The SRI-led Trauma Pod, developed for DARPA as a next-generation mobile robotic surgery platform for the military. Credit: SRI International via Wikimedia Commons.

This week, the “144” study on adverse events in robotic surgery made the rounds in media outlets such as the BBC, NBC and the MIT Tech review. An impressive group of researchers found that between January 2000 and December 2013, we have records of robotic surgical procedures killing 144 people, injuring 1,391, and involving 8,061 malfunctions – this is out of a total of more than 1.7 million procedures performed in that time period.

This is of course serious news, raises important questions, and adds to a heated conversation on the safety and effectiveness of robotic surgical procedures. A growing body of studies now argue these points (for example [1, 2, 3, 4]), and thankfully we’re starting to learn when and why this technology works or causes trouble. A lot seems to come down to how frequently a procedure is performed at a particular hospital and by a particular surgeon, for example. Hopefully this dialogue will mean safer and more effective robotic procedures as the years go on; this is generally the story with surgical technologies as they mature.

The intense focus on safety and effectiveness seems to be compromising training for new robotic surgeons.

It may also mean many fewer competent robotic surgeons, just as demand for robotic surgery soars. After two years of field research – observing close to a thousand hours of robotic and open surgery at five diverse hospitals and interviewing surgeons and residents from ten teaching hospitals around the country – I have found that the intense focus on safety and effectiveness seems to be compromising training for new robotic surgeons.  I should say from the outset that I’ve collected data only on surgery involving Intuitive’s da Vinci system, and primarily on urologic procedures. I did this to uncover best practice: the da Vinci is used far more frequently than any other robotic surgical system, and the field of urology has had – by far – the most experience with the system over the longest period of time.

Why is surgical learning compromised in surgery involving the da Vinci? Mainly because the technology allows a single surgeon to perform the bulk of each procedure. In traditional “open” surgery, senior surgeons need significant help from medical residents throughout. While I explore interesting exceptions in my research, at my sites this generally translated into a ten- to twenty-fold reduction in the time that medical residents got to spend actually doing surgery. It’s hard to hand the controls over to a rookie for long when you’re accountable for safety and quality in life-and-death work. Perhaps in response, Intuitive introduced a “driver’s ed” model that allows senior surgeons to digitally delegate surgical control to a trainee sitting in another control console. Interestingly, the presence of this model did not lead to notable increases in resident “console time” at my sites. Most often, residents watch procedures unfold on TV screens in the operating room, which likely has limited learning. As a chief of urology said to me, “Watching movies does not make you an actor.”

Most often, residents watch robotic surgical procedures unfold on TV screens in the operating room, which likely has limited learning.

This challenge adds fuel to a fire that was already burning: according to the AAMC, surgical demand is growing significantly faster than the supply of surgeons. The significant reduction in medical residents’ work weeks (from 120 hours to 80, mandated by the AAMC) has also decreased the number of surgeries that remaining medical residents get to perform. So “best practice” with the da Vinci has – on one key dimension – made it even harder for many students to get sufficient, safe, legitimate opportunities to learn how to use it.

So what are we to do about this problem? It looks as if every way forward involves challenging deeply held norms, laws and techniques related to surgical work. Change will likely require effort on multiple fronts simultaneously. It’s tempting to suggest that senior robotic surgeons should allow medical residents ten times the opportunity to struggle on their own during surgery… until you watch an expert remove potentially cancerous lymph nodes in ten minutes and on a different day watch a resident struggle to do the same in forty. Some surgeons allow this, but because of the legal, professional and quality assurance issues described above, many expert robotic surgeons won’t.

Robotic surgery will likely continue to expand in proportion to other methods, given that it allows fewer surgeons to perform surgery with less trauma to the patient.

One interesting option is to do nothing, because surgery itself is on the wane. A good number of the senior surgeons I speak with presume that new treatments – nanoparticles, nanobots and the like – will make cutting into patients less and less necessary. But many physicians and researchers expect that surgery isn’t going away for at least several decades, and that if anything, robotic surgery is going to continue to expand in proportion to other methods, given that it allows fewer surgeons to perform surgery with less trauma to the patient.

