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Roger Smith, CTO, Florida Hospital Nicholson Center, explains how the field of surgical robotics is about to face a miniature version of the dot.com boom of internet companies.
In September of 2001, Dr. Jacques Marescaux performed the world’s first transatlantic robotic telesurgery using the Zeus robotic system created by Computer Motion with funding from DARPA.1 The government’s attempts to deliver world-class surgical skills to battlefield injured soldiers via telesurgery had led to the creation and maturation of all of the technological pieces needed to launch a new medical device industry - the surgical robot. From the roots of the Zeus sprung the immensely successful da Vinci robot from Intuitive Surgical Inc. and the beginnings of a global transformation in the practice of surgery.
Nearly twenty years later, the da Vinci family of surgical robots remains the most prominent surgical device in this category. Hospitals and surgeons around the world have adopted the device and will perform more than one million procedures with it in 2018.2 Today the public at large is generally aware of the existence and use of this one specific device, though they are not aware that multiple other robotic platforms are in use as well. As we come to the close of the second decade of the 21st century there are at least a dozen robotic devices being used to advance the practice of surgery, most of these on a much smaller scale than the da Vinci, though they bring technological advances that are just as significant.
In spinal surgery the Mazor X and Globus Excelsius are used to correct scoliosis, fuse vertebrae, and insert spinal spacers. Hip and knee replacement surgeries are performed with the Stryker Mako, Smith & Nephew Navio, and Orthotaxy systems. Transoral and transanal procedures make use of the Medrobotics Flex robot. The TransEnterix SenHance is used to improve the performance of traditional laparoscopic procedures. The Stereotaxis Niobe is used to reach deep into the heart to ablate nerves that are causing arrhythmia. The Neocis YOMI offers robotic assistance with dental implants. Hair transplants are assisted by the ARTAS robot from Restoration Robotics. Robots are under development by Cambridge Consultants and Preceyes to assist with surgery on the retina and the cornea of the eye. Finally, there are multiple providers of motorized laparoscopic instruments that provide small robotic devices that fit into the palm of the surgeon’s hand, the Endocontrol Jaimy, USMI Canady, and Procept BioRobotics ablation tool. Each of these devices occupies a unique niche where they are making important contributions to the delivery of surgical care. They point to a future in which surgeons have the tools to overcome the limitations of their own physiological bodies and deliver a quality of care that leverages the strengths of human expertise, electro-mechanical precision, and computer intelligence.
There are currently nearly two dozen new robotic devices that have been announced in the late R&D or regulatory approval stages. Within five years, these will create a pool of nearly fifty robots available to healthcare systems and surgeons around the world.
What motivates the creation of this entire family of medical devices? How have so many come into healthcare in such a short time? What does the future look like in this field?
The rapid growth of surgical robots has occurred in parallel with the robotization of transportation, warehouses, and customer service. Advances in the miniaturization and efficiency of mechanical components, improved sensors, and the computer algorithms that drive them have allowed solutions to be created with impressive capabilities at affordable prices. Society has come to accept and even request the use of robotics in medical services. Financially there are deep pools of resources available from investors to explore these technologies. The internet billionaires are seeking investments that align with their own technical interests and offer significant future returns. Taken together, all these forces provide the technology, the finances, and the customers necessary to make new surgical robots a growing industry.
Robots in surgery have shown their ability to contribute to a number of improvements in patient care, surgeon capabilities, and hospital operations. First, they improve the fidelity at which a human surgeon can work. With this assistance a surgeon can inspect and view the surgical space at higher magnification and with stereoscopic 3D. He or she can manipulate instruments with more accuracy and at increased depths into the body space. These features return the level of control, access, and visualization that was previously typical of open surgery, but which had been compromised with manual laparoscopic methods and tools. Second, robots can improve the accuracy of the placement of treatment. When removing bone for a knee or hip replacement, computer assisted pre-surgical planning and robotic assisted intra-surgical guidance improves the accuracy of the cuts made to remove bone and the furrowing needed to place implants. These same capabilities are used in spinal surgery to improve the placement of screws in the vertebrae, reducing bone chipping and avoiding the weak anchoring of implants. Third, robots are increasing the safety of the workplace for surgeons and OR teams.
One of the major advantages of the Mazor X and Stereotaxis Niobe is that they allow humans to work outside of the intraoperative X-ray energy fields. This reduces the cumulative career radiation exposure of clinicians which reduces the prevalence of early onset cancer. Also, clinicians who spend less time in the energy field, spend less time burdened by lead vests which reduces the musculoskeletal injuries to their spine, neck, and shoulders that can shorten a professional career. Fourth, robotics allows more surgical procedures to take advantage of minimally invasive approaches which reduce the surgical damage due to cutting muscle, severing nerves, creating blood loss, and exposing tissue to infection. The Medrobotics Flex can enter the throat without requiring any incisions other than at the site of the tumor that is being removed. These changes also reduce the time that patients remain in the hospital, lowering the costs for both patients and insurance providers. Finally, when the entire surgical process is designed around robotic capabilities, it is possible to reduce procedure times and increase the daily throughput of patients. This means that the skills of a talented clinical team are available to a larger number of patients in need of attention.
