Usability Evaluation: formative und summative studies

Shining a light on user responses

Is the product safe? How intuitive and easy is it to use? Does the product fulfil user expectations? During a usability evaluation, we provide concrete answers to these and other questions. We look in depth at how well users learn a product and then use it to achieve an intended goal to provide you with information on the product’s user-friendliness.

We appreciate Use-Labs experience and professional service!

Benoit Detry

Senior Engineer R&D

iSTAR Medical

Methods for evaluating usability

When conducting formative and summative usability studies, Use-Lab applies a wide variety of evaluation methods to determine the best possible results for you. A study can focus on individual components of the product, such as the graphical user interface, the hardware or the user manual, or it can examine the system as a whole.

Formative studies are studies that accompany development with the aim of evaluating a current design status and identifying optimization potential. They can be performed with almost any design form, from 2D drawings to functional prototypes in any environment.

Summative studies should generally be performed with the final product including all user interface components. This of course includes training and accompanying documents. These studies and any necessary training should be carried out. They serve the final evaluation of the product safety. Following a final risk assessment, the results should show that the product can be used without unjustifiable residual risks.

In particular, the formative and summative usability studies have helped us develop up a more intuitive end-user perspective together.

Lars Michel

Senior Director Research and Development FB

Transfusion Medicine and Cell Therapies
Fresenius Kabi MedTech

Method triangulation

Method triangulation – the combination of multiple methods – allows us to perform a detailed assessment of your product.

It goes without saying that our work is always guided by the currently valid regulatory requirements in the field of usability engineering. Our active participation in various national and international standards committees and advisory boards guarantees that we are always up to date. In addition to the international basic standard, currently IEC 62366-1:2015+COR1:2016, the MDR, IEC 62366-2:2016, IEC 82079-1:2012, ISO 14971 and other international standards and guidelines, including those of the FDA, also play an essential role.

As a rule, we primarily use methods in which potential users interact with a product and are asked about their impressions. To recruit participants, we work with you to define a user profile with screening criteria in advance. We conduct many studies on our own premises. For studies with international participation, we also offer fly-in studies or conduct the studies in cooperation with our partners at other international locations worldwide.

A study can focus on individual components of the product, such as the graphical user interface, the hardware or the user manual, or it can examine the system as a whole. or it can examine the system as a whole.

When we asked Use-Lab to run a formative study for us, they not only performed the study with great competence in a short timeframe but welcomed us to their well-oiled team like family.

medac GmbH

Nice to see you

In a personal conversation, we can determine your needs and tailor our services to your requirements.

We look forward to meeting you.