Medical Design Briefs - April 2021 - 12

Medical Device Design

5
6

4
5

8
4

3
5

0
FUNCTION

VALUE

APPEARANCE

UTILITY 10
TECHNOLOGY 7
ERGONOMICS 8
CONFIGURABILITY 3
SIMPLICITY 5
SERVICE 2
SAFETY 10
BENEFIT 8
PRESTIGE 4
AFFORDABILITY 7
SUSTAINABILITY 3
RISK 9
STYLE/BEAUTY 7
FORM 5
QUALITY 7
COLOR 4
FAMILIARITY 8
CONSPICUOUS 5

Fig. 1- A process for characterizing and prioritizing that can support this effort is called perception
attributes.

Instruments Lined up in Sterile Field
Is this a grip?

If so, how do I
reach the button?
What is this feature?

I am not sure how to
hold this instrument...

This matches the pattern
of previous architypes
I use; I can predict the
scenario and outcome.

Fig. 2 - Initial assessment of devices.

www.medicaldesignbriefs.com

Cov

ToC

that can be addressed by the initial
impressions enabled by aesthetics.
An important point is that requirements typically need a good deal more
elaboration and, then, will likely need to
be divided into multiple, more directed
requirements. Not that you want to
describe how to meet the requirement -
that is for specifications - but you want
to achieve more detail. For example,
" The user should be able to power on the
device without instruction. " Realizing
this sounds like an obvious expectation,
it is surprising how many homemade
labels are on medical devices to instruct
the user how to turn them on.
It should be noted that the regulatory
perspective regarding user error and use
error are significant. This is substantive
in understanding usability. From the
perspective of FDA, it is not the user's
fault if, during the use of a device, they
commit an error or action not intended
by the user or manufacturer. Instead, it
is the responsibility of the product manufacturer to design out the potential for
error and to validate the design controls
are effective. Therefore, there is not
user error, there is just use error. In
other words, the manufacturer cannot
be responsible for the clinical skills of
the user, but they are responsible for the
user interface of their product and its
ability to minimize use error.
Discussion
Regardless of how the process is executed, design needs enough fidelity in
the requirements that influence the aesthetic (beyond corporate identity), to
address subjective attributes such as " intuitive " and " easy. " In order to design in a
systematic manner for a user's first
impression and subsequent assessment of
a system to have a purposeful meaning,
there are two key factors to inform the
design process: initial user perception
and context of use (which includes user
needs). A process for characterizing and
prioritizing that can support this effort is
called perception attributes (see Figure 1).
Utilizing perception attributes characterizes the value relationship with the intent
to influence the user's decisions regarding the utilization of a device. In the
healthcare space, the design team has to
consider all perception attributes while
also focusing even further on highly specialized use case scenarios. Ultimately,
the user's assessment is based on their
perceived value as a result of the interconnection of function and appearance.
Medical Design Briefs, April 2021

http://www.medicaldesignbriefs.com

Medical Design Briefs - April 2021

Table of Contents for the Digital Edition of Medical Design Briefs - April 2021