Human Factors in Medical
Rehabilitation Equipment:
Product Development and
Usability Testing
[Link] Mustafa
BSPT(K.E.M.U)[Link](RCRS),
Prototype testing.
The evaluation of a newly developed trial product by the end-users who
represent the target market.
Efficacy testing.
A more formal process of performance testing in a controlled setting to
determine the effectiveness of the product.
Magnitude estimation.
An experimental technique used in psychophysical experiments that
involves having a subject compare his or her current sensation with a
reference sensation.
What Is Usability Testing?
Usability measures the quality of a user’s experience when interacting
with a product or system— whether a website, a software application,
mobile technology, or any user-operated device.
Usability may also consider such factors as cost effectiveness and
usefulness.
Two international standards further define usability and human-
centered design:
• [Usability refers to] the extent to which a product can be used by
specified users to achieve specified goals with effectiveness, efficiency
and satisfaction in a specified context of user .
• Human-centered design is characterized by the active involvement of
users and a clear understanding of user and task requirements;
an appropriate allocation of function between users and technology;
What Is User-Centered Design?
“User-centered design (UCD) is the structured process for product
development that includes users throughout each phase of the design
process.
In addition, a macroergonomic approach is often used that includes the
overall business mission, goals, and culture, as well as the
target audiences’ preferences, abilities, and requirements.”
Usability testing is most well known when used to evaluate the
interface between the user and a machine or technology, such as in the
computer industry.
Examples include evaluating controls and displays on automobile
consoles or in aircraft cockpits, designing user-friendly software, and
designing human-computer interfaces and websites.
However, usability testing also applies to products that are not
considered machines, such as workstations.
Both complex equipment (e.g., anesthesia monitors and mammography
machines) and simple equipment (e.g., walkers and dynamic splints)
can benefit from experimental evaluation that concentrates on users.
PROCESS
If therapists decide to take on the task of consulting regarding the
development of a new walker, they must first become familiar with the
equipment. This includes the current design and any prior difficulties
with this or similar products.
Once familiar with the equipment, the purpose of the equipment, the
situations and environments in which the equipment would be used,
and the target populations, the team can move on to usability testing.
The first step in the usability testing process is to identify subject matter
experts (SMEs) and the user population.
An SME is any person who can be a valid judge of a design by virtue of
his or her experience, education, or research of system operations, job
performance, or task dimensions.
Second step: SMEs and representatives from the user group meet to
define groundwork for development of design objectives and task and
function analysis.
Therapists’ expertise on life skills and expectations throughout the life
span, human development milestones, disease, and future expectations
of the disease process will assist with developing the test objectives and
tasks.
Techniques used during meetings with user groups can include focus
groups and user workshops, informal discussions, interviews (structured
or open-ended), questionnaires, brainstorming, checklists, and
observations.
The next two steps, which can occur simultaneously, are to identify
design objectives more explicitly and to conduct a task and function
analysis .
Design objectives focus on product features that affect performance,
safety, expense, acceptance, comfort, ease of use, and aesthetics.
Inclusion :of these objectives in initial product development helps
confirm that the product is effective, safe, and accepted by user groups
before expensive investments are made in product creation and large-
scale production.
Design should be closely related to task and function analysis provided
by investigators, users, and SMEs as a team.
critical success factors:
During a task and function analysis, the task and subtasks to be
performed are selected in terms of those that are most demanding,
frequent, and essential for the user population.
Fifth step: the development of performance criteria. Performance
criteria should closely resemble the requirements of the task and should
be performance oriented (action oriented).
sixth step: Measurement techniques include both objective and
subjective measurements.
objective measurements include reaction time, number of errors, and
type of error.
Subjective measurements include user ratings of comfort, convenience,
ease of use, and aesthetics.
Once the measurement techniques are chosen, subjects are recruited
and trained.
Completing steps 1 to 6 before recruiting subjects is important to
guarantee full disclosure of the evaluation process.
7th step :A walk-through or trial of the evaluation process should be
conducted at this time)
The eighth step: is the actual assessment; in this case it involves a
comparison study of several prototype designs. Subjects perform one
or more of the reference tasks, and the investigator collects and
analyzes objective and subjective information.
