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DeviceTalks Weekly

16 Oct 2026 · 44m · 17 chapters

Episode artwork

Ep 306 - After FDA Authorization, J&J’s Robotic Surgery President Looks Ahead to OTTAVA’s Commercial Rollout

In short

Device Talks Weekly Ep 306 interviews Johnson & Johnson’s Rocco De Bernardes on Otava, J&J’s table-integrated soft tissue robotic surgical system, covering what changed after FDA authorization and clinical trials, plus how automation, instrumentation, and the Polyphonic digital ecosystem are intended to shape robotic surgery rollout.

Guests

Rocco De Bernardes, Global President for Soft Tissue Robotic Surgery at Johnson & Johnson (leads Otava strategy; previously discussed Otava’s clinical trial phase in 2023). Sponsor guest: Lee Ginter, Sales Engineering Manager at Harmonic Drive (strain wave gear components/actuators for medical devices).

Key claims

Otava is the “world’s first” table-integrated soft tissue robotic system with four intelligent arms built into a standard surgical table; it’s 30–50% smaller footprint than other systems; automation from day one eliminates registration/calibration steps by deploying arms from underneath the table after procedure selection; Polyphonic is an open, data-integration ecosystem (EMR, devices, video) meant to reduce data fragmentation and enable AI/insights.

Notable examples

A prospective multi-center single-arm gastric bypass trial (six institutions; five had never used a robotic system; one OR was 243 sq ft). Post-trial survey: 100% agreed it can unlock space for compact rooms; 95% workflow efficiency; 90% improved visibility/collaboration. Early U.S. commercial sites must demonstrate multi-specialty, multi-port capability; second trial underway for hernia. Instrumentation examples include a two-in-one needle driver (maneuver/needle cutting) and scissors designed to maintain consistent cuts.

Written by AI. May contain mistakes.

Chapters

0:45

Introduction to Rocco De Bernardes and Otava

Kayleen introduces her guest Rocco De Bernardes and the topic of the Otava robotic surgical system.

“And speaking of incredible medtech conversations, oh, I've got a good one for you.”
2:18

Upcoming Events and Announcements

Kayleen discusses recent events and future webinars in medtech.

“But before we get into all that good good, I wanted to chat through just a couple things.”
8:52

Update on Otava Robotic Surgery System

Rocco provides an overview of the Otava system and discusses its FDA approval and clinical trials.

“Rocco De Bernardes, Global President, Soft Tissue Robotic Surgery for Johnson & Johnson.”
14:01

Transforming R&D into a Business

Learn how an R&D program is evolving into a robust business in robotic surgery.

“We're really turning an R &D program into a new business that has the opportunity to really define what's going to be next in robotic surgery with a very bold ambition.”
14:14

Insights from Clinical Trials

Discover key learnings from the clinical trial that supported FDA approval.

“I think that the most significant learning, of course, has been the clinical trial itself.”
15:12

The Advantages of Otava's Design

Explore how Otava's compact design enhances surgical capabilities and workflow.

“otherwise we wouldn't have got the approval by the FDA, of course, but also the fact that some of our hypotheses for the value proposition of Otava was indeed a reality that was confirmed in a clinical setting.”
17:10

Automation in Surgical Procedures

Understand the role of automation in improving surgical procedures with Otava.

“but also really change the way communication, visibility, collaboration happens within the operating room and drive really efficiencies in the workflows for everyone.”
19:19

Innovations in Surgical Instrumentation

Learn about innovations in surgical instruments designed for efficiency and effectiveness.

“And that maximizes not only, you know, the reach and access during the procedure, but also minimizes, you know, the amount of work that is being required by surgical staff.”
21:11

Introduction to Polyphonic Ecosystem

Discover the Polyphonic digital ecosystem and its integration with Otava.

“whether it's in their training, whether it's during the procedure, or whether it's really reviewing after the procedure what has happened and trying to improve their own practice.”
22:04

The Future of Data in Surgery

Explore how the Polyphonic ecosystem aims to revolutionize data access in surgery.

“So I'm going to dig into kind of each of those spaces a little bit more.”
Show all 17 chapters
28:00

Consolidating Data Sources for AI Innovation

Learn about the integration of various data sources to enhance robotic surgery.

“And so we're very, very, you know, happy with, you know, how this is moving.”
29:06

Creating a Shared Digital Ecosystem

Discover how Polyphonic facilitates communication between different robotic systems.

