LIKE ANY OTHER MEDICAL DEVICE
DEVELOPMENT ACTIVIT Y, USABILIT Y
TESTING REQUIRES RESOURCES AND
TIME. HOWEVER, WITH SUFFICIENT
PLANNING, USABILITY TESTING CAN
SHORTEN THE OVERALL DEVELOPMENT
SCHEDULE BY HELPING TO GUIDE THE
DESIGN IN A SUCCESSFUL DIRECTION
AND EXPOSE USABILITY PROBLEMS THAT
MIGHT SIGNIFICANTLY AFFECT THE
SCHEDULE IF DISCOVERED TOO LATE.
Medical device manufacturers that contract ThinKeen® for usability testing services are normally asked to provide basic information in order to allow the development of a statement of work
(SOW). The following is a list of some of the details to include in a
request to conduct a usability test of a medical device in Latin
Test type. Our Client is asked to specify which type of usability
test you want ThinKeen® to conduct: Formative (performed to ﬁnalize design elements) or Summative (performed to evaluate usability features of a complete and frozeen design) , Comparative
Deliverables. List the desired deliverables. Manufacturer normally needs a draft and ﬁnal test plan and a draft and ﬁnal test
report. Other possibilities include copies of test data and photographs, raw or highlight videos (video segment compilations representing the most interesting and important participant-device
interactions), a copy of the data collection spreadsheet, or an inperson presentation of test ﬁndings. Customer questionnaire ad-
dressing all the usability feedback required, summary report with analytics to be provided.
Schedule. Our Client’s preferred project start and end dates for the overall testing effort, including
test planning, participant recruiting, and reporting due dates, are critical information forThinKeen® .
Test participants. Our Client should suggest the appropriate type and number of test participants.
For example, providing market segmentation data and stating the preferred number of test participants. Our Client should summarize the characteristics of the speciﬁc participant groups it envisions
including in the test (e.g., nurses, technicians). Such information will help ThinKeen® understand the
prospective research participants and estimate the time and effort that might be required for recruiting.
Test participant recruitment. With our Client we clarify whether ThinKeen® should take responsibility for test participant recruiting. If the manufacturer wants ThinKeen® to recruit participants, then it
should indicate whether it can provide a list of potential test participants or facilities to contact. Such
a list might be essential if the appropriate test participants have unusual characteristics. For example, ThinKeen® might need to recruit only those individuals who have used or are using a particular
type or brand of medical device (e.g., an earlier version of the one to be tested) .
Locations. Manufacturer should specify its preferred test locations along with a brief rationale for
each. One reason might be that these cities are in countries where there is the necessary support facilities to conduct usability tests at a reasonable cost, plus the selected countries represent the major
markets for the medical device to be tested.
Facility. Client should inform whether it expects ThinKeen® to conduct the test at a speciﬁc type of
facility. For example, your organization might be accustomed to such testing taking place in a classic
research facility that includes test and observation rooms separated by a one-way mirror. Alternatively, you might require testing to take place in a clinic .
Meetings. Client should inform ThinKeen® if it has to participate in a project "kickoff" meeting, test
plan review meetings, debrieﬁngs after test sessions, and a ﬁnal brieﬁng on the test results. Specifying whether the meetings should be conducted in person (and if so, where) or via Web conference or
other communication channel.
Stafﬁng. Client should state if it expects the testing effort to be a one-person task, or if conducting
the test will require two or more people given the nature of the planned activities and the need to provide direction, conduct detailed observations, and capture data. Manufacturer should indicate if it requires one of the in house staff members to play a role in the test, such as collect data, because of
the need for deep technical knowledge or to reduce cost. ThinKeen® might propose a revised staffing plan based on its experience conducting usability tests of a similar scope of a similar device.
Product. Client should share all technical and clinical information about the products to be tested including their precise intended use and indications.
Training. Client should indicate whether it expects to provide test participant training and how long it
might take . Include a detailed rationale for delivering training and suggest who might be best suited
to provide training (e.g., a certiﬁed nurse educator, company representative).
Learning aids. Indicate whether manufacturer expects to provide learning aids (e.g., instructions for
use, quick reference card, animation/video) for participants to use during testing and specify the
state of development (e.g., rough, reﬁned, or ﬁnalized) of the learning aids.
Data collection goals. Indicate whether manufacturer wants to collect other types of information in
addition to usability-related data. For example, manufacturer might want to collect feedback on a
number of industrial design and marketing issues as an adjunct to a formative usability test.
On-site observers. State how many people might want to observe the test sessions.
Remote observation. State if there is a need to provide Web-based video streaming to enable project stakeholders unable to travel to the test site to observe testing remotely.
Quotation contents. Manufacturer should indicate if you want the quotation to be organized within
speciﬁc sections, such as
Objective (i.e., project goal)
Assumptions and constraints
Technical approach, such as one divided into speciﬁed phases and linked to requirements, deliverables, and milestones
Deliverables (if not integrated with technical approach)
Project staff (including technical staff and management)
Pricing (including pricing options, as warranted)
Terms and conditions
Related experience (particularly important when communicating with unfamiliar vendors)