of the expertise that's been there done that before and been successful in the past just helps.

[Dr. Eric Gantwerker]
Have you had to go through insurance reimbursement or do you think you'll have to at some point?

[Dr. Marlan Hansen]
Currently we don't, but I think that all of robotics faces that specific issue. It also was really helpful to us to come out of the University of Iowa where we already had a lot of infrastructure and a lot of willingness and know-how to be on the cutting edge or be at the tip of the spear of cochlear implants. It really helped to be in that environment I think. It could have been really difficult in other environments so we were greatly benefited by being at this particular institution with the particular expertise that we have.

(5) Staying Resilient in the Face of Challenges

[Dr. Eric Gantwerker]
A lot of people go through this process and hear all of these innovators that have gone through it and just like, "Oh, it's simple, it's straightforward." Can you talk about your setbacks and some of your failures along the way and what you learned from that and what you would tell others about that?

[Dr. Marlan Hansen]
There's always little things and I think part of it is just believing in what you're doing and being a bit persistent and having the right team around you. I'd say one of our biggest challenges came right close to the end when we were going for FDA approval. We were within what we thought was the closing days, if not weeks of having FDA approval, and they threw us a curveball out of the blue that we didn't anticipate, and that slowed us down quite a bit. It took months to address that particular issue and it wasn't necessarily a lot of fun.

It really slowed down some of our timelines and some things like that. I would say that was the biggest challenge. There's always challenges around design. It's funny for me to look back and look at some of our early prototypes and some of the concepts that we had. Some were really good and just weren't tractable or doable and it's been a fun journey. I don't know, you always anticipate that it's not going to be just a smooth road. We didn't go in with rose-colored lenses thinking this is going to be just an easy path. We always knew it was going to be a path forward.

In my opinion, it's gone much better than I would have anticipated, maybe that's the pessimist in me but it really has gone remarkably well.

[Dr. Eric Gantwerker]
It's always good to have low expectations, right?

[Dr. Chris Kaufmann]
Yes.

[Dr. Marlan Hansen]
Yes, I don't know about that, but it's always nice to be surprised that you can actually do this.

[Dr. Chris Kaufmann]
I always had the drive that even if the challenges came up that we would get together as a team and figure it out. I think you just have strong relationships and trust.

[Dr. Marlan Hansen]
It is a great team. That's the key is the right people and belief in the system. That's key.

[Dr. Chris Kaufmann]
Having a unified direction, you're just going but yes, again, to answer the question about biggest challenge. I'd say FDA and the process we went through is obviously a de novo and they asked an interactive process. Again in the middle of COVID, they wanted additional clinical data which is FDA and they want to see the data, like Marlan said, and so we had to get together and figure out how to do that and get into a clinical study while hospitals were closing their doors.

Fortunately, we were successful again with the network and relationships that Marlan Hansen had and we were able to go around and get that done.

[Dr. Eric Gantwerker]
What has been the reaction from all the cochlear implant companies to your product?

[Dr. Marlan Hansen]
It's been fun to watch. Each one has been a little bit different. At first, I think they may have had-- Because there are some other robotics technologies that are being conceived and even developed. I think when they actually got their hands on it, they were just almost floored and how quickly we were able to get something that worked so well, I think it almost blew them away for the most part. I don't know if that's the right thing, but because we were small because we were nimble, we were able to move pretty quickly and I think that surprised them.

I think it surprised them how well it actually works and that it's a different concept than I think a lot of these other robotics have taken, where they're doing an access thing that has these large arms that come in and it's actually doing the surgery a completely different way. This is really just integrating in with the natural workflow of the surgery. I think a lot of them thought the way we did is, "Okay, now we see this, this makes a lot of sense to us."

[Dr. Chris Kaufmann]
We worked with, in terms of support in electrodes and things like that but then really seeing their full approach because we had approval and started making the rounds with it and people really seeing the system. The biggest difference is we were doing completely different than anybody else who was thinking about it. Like Marlan said they were big robotic systems, take up half their room. They take up a lot of time in training but we were a single-use disposable system where you throw away the robot at the end of the case.

