Robot Assisted Surgery Gaining Momentum and Scrutiny

These days, it is common to find surgical robots touted within the marketing collateral of hospitals and health centers. At the same time, there is also a sharp increase in the number of lawsuits against surgical robot makers, especially in the United States.

Featured on the National Geographic video “The Robotics Revolution” in 1985, Anthrobot was the first robot to assist in surgery. Within a year of its introduction in 1984, the robot was used to perform more than 60 orthopedic surgical procedures. Later, in the 1990s, PROBOT, developed at Imperial College London, became the first surgical robot in the world to perform pure robotic surgery, while ROBODOC, a robotic system designed to assist hip replacement surgeries, became the first surgical robot to receive approval from the U.S. Food and Drug Administration (FDA). During the same period, SRI International was working on a prototype robotic surgical system called the SRI System for which intellectual property rights were acquired by Intuitive Surgical. The refined version of the prototype became the flagship product of Intuitive Surgical known as the da Vinci robotic surgical system.

A New World of Procedures

A recently concluded robot-assisted surgery made history when Dr. Robert MacLaren, Professor of Ophthalmology at the University of Oxford, and his team performed the world’s first robot-assisted intraocular surgery by successfully peeling off a 1/1,000th-millimeter membrane from the inside of a patient’s eye. The removal of the membrane was an extremely delicate task. If the procedure had to be done by human hands without the help of a robot, it would have required the surgeon to slow down their own body pulse rate and time their hand movements according to their heartbeat while performing the surgery. The robot used for the surgery was the Robotic Retinal Dissection Device (R2D2) from Dutch medical robotics firm Preceyes BV, which can perform laparoscopic surgery, also called minimally invasive surgery (MIS), band aid surgery, or keyhole surgery. Due to benefits such as smaller incisions, fewer chances of infection, and shorter stays in the hospital, laparoscopic surgery is very popular among surgeons, patients, and insurance companies across the world.

According to Dr. MacLaren, “Current technology with laser scanners and microscopes allows us to monitor retinal diseases at the microscopic level, but the things we see are beyond the physiological limit of what the human hand can operate on. With a robotic system, we open up a whole new chapter of eye operations that currently cannot be performed.”

The Need for Standardized Evaluation

These days, it is common to find surgical robots touted within the marketing collateral of hospitals and health centers. According to many well-known doctors, there is an ongoing arms race among hospitals of different sizes and specialties in an attempt to attract new patients and to gain an edge over the others by dropping the name of surgical robots without enough successful clinical trials to back up the hype. Most hospitals are focused on getting quick returns on investment from robots that come with price tags of more than $1.5 million, along with extremely high annual maintenance costs. The “wow” factor related to having surgical robotics may be of little actual benefit to hospitals and could lead to very high expectations of the robotic systems, which still need rigorous and standardized evaluation. Research work carried out at the University of Illinois at Urbana-Champaign, the Massachusetts Institute of Technology (MIT), and Chicago’s Rush University Medical Center reported 144 deaths, 1,391 injuries, and 8,061 device malfunctions out of a total of more than 1.7 million robotic procedures performed between January 2000 and December 2013. There is also a sharp increase in the number of lawsuits against surgical robot makers, especially in the United States. According to Bloomberg, the most prominent market player, Intuitive Surgical, is fighting 86 lawsuits in 22 states after setting aside approximately $100 million to resolve an unspecified number of claims from 2014 through early 2016.

Cost-Effectively Spearheading Surgical Evolution

Since 2000, the list of surgical procedures performed with the assistance of a robot device has been growing at a consistent pace. According to the data made available by Intuitive Surgical, only 1,000 da Vinci robotic surgeries were performed worldwide in 2000, but that number surged to 652,000 procedures in 2015. Apart from Intuitive Surgical, there are a few more players in the market, including Preceyes, Medtronic, Stryker, Mazor Robotics, TransEnterix, Titan Medical, MedRobotics, Virtual Incision, and the highly ambitious Verb Surgical, which is the offspring of the strategic partnership between Ethicon, a medical devices subsidiary of Johnson & Johnson, and Verily Life Sciences, formerly Google Life Sciences. The robotic surgery market is full of opportunities, as well obstacles, but it also gives rise to several critical questions concerning cost, liability in case of failure, training and performance of surgeons, etc. The most important of all is to see how these expensive surgical robots, currently so popular for marketing hospitals and health centers worldwide, can transform into economical and effective devices to spearhead surgical evolution.

According to Beth Israel Deaconess Medical Center Chief Executive Paul Levy, “Technologies are being adopted and becoming widespread based on the marketing prowess of equipment makers and suppliers, not necessarily on the public good.”

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