The IDEAL Colloquium on Surgical Robots

We propose a multi-disciplinary group of stakeholders to develop guidelines for evaluating surgical robots which will be of value internationally.

Technological advances and the waning of the patent rights which allowed monopoly control of the market for well over a decade has led to a recent burst of activity in developing surgical robots.  This has brought into focus the question of how these machines should be evaluated.

Surgical robots are not treatments but complex platforms.  Evaluating their performance involves numerous dimensions, and a comprehensive evaluation plan therefore goes beyond the scope of both standard clinical research and regulatory templates for the evaluation of recognised categories of risk.

Previous paradigm shifting advances in surgical capability such as laparoscopic surgery have been marred by very poor evaluation linked to clinician enthusiasm and loss of equipoise.  This has contributed to establishment in practice without adequate evidence and unnecessary harm to patients, and has left a legacy of weakness in the evidence base about effectiveness, harms and cost-effectiveness.

Early establishment of a framework for evaluation this time around may prevent a repeat of this scenario.  The current situation creates an opportunity to develop a better evaluation system and avoid repeating previous mistakes.  The task is however considerably more complicated than it is with single-purpose devices or operations, because the complex nature of robots means that a wide range of evaluations will be need in order to ensure safety, efficacy and cost-effectiveness.  We have therefore developed a process which involves a range of specialist sub-groups each developing recommendations in their own area, which will be combined to produce a comprehensive set of guidance.

 Robotic Surgery team, by Army Medicine, licensed under CC BY 2.0

What is being proposed?

To develop a multi-disciplinary group of stakeholders and  work in a series of consensus groups to develop guidelines for evaluating surgical robots which will be of value internationally.

How will the guidance be developed?

The consensus discussions will take as a starting point three ethical propositions:

  • That evaluation and innovation should be tightly coupled throughout the life cycle of any treatment technology.
    Evaluation should be designed to be appropriate to the questions relevant at each stage in the evolution of the treatment.
  • That complete transparency about evaluation should be maintained at all stages, wherever possible.
    This includes transparency with peers, patients, regulators and journal editors.
  • That evaluation will take a due diligence approach.
    That predictable benefits and risks of harm will be studied in proportion to their likely clinical impact, and adequate surveillance will take place to identify any unexpected signals of harm

What will be included?

The three essential questions which evaluation needs to answer are:

  • Does the robot add value, and if so how?
  • What are the risks to patient safety, and what has been done to mitigate them?
  • What are the risks and benefits of ongoing iterative improvements in robot capabilities?

To answer these questions fully will require examination of a wide range of aspects of robot development and function. The following are suggestions for aspects to be included:

SAFETY

  • Mechanical & electrical safety and reliability
  • Physical Ergonomic performance – technical capacity for manipulation and vision by humans without the risk of errors or operator problems caused by design features: consideration and reduction of predictable risks e.g. due to narrow field of vision and no haptics.
  • Psychosocial ergonomic quality – creation of an environment where interaction and communication between humans in the team is optimised: reduction of predictable risks
  • Sterility, allergy, toxicity, radiation and other risk categories specified by regulators

BENEFICIAL EFFECTS

  • Performance of skilled and less skilled surgeons using the robot compared to unassisted performance: evaluation of whether robots can shorten learning curves and/or enhance minimally invasive technical performance of most surgeons to emulate elite performers
  • Study of specific procedures where superiority of the robot is predicted based on its technical advantages over non-robotic techniques.
  • Cost-benefit analysis of robotic versus non-robotic approaches

FURTHER INNOVATION (exemplars)

  • Development and evaluation of additional modes for visualising/detecting anatomy and pathology (MRI overlay, fluorescence guidance)
  • Development and evaluation of additional technical capacity through sub-task automation e.g. autonomous suturing/stapling subroutines driven by robot programmes
  • Development and evaluation of decision support capability based on robot-associated AI to alert operators to a predicted risk of technical error

How will the complexity of robots be properly considered?

The multidisciplinary team will represent all important stakeholders in the UK (and subsequently internationally) and will consider evaluation of all essential aspects of robot development and performance.  Specialist groups will be tasked with reporting on 8 important aspects of surgical robotics.

  • Engineering & Technical Performance
  • Ergonomics & Human Factors
  • Health Economics
  • Ethics
  • Clinical performance
  • Training, Mentoring & Introduction
  • Patient and clinician acceptability
  • AI and autonomous function

Stakeholder involvement

A broad range of stakeholders will be invited to take part and international membership of the group will be developed to avoid bias from over-emphasis on one set of perspectives.  IDEAL will work in partnership with two other UK organisations with a major interest in this area – the Royal College of Surgeons and the NIHR MedTech group and NIHR Incubator for robotic surgery.

Other stakeholders represented will include:

  • Oxford BRC and SITU
  • Regulatory Authorities
  • Methodologists
  • Patients
  • Surgical Innovators and experts
  • Industry partners
  • Commissioners
  • Human Factors experts
  • Health Economists
  • Ethicists
  • Representatives of surgical practice internationally

How is this progressing?

A Steering Group has been formed and approved the plans, and leads have been identified for the specialist working groups.  With the leads, a group of initial invitees has been developed to form the various working groups, and invitations are being issued from 31st March onwards.  A protocol for the study is under preparation.

Would you like to be involved?

Membership of the working groups is by invitation, but vacancies may develop between 31st March and 30th May 2021.  If you feel you are qualified to take part in one or more expert panels please contact us via the form below.