The Role of Human
Factors in Medical Device
By Daniel P. Jenkins, Research Lead, and
Paul Draper, Medical Sector Manager;
DCA Design International
The profile of human factors in medical device development
has increased significantly,
largely due to it playing
a critical role in gaining
regulatory approval for
a medical device. However, for many, the focus
on demonstrating safe and
effective use can dominate the
project involvement for human
factors professionals. This article
discusses how human factors tools
and techniques can also help to define
how to develop products that outperform their competition.
To be successful a medical device
needs to overcome two challenges. Firstly, it needs to make it to market, and
secondly, it needs to offer a recognizable
advantage over its competitors.
Making It to Market
IEC 62366 is an international standard
that outlines how human factors should be
integrated into the process of medical device development. As compliance with the
standard is critical for regulatory approval,
the introduction of the standard has served
to increase the salience of human factors
within medical device development. So
much so, that failure to adequately document the involvement of human factors is
seen as a clear project risk.
Regulators such as the FDA focus
on safe and effective use. The preferred
method for demonstrating this is the simulated use test. This test involves putting
the product in the hand of representative
users and asking them to perform a set
of pre-defined tasks. The test represents
a clear barrier to project success. At best,
failure means project delays and additional costs for design modifications, at
worst; it results in the cancellation of the
project and substantial financial losses.
Accordingly, it is clearly understandable
why such an importance is placed upon
it. This focus on simulated use tests, and
on safe and effective use, helps to ensure
poorly designed products are kept off the
market. What it doesn’t do; however, is
explicitly seek to understand how the us-
ers feel about the device, nor does it seek
to understand how the device performs
in relation to its competitors.
Establishing a Competitive
Whereas the first challenge,
making it to market, posed the
question is this acceptable for end
users, the second challenge posed
is more ambitious as it also strives
to be better than its competition.
But what does better mean?
Most people involved in the medical
device development process would like
to think that they were in the business
of making better devices. However, the
interpretation of ‘better’ is likely to change
between the diverse range of stakeholders.
For those intimately involved in the manufacturing process, such as production engineers, there is likely to be a keen focus on
the cost effectiveness of the devices. For
others with a market focus, the emphasis
may be on commercial viability.
We can learn a lot about how good
a medical device is by thinking of it
as part of a system. At the most basic
level, this system includes the medical
device and the patient. However, it
could also include other people, such as
healthcare professionals or caregivers,
or other artefacts such as other devices,
drugs, training materials, instructions
for use, apps, etc.
Once this system has been defined, the