Intuitive Surgical has been the leader in soft-tissue robotic surgery for roughly two decades, operating in a near-monopoly as potential challengers have fallen out of the market.

However, the environment is set to change as Intuitive will face competition from large medtechs like Medtronic and Johnson & Johnson, which have developed soft tissue systems of their own.

CEO Gary Guthart told MedTech Dive that while Medtronic and J&J are "capable organizations worthy of respect," robotics is a complex technology to develop and perfect.

The CEO added that "just having a robot is also not enough," and explained that aspects beyond the system are crucial, such as developing products that work with the platform, utilizing data and analytics and creating a program that can help hospitals improve procedure outcomes.

"It's a complex space," Guthart said. "I think our future is much more determined by what Intuitive does than by what the competitors do. And that will come down to knowing our customers well and making sure that we satisfy their needs."

Intuitive did get a bit of a break as both Medtronic and J&J have announced recent hurdles or delays with their systems. In October, J&J told investors that its Ottava system will be delayed by at least two years.

Guthart also spoke to MedTech Dive about how healthcare labor shortages have impacted the company, how system placements have continued despite procedure volume volatility, as well as addressed studies that have been more critical of the safety, effectiveness and cost of robotic procedures compared to traditional methods.

This interview has been edited for clarity and brevity.

MEDTECH DIVE: The healthcare labor shortage is a topic that has come up for medtechs a lot recently as companies have reported earnings or presented at conferences. How is Intuitive managing through a problem like that as it's a bit more of a longer-term issue?

GARY GUTHART: There are some things that we can do to help. We can rotate our products and our support staff into environments that help hospitals if they want to rebalance, for example, between different physical properties, different hospitals or different surgical locations.

To the extent that we can deploy support resources in non-healthcare, non-patient-contact ways — whether it has to do with inventory or some other things that we can help them with — we do that.

We help where we can.

What can the device industry do to help hospitals or other facilities solve the problem of staffing shortages?

GUTHART: I think we can do some things to help. It'll be a series of steps. I don't think there's any one activity that either they or we will do that makes for a fast turnaround.

We see hospitals looking upstream for the ability to train staff and recruit them. We see at hospitals different forward-looking recruiting strategies to make sure that they're well-staffed, and they look to us to offload some activities that, as I said before, are less direct patient care and more hospital operations. So, I think it's gonna be a combination of those things.

I think this will play out over many quarters. None of this is going to be something that resolves in weeks.

Medtronic and J&J have both been looking to enter the soft-tissue robotics space, but they have talked about challenges or delays with their systems. Does this open up any opportunities for Intuitive?

GUTHART: Surgical robots are not commodity products. They are hard to design. The design spaces require a lot of engineering trade-offs and architectural trade-offs. Just having a robot is not enough. What customers are hiring a company like Intuitive to do is help them develop their minimally invasive surgery program, of which a robot is a piece. But it's the products, the services, the training, the data and the analytics that go with all of that that really helps them get to the outcomes they want.

It really is the whole idea of an ecosystem to get to a program that works, and that is where the competitive conversation really is. Can you get there? Can you get to the outcomes?

I've been with robotic surgery since 1993, give or take 20 to 25 commercial entities that have brought something to market, about five are still viable entities, and the rest are not. So, it can be done, and it's hard. What we look at is, what can we do to satisfy the customer? Do we understand their needs? Are we able to provide an integrated solution? By integrated, I mean the products, the services, the training and the analytics. Can we deliver that in a way that gets customers where they want to go?

If we can do that, customers will vote for us, they'll keep ordering business through us, and if somebody does that better, it'll change.

You said there's been 20 to 25 entities that have tried this, and maybe five or so left standing, but is there any more legitimacy to a competitive challenge from a company like Medtronic or J&J? These are big companies with a lot of resources to use for research and development and then marketing and placing those systems when they launch.

GUTHART: These are capable organizations worthy of respect. They have gotten to where they are for good reason, not by accident. I think they will invest. I think they employ smart people, and they'll have to go work on these hard problems.

I expect them to keep going. I don't expect that they're going to walk away from the opportunity. I think that the big players feeling like they have to do it is a validation that this idea that Intuitive has been pursuing — looking deeply at what kind of outcomes can be generated and then developing a technology-enabled ecosystem to deliver it — I think that's validation of our approach.

We'll see where they go. They have the resources and the desire to stay with it, and our job is to make sure customers vote with us.

Robotic systems placements — for Intuitive and orthopaedic companies — have continued despite the volatility around procedure volumes over the last two years. Was it a surprise to see hospitals investing in these expensive systems even with the procedure uncertainty?