We have recently seen striking progress on automating surgical tasks in lab settings. When I ask experienced robotic surgeons about the future of their work, many of them suggest that relatively routine portions of a given procedure might soon be automated. The system might move more slowly than they would, and the surgeon might need to orient the system to the landscape inside the patient, but a semi-autonomous system would allow a single surgeon to perform several procedures simultaneously. But while this solution could address the demand side of the equation, it’s not obvious how it would help surgeons in training.

Trainees in surgery are still expected to build embodied competence through “live” work.

Simulation has already played an important role in resident education – Intuitive has partnered with a number of organizations to produce relatively advanced software simulations that help build basic surgical competence. The trouble here is that – unlike most highly skilled, collective work such as sports, music or law enforcement – trainees in surgery are still expected to build embodied competence through “live” work. In order to get time on the simulator, residents at most institutions have to get less sleep or time with family – in other words, surgical education doesn’t build in sufficient time for offline practice. This changed in the field of aviation so it seems possible in the field of surgery, despite a strong norm for learning in live procedures.

A final option is telesurgery: if surgeons could operate on patients remotely, we could more efficiently deploy surgical expertise across geographically distributed demand. The original DARPA grant that contributed to the development of the da Vinci specified remote surgery on wounded soldiers as a key use case. Legal, regulatory and team-dynamics barriers loom large here. As of now, law and regulation make it difficult (often impossible) for physicians to do remote diagnosis and recommend treatment – let alone operate on a patient – across state lines in the US. Also, we have decades of research showing that geographically distributed teams underperform relative to their collocated counterparts. We should be wary of a surgeon in California trying to coordinate a surgery with a nurse and a surgical scrub at the bedside in Atlanta.

No matter how safe we make robotic surgical procedures, they will become a luxury available to a very few if we fail to address the sustainability of the practice. Some hybrid of the options above on a large scale will likely be required to address the constraints that “best practice” with these systems places on surgical training. Bringing this lens to the next wave of development in surgical technology – such as Google’s joint venture on robotic surgery with Johnson & Johnson – shouldn’t take much additional effort, and could extend the benefits of minimally invasive surgery to many more at decreased cost.

References

[1] Agarwal, Piyush K., Jesse Sammon, Akshay Bhandari, Ali Dabaja, Mireya Diaz, Stacey Dusik-Fenton, Ramgopal Satyanarayana, Andrea Simone, Quoc-Dien Trinh, and Brad Baize. 2011. “Safety Profile of Robot-Assisted Radical Prostatectomy: A Standardized Report of Complications in 3317 Patients.” European Urology 59 (5): 684–98.

[2] Chang, Steven L., Adam S. Kibel, James D. Brooks, and Benjamin I. Chung. 2014. “The Impact of Robotic Surgery on the Surgical Management of Prostate Cancer in the USA.” BJU International, September, n/a – n/a. doi:10.1111/bju.12850.

[3] Sammon, Jesse D., Firas Abdollah, Dane E. Klett, Daniel Pucheril, Akshay Sood, Quoc-Dien Trinh, and Mani Menon. 2015. “The Diminishing Returns of Robotic Diffusion: Complications Following Robot-Assisted Radical Prostatectomy.” BJU International, March, n/a – n/a. doi:10.1111/bju.13111.

[4] Trinh, Quoc-Dien, Jesse Sammon, Maxine Sun, Praful Ravi, Khurshid R Ghani, Marco Bianchi, Wooju Jeong, et al. 2012. “Perioperative Outcomes of Robot-Assisted Radical Prostatectomy Compared with Open Radical Prostatectomy: Results from the Nationwide Inpatient Sample.” European Urology 61 (4): 679–85. doi:10.1016/j.eururo.2011.12.027.

Proof of the success of their efforts came the other day when they won a $430 million contract from the U.S. Department of Defense. It’s a five-year deal to supply da Vinci robots, tools and spares to Army, Navy, Air Force and Marine Corps hospitals.

