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Usability testing refers to the evaluation of a product or service by testing it with actual users. Participants try to complete typical tasks while collecting important inforomation that support the identification of any usability problems and determine the participant's satisfaction with the product.


Like any other medical device development activity, usability testing requires resources and time. In the product development process, 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. 
Usability testing can also be done pre-product launch to understand customer responsiveness to the new product.
Before even starting to design the test protocol we ask our clients relevant information in order to establish: the test type, the key deliverables, the schedule and the participant type, number and geographical distribution.
The usability test is usually structured in


Definition of Test Type & Purposes
Our Client is asked to specify which type of usability
test  ThinKeen® has to conduct: Formative (performed to finalize design elements) or Summative (performed to evaluate usability features of a complete and frozen design).
Definition of Product to be tested
Client should share all technical and clinical information about the products to be tested including their precise intended use and indications.
Definition of Features to be tested
Client might indicate the need to collect other types of information in addition to usability-related data. For example feedback on a number of industrial design issues.
Definition of Benchmarks
Will the test be comparative? If yes, with previous versions of the same products or with competition? If not, what dimensions and scale of usability will be used to grade each feature?
Definition of information to be collected
What information must be collected and in what format? Will user be asked to answer a questionnaire? 
In this phase a complete set of questions will be defined. 
Definition of Statistical analysis approach
What statistical analysis will be used and what are the implications on the sample size and distribution? What level of confidence will be sought in the hypothesis testing?
A specification of possible test locations must be developed along with a brief rationale for each. 
Determination of User Population
With our client we define the appropriate type and number of test participants including the characteristics of the specific participant groups (e.g., nurses, technicians). Such information will help ThinKeen® to understand the
prospective research participants and estimate the time and effort that might be required for recruiting.
Determination of Test Schedule
A realistic stream of milestones with focus on critical activities must be outlined and constantly updated.
Data collection and observational tools
A detailed definition of the tools required to record and collect data from multiple and internationally distributed sources in an organized manner 
Define analytic & reporting process


Data Collection and Management Platforms
ThinKeen disposes of all IT tools required to allow globally distributed users to input data electronically both via smartphone and via online multimedia questionnaires.
On-Site Presence
ThinKeen personnel follow the testing phases in selected sites with the goal of ensuring the correct deployment of the program and collecting other qualitative information such as video footage.
Online Project Management Tool
ThinKeen® will also set-up a dedicated secured online project management system allowing Client’s project stakeholders to gain access and thus allow constant visibility of up-to-date information,
files, tasks, media and milestones
throughout all the phases of the
Participants Recruitment
ThinKeen supports Clients in the delicate phase of selecting, contacting, informing and recruiting participants. ThinKeen also supports Clients in preparing both the basic agreements needed to formalize the user and institution enrollment and the presentation material needed during kick-off meeting with recruited user groups. 
Training & Learning Aids
ThinKeen also prepare training material about the usability testing that will lead and help each participant to follow the required procedures and thus maximizing her contribution.  
Expectation-Matching Capabilities
ThinKeen' analysis of the collected quantitative data will be reported in the same useful and action-oriented format that was agreed with Client at the beginning of the project.
Data will be made available in different formats including summarizing charts but also structured databases easy to reanalyze and reorganize.
The Focus Group Goals
A well structured focus group is the best occasion to better understand and complete the quantitative information gathered and analyzed during the fisrt phases. In many cases the Focus Group gives very specific information that trigger a second phase of the usability testing with much narrower scope.
The Focus Grou Structure
The focus group is normailly built in 3 phases:
-    An open dialogue about participants’ insights.
-    A presentation of the analysis of quantitative data
-    A session focused on identifying and verifying qualitative data that supports and clarifies the quantitative findin
Follow-up Focus Group
The goal is to gather the ten most collaborative customers to gain further insights to ensure a successful launch of the new product configurations. This session should take place as soon as possible after the data collection (but not before a preliminary summary of the data is completed). This will allow a “deeper dive” into any concerns and opportunities.
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