“And just to make sure that I completely understand.”
30:28

Automation in Otava: A Human-Centric Approach

Understand how automation through Otava enhances efficiency in surgical procedures.

“Was that the intention from the very beginning?”
33:09

Simplifying Surgeon Transitions to Otava

Learn about the ease of transitioning for surgeons to the Otava system.

“But as you can imagine, because of that inherent ability and capability with our motorized joints, we're going to be able to potentially deliver much more in the near future.”
35:55

Commercial Rollout Plans for Otava

Explore the strategic plans for the commercial rollout of the Otava system.

“You hit exactly where I was trying to go with it.”
38:28

The Future of Surgical Robotics

Discuss the evolving role of surgical robotics and future innovations.

“Otava is going to grow tremendously over time.”
42:01

Optimism for Otava's Future

Discussion about the potential and future of the Otava robotic surgical system.

“And I fundamentally believe that Otava can be a foundation for all of that.”
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Transcript

Automatic transcript. May contain errors.

0:01Hey everyone, I'm Kayleen Brown, Managing Editor for Device Talks, and welcome back to another episode of Device Talks Weekly. It feels weird for me to say that. It feels weird for me to do the introduction, and if it feels weird for me, I'm sure it feels pretty weird for you too. But know that we're in the same boat, and we built, as a collective, Device Talks Weekly to bring medtech conversations to you, so it is my absolute honor to continue to do that. with all the love in the world and knowing that this podcast has been beloved by our industry and built by, in my opinion, the king of medtech, Tom Salemi, it's important that we can continue to share these incredible medtech conversations with you.

0:45And speaking of incredible medtech conversations, oh, I've got a good one for you. This episode, I have the opportunity of sitting down with Rocco De Bernardes, Johnson & Johnson's global president for soft tissue robotic surgery about the company's Otava robotic surgical system. In my conversation with Rocco, we discuss why Otava's robotic arms are built directly into the operating table. I also ask what's happened since the clinical trial and recent FDA authorization. And then I finish up with how the system's automation instruments and how polyphonic could shape the future of robotic surgery.

1:24Oh, as I say this out loud, I cannot believe that I had the opportunity to conduct that interview. I mean, it makes me really think about all of the opportunities that have come my way because of Tom. So I'm going to dedicate this episode of Device Talks Weekly to Tom. Chef, thank you. This one's for you.

1:47Are you ready for this? Ready.

2:17We're just minutes away from my interview with J &J's global president for soft tissue robotic surgery. But before we get into all that good good, I wanted to chat through just a couple things. This week, I just finished our Connected Health Week, where I got to spend three days with leaders from BD, Carl Stortz, and Phillips. If you missed it, you can catch it on demand. Go to www.devicetalks.com. Also, join us for our upcoming Device Talks Tuesdays. Again, you can go to devicetalks.com to register. And November 10th through the 12th, we're bringing Orthopedic Technologies Week. Another three days of focused content around the orthopedic industry.

2:55I will be moderating those webinars. Remember, devicehawks.com. That's the gold. Go there. Register. Cannot wait to see you live. Let's talk about this episode. My plan was to bring back the New Markers Newsmakers, but it just so happens that it's MEA weekend in Minnesota. I say that, but I have no idea what it means. But Chris assured me that if you're based in Minnesota, it's a really big deal and you'll know exactly what that is. So I promise we'll bring back newsmakers next week. Now, before I kick off my keynote interview, I want to hear from this episode's sponsor, Harmonic Drive. Lee Ginter, sales engineering manager for Harmonic Drive.

3:38Welcome to Device Talks Weekly. Great. Thanks for having me. So Lee, I always love having Harmonic Drive on the podcast. Let's start at the very top. Can you tell us more about Harmonic Drive? Certainly. Harmonic Drive is a global company. We have offices and manufacturing located in the USA, Japan, and Germany. Harmonic Drive came about in the early 1960s as a result of an inventor named Walt Musser, who invented what's called a strain wave gear back in the mid-1950s. And that product line was patented and became a commercial product in the early 60s. And that's when Harmonic Drive formed. Essentially, the Strainwave gear is a very unique gearing mechanism that's lightweight, compact, very accurate, and has a high reduction ratio that we can use in many different industries, including medical, aerospace, semiconductor, defense, a variety of industrial applications.

