Medical Design Briefs - April 2021 - 11

Introduction
Medical device manufacturers are typically focused on developing and commercializing their core technology to
meet the needs of the healthcare industry and differentiate themselves from
their competitors. Quite often the development of their technology is the foundation of the company. For this reason,
it is common that the user experience,
specifically the aesthetics, of a medical
device is a lower priority, or even an
afterthought. However, there are cases,
where the appearance of the design
may be a higher priority when driven by marketing for important
commercial objectives. The relationship between marketing and
engineering can become conflicted when developing the aesthetic,
and user experience diverts time
and resources from the engineering of the technology.
The focus of these challenges is often
manifested in the device's requirements.
There are many types of requirements,
marketing, system, user interface, and
product requirements, for example. The
variations in
these are typically a function
of the company's quality system and at what

point in the development process they
are established. Even though designers
are rarely involved in the direct development of the requirements, they are often
caught between the priorities of marketing and engineering, resulting in a role
of bridging the two potentially contentious priorities.
There are exceptions where some
companies utilize their designers in
research roles prior to formal product
development. In these cases, the designers may be responsible for generating
inputs to the requirements. Although
this may provide the designers intrinsic
insight to enable them to better bridge
the needs and expectations of marketing and engineering, it doesn't necessarily rationalize the characterization and
relevance of an appropriate aesthetic.
This is where usability engineering (UE)
or human factors engineering (HFE)
comes into the process.
Perspectives in Aesthetics
Research by HFE has documented the
nature of a user's choices and behaviors
as being significantly influenced by the
aesthetics of product. This
insight illuminates the potential impact aesthetics can
have on ease-of-use as well
as use-safety. These two
characteristics of a de-

Medical Design Briefs, April 2021

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vice have an influence on requirements
from different perspectives and different
stakeholders. Ease-of-use and delight impact the design from the perspective of
commercial objectives, marketing being
the lead stakeholder initially and it may
be shared by Industrial Design (ID), User
Experience (UX ) design, and UE later
during development.
Use-safety impacts the design from the
perspective of regulatory objectives, engineering being the lead stakeholder.
However, the engineering stakeholders
for regulatory objectives are not necessarily the same as those focused on technology. Use-safety is the responsibility of
UE/HFE, which may be initiated as part
of system engineering or implemented
as part of quality engineering (the former being more likely to be proactive
since their influence is early in the design and development process).
These two perspectives highlight the
deficiency of an umbrella requirement
like, " the device should be easy to use, "
as not having nearly the specificity to be
implemented properly and validated
affectively. Technically, it doesn't address
use-safety, though likely that wasn't purposeful. In fact, ease-of-use and usesafety are commonly opposing criteria
when it comes time to implement. The
harmonization of these objectives in a
design can be a significant challenge
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Medical Design Briefs - April 2021

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