Even the field of robotics in general, it's a novel concept where you have a miniature robotic system that is disposable. I remember going and doing a demo. Walking in, there was another robot there that they had been doing and it's taking up the OR. So I walked in with a briefcase and you open it up, five minutes set it up, and then doing the insertion. Everybody's just amazed at how it fits into everything that's there, you don't have to change anything and you get submicron precision and control.

(6) Inserting Cochlear Implants using iotaMotion

[Dr. Eric Gantwerker]
That's great. Yes, let's talk a little bit about the product itself. It's implant-agnostic so it'll do any of the electrodes?

[Dr. Marlan Hansen]
It'll do lateral wall electrodes from all the cochlear implant manufacturers. There's a perimodiolar electrode from one of the manufacturers that is inserted with a sheath and we have prototypes to be able to do that but it's not yet ready to be used for that particular electrode array.

[Dr. Eric Gantwerker]
Got it. When surgeons are doing the insertion, they can feel that a little bit of feedback when it feels like it's gone in. How does the robot know when to stop and does it have that force feedback on the electrode array?

[Dr. Chris Kaufmann]
I actually started in the lab looking at different insertion forces and that's how the whole system develops. Really what we found is it's the slow insertion speed that actually overshoots and decrease in the outliers that actually decreases the overall forces and causes the high spikes that cause the damage in the lab, at least. In an effort to kind of fit it in, the cost perspective plus intraoperative setting and keep it small and miniature and disposable, what we found was that you can actually with the buckling electrode array, we have, we can visualize the forces.

Marlan can talk more to this. Visualize the actual forces just by the inherent mechanical properties as well as there's some built-in hardware-based maximums if you will, that limit that.

[Dr. Marlan Hansen]
Yes, maybe a point to bring out is actually a surgeon can't sense the type of forces that would cause trauma within the cochlear. If a surgeon is feeling some major resistance either there's a lot of scarred tissue or other things built up in that ear or your charging through some things and the damage has been done. It's well below the threshold of what a human can perceive, a human hand.

[Dr. Eric Gantwerker]
Which is a huge value obviously, how about handling a typical anatomy, like a common cavity or something along those lines?

[Dr. Marlan Hansen]
That's a good question. Yes, right now, we just limit ourselves to normal cochlear. It's not to say that in the future we wouldn't also consider using it in malformed or otherwise diseased. It probably would not ever be used realistically in ossified cochlear, or cochlear with a lot of scarring in them, but in malformed cochlea, there might be. Just to be able to get it launched and to get it into the hands of surgeons and get field use and feedback, we limited it to ears that have normal radiographic anatomy at least.

(7) Encouraging Surgeon Enthusiasm for iotaMotion

[Dr. Eric Gantwerker]
Absolutely. Let's talk about the surgeons. In other technologies, as they come to the clinical realm, we've seen fear for some of the technologies "taking over people's jobs". We've seen this in artificial intelligence, radiology, and dermatology. There's some element of robotics as well. Have you had any push-back from surgeons with regards, "Oh, this is what I do every day. Why do I need a robot to do this for me?"

[Dr. Marlan Hansen]
Yes, not much. There was one surgeon that said something like that.

[Dr. Eric Gantwerker]
You don't have to name names. It's okay.

[Dr. Marlan Hansen]
There was one surgeon, he claimed that he was better than a robot, or as good as a robot. Actually, it's been fun. We'll have these things at conferences where a lot of surgeons will come by our booth and we can put on a force transducer. We can let them insert an electrode array, and then we can put it up against the robot and it can be the John Henry sort of task, and they can see. We're yet to find the surgeon that wins. There might be one out there. There's one that thinks he is better. For the most part, this does not take the surgery away from the surgeon.

The surgeon still does all of the surgery. This actually enables the surgeon. One of our most experienced surgeons using it loves it because it gives him now two hands free. It gives him more ability in surgery. It's not only steadier, but he can be more precise and more better with it. They actually enjoy it. They have fun with it. It's not taking the surgery out of their hands and putting it into something else. The other thing that's important to understand is that they remain completely in control.

