Artificial intelligence (AI) is expanding its use in a variety of surgical specialties, including general surgery, ophthalmology, cardiothoracic surgery, and vascular surgery, to name a few. In the last few years, AI has made its way into operating rooms.

Though it isn’t able to replace the surgeon, it holds the potential to become quite a valuable surgical tool. AI will soon play a significant intraoperative role. Today’s modern operating room contains screens, robots, and computers as healthcare grows more digital—AI technology bolsters this by aiding in real-time clinical decision-making.

The technology promises to be invaluable for surgeons by improving patient outcomes and minimizing surgery’s variability. However, there’s a huge learning curve in showing this technology’s safety to hospital leaders.

Concerns around patient privacy are at the forefront of all discussions involving AI in healthcare, so technology companies must take on the role of educating clinicians and healthcare leaders on AI’s safety and reliability.

In order to further explore this topic, Medical Product Outsourcing spoke to Dustin Vaughan, VP of R&D Robotics at Asensus Surgical. The company’s Senhance technology is a robotically-assisted surgical system used for minimally invasive procedures like gynecology and colorectal surgery. It features a digital interface with a surgeon-controlled camera via eye-tracking and haptic feedback for enhanced precision, reduced fatigue, and potentially faster recovery for patients. 

Vaughan boasts over 15 years of experience in engineering and product development. He’s responsible for the strategic direction of global engineering and development staff for robotic capital systems across multiple disciplines.

At Asensus, he oversees development and advancement of the company’s medical devices, including the Intelligent Surgical Unit, the first augmented intelligence system approved by the U.S. Food and Drug Administration (FDA) for use in surgery.

Augmented intelligence and artificial intelligence can be easily confused, but they’re fundamentally different in what they set out to accomplish. Augmented intelligence, according to Asensus, is designed to elevate a person’s ability to take a certain action by enhancing human capabilities instead of replacing them. In surgery, it automatically identifies structures of anatomy, safety hazards, and more. Integrated with digital tools, it provides real-time insights to help surgeons make more efficient, precise, and safe medical decisions.

Sam Brusco: What value can AI bring to the operating room? 

Dustin Vaughan: Artificial and augmented intelligence can provide surgeons with real-time data-driven insights to improve both performance of surgical teams as well as patient outcomes. Continuous feedback through all points of operations provides surgeons with vital guidance and support that is often difficult to achieve in today’s digital healthcare environment.

For example, during a procedure, AI-driven endoscope video analysis can provide real-time feedback for critical structures during surgery. Additionally, post-operative analytics based on machine learning tools can help hospital staff evaluate their performance and plan for future procedures accordingly. 

Brusco: What is Asensus doing to make sure patient data is de-identified and protected? 

Vaughan: At Asensus, we integrate security by design practices into every step of the development cycle of our devices. This proactive approach ensures security concerns are considered at every point of development, from planning to deployment and maintenance. We also carry out “penetration testing”, which is simulated cyberattacks to identify potential system vulnerabilities that use both white box and black box testing.

When data is collected during a procedure, it is de-identified before being analyzed and shared with surgeons and institutions. Our augmentOR Portal is collecting data on a continuous basis to inform surgeons and improve overall performance, and protecting sensitive patient data is vital at each stage. 

Brusco: Why is there a large learning curve to demonstrating the safety of AI technology to hospital leaders? 

Vaughan: As hospital leaders become more aware of the potential data security risks that can be introduced through many AI approaches, they often want to see the details of both training and validation datasets before adopting them within their organizations. Many are also unaware of the ongoing process of validation, monitoring, and governance involved with AI safety. It’s understandable there would be a learning curve, given the complexity of healthcare and how new these AI tools are. As we continue to demonstrate the efficacy and safety of these tools, the broader hospital administration and surgeon community will continue to develop trust in them. 

This is also heavily dependent on each medical device manufacturer and the level of transparency they provide for the behavior and consistency of their tools.

Brusco: What can be done to mitigate this? 

Vaughan: There must be strong, collaborative working relationships between health system leaders and technology experts. When we can demonstrate that AI tools are clinically validated to work reliably in operating room environments, and that effective measures are being taken to mitigate patient harm and protect sensitive patient data, hospital and health system leaders will feel more confident in deploying AI tools in OR settings.

Hospital leaders should be included and involved in the earlier stages of decision making about deploying AI tools. Surgeons and leaders should be comprehensively trained on safety protocols, and technology leaders should be readily available to answer any questions as they arise regarding the technology and its safety. This will help avoid any miscommunications and hesitations surrounding AI’s adoption and usage.

Brusco: What is on the horizon for Asensus’ technology and AI in surgery?

Vaughan: We are continuing to advance our cloud-based pre- and postoperative analytics platform, augmentOR Portal, which we released last year. The Portal helps teams access de-identified, actionable data to reduce the variable nature of surgery. We are also making more advancements in our Performance-Guided Surgery pipeline including the development of the LUNA Surgical System, the next generation of our digital surgery platform which we are excited to bring to market. 

Since being acquired by German medical equipment manufacturing giant, KARL STORZ, we are set to expand the realm of performance-guided procedures with some of the groundbreaking offerings that we are heads-down developing at the moment.