A Comprehensive Guide on Development to Impact of Surgical Robots

By Muhammad OsamaJan 29 2024Reviewed by Susha Cheriyedath, M.Sc.

In an article published in the journal Nature Medicine, researchers proposed a comprehensive and practical guide for evaluating surgical robots, covering their entire life cycle from preclinical development to long-term monitoring. They utilized existing ideas, development, exploration, assessment, and long-term monitoring (IDEAL) frameworks and provided practical recommendations for device developers, clinicians, patients, and healthcare systems. Moreover, they discussed the key challenges and opportunities for surgical robotics, such as the integration of artificial intelligence (AI), the ethical and economic implications, global health equity, and environmental sustainability.

Background

Surgical robots are devices that assist surgeons in performing minimally invasive surgery by providing enhanced surgical precision, dexterity, ergonomics, and telesurgery. The first surgical robot was introduced in 1985, and since then, the field has expanded in size and scope with the development of new platforms and technologies, such as AI and autonomy. However, evaluating surgical robots is challenging due to their complex and dynamic nature, the potential for wider system disruption, and the ability to integrate with complementary technologies.

Existing frameworks and standards for evaluating surgical devices are often inadequate or inconsistent and do not account for the specific features and risks of surgical robots, especially those with autonomous functions. Therefore, there is a need for a structured and rigorous evaluation pathway that can guide the development, comparison, and monitoring of surgical robots across different settings, indications, and multiple perspectives, such as technical, clinical, human, economic, ethical, patient, and environmental.

About the Research

In the present paper, the robotics colloquium was established to create proposals for a comprehensive guide to evaluating surgical robots, using the existing IDEAL as a template. The IDEAL framework provides an exploratory pathway to complex innovations and tools spanning from initial adoption to extensive use. The colloquium involved seven representatives with experience in technical evaluation, health economics, AI, ethics and surgical training, human factors, clinical evaluation, and patient representatives. The panel reports were synthesized by a group of experts from sustainability, global health, and medical statistics, and their suggestion was considered from the perspectives of four key stakeholders: clinician, device developer, wider healthcare system, and patient.

Research Findings

The colloquium produced a list of stage-specific recommendations for systematically evaluating robots, considering the perspectives of four key stakeholders: the device, the clinician, the patient, and the system. The guides are based on the use of appropriate methodology to address the questions at every stage in the life cycle, adherence to the principles of medical ethics, and maximum feasible transparency. The recommendations cover the following:

• Preclinical development and evaluation or IDEAL stages 0, 1, and 2a: This phase involves testing the safety, feasibility, and acceptability of the robotic device, as well as its integration with AI. The suggestion encompasses several key elements. These include standardizing the publication of clinical and technical data, documenting changes to devices and AI models, evaluating robotic autonomy, performing early economic and sustainability modeling, and considering the impact of surgical robots.
• Comparative evaluation or IDEAL stages 2b and 3: This stage entails comparing the effectiveness of the robotic device against the current surgical standard, using collaborative prospective cohort studies and randomized controlled trials. The recommendations include documenting clearly defined safety and effectiveness outcomes, using existing consensus core outcome sets, validating, and using next-generation outcomes and measures, performing decision-analytic modeling and formal economic evaluations, analyzing learning curves and trust in AI, ensuring informed consent, and minimizing bias, and addressing ethical issues such as responsibility and fairness.
• Long-term monitoring and technological evolution or IDEAL stage 4: This stage involves monitoring the performance of the robotic device in real-world settings, using registries, observational cohort studies, or real-world datasets. The guidance includes using high-quality, transparent, and valid data, addressing regulatory, political, and commercial barriers to data sharing, accounting for confounding factors and sources of bias in statistical analyses, reevaluating the device for changes in risk, indication or performance, standardizing training programs and credentialing, analyzing adverse events, maintaining patient-centered outcomes, and assessing cost-effectiveness, global health equity, and environmental impact.

Applications

The presented guide has several applications for different stakeholders. For device developers, it provides a roadmap for generating high-quality evidence to support the safety and effectiveness of their products, as well as to inform regulatory approval and market access. For clinicians, it offers a framework for assessing the usability, reliability, and integration of surgical robots as well as for ensuring adequate training and credentialing. For patients, it ensures transparent and ethical consent processes as well as access to relevant and unbiased information about the risks and benefits of robotic surgery.

Conclusion

In summary, the novel manual is comprehensive and effective for assessing surgical robots. This is intended to be a living document that can be updated and refined as new evidence and challenges emerge. Moreover, this can inform and guide the development, regulation, and implementation of these devices, as well as the training and education of the surgical team.

The researchers also identified several areas for further research and development, such as standardized metrics, health economic assessment models, global applicability of recommendations, ethical frameworks for AI-enabled robots, and next-generation outcomes and measures. The colloquium hopes that the guide will facilitate the safe and ethical translation of surgical robots and ultimately improve the quality and outcomes of surgical care.