The way we have this designed to mitigate risk and to really make it work well, we want the surgeon to be in control of things the whole time. The surgeon's in control of the insertion and they can go slower, they can stop, they can reverse, they can alter the trajectory by manipulating the array a little bit. All of those things. I think surgeons actually have a fun time with it. We've almost universally found that to be true.

[Dr. Chris Kaufmann]
I would agree. I think the other point to bring up, I think, is patients, when they're going into surgery, they want the best care possible. I think you're seeing this in other robotic areas of having the tools available, whether it's AI, whether it's robotics, or there's imaging, optimized care. Optimize the chances of successful outcomes when most patients are asking for the best tools available.

[Dr. Marlan Hansen]
I've used it many times and one of the great things is it enables other technologies that complement what we're doing. We now use technologies, for instance, the electrocochleography, which is a way of monitoring the function of the cochlea. You can now integrate your insertion with these other devices and you have much more control, much better ability to respond and to deal with whatever's happening if you do these things robotically. You just feel a lot more comfortable with what you're doing, you know what's going on.

You can think of this as like driving a car, I think, is a good analogy. You just go really slow and you're not going to cause problems. Even if you do happen to hit a tree, you're not going to dent your fender if you're going slow. It does though, enable a lot of these other technologies. The other thing that was really fun, is we had a couple of patients where they have hearing in their ear that we're not putting the electrode in and we do it under local. We can be stimulating the implant that we're putting in while we're putting in and robotically going very slow.

They can tell us how it matches the tones that we're putting in their other ear. We put a 750-hertz tone in their other ear and they say, "It's a little bit higher than that." Put another tone in, "Now it's getting lower. Now it's close. That's it. That matches that tone I'm hearing in my other ear." We can do all of that while the patient's awake and we're putting in the electrode. Some of those things, you just can't do that if you're doing it manually. It makes it fun for the surgeon.

(8) Future Applications of Robotic Cochlear Implant Insertion

[Dr. Eric Gantwerker]
That's incredible. As we've seen with the other technologies, once doctors and surgeons get past that irrational fear of the technology, they start to realize how it actually may enable them to do their job may be better for patients. I think that's universal to all the different technologies that are in this space. What's next for your guys, for your company, for the technology?

[Dr. Marlan Hansen]
There's a lot. We're in very much a limited market release, where we're just doing our initial few 100 cases, and really have a good sense of how it's performing out in the field and what we need to do. We already know of some things that we're doing to improve the next version that comes out. Then we have several other complementary and additional technologies that build on top of this. This is the first thing, and it's going to go from something that does just lateral wall electrode arrays to do all electrode arrays.

It's going to move from something where we now integrate it with other technologies, whether it's electrocochleography, or imaging, or preoperative planning. Like Chris talked about earlier, eventually, the vision is that this becomes implanted with the original cochlear implant. Then we can access that transcutaneous or percutaneously while the patient's awake in the clinic. We can adjust or dial in the position of the electrode array for that individual patient, so that we can either move it forward if they lose further hearing.

Two years later, we can move it forward, or if they have a dead zone in their cochlea that's not been able to be stimulated, we can adjust the position of the electrodes. It personalizes the position of the electrode for individual patients. We're obviously interested in, not just cochlear implants, but there's a lot of other medical devices that require a similar type precision that are based on the same concepts.

[Dr. Eric Gantwerker]
That's incredible.

[Dr. Chris Kaufmann]
I would agree. I think, from a high-level, just continuously improving and continuously learning. I think that's what it's about, and listening to the needs and where the market headed.

[Dr. Eric Gantwerker]
It's interesting, you thought about all the other applications in this space and of your technology. When I came to the educational technology space in gaming, I started to pay attention to what the rest of the industry was doing. Have you seen other robotic applications within otolaryngology or other specialties that is interesting or exciting to you that you've been following?

[Dr. Marlan Hansen]
Yes, definitely, some of the technology, we're interested in seeing how we can leverage that or integrate that into the things that we're doing. Some of that has to do with planning and trajectory. There's other robotics that are being used. Obviously, the big robotics is used now commonly for-- Some oropharyngeal surgeries are now being done robotically. There's other robotic systems where even doing fine manual things, it stabilizes the natural tremor of a surgeon's hand and diminishes that if you're doing really fine micro.