4:43Let's narrow the scope a little bit more. So how does Harmonic Drive work with medical device companies? So Harmonic Drive works with many medical companies. We start off from the ground floor working with engineering. In many cases, many of these medical devices have some custom requirements and that's where Harmonic Drive shines. Our product pipeline can be highly customizable, and we do it quite well. We've been doing it for, you know, 50 years. So the really difficult part is the beginning stage is sorting out all the technical and customization requirements, and we do it quite well. What about your most popular products?

5:27Can you tell us more about those? Sure. You know, the harmonic drive portfolio, it's quite diverse. When it comes to medical applications, by far, our most popular product lines, because it gives the customer the most flexibility for their design, is what we call our component sets. And that's the building block of the strain wave gear. It's essentially three components and it can be highly customized to fit the customer's need, but it gives the customer and the design engineer the flexibility to design their system around our product. So by far, that is the most popular approach with our product line.

6:17Now, assuming the customer wants more value to that, we have the flexibility now to add perhaps a motor. Maybe the customer didn't want to integrate their motor with our gearhead. We have the capability and the services to provide that to the customer as more of a turnkey solution. I can definitely see why these are some of your most popular products, especially for MedTech. What can you tell me about some of the more recent products that you've been offering? Yeah, so from the value-add side, one of our newer products that is kind of the next generation of our actuator product line, which is the integrated gearhead and motor, is what we call our IDT product, integrated drive technology.

7:08So that even takes the customer design to the next level and provides ease of use, a complete solution without having to use an external servo drive. And, you know, that could support EtherCAT communications, which is becoming more and more popular. And we also support CanOpen network communication as well. Last question for you, Lee. Let's look into the future. Where do you see your business going in the next three to five years? We're still focusing at this point, heavily focused. For example, we're having the discussions on medical devices here, but the medical industry is one of our top two or three targeted market segments.

7:51We see lots of growth, tremendous growth in that marketplace, anywhere from surgical robots to simpler medical devices in general. But we've seen, you know, if you look around all these different startup companies in the medical industry, and many of them are going to some type of surgical robotic arm mechanism. And we're excited that we have the opportunity to participate in those type of applications. And we'll be focused on them and adding resources to support that growth. Excellent. Well, time flies when you're having fun. Lee Ginter, Sales Engineering Manager for Harmonic Drive. Thank you so much for joining me on Device Talks Weekly.

8:39I really appreciate it. Great. Thank you so much for having me. And to our audience, to learn more about how Harmonic Drive works with medical device companies, please visit their website at harmonicdrive.net. That's H-A-R-M-O-N-I-C drive.net.

9:01Rocco De Bernardes, Global President, Soft Tissue Robotic Surgery for Johnson & Johnson. Welcome back to Device Talks Weekly. Thank you, Kayleen. It's a real pleasure being back with you. Thank you for having me. So we have had the pleasure of having you on the podcast in 2023, where we got to know more about you and how you found your way into medtech. So I'm going to drop that link to that episode into the show notes. So if our listeners missed it, I would be shocked if they did. But if they missed it, they can get that inside scoop. And that said, I know that our audience is really keen to get an update since you were last on.

9:36So I really want to focus our time on the Otava Robotic Surgical System. But for our listeners who may not be familiar with Otava, can you give us a high-level overview of that robotic surgical system? Of course, my pleasure. It has been an exciting time over the last few months with the FDA approval. I'm going to talk to that in a second, but Ottawa is a new category within the soft tissue robotic space. It's the world's first table-integrated soft tissue robotic surgical system. We've broken the mold of having robotic arms attached to carts or big booms. The four robotic arms, which we called intelligent robotic arms are integrated into a standard size surgical table.

10:25So it's a world first and we're very proud that we're able to make such a, you know, an incredible engineering feat a reality so that, you know, we can bring a new solution to surgeon surgical teams around the world. That's a really great place to start because it is for robotic arms. So what was the, like what went into making that choice and having it be part of the operating table? What is, like, why was that designed differently? And how do you think that that difference enables better outcomes in the OR? That's a great question. And of course, you know, we all start with, you know, what are the unmet needs that we're trying to solve for?

