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 cuts than open surgery.  The robot is capable of smaller, more precise movements that would be possible with a human arm.  It is also much easier for the surgeon to work with the surgical tools than would be possible with, say, an endoscope.  The NIH notes that robotic surgery is used for an increasing range of procedures, including coronary artery bypass, cancer excision, gall bladder 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 course of the surgery, and that the post-surgery healing time is lower, and less risky as well. In particular, with less of the body exposed, there is lower risk of infection.  With the surgeon able to operate with greater precision, there is less risk of damage done internally.  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 was in the industrial world, where robotics have been used in manufacturing for a few decades now, performing simple tasks.  In many instances, the robot evolved from basic machines that were performing routine tasks. Over time, the machines were able to handle increasingly complex tasks, in particular with the development of sensor technology. As the term robot was originally introduced to describe a synthetic people, by Czech playwright  Karel ?apek 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 sort of human or animal characteristics, or could operate independently.  Thus, while a modern surgical robot is a human-guided tool, its anthropomorphic nature justifies the use of the term to distinguish this tool from other surgical tools.

Robotic arms were used in industry, even on space shuttles, long before their use was applied to medicine. Industrial robots are capable of highly precise movements, repeated at high speed, but there are considerable differences between industrial applications 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 possible on an assembly line where the movements are highly routinized, surgery requires dealing with a different body each time, and the differences between bodies, and the subtleties of recognition of different areas inside the body have 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 body, thus, require a human presence.  There are many issues that arise with the need for human intervention in the robotic surgery process.  With even the most sensitive of instruments, there is a loss of haptic feedback (force and tactile) that occurs, lowering sensitivity for the operator. Further, the use of monitors requires  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 enhancing the hand-eye coordination challenges inherent in operating robotic surgery equipment.  There are also range of motion issues, wherein the instruments are more rigid than a human being would be.  While doubtless some of these challenges identified by Lanfranco in 2004 have been overcome to some extent, many remain today, limiting the instances where robots are appropriate, even in laparoscopic surgery.

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

Development Period

The use of Puma 560 in transurethral resection of the prostate was promising, but the...  The PROBOT was therefore developed in order to perform this procedure, a purpose-built machine.  This development ushered in the era of using purpose-built machines, fine-tuned to the specifications needed for a particular procedure, in robotic surgery.  The promise that early efforts like the Puma showed encouraged engineers to engage in more development of medical applications.  At this time, the medical field was largely making use of existing technology, adapting it for its own needs.  Integrated Surgical Supplies  in Sacramento developed ROBODOC for hip replacement surgery, and this was the first robotic surgery device that was granted approval by the FDA (Lanfranco, 2004).
The ROBODOC had to go through the standard FDA approval system for medical devices. The process was instituted in the 1970s, therefore in an era where there were no robotic medical devices.  A robotic surgical device would be a Class III device, the highest risk category, and therefore would have the highest level of regulatory burden.  The ROBODOC's approval took  much longer than it could have because the patent owners would go bankrupt before the approval process could be completed.  As a result, there has been considerably debate in the medical community about the approvals process for medical devices, in that many feel the development of robotic surgery devices has been hampered by the burdensome nature of the regulatory process.  The counter to this is that surgical devices should have high standards, as the cost to patients of device failure is likely to be catastrophic (Curfman & Redberg, 2011).

The ROBODOC was basically a workstation.  It worked in several stages.  In the first stage, the orthopaedic surgeon uses the device to examine the bone, and ROBODOC proved to excel at this. The pre-operative plan is then developed, with the assistance of the device, and the ROBODOC then is used by the orthopaedic surgeon to perform the actual surgery.  The device was tested on more than 850 patients at half a dozen hospitals by the mid-1990s, when it still had not yet completed the FDA approvals process (Pransky, 1997).

The next wave of development in robotic surgery sought to resolve the issues in mechanics that were acting as a constraint on what surgical robots could do.  In particular, the mechanical motion limitations and low haptic feedback sensitivity were seen as issues that needed to be addressed to develop robotic surgery for laparoscopic applications (Davies et al, 1997).

A further issue in the development of robotic surgery by the late 90s and early 2000s was training.  Because so few devices had received FDA approval at this point, their use was not widespread, and thus training on the usage of these devices was not widespread. 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 larger interest among these residents in laparoscopic surgery.  More encouraging, however, was that 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 and to a lesser extent the training hospital level remains nascent, despite the growing popularity of the field among physicians, insurance companies and patients.  It should be noted that the FDA does not regulate the training or practice of medicine, and with robotic surgery systems the training is just as important as the device itself.  While this has always been the case in surgery, the fact that so few physicians are learning robotic surgery in their medical school training is a cause for concern, and will stunt the adoption of the technology in the field.  The absence of such standardized training can result in a dramatic difference in the skill of physicians at using robotic surgery equipment, and gives rise to the necessity for manufacturers to develop their own standardized training and certification programs to ensure that quality standards in the application of robotic surgery in the field are maintained to a high level.  Such training would also serve to minimize malpractice risk, so there is definitely benefit ot the industry to have such programs.

By the early 2000s, the focus of robotic surgery was focused on laparoscopic applications.  The future of robotic surgery was understood to be focused on smaller devices with greater tactile sense and more refined movements (Camarillo, Krummel & Salisbury, 2004).  The past decade of development in robotic surgery has thus remained based on the arm-and-hand anthropomorphic model of robot and the use of a…