A consortium of European researchers from the commercial and academic robotics communities has developed a robot designed to help surgeons perform delicate, keyhole neurosurgical procedures. The resulting ROBOCAST system (for ROBOt and sensors integration for Computer-Assisted Surgery and Therapy) promises to enhance surgical planning, provide trajectory targeting beyond the capabilities of human surgeons, and supply surgeons with haptic feedback to improve their performance.
The robotic surgeon’s assistant could eventually be used to help surgeons insert cameras, collect samples of blood and cerebral fluid, remove brain tissue, and provide deep-brain stimulation?all vital procedures in the battle against a wide range of medical conditions, from brain tumors and clinical depression through Tourette syndrome and Parkinson’s disease.
The robot assistant’s modular build consists of a human-computer interface with intelligent context-sensitive communication, a haptic (force feedback) control mechanism, an autonomous trajectory planner, a high-level controller, and a set of field sensors.
ROBOCAST’s control system autonomously provides path planning by analyzing preoperative diagnostic information. It can also update the plan when unforeseen events occur during surgery. The robot is not in control, however. That’s the surgeon’s role, and the surgeon remains free to make changes to the payload’s trajectory during a procedure if he or she wishes to.
Last year, the ROBOCAST team demonstrated ROBOCAST’s capabilities, successfully performing an intervention on a dummy in an actual operating room. However, the robot needs to be further refined and validated before it can be used on humans.
The basic cost for creating a ROBOCAST system is an estimated ?250,000, says project coordinator Giancarlo Ferrigno, a professor in the Neuroengineering and Medical Robotics Laboratory (NearLab) at the Politecnico di Milano University. Biomedical systems are usually sold at four times the production cost, says Ferrigno, so if ROBOCAST were commercially available it would sell for an estimated ?1 million.
Margins such as those, particularly when they arise from a fast-growing industry, the need for whose products can be readily justified, naturally attract considerable commercial interest. And in fact, the participation of commercial robotics entities alongside university-based researchers is mandatory for the success of projects like ROBOCAST, says NearLab’s Elena De Momi, who also worked on the project. ?Commercial participation assures you the project is interesting to and useful for end users. It also means that you have end users involved in the project design. The European Commission wants to see that somebody is taking care of commercializing either the whole product?or part of it?in the end,? says De Momi.
In one example of the assistance provided by commercial robotics companies, the Israeli medical robotics firm Mazor Robotics helped create ROBOCAST’s trajectory management system and has plans to incorporate the robot’s linear actuator in its SpineAssist device.
If the bot gets to market, one of the robots ROBOCAST will have to compete against is French company MedTech’s ROSA, a computer-assisted medical intervention system for neurosurgical procedures. Within a year of its 2009 launch, ROSA had been installed in seven European hospitals, with two North American installations under way. That growth has continued, with MedTech recently completing a ROSA installation in the 400-bed Schön Klinik Vogtareuth, which is part of the Schön Klinik Group, one of the largest owner-managed clinic groups in the German market.
Marketing Strategies and Cost Analysis
Notwithstanding, with government approval taking three to five years, if not longer, getting a medical robot to market remains a challenge. Succeeding in the market once you get there is yet another matter. Medical robots remain extremely big investments for hospitals, with prices of $1 million to $2 million not uncommon for advanced systems.
Meanwhile, some experts question the commercial viability of robot-assisted surgeries. In answer to these critics, De Momi notes that the ROBOCAST system is not designed to save hospitals money, but to increase the accuracy of neurosurgical interventions. ?It’s social costs that you are decreasing, in terms of better outcomes, not the cost of the intervention itself,? she says.
Gabriel Barbash, former Israeli surgeon general and current director general of the Tel-Aviv Sourasky Medical Center, notes that the increased costs associated with robot-assisted surgeries are not justified in many cases. However, neurosurgery may be an exception. ?The most important significant potential contribution of robots in surgery is if the robot is enhancing the decision making or the procedure. When you are talking about neurosurgery, there is a true need for enhancement of the decision making of the surgeon,? says Barbash.
That’s because the complicated nature of neurosurgery?which allows for extremely limited margins of error?drives the need for navigation assistance. ?There is no respected neurosurgery unit in the world that’s not using some navigation means during surgery. This is not the case in robot-assisted surgeries in other places. There they [developers] are talking about technical issues of dexterity and viewing angle. But in my mind these technical issues do not justify the extreme increase in the cost of the procedure,? he continues.
Barbash has been critical of the increased costs associated with robot-assisted surgeries in the past. In a co-authored August 2010 article published in The New England Journal of Medicine, he wrote: ?Doctors and patients often embrace new modes of treatment before their merits and weaknesses are fully understood. These technologies can lead to increases in costs, either because they are simply more expensive than previous treatments or because their introduction leads to an expansion in the types and numbers of patients treated.?
Barbash found that, on average, the additional variable cost of using a robot-assisted procedure was about $1,600, or about 6 percent of the total cost of the procedure. When the amortized cost of the robot itself was included, the additional total cost of using robot-assisted procedures rose to about $3,200, or about 13 percent of the cost of these procedures.
?In general terms, when you are dealing with neurosurgery there is a proven need for supporting technologies to enable a surgeon to do a better job. That is not a cost-effective case in my mind in general surgery or urology,? notes Barbash.
Hospital administrators considering the purchase of medical robots are driven less by outcome research than they are by marketing issues, he continues. ?They are looking at the competition that they have for patients. And they want to work out whether the robot is going to attract more patients or attract more physicians who will in turn attract more patients.?
Adoption of medical robots?and the associated cost impact?is powerfully influenced by the social policy climate in which the robot finds itself.
Cost-oriented environments like those in the United Kingdom, Europe, or Israel, are less inclined to adopt medical robotics. In the United States, however, ?where cost is not as important,? the impact is very different, says Barbash, who compares adoption rates for da Vinci surgical robots in the United States versus the United Kingdom by way of example. ?By the end of 2010, the U.S. had 1,400 da Vinci installations for over 300 million people, while the U.K. had fewer than 30 for more than 50 million people, which shows the difference the environment can make to medical society’s acceptance of expensive technologies.?
The ROBOCAST project received ?3.45 million of its ?4.55 million budget under the European Union’s Seventh Framework Programme’s subprogram for cognitive systems, interaction, and robotics. The consortium is now working on the Active Constraint Technologies for Ill-defined or Volatile Environment (ACTIVE) project, with the aim of developing a robotic neurosurgery system for patients who will remain awake during surgery. ACTIVE has received ?5.78 million in EU funding and is expected to run until 2015.Read More