Finally, the evaluation process is conducted as either a formal or an
informal research project. The results are used to critique or redesign
the product.
The process is repeated as new information becomes available or the
design is changed. A design is proposed, tested, rejected (or accepted),
and revised repeatedly.
One or two design options are then chosen for rigorous evaluation. The
evaluations can be categorized as experimental or nonexperimental,
formal or informal, two-dimensional or three dimensional, and
nonperformance or performance oriented.
An experimental evaluation requires measurement of subject
performance under contrasting conditions in a controlled environment
and use of experimental and statistical controls.
A non-experimental evaluation does not require contrasting conditions
or strict controls. For example, evaluating a subject’s reaction time
Having subjects complete a subjective rating scale while using a single
product on the job is non-experimental.
Formal assessments have definite procedures and are well defined;
informal assessments have less well defined objectives and procedures.
For example, a questionnaire is formal, but an open-ended group
discussion is informal.
Two-dimensional evaluations examine a product’s attributes through
checklists,
three-dimensional evaluations may use mock-ups or prototypes and
can incorporate either nonperformance or performance measurements.
An experimental evaluation of two or more prototypes determines
which design is better or best according to user performance and
preference.
If only one product is evaluated, the assessment addresses the same
design questions of effectiveness, ease of use, accomplishment of the
mission, and deficits or areas that need improvement, but only for that
one product.
As mentioned, an important aspect of usability testing is that it is
performed during each stage of development. Even after the product is
on the market, usability assessment can be conducted to ensure the
product remains useful and effective.
If product development occurred without usability testing, evaluation
may be the first step in determining whether change is needed. The
user population, especially clients, may not voice their concerns about
the effectiveness of a product. This leaves the responsibility with the
developers and SMEs.
The information gained from a usability evaluation after the product is
on the market can determine the need for product redesign and assist
medical personnel in making recommendations.
Information regarding the effectiveness, efficiency, and ease-of-use of a
product is important in the recommendation of a product for purchase
by a client, a client’s family, or a medical facility.
PRODUCT DEVELOPMENT, EFFICACY TESTING, AND COMPARISON
TESTING OF AN ASSISTIVE WALKER
Given that therapists have accepted the job as consultants and
members of the ergonomic evaluation team, they first review the
literature and construction of walkers and re-familiarize themselves with
the types of clients who use them.
They review the accoutrements that users may want, such as baskets,
pouches for carrying small items, and drink holders. They examine the
balance characteristics of walkers. Some are balanced at the center
handle; these walkers are designed for clients with hemiplegia and
thus with limited use of one hand.
Wheeled walkers may be especially beneficial during the early
rehabilitation process, but it is difficult to know whether one with front
wheels only or one with three wheels will best serve a client.
Other important features are the weight, portability, and stability of the
walker and the height, shape, and size of the grip handles. Some clients
may want a walker with an attached seat.
Given that the New Equipment Company has an idea for a new walker
design, the team decides to start there. They plan for three iterations of
the usability process.
Each phase is considered part of the usability testing.
Usability testing means that the product is evaluated by obtaining
information from representative users, often while they use the
product.
the goals of usability testing are to develop a product that accomplishes
the purpose for which it was designed, is easy and safe to use, and will
be used.
Phase 1--------phase 2-------phase 3
Phase1:product development(pilot testing of walkers)
User or investigator SMEs----->2)Interaction--3)Establish design
objective---4)Conduct task and function analysis---5)Develop
performance criteria----6)Establish measurement
technique”subjective or objective---------7)walk trough
---8)Assesment---9)Product
Phase 2: efficacy testing, (walker vs no-walker)
User or investigator------->2)Interaction--3)re-Establish design
objective-4)Re-evaluate task and function analysis---5)Re-establish
performance criteria----6)Re-establish measurement technique
“subjective or objective”-----7)Training---8)Assesment--9)Product
Phase 3:useability comparison testing(comparison of walkers)
User or investigator------->2)Interaction--3)Establish design objective-
4)Task and function analysis---5)Develop performance criteria----
6)Establish measurement technique "subjective or objective---------
7)walk trough/training---8)Assesment---9)Product
First Iteration: Product Development
The first step is to identify the SMEs, users, and investigators .