11:09And really, it all starts with the surgeon at the center, the surgical team, the hospitals. And what we learn is that even the most advanced hospital and clinical teams are trying to advance surgical care while balancing the realities of infrastructure, staffing, or efficiency, data access, and growing demand for robotic surgery. So Otava and Polyphonic, I shall say, together are designed to really complement those efforts by leading institutions around the world with features that are intended to help enhance our capacity, streamline workflow, make it easier for surgical staff to use our system, improve visibility to data, and support broader access to robotic-assisted surgical care.

11:59And so if you think about the ability to integrate four intelligent surgical arms into the table, it's really an idea not only to reduce footprint and space needed by a robotic system in the operating room, really thinks about how that can unlock potentially very different workflows. And the idea is to have a robotic system that, as opposed to being at the center of the operating room and everything has to adapt to that robotic system, is to have a surgical robotic system that adapts to those natural workflows that surgical teams would otherwise have as they perform procedures in the operating room.

12:46So it's really about adapting into the OR as opposed to forcing upon the OR and the surgical team a technology. And that's really, you know, how we thought about it. And, you know, that brings, you know, really, you know, important advantages that I'm very happy to talk about. I can definitely see what went into not forcing a workflow or asking the team to adjust to a new workflow, but to adapting to it. So it makes a lot of sense. And when you were on the podcast in November of 2023, you were just heading toward your clinical trials. So now that we have an overview of what Otava really is, I want to talk about those clinical trials a bit.

13:29The system has now been used in patients. It's received FDA authorization. Maybe we can start with what have you learned in development? and how has that changed your thinking pre our conversation in November of 2023 when you were just entering those clinical trial journey? Yeah, I mean, first of all, you know, for us and the team, you know, the fact that we've been able to be in the clinical setting already and through that obtaining an FDA approval has been an incredible milestone, as you can imagine. We're really turning an R &D program into a new business that has the opportunity to really define what's going to be next in robotic surgery with a very bold ambition.

14:13And so we've learned quite a bit along the journey. I think that the most significant learning, of course, has been the clinical trial itself. We had a prospective multi-center, single arm clinical trial focused on why gastric bypass procedures. Why, first of all, those procedures? because they're in the general surgery space, which we felt very strongly about should be our starting point for our venture in Ottawa. But also they're a procedure that has a certain level of complexity. So we wanted to demonstrate from the very beginning that Ottawa is indeed a capable multi-port robotic system that can handle highly complex as well as simple procedures.

15:03And so that was an important element as we thought about it. And so during the clinical trial, we learned not only about the safety and effectiveness, otherwise we wouldn't have got the approval by the FDA, of course, but also the fact that some of our hypotheses for the value proposition of Otava was indeed a reality that was confirmed in a clinical setting. For instance, we had six participating institutions, so six different OR environments that Waritava was tested. Five of the six never had a robotic system used in those operating rooms. And in one of the cases, we had an operating room that was 243 square feet, so a very small one.

15:55So we could really demonstrate that Otava indeed can operate also in very small settings. Think about what that can do in terms of expanding capacity for institutions that are looking to bring robotic surgery to more patients. And that is because of the fact that Otava is indeed 30 to 50 % smaller from a footprint standpoint than other robotic systems in this space. The other element that we learned is that we had a 20-person post-clinical trial survey that we run. And so we had 100 % of the participants that agreed that Octava could unlock space and allow compact rooms to become robotic suites.

16:4495 % agreed its footprint creates workflow efficiencies. and 90 % of the grade it improved visibility, collaboration, and communication. So this is a small sample survey, 2020 respondents, but it's definitely encouraging in terms of demonstrating that indeed Otava can not only allow smaller OR to host robotic systems, but also really change the way communication, visibility, collaboration happens within the operating room and drive really efficiencies in the workflows for everyone. The approach here is adapting to the current workflow and adapting to the current footprint. Can you talk to us about that a little bit more?

17:32What was the thinking and can you expand on the importance of that in the hospital workflow? Yeah, just, you know, as I, you know, reflect again on the unmet needs and how we're thinking about really bringing meaningful value even to the most advanced robotic programs here in the United States and outside of the U.S. is really, you know, driving more capacity and bringing more access to patients from a robotic surgery standpoint. And so the smallest footprint that I talked about, you know, Otava has the smallest multipower soft-teacher robotic system footprint that exists today in the market. That, per se, allows hospitals to invest in robotic surgery without having to restructure, refurbish ORs to be larger, to be more advanced to host robotic systems.