The DoD contract comes shortly after the company successfully received FDA approval for two of its new surgical systems last year – the da Vinci Xi, a gantry-style upgrade to their basic system that includes a higher definition vision system, better consoles and controls (and in some cases two sets of controls and consoles) and a general upgrade of everything else, and the new da Vinci SP (single port) system. The SP system squeezes a 3D high-def camera and three fully articulating instruments through its 25 mm cannula (single thin tube containing the arms and end-of-arm tools; the tube goes through a single hole in the body).

Intuitive’s 2014 revenue was $2.1 billion and the number of procedures performed using da vinci products grew 9% year over year to almost 600,000. Quoting from Intuitive’s Annual Report about 2015:

“In 2015, our focus will be on accomplishing the following objectives: First, we will focus on the expanded use of da Vinci in general surgery, particularly colorectal surgery and hernia repair. Second, we will work to complete our launch and new product introductions of the da Vinci Xi Surgical System in key markets globally. Third, we will continue to develop our organizational capabilities and markets in Europe and Asia. Finally, we plan to build da Vinci SP prototypes that are compatible with our da Vinci Xi system and initiate customer evaluations.”

 

In spite of this success, or perhaps because of it, Google and Johnson & Johnson announced a collaboration to produce a competing line of products to use robots to assist surgeons. The announcement of this strategic pooling of resources didn’t include a price tag or investment amount.

According to the San Jose Mercury News, “Google stressed that the life sciences team at Google X will only be providing software and sensors for the proposed systems, with J&J’s Ethicon unithandling the rest of work. The Mountain View company’s robotics arm – Google acquired robotics firm Boston Dynamics in late 2013 – will not be involved.”

“We think we can use some of our machine vision and image analysis software to help surgeons see better as they operate (e.g. to highlight blood vessels) or make it easier for them to see information that’s relevant to the surgery at just the right time,” a Google spokeswoman said.

An Intuitive Surgical spokeswoman said that the effort by Google and Ethicon was a validation of Intuitive Surgical’s work.

“This announcement is just the latest confirmation that computer-assisted surgery continues to grow to the point that others can no longer sit on the sidelines. Computer-assisted surgery will continue to flourish around the globe and competitors have been expected.”

“A feature of the slave robot is, it’s powered entirely by air. Nearly all conventional robots are electrically powered, but by driving this robot pneumatically, we’ve made it possible to gently absorb the force when the robot touches something. The force on the tip of the robot is estimated from the air pressure data, and that information is sent to the surgeon’s master robot. So, it can be fed back to the surgeon’s hand. Alternatively, a large force can be produced by a very lightweight, compact unit. An advantage of this system is, the robot overall can be made extremely compact.”

“Here, the user is operating the master robot. This demonstration enables you to experience, for example, how you can feel the reaction force when you pull the rubber band.”

“Of course, you can eliminate shaking of the hand, change the motion ratio, and change the force feedback factor. So, depending on the medical staff and the situation, the parameters can be varied, to make the system easier to use on the spot.”

“Currently, we aim to build this system for one-third to one-tenth the cost of the da Vinci surgical system. So, we think we can make it better in terms of cost as well.”

“Right now, we’re working with surgeons, who are actually using this system and giving us feedback on how to improve it. We’re receiving support from MEXT, and we aim to achieve a practical version within 4 to 5 years.”

Often funding sources – the groups taking the risk – are not the beneficiaries of the rewards of the venture. Intuitive Surgical is an example.

NSF, DARPA and NASA funded a project to solve a very real problem: providing medical attention to Americans in remote places such as space, war or scientific expeditions. The initial concept was to be a telepresence project but with no known solution. That was the high-risk research project funded by the three agencies.

During the development phase, two enterprising team members, Frederic Moll and Robert Younge, concluded that true remote-presence surgery couldn’t be achieved with then-current technology but could be achieved within a controlled network,and by so doing there would be many benefits to the surgeons and patients involved. The two wrote a business plan, got venture money and proceeded to develop the system now known as the da Vinci Surgical System within a company subsequently named www.

