Medical

The development of new medical devices for the use of patients provides two challenges: the device must fit severe norms and approval directives and it has to suit a highly involved target group that needs products fitting their everyday life. These preconditions lead to a high priority towards an optimal user experience of medical devices.

To launch a medical device it has to fulfill the medical products directive 93/42 EWG. This includes creating an ergonomics file that documents all means to achieve an acceptable usability. This means have to be carried out in accordance to the norm DIN EN 60601-1-6.

A fundamental part of meeting the norm’s requirements is conducting validation tests with representatives of the target group. This means that a key criterion to be in accordance with the norm is doing usability testing. The norm even strikes out that testing should be done from the very beginning of the development, involving Usability experts.

We support our clients during the development process of usable new medical products and help matching the requirements of relevant norms and directives.

Selected references

No further brands listed due to non disclosure agreements.

Case studies

Our medical clients strongly emphasize discretion. Therefore neither our client names nor projects carried out together with them must be published. As a consequence the following chapter only includes general descriptions of projects conducted for the medical industry.

Example 1: User experience test

SirValUse has conducted dozens of user experience tests with prototypes of digital and analog medical devices. Most of these tests were conducted together with real patients, medics and medical consultants in several countries.
The goal of these tests was to further optimize the devices to ensure they can be used quick, easy, safe and convenient without impacting the patients daily life.
Most often, these tests are carried out iteratively to check the implementation of changes made since the last test.

Example 2: Quantitative benchmarking tests

These studies are most often conducted in several countries using large sample sizes of about n=400 users.
The tests base on highly standardized face-to-face session with qualified moderators. These types of studies were most often used for the following purposes:
• A winning prototype or concept should be selected from several devices, basing on a statistically valid sample size. The winner was further developed.
• We evaluated the success rate of certain devices to proof whether or not the device is ready (FDA) approval.
• A competitor benchmarking should evaluate the value of our clients' products.

Example 3: Validation testing for DIN EN 60601-1-6 and / or CE label

At the end of a development process a final validation of a medical product is necessary to ensure that the product is in line with DIN EN 60601-1-6 in order to receive a CE label for the product.
SirValUse conducts highly standardized tests that proof whether the product meets the necessary requirements when carrying out relevant tasks with the product. Our clients use the test results as a reference for receiving a CE label or FDA approval.