Robotic Surgery: History, Innovation, and Public Perception

Introduction

The NIH (2014) defines robotic surgery as "a method to perform surgery using very small tools attached to a robotic arm," wherein the surgeon operates the robot. Robotic surgery was developed to enable the performance of surgical procedures through smaller incisions than open surgery. The robot is capable of smaller, more precise movements than would be possible with a human arm, and it is much easier for the surgeon to work with the surgical tools than would be possible with, for example, an endoscope. The NIH notes that robotic surgery is used for an increasing range of procedures, including coronary artery bypass, cancer excision, gallbladder removal, hip replacement, hysterectomy, kidney transplants, and pyloroplasty (NIH, 2014).

The minimal invasiveness of robotic surgery means that there is lower risk to the patient during the procedure and that post-surgery healing time is shorter and less risky as well. In particular, with less of the body exposed, there is a lower risk of infection. With the surgeon able to operate with greater precision, there is less risk of internal damage. With minimal scarring, faster recovery time, and less trauma to the body, robotic surgery has become popular with both physicians and patients alike (NYU, 2012).

Inception Period

The basic structure of surgical robots today is the arm-and-hand model. The precursor to this model originated in the industrial world, where robotics have been used in manufacturing for several decades, performing simple tasks. In many instances, the robot evolved from basic machines that carried out routine operations. Over time, machines were able to handle increasingly complex tasks, particularly with the development of sensor technology. As the term robot was originally introduced to describe a synthetic person by Czech playwright Karel Čapek in 1920, there are specific anthropomorphic connotations to the word (Lanfranco et al., 2004). Thus, a machine would not necessarily be considered a robot unless it had some human or animal characteristics, or could operate independently. While a modern surgical robot is a human-guided tool, its anthropomorphic nature justifies the use of the term to distinguish it from other surgical instruments.

Robotic arms were used in industry — even on space shuttles — long before their application was extended to medicine. Industrial robots are capable of highly precise movements, repeated at high speed, but there are considerable differences between industrial and surgical applications that needed to be resolved before robotic surgery could become normalized in medicine. Lanfranco (2004) notes that the "technical and mechanical nature of the equipment" is a barrier. Whereas precision is achievable on an assembly line where movements are highly routinized, surgery requires dealing with a different body each time. The subtleties of recognizing different internal anatomical structures present a level of nuance and challenge far beyond what a pallet-stacking robot might encounter in the course of its duties.

The challenges of working inside the human body therefore require a human presence. There are many issues that arise from the need for human intervention in the robotic surgery process. Even with the most sensitive instruments, there is a loss of haptic feedback — both force and tactile — that lowers sensitivity for the operator. Furthermore, the use of monitors demands a very high level of hand-eye coordination, more so than even conventional surgery. The instrument must also be moved in the opposite direction to the desired target, further compounding the hand-eye coordination challenges inherent in operating robotic surgery equipment. There are also range-of-motion issues, as the instruments are more rigid than a human hand. While some of the challenges identified by Lanfranco in 2004 have been overcome to some extent, many remain today, limiting the instances where robotic tools are appropriate even in laparoscopic surgery.

Nevertheless, the use of robots in medicine has long been attractive. The first work with robots in surgery involved the Puma 560 in 1985, which was used to perform neurosurgical biopsies with superior precision compared to existing manual techniques (Kim et al., 2002). The Puma 560 was later used in other applications as well, and the promise shown by this early robot led to investment in further development. At this point the field was nascent, and the Puma 560 was used in non-laparoscopic surgery.

Development Period

The use of the Puma 560 in transurethral resection of the prostate was promising, but the device was not purpose-built. The PROBOT was therefore developed specifically to perform this procedure, ushering in the era of purpose-built machines fine-tuned to the specifications of a particular operation. The promise shown by early efforts like the Puma encouraged engineers to engage in greater development of medical applications. At this time, the medical field was largely adapting existing technology to its own needs. Integrated Surgical Supplies in Sacramento developed ROBODOC for hip replacement surgery, and this was the first robotic surgery device to receive FDA approval (Lanfranco, 2004).

The ROBODOC had to navigate the standard FDA approval system for medical devices. This process was established in the 1970s, before robotic medical devices existed. A robotic surgical device would be classified as a Class III device — the highest risk category — and therefore would face the highest level of regulatory burden. ROBODOC's approval took far longer than expected because the patent owners went bankrupt before the process could be completed. As a result, there has been considerable debate in the medical community about the approvals process for medical devices, with many arguing that the development of robotic surgery devices has been hampered by the burdensome nature of regulation. The counterargument is that surgical devices should be held to high standards, since the cost to patients of device failure is likely to be catastrophic (Curfman & Redberg, 2011).

