Frost & Sullivan believes that surgical robots will become a standard of care as early as 2020. However, only 5 to 10 percent of all open surgical procedures were performed by robot-assisted systems in 2016, so the rate of uptake over the next few years will provide a clearer picture of how this market is developing. Here are some advances.
On April 11, 1985, Long Beach Memorial Medical Center in California used an industrial robot (Unimation PUMA 200) to insert a probe for use in a brain biopsy using computed topography navigation. This was the first recorded robotic surgery procedure. Of course, the field has come a long way since then. Robotic surgery, or robot-assisted surgery, allows doctors to perform many types of complex procedures with more precision, flexibility and control than is possible with conventional surgical techniques. A true robotic surgery system uses a camera arm and mechanical arms with surgical instruments attached. A surgeon controls the arms while seated at a computer console.
Frost & Sullivan continues to monitor developments in robotic surgery, and has traced its march forward over the past few decades.
Autonomous Surgical Robots: The First Generation
The evolution of robotic systems has taken a route that is contrary to logic: the early, first-generation robots—some even cleared by the U.S. Food and Drug Administration (FDA)—were autonomous, meaning they could carry out some procedures entirely by themselves without a surgeon’s guidance. Some of these were in fact industrial robots adapted for clinical use. Examples include the 1991 Probot developed at Imperial College London and used for a urological procedure, and the 1992 Selective Compliance Assembly Robot Arm (SCARA) used for a total hip arthroplasty (THA). However, the first surgical application used in humans was with the ROBODOC for THA in 1992; it received FDA clearance in 1998. Two other surgical robots, both based on sound science, were never used clinically: BRIGIT’s price of $100,000 was the reason despite FDA clearance, and VectorBot’s full autonomy was a problem—surgeons wanted robots to be collaborative assistants, not replacements. This gave rise to the second generation of surgical robots that involved the concept of the master and slave.
Robotic-Assisted Surgical Devices: The Second Generation
Yielding to surgeons’ demands, the industry pivoted toward robotic-assisted surgical devices. In the master-slave configuration, the robot (slave) translates the surgeon’s (master) hand, wrist and finger movements.
The surgical team assists at the patient’s side, preparing entry sites and installing instruments as requested by the surgeon. The robotic system has three or four robotic appendages: two or three for instrument manipulation and an endoscope that is equipped with image processing and visual acuity tools that provide surgeons with an enhanced, three-dimensional view of the surgical site. The instruments have seven degrees of motion that mimic the human hand and wrist. The robotic arms enter the patient through a 1- to 2-centimeter opening. The surgeon controls the endoscope, with 360-degree rotation, distal and proximal movement, and zoom capability. The console instrument controls that the surgeon uses emulate scaled-down movements of instruments inside the patient.
Examples of this generation include the Rio from Mako (which was acquired by Stryker in 2013), Hansen’s Sensei, and the pioneer and the most popular of all: Intuitive Surgical’s da Vinci robot. The da Vinci received its first FDA clearance in 2000 and the company realized the unique position it was in. At that stage, its only competition was Computer Motion, Inc. After multiple patent infringement lawsuits against each other, the two companies decided to merge in 2003. Thus, Intuitive Surgical achieved a 100% U.S. market share!
More than 3 million procedures have been performed by more than 3,600 da Vinci systems installed in 64 countries. With several FDA and international market regulatory clearances, its primary clinical uses include urology, gynecology, general surgery and cardiothoracic procedures.
The Need for Third-Generation Devices
Given the high price tags on these systems (the base price of a da Vinci system is upwards of $1 million) and the lack of plausible evidence of a sufficient return on investment for hospitals and health systems, there is criticism and pushback about this technology from some parts of the industry. For example, Dr. John Santa, the former director of the Consumer Reports Health Ratings Center, commented in a 2016 Healthline article: “This is a technology that is costing the health care system hundreds of millions of dollars and has been marketed as a miracle—and it’s not. It’s a fancier way of doing what we’ve always been able to do.” Surgeons also are demanding a better haptic interface. The tactile experience—the sense of touch to “feel” what the robotic arm faces—is also important feedback for a surgeon while carrying out a procedure. Once again, the industry is beginning to pivot to accommodate these demands.
The Road Ahead
Newer market entrants are developing products in three categories:
Overall, Frost & Sullivan believes that surgical robots will become a standard of care as early as 2020. However, only 5 to 10 percent of all open surgical procedures were performed by robot-assisted systems in 2016, so the rate of uptake over the next few years will provide a clearer picture of how this market is developing. Analysts believe these devices have the potential to penetrate as much as 50% of all surgical procedures, making it a highly lucrative market. Will you opt for a robot to operate on you, if the time comes?
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