Medical Design Briefs: 2021 Technology Leaders - 25

TECHNOLOGY LEADERS Medical Robotics
Is a Medical Robot Really a Robot?
F
irst of all, there are no true medical
robots; none of the systems out
there called medical robots are
autonomous with regard to duplicating
human activity, and few are even
semi-autonomous. They are arguably
bionic constructs; that is, enhancing the
healthcare provider's performance by
electronic or electromechanical devices.
The key here is that these devices en -
hance the abilities of the user, but do not
replace them. It is reasonably too late to
change the vernacular, and it is just a matter
of semantics anyway. But why is this distinction
important to design and development?
This article addresses two of the
reasons why the distinction is important:
* The regulatory strategy can be significantly
different from other medical
devices, especially regarding the level
of autonomy, team usability validation,
and training.
* Understanding that these systems are an
extension of a clinician's current ability
and that they enhance an activity that
clinicians may also do manually, thereby
having an important impact on the user
interface design and development.
Strategic Regulatory Impact
Even though many of the current
robotic systems are based on technology
that could very well execute a procedure
autonomously, the scope of validating
the safety and efficacy for FDA approval
would be cost prohibitive. This is be -
cause you would have to demonstrate
that the robot can safely manage contingencies
that are often unpredictable during
a procedure. This would require validation
trials of a scale similar to pharmaceutical
clinical trials, where hundreds, if
not thousands of patients are required.
Unlike a medication, which is a highvolume
consumable that is reimbursed by
a payee, a piece of capital equipment marketed
to a healthcare facility, does not
have the same return on investment that
could justify such an investment in validation.
However, by keeping the clinician in
control and the system relegated to an
extension of their abilities, the human is
still responsible for the outcome. Now,
with the clinician as the decision maker,
the validation process is a function of the
Medical Design Briefs 2021 Technology Leaders
Design and usability validation of robots can be significantly more complex than conventional medical
devices. (Credit: Sompong Sriphet)
clinician's interaction with the robotic system's
user interface. In other words, the
manufacturer doesn't have to validate the
user's clinical abilities, just that the robotic
system meets expectations for efficacy,
safety, and performance. That said, both
the design and usability validation can still
be significantly more complex than conventional
medical devices.
Using a surgical robotic system as an
example, it being an extension of the
surgeon's abilities, the robotic system
impacts the rest of the surgical workflow
as well - that being all the other actors
involved in the surgical procedure. It is
important to note that a conventional
surgery, be it open or laparoscopic, is
typically a symphony of interactions
between a team of clinicians. These clinicians
may include lead surgeon, first
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assist, sterile nurse/tech, circulating
nurse, anesthesiologist, and possibly others
(e.g., perfusionist) or duplicates of
some of the actors listed. In addition, if
it is a teaching hospital, there are interns
and fellows on the team.
The importance of understanding all
the people involved in order to result in
a favorable outcome for the patient is
because now we are introducing a new
actor into the operating room: the robot.
Oftentimes this impacts the manner in
which the lead surgeon interacts with the
team, as well as requiring a physical footprint
for the robotic system in an already
congested environment. Moreover, once
you remove the team leader from the
sterile field and isolate that participant in
a control console, the team dynamics are
profoundly impacted.
25
Robotic systems are an extension of a clinician's current ability and enhances an activity that they may also do
manually.

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