The ROBODOC functioned essentially as a workstation and operated in several stages. In the first stage, the orthopaedic surgeon uses the device to examine the bone — an area in which ROBODOC proved to excel. A pre-operative plan is then developed with the device's assistance, after which the ROBODOC is used by the surgeon to perform the actual operation. The device was tested on more than 850 patients at approximately half a dozen hospitals by the mid-1990s, at which point it had still not completed the FDA approvals process (Pransky, 1997).

The next wave of development in robotic surgery sought to address the mechanical constraints limiting what surgical robots could accomplish. In particular, mechanical motion limitations and low haptic feedback sensitivity were identified as issues that needed to be resolved to advance robotic surgery in laparoscopic applications (Davies et al., 1997).

A further issue in the development of robotic surgery by the late 1990s and early 2000s was training. Because so few devices had received FDA approval at that point, their use was not widespread, and training on these devices was similarly limited. Given the need for exceptional spatial reasoning and hand-eye coordination, the learning curve for most robotic surgery applications is steep. A study in 2002 showed that just 14% of residents were receiving any training in robotic surgery, despite much greater interest among these residents in laparoscopic surgery. More encouragingly, 23% of directors of medical programs indicated that they were seeking to institute robotic surgery training programs (Donias et al., 2002). For the most part, however, the development of such training at the medical school level — and, to a lesser extent, the training hospital level — remained nascent, despite the growing popularity of the field among physicians, insurers, and patients.

It should be noted that the FDA does not regulate the training or practice of medicine, and with robotic surgery systems training is just as important as the device itself. The fact that so few physicians were learning robotic surgery during their medical school training is a cause for concern and will stunt the adoption of the technology in the field. The absence of standardized training can result in dramatic variation in physician skill when using robotic surgery equipment, and it gives rise to the necessity for manufacturers to develop their own standardized training and certification programs to ensure that quality standards are maintained. Such training would also serve to minimize malpractice risk, providing clear incentive for the industry to support such programs.

By the early 2000s, the focus of robotic surgery had shifted to laparoscopic applications. The future of the field was understood to depend on smaller devices with greater tactile sensitivity and more refined movements (Camarillo, Krummel & Salisbury, 2004). Development over the following decade continued to be based on the arm-and-hand anthropomorphic model, with surgeons controlling the device, but with progressively smaller robots seeking to build on the advantages offered by the technique — minimizing trauma, enabling faster healing, and eventually making possible more refined surgical interventions. In recent years, robotic surgery has been approved for use in children and adolescents, highlighting that regulatory authorities are becoming more comfortable with the technology (Nakib et al., 2013).

During this stage of development, it should be noted that opinion within the medical profession has not been universally positive with respect to robotic surgery. Some critics have argued that empirical evidence does not conclusively demonstrate that robots produce better outcomes (Nakib et al., 2013). Others have contended that the costs associated with robotic surgery — robots are expensive to develop, which can translate into higher costs for patients — and the associated health risks do not necessarily outweigh its benefits (Paul & Sedrakyan, 2013). It is worth, however, putting such arguments into context. The first surgical robot was developed in 1985, and the first FDA approval did not come until the late 1990s. The field is, for commercial purposes, only about 15 years old. Commercial air travel, at a comparable stage of technological development, was not yet feasible either — early mail planes required dozens of stops to travel from the west coast to Chicago. The point is that technology develops. If robotic surgery today offers minimal advantage over conventional techniques, there seems little doubt that in ten or twenty years it will represent a dramatically superior technology.

Conclusion

Robotic surgery is a technique that remains in its infancy. First developed in the 1980s on the basis of industrial robot technology, it is only in the past 15–20 years that robotic surgery innovation has focused on laparoscopic surgery, which is touted as one of the main benefits of the approach.

The medical profession remains divided on the merits of robotic surgery. Its use has increased, driven in part by what some perceive as the overselling of its benefits and by insurers attracted by the promise of lower cost and lower risk. The medical evidence is inconclusive as to its advantages over conventional techniques, though this is typically the case during the early stages of transformative innovations — as the first 15 years of airplanes, automobiles, and computers all amply illustrate. Despite objections from many quarters, robotic surgery has received FDA approval across a range of applications, and ongoing efforts are being made to address the technique's current limitations. In time, robotic surgery will deliver the promised improvements in outcomes, and at that point it is likely that both public and medical perceptions will shift accordingly.