Come on in MedTech,
Make Yourself at Home
By Sam Brusco, Associate Editor
Healthcare technology’s transition into the home means that a large number of users will not be
clinicians trained to operate the devices. As such, the
technology’s design must appeal to the sensibilities
of the user, who more often than not, will have a
layman’s understanding of the device. Users could
potentially receive training in the device’s operation
before use, but successful home healthcare technology
should be both easy-to-use and appealing. To discuss
this, MDT spoke to Laurie Reed, VP of research and
usability at Farm. She offered her insights on the
design challenges and concerns of human factors
engineering for home healthcare technology:
Brusco: What considerations must be made in interface design?
Reed: Interface design must take into account the physical, emotional, and cognitive limitations of its users and the intended use
environment. This means developing an interface that’s easy-to-use
by people with various levels of education, abilities, and experience
with medical devices, in many different settings. Imagine a common
home product such as an inhaler – which may be used by anyone
with asthma or COPD. This includes anyone from age three to 93
and their caregivers. It may be used anywhere, including patients’
homes, cars, workplaces, the outdoors, in public spaces, etc.
There must be a robust set of user requirements and design constraints that reflect the needs of the end users, which is best achieved
through user research. In the case of the inhaler, these design requirements should include intuitiveness, portability, and ergonomic
achievement. Preventing error and assisting users in recovering from
error is of the utmost importance for any medical device, even more
so in a home scenario. Special consideration should also be given
to the product’s supporting documentation, including user manuals,
quick reference guides, and training videos. These references are
key components in the successful use of a home medical device,
especially in circumstances where the end user does not receive any
form of training from clinicians.
Brusco: How important is designing for aesthetics?
Reed: Achieving an easy-to-use and safe design are higher priorities, but aesthetics should not be overlooked. An aesthetically
pleasing and non-threatening home healthcare device leads to both
increased user adoption and compliance. Non-threatening products
allay users’ fears about operation outside of the clinical environment.
Interface elements that mimic well-known consumer products may
feel more approachable by untrained users. When
users get to choose a medical device rather than being
prescribed a specific one by their doctor, aesthetic
appeal may give manufacturers an edge. Users don’t
want to be seen as “being sick”; they may prefer to use
something that could be mistaken for a cell phone or a
small consumer electronic device, rather than a product
associated with the stigma of a medical device.
Brusco: How are environmental concerns addressed?
Reed: Early user research is critical at this stage.
Contextual inquiry or ethnography [i.e., direct obser-
vation of the potential use environment(s) and direct
user interviews] usually leads to a rich set of findings
related to environmental concerns. These findings
become design inputs as the team turns them into user requirements
and design constraints. When designing a home drug delivery system,
user research may indicate the challenge of ensuring the medication is
used with an aseptic technique and remains free from contamination.
During concept development, the team will attempt to create designs
that address these issues, whether it be a bag system that automatical-
ly fills up with the drug aseptically or a housing made out of material
that protects the medication from bacterial pollution.
Brusco: Where’s the direction of the market headed?
Reed: In October 2013, an AAMI/FDA Summit was held on
“Healthcare Technology in Nonclinical Settings.” The clarion
themes identified included deepening all stakeholders’ understanding of use environments and their remarkable variability;
coordinating multiple and recurring transitions in care to improve
patient safety; adopting a systems approach, encompassing people,
workflows, therapies, technology, and payment to redesign the full
spectrum of healthcare in nonclinical settings; standardizing and
simplifying; and designing with empathy.
All of these involve human factors skills or principles. Regulatory bodies have recognized the important role of human factors
engineering. In 2011, the FDA released an important guidance
document that defines how they expect human factors to be
applied to the design of medical devices. The EU Medical Device
Directives now include requirements for the establishment of a
Usability Engineering Process, so other countries are starting to
adopt a similar stance on usability. The human factors regulatory
requirements center largely on safety and ease-of-use. Ultimately, OEMs need to incorporate human factors engineering into
the design of their home healthcare devices in order to have a
successful submission and a safe product. MDT