All of these advantages have contributed to the growth of robotic systems and the breadth of their use in surgery. But these are also counterbalanced by several challenges faced by the healthcare systems that deploy them. The first and most recognized challenge is the cost of the robotic platform itself. The traditional large robotic systems cost between $1.5 and $2 million each. For a healthcare system to make this large capital investment, they must have a significant volume of procedures that can be addressed by the robot and the potential to increase that volume once the robots and the clinical teams are in place. This is a significant hurdle for small hospitals and those in countries with modest healthcare budgets. The second challenge is the expense of the customized instruments that are used by each robot. One instrument may run from $1,500 to $2,500 and a single procedure requires three to six of these. When the instruments are single-use or multiple-use disposable, this directly increases that cost of providing the procedure, costs which generally cannot be passed on to the insurance provider or the patient. This leads to the third challenge, multiple-use disposable and reusable instruments must be processed for sterility following each case. These specialized instruments require specialized training in the sterilization process that will work for them, adding to the labor costs in preparing them for surgery. Specialized training is also necessary for the entire clinical team, which includes the surgeon, first assistant, support nurse, surgical technician, and circulating nurse. When there was just one robot in popular use, this specialized expertise created one cohort of clinicians who could perform robotic cases and another which could not. In a future with multiple very different robotic systems, OR teams will need to be proficient with multiple systems or be divided into system-specific teams that master only a single robot, both of which present significant challenges in staff training and scheduling.
Faced with these kinds of challenges, it is clear that a healthcare system can afford to purchase and integrate a very limited number of these advanced devices into their medical services. The number of robots that can be successfully incorporated into any one specialty is not immediately clear, but it is certainly much less than the dozen that are going to be offered for the most popular procedures in the abdomen, brain, and hip/knees. As these new robotic systems come to market there will be a war of attrition as each demonstrates its advantages over the others. The field of surgical robotics is about to face a miniature version of the dot.com boom of internet companies that occurred in the late 1990’s. A few will become immense successes like Amazon, Google and eBay, while others will follow the path of Pets.com and AltaVista.
When the dust settles there will be multiple very useful robots in daily use, but certainly not every robot that is introduced will succeed. Looking at previous industries with explosive competition like the cellphone and the automobile, one can imagine a scenario in which three dominant platforms control most of the market for a specific application. This is similar to the three operating systems that dominate computers (Windows, Linux, iOS), the leading providers of cellphones (Apple and Samsung), and the original consolidation of American automobile manufacturers (GM, Ford, Chrysler). There is limited space for mass prosperity in highly complex products.
Just as there is now no serious transportation without an automobile and no knowledge work without a computer, there will be no surgery without some form of electro-mechanical augmentation of human capabilities. Today we call those devices robots. The terminology of the future will be more refined and specific, but we will see within it the robotic devices of this decade and the improvements that have come to surgical care because of those devices. The goal of these systems is not automation for its own sake, but a healthcare future at lower cost, with more universal access, using more skilled clinicians, delivering higher levels of quality care, and integrated healthcare delivery across all phases of an encounter. The robots that we know today are just the beginning of a very exciting future. MTM
About the Author
Roger Smith, Ph.D. is currently the Chief Technology Officer for the Florida Hospital Nicholson Center where he is responsible for establishing technology strategy and leading research experiments. He has served as the CTO for the US Army PEO for Simulation, Training and Instrumentation (PEO-STRI); VP and CTO for training systems at Titan Corp; and Vice President of Technology at BTG Inc. He holds a Ph.D. in Computer Science, a Doctorate in Management, an M.S. in Statistics, and a B.S. in Applied Mathematics. He has published three professional textbooks on simulation, 12 book chapters, and over 100 journal and conference papers. His most recent book is A CTO Thinks About Innovation. He has served on the editorial boards of the Transactions on Modeling and Computer Simulation and the Research Technology. Management.
References
1. Jacques Marescaux, Joel Leroy, Michel Gagner, Francesco Rubino, Didier Mutter, Michel Vix, Steven E. Butner & Michelle K. Smith. Transatlantic robot-assisted telesurgery. Nature, volume 413, pages 379–380 (27 September 2001) www.nature.com/articles/35096636
2. Intuitive Surgical Investor Presentation - Q3 2018. (August 2018). https://isrg.intuitive.com/static-files/8bbddc9e-579c-47a1-ac91-fabe26e5e278
Originally published in Issue 4, 2018 of MT Magazine