It's hard to believe it's been nearly two decades since Intuitive Surgical launched its first da Vinci system. And yet, in many ways, the field of robotic-assisted surgery is still in its infancy.
"There's no university program on robotic-assisted surgery today," said Sal Brogna, an executive vice president and the chief operating officer at Intuitive. "We're at the early stages of creating a whole new technology sector. I assume someday you'll go to universities and they'll have robotic-assisted surgery courses, but we're creating it now."
Intuitive's da Vinci became the first robotic-assisted surgery system to be cleared for general laparoscopic surgery back in 2000. Today, the Sunnyvale, CA-based company is on its fourth-generation da Vinci system that is designed to be a comprehensive surgical device and can serve multiple surgical specialties, from urology and gynecology to general surgery, thoracic surgery, and even ear, nose, and throat surgeries. As of Sept. 30, 2017, Intuitive had 4,271 surgical systems installed worldwide, including 2,770 in the United States.
“It’s been a great journey for us, very rewarding," Brogna told MD+DI. "We obviously started in a very simple place that was a very compelling story, ‘let’s make robotics help cardiac surgeons by doing bypass surgery without cracking open the chest.’ That was a very compelling story. We never fulfilled all the requirements for cardiac surgeons, but as we moved in and other people saw the technology – and that’s been the fun part about the business – as other surgeons saw the technology emerge, they found applications that were relevant, the urologists being the first ones that brought it into prostate [procedures]. Over the years, it’s been a great learning experience because we work closely with surgeons and as more and more specialties came to us, we had to add features and capabilities that the prior generations didn’t have."
The fourth-generation family of da Vinci products, specifically the da Vinci Xi platform, was strongly targeted toward the general surgery market, Brogna said. He described general surgery as a rich marketplace with about a handful of subspecialties within it and the surgeons in those subspecialties had very unique and demanding requirements for a robotic-assisted surgical system. That's why the da Vinci Xi has many capabilities that previous generations of the system just didn't have.
Competition Breeds Innovation
Intuitive Surgical enjoyed a long run as the only company with a robotic-assisted surgical system cleared for general laparoscopic surgery in the United States. Today, the market pioneer is faced with competition from more than a dozen newcomers that are exploring various configurations and approaches to robotic-assisted surgery.
A real turning point in the space came in October 2017 when Morrisville, NC-based TransEnterix received FDA clearance for its Senhance Surgical Robotic System, which is used in gynecologic, colorectal, hernia repair, and cholecystectomy procedures. At the end of the third-quarter, TransEnterix had roughly 14 Senhance systems installed.
With the Senhance, surgeons can sit at a console unit or cockpit that provides a 3-D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. Two key differentiating characteristics of the system are the force feedback, which helps the surgeon "feel" the stiffness of tissue being grasped by the robotic arm, and eye-tracking, which helps control the movement of the surgical tools.
Competitors in the robotic-assisted surgical space would also do well to keep an eye on Caesarea, Isreal-based XACT Robotics, which received a CE mark in September to sell its robotic navigation steering system in Europe. The XACT robotics system is currently being used for CT-guided percutaneous procedures in the abdomen. Later this year, the company expects to expand into additional clinical centers and with other imaging modalities, such as cone-beam CT and fluoroscopy, and for additional indications, including spinal and lung procedures.
Another company hoping to bring new options to the robotic surgery field is Virtual Incision, which is developing a two-pound robotic device that operates entirely inside the body through a single abdominal incision and is expected to be less expensive and more portable than existing laparoscopic surgery robots. The company is gearing up to seek a 510(k) clearance for its device.
So, how has Intuitive Surgical responded to these competitive pressures? Surprisingly well.
In 2017, Intuitive's leadership began emphasizing the importance of investing in product development to prepare for new entrants to the surgical robot market. In May, the company received FDA clearance for its da Vinci SP surgical system for urologic procedures that are appropriate for a single port approach. Brogna said designing a system that brings four robotic arms through one singular 25mm port was a "really compelling and hard challenge."
"We didn't have to do it, we chose to do it," he said. "We said if we could do that there will be derivative technologies that flow across the product line, and that's what has happened. There is technology from our da Vinci SP that we're just releasing that is already in our Xi product that was released four years ago. It took us 12 years to get to da Vinci Sp and it was a tremendous learning challenge.
Brogna also touched on the company's most recent technological development, which is a flexible catheter program that is still being reviewed by FDA. If cleared, that device will allow surgeons to navigate through the body through natural orifices without the need for a surgical incision.
Raynham, MA-based Medrobotics received FDA clearance to market its Flex Robotic System for colorectal procedures, making it the first such system to reach the U.S. market for that indication. The technology, which has been described as slithering like a snake, is expected to give colorectal surgeons new treatment options that may not be possible with traditional instruments.
"Many of the ideas that we see coming from competitors are ideas that we have attempted and, in some instances, have rejected, whether it is for workflow improvements, or safety requirements, or cost-effectiveness," Brogna said. "Each of them are nice and novel, and we salute their inventiveness and we welcome the challenge that they bring to the marketplace."
Competition is good for the sector, he added, in part because it encourages Intuitive to rise to the occasion and strengthen its own product lines.