18:30That's a big advantage. Also, even in existing operating rooms, surgeons' clinical teams have more space to move, communicate, surgeons are saying there is better visibility towards what happens around the surgical tables around the patient. There's a lot of assistance that happens, you know, bedside. So Otava creates a lot of space also for the surgical staff and the first assist to support the surgeons behind the console while operating. The second element is that, you know, there is a lot of complexity in the operating room. So one of the key elements that we have integrated in our design principles is automation, automation from day one.

19:17So there is no need, like in the case for boom-based or car-based systems, where you need to move stuff around the surgical table to register it, calibrate it, to ensure that the arms have enough space to move and do what they need to do inside the patient's abdomen. Otava has automation from day one. It means that the surgeon can select the procedure that he or she is going to perform from the screen, and the arms are going to deploy from underneath the table and go into an initial position for docking of the arms to the trocars that have been placed across the minimal incisions. And that maximizes not only, you know, the reach and access during the procedure, but also minimizes, you know, the amount of work that is being required by surgical staff.

20:12Think about training. You know, today you have a lot of, you know, surgical staff are highly trained in robotic surgery because it's such a specialized field. Imagine, simplify that to the point where anyone pretty much by pressing a button can set up a robotic system. Can you imagine what that can do from a hospital economic standpoint, flexibility of deployment of surgical staff and so on? The third element is instrumentation. Of course, you can expect a company like Johnson & Johnson to deploy its expertise to Ottawa. and this is where we're really bringing the science of tissue management that we've been working on for so many decades to Ottawa, really with the focus of minimizing post-op complications, whether it's bleeding, leakages, and post-operative infections.

21:06So that's really a major focus for us, and we believe we can bring a lot of value there. And last but not least, Polyphonic is a digital ecosystem, an open ecosystem around Octava with the intent of taking data that are extremely fragmented in the operating room and integrating them into an open digital ecosystem secure that can allow surgical staff to turn those data into meaningful insights for them. whether it's in their training, whether it's during the procedure, or whether it's really reviewing after the procedure what has happened and trying to improve their own practice. So that's a lot.

21:54We're talking about automation. We're talking about surgical instrumentation. We're talking about polyphanic. And we were talking about the footprint. This was a terrific high level. So I'm going to dig into kind of each of those spaces a little bit more. Let's start with surgical instrumentation. So we were both kind of smiling when we think about J &J. I mean, you have decades of experience when it comes to developing surgical instruments. So I have to wonder, how did that influence the design of Otava? Was there one instrument or one surgical task where maybe that experience led to a meaningful design decision?

22:37Absolutely. I mean, that's one of the key elements of how we bring value ultimately to institutions and surgeons around the world. And our lens has always been that we need to look at surgery holistically, open lab, robotic procedures. We want to drive, as a program, we want to drive consistent performance across all of those procedures. And the idea is to bring innovation not only into the robotic space. Of course, Otava is our leading-edge technology, and we want to innovate in support of that technology. But we also believe that while we're innovating for Otava, we should continue innovating across open lab and robotic.

23:27And what we've done is really develop technology that are going to deliver that consistent experience across laparoscopic and robotic surgery. For instance, whenever a surgeon is going to use a handheld device or a robotic device, let's take it as an example stapling, that shouldn't be different, right? That same surgeon was using one morning a laparoscopic device, and then in the afternoon a robotic device, the experience and the performance should be pretty much the same. So that's, you know, an important design principle angle that we're taking here. And then the second design principle is that, you know, ultimately we're not just simply trying to replicate, you know, the current experience of robotic surgery.

24:16And we say, okay, you know, there's standard instrumentation that is needed and we're going to offer that because we understand it's important. And we're always challenging the assumptions behind it and look at ways to really serve unmanned needs, you know, even within instrumentation. We have designed, for instance, a simple two-in-one needle driver, a needle driver that allows the needle to be maneuvered and advanced, and at the same time, a needle driver that allows for suture cutting so that every movement of the surgeon is very smooth and optimized because time is money. and we want to make sure that we're thinking through how we bring efficiency in every single movement.

25:04That exists already, but what we've done is we've minimized the possibility that inadvertent suture cutting happens. And so we have designed, and surgeons have been very enthusiastic about it even during the clinical trial. Another thing is, you know, a simple thing such as the scissors. You know, scissors in the market, we've heard, can dull very quickly. And so the ability to perform consistent and complete cuts is something that is important to surgeons. And so we address that need in our design principles. And then, of course, we're going to, you know, bring that into the advanced instrumentation, such as advanced energy and stapling devices.

