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As robotic control systems and artificial intelligence (AI) programs continue to advance, researchers like Houston Methodist’s Pedro T. Ramirez, MD, FACOG, are becoming increasingly aware of surgical robots’ potential to transform the surgical technology landscape. “In the near future, I think surgical robots could perform entire procedures,” Ramirez said.
Pedro T. Ramirez, MD, FACOG
If Ramirez is right, there’s a major problem.
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Compared to other types of medical devices, surgical technology, including robots and AI, are historically under evaluated before implementation. Just a series of small case studies that document feasibility and potential patient benefits may be enough to push new technology into the market. Moreover, evaluation after the technology has been implemented is especially lacking. This innovation without evaluation can lead to catastrophic consequences for health care and society. “That’s why it’s critical to develop an evaluation framework for these new surgical technologies before and after they’ve been approved for use—a current knowledge gap in the field,” Ramirez emphasized.
The implementation of surgical technology is influenced by manufacturer campaigns, surgeons’ desire to improve, and personal biases. Unfortunately, these factors can further discourage rigorous and continuous evaluation of new technologies.
As chair of the Department of Obstetrics & Gynecology, Ramirez has spent more than 25 years treating gynecologic cancer through both open and minimally invasive surgery, including robotic surgery. However, Ramirez knows all too well that new technology does not always equate to the best outcomes for patients. For most of the early 2000s, minimally invasive surgery was considered the gold standard approach to treating cervical cancer. Then, a landmark study in 2018 led by Ramirez suggested otherwise. The study, published in the New England Journal of Medicine, revealed that minimally invasive surgery using robotics and laparoscopy to treat early-stage cervical cancer was associated with worse health outcomes when compared to the open surgery approach. These results changed the standard of care for treating cervical cancer. Since then, Ramirez has become more involved in ensuring surgical robots are used in the safest, most effective capacity. Accomplishing this goal requires a keen focus on the continuous evaluation of surgical technology once it becomes available on the market.
In the near future, I think surgical robots could perform entire procedures.
Pedro T. Ramirez, MD, FACOG
Chair, Department of Obstetrics & Gynecology
“Unfortunately, there hasn't been a formal entity that has provided guidance on how to evaluate and incorporate new technology, specifically robots and AI, into surgery,” Ramirez explained. “So, I joined the IDEAL Collaboration to help implement a robotics colloquium to address this need.” Founded in 2007-2008 at the University of Oxford, the IDEAL Collaboration is comprised of a group of research methodologists and surgeons with a common goal of improving surgical innovation research. While the group has already established an IDEAL Framework to evaluate surgical innovation and devices, the nature of surgical robots and AI pose new questions and concerns that go beyond the IDEAL Framework and the boundaries of classical evidence-based medicine.
Current IDEAL Framework for surgical innovations and devices, from early adoption to widespread use. Image credit:
“We felt that robotics needed its own evaluation framework because it is a technology that is growing so quickly and being integrated so fast,” Ramirez explained. “We need to become more critical of robotic technology as it is introduced to the field, especially when AI is involved and there’s potential for increasing device autonomy.” Using the existing IDEAL Framework as guidance, Ramirez and a team of diverse experts— surgeons, engineers, economists, patient representatives, and social scientists—began developing the IDEAL Robotics Colloquium in 2022. Dividing into panels, these experts participated in a series of virtual discussions focusing on key concerns regarding surgical robotics: AI, technical evaluation, clinical evaluation, human factors, health economics, ethics and surgical training. Through these discussions, significant questions emerged. For instance, what is the patient consent process and legal implications if a surgical robot performs most of a surgery? If surgical robots gain autonomy due to AI, will surgeons begin questioning their own intuition? If so, what are the implications of this? “We’re moving toward a technology where the surgeon can potentially be on autopilot or standby,” Ramirez said. “These types of advancements come with ramifications if the technology is not evaluated and used properly.” Taking these concerns into account, Ramirez and his team published the IDEAL Robotics Colloquium in Nature Medicine in 2024. The new framework outlines recommendations for surgical robot evaluation during development, comparative study and clinical monitoring. This framework also provides practical recommendations for developers, clinicians, patients and healthcare systems while considering multiple perspectives, including economics, surgical training, human factors, ethics, patient perspectives and sustainability.
Key stakeholders must be considered for successful surgical innovation. Image credit:
Ramirez’s next goal is to raise more awareness of the IDEAL Robotics Colloquium among surgeons and manufacturers. While adopting critical mindsets can take time, he believes the framework is a prime opportunity to shape how we use surgical robots in the future. Read more of Dr. Ramirez’s work.
Hani J. Marcus, Pedro T. Ramirez, Danyal Z. Khan, Hugo Layard Horsfall, John G. Hanrahan, Simon C. Williams, David J. Beard, Rani Bhat, Ken Catchpole, Andrew Cook, Katrina Hutchison, Janet Martin, Tom Melvin, Danail Stoyanov, Maroeska Rovers, Nicholas Raison, Prokar Dasgupta, David Noonan, Deborah Stocken, Georgia Sturt, Anne Vanhoestenberghe, Baptiste Vasey, Peter McCulloch & The IDEAL Robotics Colloquium
Callie Rainosek, MS
April 2024
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