RAS devices, also known as computer-assisted surgical devices, are used by trained physicians in an operating room environment for laparoscopic surgical procedures in general surgery, cardiac, colorectal, gynecologic, head and neck, thoracic, and urologic surgical procedures. These medical devices enable the surgeon to use computer, software, and robotic technologies to control and move surgical instruments through the mouth or through one or more small incisions in the patient's body for a variety of surgical procedures. Some common procedures that may involve RAS devices include gallbladder, uterus, or prostate removal.
Surgical Robotics Market
Intuitive Surgical is currently a market leader in surgical robotics. Their da Vinci surgery system is a relatively new technology that competes with established and emerging treatment options including: conventional Minimally Invasive Surgeries (MIS), open surgery, interventional approaches, or pharmacological regimens in both disease management and reconstructive medical procedures.
Robotic surgery market has sharply gained in profile in recent years in Japan. Robotic surgery frontrunner Intuitive Surgical’s daVinci System was first imported into Japan in 1999.
Robotics Assisted Orthopedic Surgeries
Robotic-assisted surgery in orthopedicsis believed to have the ability to transform the orthopedic surgery through potential benefits including improved positioning, alignment, and miniaturization. However, the clinical and economics have not yet been well established as Robotic surgery market is still considered to be relatively new and can be costly capital expenditures. In December 2013, Stryker acquired orthopedic robotic surgery company MAKO Surgical. MAKO Surgical was founded in 2004 and was the first company to make headway in the field of orthopedic robotic surgery. MAKO markets the RIO Robotic-Arm system, which utilizes a mix of the company’s pre-operative and intra-operative planning systems, visualization technology, and robotic-arm systems as well the company's proprietary implants in total hip arthroplasty and partial knee resurfacing.
Emerging Players and New Entrants
In March 2015, J&J and Verily (Google) established a joint venture surgical solutions platform called Verb Surgical to develop leading-edge robotic capabilities and best-in-class medical device technology to improve efficiency, patient outcomes and improve access to minimally invasive surgery.
From a tactical standpoint, Verb will likely seek to build up the installed base by leveraging J&J’s sizeable presence in the surgery market. In addition, given the open nature of the platform Verb is building, the company plans to work with other companies down the path. The company’s long-term goal is to reduce limitations that currently prevent a surgeon from using a robotics platform.
In Feb 2016, Titan Medical, a Canadian MedTech firm unveiled its SPORT (Single Port Orifice Robotic Technology) surgical robot. The device is similar to the da Vinci system from Intuitive Surgical in that it provides 3D visualization and intuitive finger controls.
TransEnterix is also making inroads in to the surgical robotic system. The company acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company in a deal valued $100 million in September 2015. SOFAR has developed the TELELAP ALF-X advanced robotic system which has received the European CE Mark.Medtronic/Covidien is reported to be working on a surgical robotic device as well.
In Japan, Hogy Medical, Olympus,HOYA, Kawasaki Heavy and Sysmex are investing on surgical robotics. Panasonic announced to start nursing robotics business in September 2014. While Honda is developing a nursing robotics for walking assistance using Honda's technology from ASIMO, Toyota is working to launch walking and balancing assisting robotics in the near future. Toyota currently provides testing robots to 20 institutions for clinical trials since fall 2014.
RAS devices have come under scrutiny in the past by FDA. In 2013, the FDA sent a 12-question survey to ten hospitals using its MedSun network asking questions about the types of RAS surgeries that were being performed. The agency noted at least 70 cases of adverse events had been recorded between 2009 and 2013 and found that surgeons’ training protocols may be to blame. Payers and providers have also questioned whether RAS procedures offer any additional benefit over non-robotic procedures. Generally, CMS and other payers consider RAS devices as being “incidental” to the primary procedures and RAS procedures are usually covered since they aren’t paid more than what providers get for non-robotic assisted procedures. However, if questions are raised about the safety or appropriateness of RAS procedures, payers can issue policies. Apparently some payers do have RAS policies in place.
The robotics technology is relatively new and there are several clinical and scientific challenges associated with regulation of RAS devices, such as appropriate nonclinical and clinical evaluation of RAS devices, use of third-party surgical instruments with legally marketed RAS devices, and clinical training programs.
Today’s robots can be very costly, machine are priced greater than $2.5 million. In terms of value, taking into account both quality and costs, robotic surgery may be considered economically unjustifiable for most general surgery applications.
Based on feedback from surgeons, the next robotic systems must improve on cost and efficiency. In essence, the objective is to eliminate the barriers to adoption and allow the surgeon to always be in a position to use a robotic system if needed. Next generation technologies that are likely to become features of future robotic surgery industry include the addition of automation, navigation, sensory data (haptic feedback), advanced visualization technologies, and algorithmic software that can seamlessly integrate all these developments. The potential advantages of robotics justify further evaluation and application of computer assisted technology in the operating room.
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