25:51and we're very excited about what we're going to be able to bring in this space. I feel like I hit a goldmine with that. And I have so many follow-up questions, but I want to move us forward a little bit. You had talked at a very high level, polyphonic. So just to remind our audience, can you just start with what is it exactly and how does it work directly with Otava? Yeah, so think about Otava is our robotic system. It consists of a console, a tower, and a surgical bed with four intelligent arms, which are integrated in it. So that's the main hardware component of Otava. Polyphonic is a digital ecosystem around it.

26:34Think about kind of a surround digital ecosystem that really allows Otava to capture data, but not only capture data from Otava, capture data from multiple devices within the operating room, from EMR systems, from different systems that today creates a lot of fragmentation from a data generation standpoint in the operating room. And so the idea for a polyphonic or a digital ecosystem is to be open. It means, first of all, should be open to or agnostic to where data sources are coming from. So it can be Otava, it can be another J &J device or technology, it can be other technologies, third-party technologies.

27:24We have the ability to integrate those data into polyphonic. The other element of polyphonic openness is that we're not trying to do everything in support of our technologies only, and therefore we believe that all of the innovation is going to come from us. So Polyphonic, as an open digital ecosystem, has the intent to allow institutions, startups, third parties to innovate on it. So we want to offer a platform for innovation through Polyphonic that is going to be awfully very compelling also to others within our industry. And what we're doing is basically we're consolidating those very different data sources, robotic data, video data, video feeds, digital data from other sources, creating a data pool that is going to be organized in a way that, for instance, AI algorithms are going to be developed on it based upon on it.

28:30And so we're very, very, you know, happy with, you know, how this is moving. And most importantly, we believe that it's going to create enormous value for institutions that are looking not only to innovate together with us, or third parties are looking to innovate together with us, but also, and most importantly, institutions are looking to have more access to data because they feel that today, A lot of the data is not being given back to them in the way they wish and they would like to see companies share the data. And this is what we're trying to do with Polyphonic. So, wow. That is really exciting.

29:16And just to make sure that I completely understand. So when you do say open, you mean in practice that all of the data and the applications come together across systems. And even if they're different robots, as an example, they don't remain on this like a digital island. So they're all speaking to each other, all shared repository of information, if you will. Absolutely. Absolutely. And that's why Polyphonic, for instance, is not, you know, it starts with us, right? is Otava is going to be delivered with Polyphonic from day one. So there is a full integration between Otava and Polyphonic, but Polyphonic is also going to support Monarch, Dualto, our latest generation of energy generator.

30:04Forgive me the duplication words. But also, if customers decide to use it on other devices, they might be able to do that. You know, the video feeds might come from a very different laparoscopy tower, for instance, that is available in the operating room. So we're open to, you know, those data sources. I love that so much. Was that the intention from the very beginning? It was, yes, absolutely. Absolutely. Because, you know, it's based upon the recognition that hospital assistants do not necessarily want to have, again, have to support different digital ecosystems from different companies and those ecosystems being disconnected from each other.

30:52Our proposition is that we want to build a coalition from a data integration standpoint, from a collaboration standpoint, and really be a facilitator of data as opposed to a protector of data around a specific technology that we have developed. I admire and respect that so much. I think the last thing I wanted to unpack when you gave that beautiful overview was automation. And you said that automation is part of Otava from day one, which really caught my interest here. For, again, clarification, the automation component is through docking. So from initial setup, the press of a button, it saves time, getting it all set up.

31:45Is that accurate or is there an extension or after that initial docking, is there more automation? Yeah, so, you know, as I mentioned, you know, we've made, you know, very unique architectural choices. One of them is to integrate the four intelligent ARGs into the table. Another one which I haven't talked about, which is really one of the key enablers of automation, is the fact that every joint is motorized and sensorized to a certain extent. So we know at all times where every joint, every arm is in space with respect to the other three arms. And so think about that, that can unlock in terms of allowing arms to move in space, for instance, minimizing collisions.

32:36And that's important because if you want to set up a procedure and you have a fixed starting position underneath the table, you need the arms to move in space in a way that is synchronized and is not colliding while they do so. And so the initial value proposition is really that ease of setup and turn down. It's very simple. You select the procedure, press a button, the arms go into that position, initial position without having to register or calibrate cards or booms. But as you can imagine, because of that inherent ability and capability with our motorized joints, we're going to be able to potentially deliver much more in the near future.

