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Formative Testing of medical Devices

 

Whether a product is really good can only be seen when it comes into contact with the subsequent user. The time of the first contact is decisive for the quality of your product.

Our idea is to test your medical device as early as possible during development. These tests during development are called formative tests and aim to detect and change weaknesses in the usability and safety of the product (and in our case also the user experience) at an early stage.
Before the product is on the market and a change becomes really expensive.

In our 300(+) projects, we have been able to identify and fix some major problems early on that are almost invisible to the developers.

To make these early tests succeed, we use a variety of prototypes to quickly create experiential experiences for users without programming or any manufacturing.
Testing can then be done either in our labs, at your site, or in the field.
This allows us to show you what needs improvement and where you are already doing well.

The methods we use for the formative tests depend strongly on your question and are always individually adapted to your product. Generally, we use methods where users can directly try out the prototype and are asked about it (so-called usability tests).
However, other methods are also used at the beginning of development (e.g. Contextual Inquiry – an on-site survey if there is already a predecessor or competitor model, or an expert assessment if there is nothing to see yet).

But even here we are pragmatic: Since the final summative test is usually a usability test by default, we also use this method formatively, quasi as a trial run, to hear the certainty of an approval and to minimize your risk.

 

The obligation: Summative testing for medical devices.

Formative Testing by experts: schedule an call and get advise now.