There's surgery like cochlear implant, or microvascular anastomosis, or sewing nerves together, or something like that that require these really fine things. There's quite a bit of it that's being developed.

[Dr. Eric Gantwerker]
We've seen some of the robotic bronchoscopy and it's always interesting for us because they basically use a game console controller to be able to control the robot. It's always really funny how things have come full circle a little bit.

[Dr. Marlan Hansen]
The gaming industry's actually pushed technology forward a lot faster than some other things have done.

[Dr. Eric Gantwerker]
Absolutely. I think that's been where you go for the cutting-edge technologies to look where games are. Movies in the entertainment industry have really tried to push the envelope, and we're trying to figure out how to integrate that back into medicine and medical education. It's an interesting space and an awesome space to be at. Both have been a longish journey. We have other entrepreneurs and people who are looking to do product development who listen to the podcast. What would your top advice be to those individuals?

[Dr. Marlan Hansen]
If you have something and you think it's going to work, you ought to give it a try. Go for it. Sometimes it may take you a while. It's probably going to go a little bit differently than you initially conceived and you've got to be willing to bring people on and work with people and listen and understand, really, but it's fun. It's a fun journey and I think the fun part of it is to see something that you think can be a benefit and then see it through to where it actually is making an impact in patients' lives. It becomes very meaningful and gratifying at that point. Do it.

[Dr. Eric Gantwerker]
Chris, any thoughts?

[Dr. Chris Kaufmann]
For me, it was always fun. I think that's the key thing that starts with that. Do something that doesn't feel like work, but you're spending every minute of the day doing. Combine that with a passion and drive. I think the scene that we've said throughout this is really persistence because there's going to be roadblocks and you just have to be able to iterate ways around it. If you have that discipline and just keep the purpose and target in mind and the goal in mind, you'll get there.

[Dr. Eric Gantwerker]
Fantastic. Any closing comments? Any thoughts? Anything else about iotaMotion we didn't cover? Anything else that our audience would want to hear about?

[Dr. Marlan Hansen]
No, this has been fantastic. Appreciate the opportunity. It's going to be a lot of fun to see where things go in the future. There's so much and it's fun to be involved in that kind of stuff.

[Dr. Eric Gantwerker]
Fantastic talking about iotaMotion and both of your journeys along this pathway, I think our BackTable innovation audience will be really interested to hear about this. How can they get in touch with you all? How can they find out more about your company?

[Dr. Chris Kaufmann]
Yes, you can go to our website, it's iotaMotion.com or you can shoot us an e-mail, ckaufmann@iotaMotion.com and hansen@iotaMotion.com.

[Dr. Eric Gantwerker]
Fantastic. Thank you both for being on the show. This was a true pleasure.

[Dr. Marlan Hansen]
Thanks, Eric.
[Dr. Chris Kaufmann]
Thank you, Eric.

Podcast Contributors

Dr. Marlan Hansen

Dr. Marlan Hanen is a clinician-scientist trained in neurotology/skull base surgery and cell and molecular biology. He is a Department Chair of Otolaryngology and a Professor of Neurosurgery and Molecular Physiology & Biophysics at the University of Iowa.

Dr. Christopher Kaufmann

Dr. Christopher Kaufmann was an Otolaryngology Head & Neck Surgery resident and NIH research fellow at the University of Iowa prior to leaving surgical training to join iotaMotion full time to lead product portfolio strategy and technology development.

Dr. Eric Gantwerker

Eric Gantwerker is a Pediatric Otolaryngologist at Cohen Children's Hospital at Northwell Health/Hofstra, Associate Professor of Otolaryngology at Zucker School of Medicine at Hofstra/Northwell, and Vice President, Medical Director at Level Ex.

Cite This Podcast

BackTable, LLC (Producer). (2023, January 10). Ep. 84 – Your Implant Robot: The Future of Robotic Assisted Surgery [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.