Shortly before going public, and before getting FDA approval, Intuitive Surgical was sued for patent infringement by Computer Motion, Inc., which had its own system, the ZEUS Robotic Surgical System – a system which was already approved for use in Europe.

The litigation was resolved in 2003 when the two companies agreed to merge, thus ending the litigation. The ZEUS system was ultimately phased out in favor of the da Vinci system. The litigation created an active depository of intellectual properties – hundreds of patents and trade marks – that Intuitive Surgical has vigorously defended in a way that has created a competitive void in the commercialization of similar devices and systems.

Consequently Intuitive Surgical has grown to be a growth company with large profits and is listed on the NASDAQ stock exchange (NASDAQ:ISRG). But it didn’t exactly happen with the high-risk / high-reward formula. Intuitive Surgical and it’s VC backers got the reward and NSF, DARPA and NASA are still searching for their solution.

SRI and Stanford University did get money for licenses to use the technologies they developed, but not the huge rewards stemming from the successes of Intuitive Surgical.

As is often the case in startups, the solutions and products that finally emerge in the marketplace are ones that are different from those that initiated the startup. Sometimes this involves changes in funders, partners and ownership and those that reap the final rewards are often removed from the originating project.

High risk takers are most often governmental agencies with a strategic social/political issue to resolve. Corporate R&D departments also invest in future scenarios but to a lesser extent – they most often pragmatically acquire the technology they need and rework it to fit their specific requirements.

Hence the dilemma: does the initial risk taker expect to get the double reward of (1) product solution and (2) profits from their sale, or just the altruistic reward of seeing that their initial problem, for which they are risking their money, is being addressed in the broader marketplace solving the original problem, reward or not?

VGo Communications wins infringement lawsuit brought on by InTouch Health and also initiates a patent reexamination of four other InTouch patents.

InTouch Health, a company that has been providing remote presence services to the medical community for the past decade contacted VGo and suggested that they agree to a licensing agreement of InTouch patents. A suit followed and, in a Los Angeles Federal District courtroom yesterday, a jury found that VGo Communications did not infringe.

VGo requested that the US Patent Office re-examine four patents held by InTouch. VGo provided supporting documents on why those patents were invalid. To date, the US Patent Office has ruled on three of the re-examination requests and has rejected all of the claims within those patents previously granted to InTouch. The fourth patent is still in the re-examination process. This is just the beginning of what appears to be an ongoing round of claims and counter claims and appeals leading off to a decision – instead of by a jury – by patent experts at the Appeals Court.

In rhetoric typical of the best political spin doctor, Peter Vicars, CEO of VGo Communication said, “InTouch Health has been taking advantage of an overworked patent system in order to secure invalid patents that they then use to bleed competitors with frivolous lawsuits. New companies are producing competitive products at prices significantly less than what InTouch charges so InTouch is using teams of lawyers to maintain their exorbitant prices.”

Rhetoric aside, VGo’s low-cost two-way audio video communications combined with remote controlled mobility enables nurses, doctors and social workers to check on patients without having to be physically present. They feel better cared for and appreciate the extra effort. Recovery times are quicker and re-admissions are reduced. More time for the healthcare worker and lower costs for the healthcare organization.

The entry into the healthcare marketplace by VGo – a marketplace nurtured and developed by InTouch over the past decade – appears to be the root cause of the suit. InTouch trail-blazed the products, the FDA clearances, the marketplace and they want to protect their turf.

At a recent conference on remote presence telemedicine the most enlightening thing I saw was four hours of tightly-packed presentations by critical care doctors and hospital administrators, all users of InTouch Health’s remote presence robots, all portraying different aspects of why remote presence in health care is relevant, is saving lives and is necessary today and why it will continue to be in the future. InTouch has created a market that didn’t exist with products that weren’t being used in the way they are now. Certainly on a personal note one would think that there is room for more companies to assist in this very noble work.

But this is where patents kick in to protect that investment in market and product development which InTouch did. In fact, patents protect the holder for 17 years. Thus the courts decision is a bigger subject than just InTouch vs. VGo.

