Medical Design Briefs: 2021 Technology Leaders - 26

TECHNOLOGY LEADERS Medical Robotics
Although the intention is often to
make the robot an optimized instrument(s)
for the surgeon, in application,
it can affect the responsibilities of the
extended surgical team and their responsibilities.
For example, there may be a
requirement to exchange end effectors
over the course of the procedure, which
requires team members to interact with
each other and the robot, while the lead
is interacting with them without face-toface
communication. Keep in mind that
a significant portion of communication
is nonverbal. Granted, the actors are
wearing masks, but they have learned to
read facial expressions inclusive of the
mask in addition to body posture.
The point of understanding these team
dynamics is that when it comes time to
validate the user interface of the robotic
system, the team has to be considered
and often included in the validation test.
Moreover, the teams may or may not be
cohesive; that is, in a teaching hospital
the team members may change often,
whereas in a private institution, they may
be a seasoned, cohesive team. For usability
validation, both team types would
need to evaluate the design. Even more
important is that upstream usability engineering
research must be conducted in
order to inform the design and regulatory
team of the requirements for future
validation based on well- understood userelated
risk assessments.
The use-related risk assessment can
impact yet another regulatory path strategy
for a robotic system, complicating
risk mitigation and the subsequent validation.
This specifically involves training
models for the robotic system.
Legacy, manual surgical devices, typically
do not require formal training; i.e.,
training beyond orientation or an " in service. "
The difference between orientation
and formal training is that orientation is
not considered a risk mitigation from a
regulatory perspective. In order for training
to be a risk mitigation, or design control,
it has to have robust documentation
that demonstrates, to the regulatory bodies,
the degree of control and repeatability
the manufacturer maintains.
This means that under the design control
process, there is a protocol for how
the trainer is trained, a record of who was
trained, when they were trained, if and
when subsequent training is required,
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The definition of system may include the robot proper, the control console, the robot drapes, and the end effector's
instrument attachments.
and what qualifications for use of the system
the training results in. The definition
of system may include the robot
proper, the control console, the robot
drapes and the end effector's instrument
attachments. It may even include the
cleaning and reusability of the instrument
attachments. Obviously, formal
training is a far greater ongoing burden
and responsibility for the manufacturer.
User Interface Design Impact
The team dynamics and the impact of
the introduction of a robotic system into a
surgical procedure have comparable
influence to the regulatory impact with
regard to the design and development of
all the system's user interfaces - virtual
and physical. The same 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 first the
understanding of negative and positive
transfer bias in the physical user interface.
This also applies to the cognitive
load requirements of the system, especially
if the system is expecting the surgeon
to be responsible for what was previously
a team effort. Then there is the accommodation
of team dynamics and communication
as discussed in the regulatory
strategy impact. These considerations
also apply to the other user interfaces
such as end effector access to the anatomy,
instrument attachment, and draping.
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Returning to the surgeon's user interface
example and the associated biases,
the manner in which the surgeon executes
a manual procedure, the variety of
instruments and their specific user interfaces,
the instruments' capabilities, kinematics,
and feedback 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 - changing the rote
manner in which a task is performed relative
to how it was learned and practiced
previously.
Conversely, the user interface design
can afford positive transfer bias by emulating
or carefully transitioning from a
norm behavior and interface to the new
user interface and workflow experience.
Depending on training to convert the
user's previously learned skills and
behavior is not a viable strategy. A pro -
active approach to understanding the
user's expectation and aspiration with
an in-depth understanding of the perceived
attributes that afford the intended
behavior is a more robust approach.
This article was written by Sean Hägen,
Founding Principal and Director of Research
& Synthesis at BlackHägen Design,
Dunedin, FL. He focuses on the user research
and synthesis phases of product development,
including usability engineering, user-centric
innovation techniques, and establishing user
requirements. For more information, visit
http://info.hotims.com/79411-343.
Medical Design Briefs 2021 Technology Leaders

http://info.hotims.com/79411-343 https://www.medicaldesignbriefs.com

Medical Design Briefs: 2021 Technology Leaders

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