This group could include product developers, medical personnel who
have prescribed walkers for clients, therapists and nurses who work
closely with clients who use walkers, family members of clients who use
walkers, and the clients themselves.
A target group, such as those with hemiplegia and those with cerebral
palsy, differ.
For example, a client who has problems with balance and coordination
may not want wheels on his or her walker, and a client who quickly
becomes fatigued may need an attachable seat that folds while he or
she is walking.
Identification of a target group should be based on demographics;
knowledge, skills, and experience; attitude; lifestyle; cognitive and
physical abilities; and cultural background.
Design Objectives for Product Development
Primary
Walker, Lightweight, Adjustable height, Adjustable width,
Stability, User, Appropriate weight distribution. Ability to maintain
erect posture during use
Secondary
Comfort, Ease of use, Ease of adjustment, Ease of storage.
Portability, Optimum grip height, Shape, Size
Tertiary
Attractiveness, Convenience
The design objectives and the information gained from the task and
function analysis are used to develop performance criteria.
Second Iteration: Efficacy Testing (Controlled Setting)
The goal of efficacy testing is to determine whether the walker improves
the user’s ability to walk and maneuver through the activities of daily
living—
Therefore, testing consists of having subjects use the walker, as
opposed to not using a walker, while performing several representative
tasks.
If the investigator believes that walkers have been shown to be effective
ambulation tools and that such an evaluation would be superfluous, this
phase can be eliminated.
If this phase is eliminated, usability testing begins with a comparison
between the new design and existing designs.
The interaction among SMEs, users, and the investigator should focus on
the results of the pilot test accomplished during phase 1.
The design objectives for the walker most likely will remain the same as
those identified in the development phase.
During efficacy testing, the number of subjects will probably
be greater than the number who participated in the pilot
test.
Adequate results can be obtained with a relatively small
number of subjects, especially because this is a repeated-
measurements study.
The results should give the investigator clear information
about the efficacy of use of the walker (as opposed to no
walker) in terms of both the subjects’ performances and their
preferences.
Efficacy testing provides information on the benefits and
limitations of using the walker in three different situations for
men and women. Initial results suggest that the walker is
beneficial .
Third Iteration:
Comparison Field Testing
The second iteration of the usability cycle (effi - cacy testing) revealed
that the walker was helpful in improving ambulation and maneuvering
in using a restroom. However, the following concerns were identified
during testing:
• The gripping edge of the walker was uncomfortable and caused pain
on the thenar eminence during ambulation.
• Subjects requested a handle material that does not feel cold to the
touch and comes in different colors.
• Subjects requested detachable accessories, such as a tray for holding
objects, a recessed cup holder, and a basket with adjustable sections.
• The fold-up seat was weak and unstable and did not have appropriate
contour or padding.
The concerns must be discussed by SMEs, subjects, users, and
investigators. The cost of product development and the purchase price
must be considered, along with the preferences expressed.
both the old and the new design objectives can be tested by
walking, this task is chosen as representative. The purpose of
the comparison field testing is to compare one or more
designs with one another in a realistic environment.
The task in comparison testing should be similar to the task
used during efficacy testing in the laboratory.
The tests can be conducted in nursing homes, rehabilitation
centers, or even in a home environment in which throw rugs,
narrow halls, and wheelchairs are obstructions.
It can also be conducted in a work setting in which storage
cabinets are located in the halls, ramps are located between
split-level floors, and low-level ambient light is used.
The results of the comparison test in the example were as
follows:
The new design was ranked as the preferred walker compared
with the other two walkers. The subjects’ heart rates were
lower with the new design. Subjects completed the task faster
when they used the new design; however, time to stand and
sit was slower.
Subjects found the new design easier to use. Use of the new
design increased comfort and decreased pain and strain.
No differences were found for ratings of stability, perceived
exertion, or performance of ancillary tasks.
These results showed the new design to be superior for
ambulatory assistance as measured by user preference and
Performance.