"We follow the competition, we hope that they can get to the market, because it validates a market that we took 23 years to really get established, and it's encouraging to see," Brogna said. "In the end, I think all patients will get better outcomes and less variability, and I think robotic-assisted surgery is clearly going to be the future of all surgery. It's just a matter of how long it takes for us to evolve and give surgeons everything that they need."
This Isn't Your Father's Spine Surgery
One of the most promising areas of robotic-assisted surgery is in spine procedures. Medtronic made a big splash last week with the news that it has agreed to acquire Caesarea, Isreal-based Mazor Robotics. The two companies first began working together in May 2016 through a multi-phased strategic and equity investment agreement. Last year, Medtronic became the exclusive worldwide distributor of the Mazor X system, leading to the installation of more than 80 Mazor X systems since launch.
Mazor launched its Renaissance Guidance System in 2011 for brain and spine procedures and launched the Mazor X system for spine procedures in October 2016. While the company no longer discloses direct placement numbers, Mazor had a worldwide install base of 188 at the end of 2017, including 129 in the United States.
Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic, took some time during the North American Spine Society meeting this week in Los Angeles to talk to MD+DI about the company's vision for robotic-assisted surgery.
“The vision is pretty bold. I mean, the vision is to transform spine surgery," Martha said. "Right now the outcomes in spine surgery are not consistent enough, there’s too much variation across the board, and that’s led to patients not having a lot of confidence in spine surgery. It’s something that’s necessary if you have a structural problem in your back, but unfortunately, the outcomes have been too variable."
The days of open spine surgery where the surgeon is relying on his or her experience over time, without the help of enabling technologies like intraoperative-imaging and surgical navigation are coming to an end.
"We think it’s definitely shifting to a spot where you’re using that enabling technology, not just for technology’s sake but to actually improve patient outcomes," Martha said. "So we believe we can really mitigate that variation and ultimately transform the surgery to where the patients have a lot of confidence in spine surgery like they do when you get a stent put in or something like that.”
Being the market leader in the spine industry, Martha said Medtronic has an opportunity – and in many ways, an obligation – to improve outcomes and patient confidence in spine procedures. That's where Mazor comes in.
"People talk about robotics, but we believe robotic-assisted surgery is a lot more than just a robotic arm," he said. "It's pre-surgical planning software, a robotic arm, interoperative 3D imaging, navigation, powered instruments … all this needs to work together seamlessly in order to enable these better outcomes."
Medtronic also has experience in integrating these types of technologies seamlessly into the surgeon's workflow to remove some of the barriers of adoption, Martha noted.
"This is the first meaningful and sustainable competitive differentiation in the spine industry that we’ve seen in the last decade," he said. "This is something that we believe will define the industry."
That said, there are other large spine companies that are also helping to shape the market with robotic-assisted surgical systems. Stryker, Zimmer-Biomet, and Globus Medical are also competing in the space. Globus sells the ExcelsiusGPS robotic system, Stryker has the Mako, and Zimmer-Biomet has the Rosa Spine.
How Will Machine Learning and Other Emerging Capabilities Impact Robotic Surgery?
Down the road, another disruptive competitor is expected to emerge in robotic-assisted surgery. It's well-known in the industry that Johnson & Johnson has partnered with Google to form a joint venture, dubbed Verb Surgical. Though highly anticipated, not a lot is publicly known yet about what Verb Surgical is calling its digital surgery program. What is generally understood, however, is that the platform is expected to include advancements in robotics, visualization, instrumentation, data analytics, machine learning, and connectivity.
Both Intuitive and Medtronic are already actively working on similar advancements.
"In terms of AI and machine learning, if you think about the planning component of this, you’re presented with some images and the patient presents with whatever the symptoms are, and then you use analytics to determine if the surgery makes sense and if so, what’s the best path," Martha said. "All this data analytics and machine learning should be guiding that."
Brogna said some of the early results he's seen from Intuitive's researchers in those emerging technology areas are quite promising.
"As the robotics were an augmentation to the surgeons and gave them better precision and control, machine learning will give them insights about their cases, will be able to help them understand how they can improve their techniques and get into better training curriculums, but will also be able to give them real-time updates of the case," he said.
For example, Brogna said the integration of machine learning could give surgeons guidance if they get stuck in a particular part of a procedure. Perhaps a short video would automatically pop up to help them through that particular challenge, he said.
Just last week, Santa Barbara, CA-based InTouch Health announced that is working with Intuitive to build an Internet of Medical Things that will enable the surgical robotics company to access its surgical systems within hospitals or surgery centers.
"We've had our systems networked back to our corporate servers for over a decade, and we rely on interconnectivity between taking data from the systems that help inform us for future designs, and help give customers insights on how the product is performing in their hospital," Brogna said. "But with the InTouch engagement, we hope to expand that. We see a growing need for the engagement of more devices in the OR and connecting them more."
One exciting outcome of the InTouch partnership is the possibility of enabling remote proctoring, meaning an expert surgeon would be able to participate in a surgery remotely. They won't be able to control the robot, Brogna said, but from their screen they can have a headset on and offer guidance to the surgeon that is performing the procedure, helping them through their learning curve.
"There are other things we're doing with delivering preoperative images and segmentation of the images to give surgeons a more natural guidance," he said. "So having secure networks that go from either the cloud or from our servers into the ORs is something that we see as an important part of the future."