33:23so it might extend beyond the setup or turn down of a procedure it might extend to during the procedure what that could unlock but I think that the key design principle here again is that we want to take a very human-centric approach right it's not about replacing anyone it's really about making everyone's life a bit simpler in the operating room and making sure that we're setting everyone up for success in the simplest possible way, both the surgeon and the surgical staff supporting the surgeon. I want to continue that line of thinking here for a moment. So you're absolutely right. You know, surgeons are humans.

34:11So what would you say would make a surgeon who maybe is already comfortable with another system feel more comfortable adopting Otava? And you'd be surprised how natural the transition has been for some of those leading surgeons that have been with us in the clinical trial and continue supporting us, all thought leaders in this space. And we're always extremely thankful for all of their contributions to Otaba. and the reason for that is that when we set the roadmap and the architecture for Tava one of the key things that we focus on is to make sure that we limit the amount of training necessary for surgeons to transition from one platform to the other we understand that in the future hospital system will have potentially a multitude of robotic systems so how do you switch from one OR to the other, from one procedure to the other, potentially having different commands, different ways to engage with the robotic system.

35:22So we thought very deeply about, okay, how do we make that transition so simple that a robotic surgeon can transition from one system to the other without having to relearn every single time the gestures, the commands, the movements. and the feedback that we've got so far is that we've accomplished that and surgeons are very happy with how little it takes to transition to Otava. You hit exactly where I was trying to go with it. I mean, if the future goes the way that we think it's going to go, this is what we want to see. So just a couple last questions for you, Ruko. I know that you and your team, you plan to launch Otava with select U.S.

36:13customers first. So what must those early sites demonstrate? And I want to think about it clinically, operationally, and economically before you're ready to expand beyond the U.S. Yeah, I mean, Otava has a very ambitious goal. You know, we were coming to this space because we believe we want to lead in this space. We want to be leaders in robotic surgery. For us to be able to do that, it starts, everything starts with a strong foundation, a strong foundation in general surgery to begin with. And, you know, we're very committed to making sure that we continue working together with leading institutions and surgeons here in the U.S.

37:00to make sure that we continue confirming our hypothesis in terms of our value proposition to the marketplace while continuing gathering additional evidence around our value proposition, right? Because we've had an initial clinical trial in Rouen-en-Y gastrobypass that has given us a FDA approval for 10 procedures in the upper abdomen and general surgery space. We have already started our second clinical trial in your hernia. we want to continue building on that evidence and expand into new specialties. So TAVA has to be a multi-specialty, multi-port system. And so you're going to see us move very quickly to expand those indications through addition clinical trials.

37:44And then, of course, we have established a very focused commercial organization, service organization. We want to make sure that everything is ready and we can support the commercial rollout and the speed at which we want to go with that commercial rollout with the proper commercial models and service organization to do all of that. And last but not least, FDA approved a foundation for us. And so we're very excited that Otava is just at the very beginning. And so you're going to see a lot of new innovation coming to Otava, whether it's new software, new instrumentation, new visualization capabilities.

38:32Otava is going to grow tremendously over time. And again, that's all contingent on our architecture, which is an expandable one. We have designed Otava so that Otava can grow with capabilities that are going to just enhance the value proposition and the response to those unmet needs that I talked at the very beginning. My heart is racing just thinking about the possibilities. Congratulations to you and your team. One final question, and this is, Roko, from your own perspective, not from Johnson & Johnson, but your own perspective. What do you think surgical robotics and the role of systems like Otava will look like a decade from now?

39:17That's a great question. It's a big one. And first of all, I like to say I fundamentally believe that, you know, surgeons are going to continue being at the very center of surgery. And technologies will ultimately, you know, serve surgeons and surgical teams to do better and make sure that they do best what they do every single day, which is serve patients. and so that's really how we're thinking about it. Definitely there's going to be a huge convergence of robotics, software, data, AI, automation and so I think the robotic system is going to stay at the center of everything but it's not going to be the only element.

