Usable Design Process

Requirements analysis (User Research)

A requirements analysis or user research forms the beginning of the development process. In this phase we concentrate on getting to know and understand the future users and their working environment. In the course of this, the usage context of the medical device is defined, which includes, for example, determining the requirements and wishes of typical users with regard to the applicability of the product.

Use-Lab offers all common analysis methods, e.g. context- or task analyses, and uses scientific methods to provide you with reliable results.




The specification directly follows the requirements analysis (user research). In close collaboration, we support you in the creation of a requirement specification. All relevant product requirements are bundled there, creating a basis for optimal usability of your product.

The focus is on safety, effectiveness, efficiency and satisfaction in order to ensure smooth interaction between user and product.

The specification of a product or the user interface of the product should take place very early in the design and development process. It forms the basis for all subsequent development activities. Often the specification is based on predecessor or competitor products or the risk analysis for the use of the product. Ideally, an objective requirements analysis is carried out in advance, involving potential user groups and possible application environments. This ensures that the specifications are up-to-date and objective.

The specifications are then verified in a formative or summative usability study.

Usability Evaluation

"Usability Evaluation" is the generic term for different methods with which we test whether and to what extent a product is safe and easy to use.

In general, usability evaluations can be divided into formative and summative studies. Formative studies are seen as studies accompanying product development with the aim of evaluating a current design status and determining optimization potentials. They can be carried out with almost all design forms, from 2D drawings to functional prototypes and in any environment.

Summative studies should generally be carried out with the final product including all components of the user interface and, if applicable, the necessary training concept. They serve the final evaluation of the application safety and should confirm, after a final risk assessment, that the product can be used without unacceptable residual risks.

Usability Test


When conducting formative and summative usability studies, Use-Lab uses a variety of evaluation methods in order to determine the best possible results for you. These will be coordinated with you. The study can focus on individual components of the product, such as the graphical user interface, the hardware or the user manual, or it can illuminate the system as a whole.

We also rely on "Method Triangulation", i.e. a combination of several methods, in order to be able to optimally assess the usability of your product. For example, in addition to our observations, we also take into account objective performance characteristics such as the time required per task or questionnaires for subjective evaluations in order to obtain a picture that is as comprehensive as possible.

Of course, our work always takes into account the current regulatory requirements in the field of usability engineering. Active participation in various national and international standards committees and advisory boards guarantees that our work is 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 important role.

Usability Test

Use-Lab usually conducts studies with potential users for your product. Together with you, we define a user profile with screening criteria in advance, which we take into account during recruitment.

The participants then usually visit our premises in their free time. For studies with international participation, we offer fly-in studies. Alternatively, we can carry out the studies in cooperation with our partners almost anywhere in the world.

Usability Test

  Thore Reitz or Torsten Gruchmann