GUTHART: Early in the pandemic, we were surprised with how quickly interest in new placements or capital placements recovered. As we've talked to customers and visited with them and got to know them, I think it's becoming clearer that high-quality, minimally invasive surgery, which is what our systems help hospitals provide, decreases downstream resource constraints. It decreases ICU needs and it decreases the amount of time staff are rounding on patients in the hospitals; it eases the hospital burden. For them, it was an acceleration of a trend that was happening already.

The second thing is that institutions and hospitals are looking forward and saying, "There's a time at which the pandemic will wane, and we want to be well-positioned to be serving our customers." In other words, we don't want to just be in a timeout. We want to be thinking forward about what we can do.

One of the things I worry about is when you have strong capital performance, you're building capacity in your installed base that may not be utilized in the future. You don't want to over-build capacity. It's not healthy for the hospitals, and it's not healthy for us. What's been great through this period is even with the pandemic, systems out in hospitals have been more utilized on average per year, not less utilized, which tells me that even though we're having great capital placements, they're being used. That's been positive all the way through.

Last year, there was a study the in Annals of Internal Medicine that looked at abdominal robotic surgery procedures compared to more traditional methods. The article concluded that there was no clear advantage in terms of robotic surgery. Other studies have looked at the safety, effectiveness and cost of robotic surgery compared to traditional methods.

Can you respond to studies that have been more critical of robotic surgery as the adoption and placements have been growing?

GUTHART: I won't speak to the specific one you mentioned because it's not in front of me. But what I'll tell you is the following: In surgery, level one evidence — prospective randomized clinical trials — are rarely done because you have a lot of variability. You have the variability of the patient population, but you also have the variability of the surgeon population and the surgeon experience. And you also have technology changes throughout the study period. So, you don't see a lot of peer-reviewed prospective randomized clinical trials in surgery as a whole.

The folks who look for what they call "level one evidence" as comparators typically find not much data. That has nothing to do with robotics, it has nothing to do with Intuitive, and it has everything to do with trying to manage variants across populations of patients, surgeons and technology. Those studies tend to not be often done, and they tend to be way too small to be particularly predictive. As a result, what you wind up getting are things that don't predict well what's happening in the general population across the country.

The solution to this is real-world evidence. It's not running massive prospective randomized clinical trials, and even regulatory bodies are realizing that real-world evidence can be powerful here. When we look to the real-world evidence, and that is large-scale registries or it's in electronic medical records, you see really strong performance for robotic-assisted surgery as compared to open surgery and laparoscopy. That data set, that set of real-world evidence that's in the hands of our customers — it's not Intuitive's data, it's theirs —  has been what's catalyzing the growth in the adoption of robotics.

If you're a skeptic on the outside, and you said, "Hey why is this growing if there's not a lot of level one peer-reviewed evidence?" The answer is that institutions that own that data and run those electronic medical records do the analysis quite deeply. And when they do it, and I speak to them often, they find that they're getting great outcomes. They find that their costs for robotic-assisted surgery are as good or better than the existing approaches, and that patient and surgeon satisfaction is higher.

Many of these institutions own their fifth, sixth, seventh da Vinci system in a hospital, or their 100th across their integrated delivery network. I think it gives lie to the critic's approach that it's a marketing tool. I just don't think that's backed up by the evidence.

Some of the safety concerns that have come up amid the growth in robotics have been that surgeons may not get adequate training, or a limited amount of training, on the system. How do you view the responsibility of training surgeons, in regards to Intuitive vs. hospitals? And has the company focused on investing in and growing your training program?

GUTHART: We have always viewed training as an extremely important element in the introduction of our technologies. There's a part of training that we handle directly, and that's technology training — What is the machine? How does it work? What do the messages mean? What do these buttons do? We call it the technology training pathway, and we do that carefully.

We've made significant investments year after year for the last two decades, and it is an absolutely outstanding program. It's multifaceted. It allows for online learning as well as virtual reality learning as well as hands-on learning. Increasingly, it has objective performance criteria for the surgeon to evaluate their own performance. That side's been great.

At the same time, in terms of teaching surgical technique, that is not the responsibility of the company. That's the responsibility of medical institutions and academic medical centers. We support them. We allow surgeons to get in contact with training resources. We support through surgical societies, residency training and fellowship training. We've continued our investments there. We routinely get very high marks from our customers on our investments and execution in training.

Again, the need for care in training goes beyond robotic-assisted surgery and Intuitive to really any new technology in a clinical setting, or a new technique. You don't even need new technology. It can be just a new technique. This issue of investment in care and then training is, I think, ubiquitous in the field.

The last thing I'd say is that with the digitization of a lot of things that happen in the operating room that's facilitated by robotic-assisted surgery, we have more data than ever and opportunities to use that data to help surgeons improve their skills. I'm excited by that. In the future, we'll continue to see improvement on the training side.