As part of medicine’s unending push for improved speed, precision, and outcomes, the last few decades of medical progress have involved increasingly broader application of robotics. From the first robotic surgery 30 years ago—placement of a probe for a CT-guided brain biopsy using a Unimation PUMA 200 robot—surgical robotics has evolved at an exponential pace. There were 1,000 robotic surgeries in the world in 2000. By 2011, this number had risen to 360,000, and to 570,000 by 2014.

The use of robots to conduct surgery can provide high-definition three-dimensional visualization, enhanced dexterity, and greater precision and control for surgeons. However, set-up times often make robotic procedures lengthier than their conventional counterparts. This poses a conflict for healthcare providers, as less procedures can be carried out, and has made the health economics case for surgical robotics a difficult one to argue. In addition, some studies have reported greater complication rates and higher costs associated with the use of robotic surgery. What’s even more concerning is that we still lack an industry standard for the training and credentialing of physicians to use a surgical robot even though it has been years since the FDA first approved Intuitive Surgical Inc.’s Da Vinci robot (which now dominates the robotic surgery industry in spite of an average cost of $1.5 million per unit).

Despite these concerns, research in and funding for surgical robotics continues unabated. Most recently, Auris Surgical Robotics Inc., the developer of a robotic system for eye surgery, finished raising nearly $185 million in two rounds of financing. Auris is led by Frederic Moll, the father of medical robotics and the founder of Intuitive Surgical, Hansen Medical Inc. (a major designer and manufacturer of medical robotics for positioning and control of catheter-based technologies), and other robotic corporations.

The financing stems from Auris’ 2013 announcement of a collaboration with BIOLASE, Inc. to integrate the latter’s WaterLase laser technology into a robotic microsurgical system for cataract removal. WaterLase technology is purported to offer improved cutting precision and system compatibility as well as a lack of tissue trauma. This should have major advantages over traditional phacoemulsification and should create a new standard for safety, speed, and effectiveness in cataract removal.

While this major funding and research commitment towards advances in robotic microsurgery may be a major step for medicine, it has brought on a new wave of criticisms in light of several lawsuits still pending against Intuitive Surgical and other manufacturers of robots used in medical procedures. In particular, patients have alleged burn injuries caused by electricity leaking out from microscopic cracks that developed in the protective covers insulating some of the Da Vinci robot’s tools. Such injury can also increase the risk of negative surgical outcomes, including bowel perforation.

As in most surgery malpractice suits, the plaintiffs must establish that the surgeon’s actions were at odds with the standards accepted by the medical community in order to prove that the surgeon breached the duty of care to the patient. Similarly, medical device manufacturers have a duty of care to the purchaser and anyone else that might predictably come into contact with their device.

As such, we must ask whether robotic surgery truly warrants continued funding and research, or whether the increasing use of robots in medicine is due to society’s propensity to embrace innovations without sufficient rigorous, standardized evaluation. In addition, are hospitals and surgeons simply attempting to attract new patients by offering the latest technology? In any case, can robot manufacturers improve their products to the point of removing any doubt about the outcomes and cost advantages of robotic surgery over conventional surgery? And if so, will this create a push for fully automated surgeries that remove the need for direct human physician supervision or control?

Neil Issar

 

Comments are closed.