How Robot Assisted Surgical Devices (RASD) are not really robots

Late co-principal, founder and director of research and synthesis at BlackHägen, Sean Hägen, explains how medical robots are not really robots.

Robot Assisted Surgical Devices (RASD) are not really robots. To be a bonafide medical robot, the system would have to duplicate human activity, and today none of these RASDs are autonomous, or even semi-autonomous with that ability. They are bionic systems created specifically to enhance the healthcare provider’s performance with electronic or electromechanical devices.  

This distinction is critical to the design and development of the robotic system.  

Looking at the Regulatory Impact  

Many current robotic systems are based on technology that could execute a procedure autonomously but the complexity of validating safety and efficacy for regulatory approval would be cost-prohibitive. Regulations require a demonstration that proves the RASD could safely manage contingencies that are often unpredictable during a procedure. A machine programmed by humans can only do what it’s been trained to do and thus lacks the creativity and quick thinking that a human brings to reacting and managing a contingency.  

Sophisticated capital equipment such as a RASD does not have the same ROI that could justify such a massive validation investment. However, as the clinicians are in control and the system is recognised as an extension of their abilities, the human is still responsible for the outcome. This means that the validation process must be viewed as a function of the clinician’s interaction with the robotic system’s user interface. 

Case in Point 

A surgical robotic system impacts the surgical workflow meaning all the staff involved in the surgical procedure. A conventional surgery is typically a symphony of interactions between a team of clinicians.  

The identification of all the people involved is crucial to ensuring a favourable outcome for the patient because there is a new factor in the operating room – the robot. A new physical layout may also be required to accommodate the robotic system in an already congested environment. This can impact how the team members interact with each other.  

The intention of the robot is to introduce an optimised instrument for the surgeon, but in application, it can affect the responsibilities of the extended surgical team.  

These team dynamics are important when it comes time to validate the user interface of the robotic system and must be considered and often included in the validation test.  

Impact of User Interface Design 

User research insights that can inform the use-related risk assessment and regulatory strategy apply to the design and development of the robotic system’s user interface.  

Consider the example of the lead surgeon’s user interface. There is a need to understand the negative and positive transfer bias in the physical user interface. There is the accommodation of team dynamics and communication.  

The way the surgeon executes a manual procedure can result in either a positive or negative transfer bias depending on how the new control interface is designed. Negative transfer bias can introduce a potentially hazardous condition and use error that could lead to harm.  

Conversely, the user interface design can afford positive transfer bias by emulating or carefully transitioning from a norm behaviour and interface to the new user interface and workflow experience. A proactive approach to understanding the user’s expectations and aspirations with an in-depth understanding of perceived attributes that determine the intended behaviour is a robust approach. 

Medical Robots with a Human Touch 

Introducing medical robotics into a clinical environment offer advantages to clinicians and patients but must always be considered enhancements to the processes and procedures, not replacements. The human touch will always be important in certifying risk mitigation, patient and environmental safety, and regulatory requirements. Design and development of these devices include a myriad of steps that should be deployed early on to make sure that not only the device itself, but its complex interfaces mirror the users’ behaviours to assure the optimum outcomes for all.    

It is with deep sadness that Sean passed away shortly after writing this article and everyone at Medical Plastics News sends their thoughts to those close to him.