40:11I think the value equation will extend into how we think about the performance of the operating room as a whole, not just from an angle of a robot, but, you know, look at the operating room as a whole. And then, of course, you know, how we look at the performance of surgery as a whole along the patient pathway. And, you know, the data that we hope, you know, we hope to gather and hoping to give back to institutions and surgeons are going to be at the very center of that, right? I think it's that surgical intelligence that we want to build together is going to be key to that. I think it's, you know, my hope is that ultimately our success is going to be measured by, you know, how more accessible robotic surgery is going to be, how more connected and more intelligent to a certain extent surgery is going to be to elevate the floor and the ceiling for everyone to a certain extent or what's possible in surgery through data and insights.

41:24from those very different data sources that I talked about. And then, ultimately, my hope, my wish is that technology is going to be there to, again, to help surgical teams improve their practice, extend their professional lives. And, you know, if you look at, you know, the projections of number of surgeons into the future, you know, technology is going to be needed to ensure that not only we're raising, you know, those standards in surgery, but also we're potentially amplifying individual capabilities that surgeons can bring to their institutions. And I fundamentally believe that Otava can be a foundation for all of that.

42:08Otava together with Polyphonic, of course. And we're all very excited about the possibilities of what it could be in the future. I can tell you I'm absolutely full of hope. And again, congratulations as far as you've made it. And I'm so excited to follow your success. Hopefully, we won't have our next conversation three years from now. We'll make it sooner than that. Rocco de Bernardes, Global President for Soft Tissue Robotic Surgery of Johnson & Johnson. Thank you so much for joining us on Device Talks Week. Thank you, Kayleen. It was a real pleasure. Thanks again for having me. And we're happy to stay in touch.

42:50and that's a wrap on another episode of device talks weekly i hope you enjoyed this episode as much as i did and i hope that you learned something about j &j's otava robotic surgical system i so appreciate rocco's time thank you so much j &j thank you rocco and speaking of thank yous huge thanks to this episode sponsor harmonic drive again to learn more about how harmonic drive works with medical device companies, please visit their website at HarmonicDrive.net. I will bring you another episode of Device Talks Weekly next Friday, so make sure to stay tuned. If you aren't already subscribed to the Device Talks Podcast Network, please do so.

43:29Also, follow me, Kayleen Brown, on LinkedIn. And while you're there, follow Device Talks as well. I have loved every moment of this. And again, I so appreciate everything. I will see you all next week. And until then, thanks for listening.

From the publisher

In this episode of DeviceTalks Weekly, Host Kayleen Brown welcomes back Rocco De Bernardis, Global President for Soft Tissue Robotic Surgery at Johnson & Johnson, to discuss the company’s OTTAVA™ Robotic Surgical System.

De Bernardis explains why OTTAVA’s four robotic arms are integrated into the operating table and how the system’s smaller footprint could give surgical teams more room to work while helping hospitals bring robotic surgery to additional operating rooms. He also shares what Johnson & Johnson learned from OTTAVA’s clinical trial, including how the system performed in different operating-room environments and what the company’s FDA authorization means as it prepares for a commercial rollout with selected U.S. customers.

The conversation also explores the technology behind OTTAVA, including its automated setup and docking, surgical instrumentation, and Polyphonic™, an open digital ecosystem designed to connect data from devices and systems across the operating room. De Bernardis discusses how these technologies could improve workflow, support surgical teams and create a foundation for the future of robotic surgery.

Catch the 2023 interview with De Bernardis here: https://www.devicetalks.com/hear-why-j-a-vc-discusses-the-impact-of-glp-1-drugs/ 

Special thanks to this episode's sponsor, Harmonic Drive. To learn more about how Harmonic Drive works with medical device companies, visit harmonicdrive.net.

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Chapters

  • (00:00:00) - Message from Kayleen Brown, Managing Editor, DeviceTalks
  • (00:03:35) - Start of interview with Lee Ginter, Sales Engineering Manager, Harmonic Drive
  • (00:09:01) - Keynote Interview with Rocco De Bernardis, Global President for Soft Tissue Robotic Surgery, Johnson & Johnson
  • (00:09:52) - Why OTTAVA™ Integrates Robotic Arms Into the Operating Table
  • (00:13:35) - What Johnson & Johnson Learned From OTTAVA’s Clinical Trial
  • (00:17:47) - OTTAVA’s Smaller Footprint and Automated Setup
  • (00:21:59) - Designing Surgical Instruments for Greater Efficiency
  • (00:26:21) - Polyphonic™ and the Future of Connected Robotic Surgery

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