There has been a lot of gossip and more serious discussion within the healthcare devices industry about patents, their use in marketing strategy, their hindering product development, and their true value as intellectual property (IP).

Within the robotics healthcare community, much of that gossip has been focused on Intuitive Surgical and their da Vinci Surgical System. From the beginning, when Intuitive spun out from Stanford and SRI, they immediately had a legal battle with Computer Motion, the inventor of a similar system called Zeus. Since that time Intuitive has regularly contacted competitors to either get them to cease operations or license their patents. Many felt that this thwarted development of competing or better systems than the da Vinci. They have suggested that Intuitive Surgical has made a strategy of amassing large numbers of patents to try to protect their product and market share.

This is the essence of the arguments that people have used against Intuitive Surgical for the past 10 years. Except that no company has asked the Patent Office to reexamine their patents… yet.

In their suit with Computer Motion a decade ago, Intuitive won. But shortly thereafter, Computer Motion won their counter-suit. Stalemate. The two companies met outside of court and agreed to merge, shut down the Zeus operation, pay off the owners of Computer Motion with a small cash amount and 30% of Intuitive Surgical stock – a company that today has a net work of close to $21 billion. Thus the consequences of these patent battles are significant.

Yulan Wang, the founder of Computer Motion, moved on after the acquisition [of Computer Motion by Intuitive Surgical] to found InTouch Health, the very same company that just lost their battle with VGo.

New systems have proliferated in remote presence and robotic-assisted non-invasive surgeries but, in the case of surgical systems, none have yet to make it to market. RAVEN and SPRINT are two such systems presently in the news with reviews indicating that they are viable competitors to the da Vinci system.

The Raven operating system is helping the open-source community advance the state of the art in surgical robotics. In a joint venture between the University of Washington and UC Santa Cruz, the National Science Foundation funded the development of seven identical Raven II surgical robots. Each system has a two-armed surgical robot, a guiding video camera, and a surgeon-interface system built on top of ROS.These surgical robots are linked via the Internet so researchers can easily share new surgical robotics research and developments. Five Raven II robots have been given to major medical facilities at Harvard University, Johns Hopkins University, the University of Nebraska, UC Berkeley, and UCLA.

“SPRINT” is an EU-developed master-slave teleoperated robotic platform designed for bimanual interventions by means of a single access port. The system is composed by two main arms, a stereoscopic-camera, and additional devices, e.g. retractor or other assistive instruments that can be inserted through a central tube left free in the access port after the introduction. The surgeon console is composed of two master manipulators, a foot-switch and a 3D full-HD display.

Single-port surgical system by Intuitive Surgical.

Intuitive Surgical has recently announced their single-port surgical system, a competing concept to the SPRINT system. One can see another patent battle coming.

In the early years of automobile development, a group owned the rights to a two-cycle gasoline engine patent. By controlling this patent, they were able to monopolize the industry and force car manufacturers to adhere to their demands or risk a lawsuit. In 1911, independent automaker Henry Ford won a challenge to the patent. The result was that the patent became virtually worthless and a new association – which would eventually become the Motor Vehicle Manufacturers Association – was formed. The new association instituted a cross-licensing agreement among all U.S. auto manufacturers: although each company would develop technology and file patents, those patents were shared openly and without the exchange of money between all the manufacturers. By the time the U.S. entered WWII, 92 Ford patents and 515 patents from other companies were being shared between these manufacturers, without any exchange of money – or lawsuits. The best braking system was shared by all as was the best window wiper, and many, many other inventions passed freely from one car company to the others.

If something like this were to happen in the medical robotics arena, these wonderful new inventions would be available all over the world and patients, care-givers and healthcare systems would all share in the benefits and lives saved.

Perhaps there will be a time in the near future when new products like RAVEN and SPRINT will have a similar success as did VGo – maybe even without the costs and resources diverted from product development to fighting court cases.

Nevertheless, InTouch Health today filed an appeal of the verdict and also the patent reexaminations.