Out Data Driven UX Design Process (3DUX®)
Our approach to safe and efficient use of a medical device or IVD is the Data Driven UX Design process (3DUX® for short). It ensures that important design decisions, which are essential for safe use, are made based on data.
The process relies on a mix of usability & user experience design and user research with real users – it doesn’t matter if they are expert or lay users. Even with multiple user groups, the process works flawlessly.
The right users
Together with you, we define the intended users and get to know their characteristics, goals, tasks and the use environment in a usage context analysis. Only those who clearly specify who the intended users are can also prove that precisely these users can use the product safely.
We are happy to recruit the right users for your studies. In doing so, we draw on a large database of participants. It does not matter whether you need lay users or medical professionals. We document the findings for you in the Use Specification.
Identifying risks and risk assessment
The consideration of potential risks plays an important role in the development of medical devices and IVDs. We help you to identify, control and document critical hazards and to exclude them as far as possible through the user interface design.
Together with you, we create the hazard-related use scenarios for the summative tests. Especially for products with several defined user groups, the 3DUX® process is a great help here.
Define the user requirements
We define what your product must do in order to be used safely according to its intended purpose by the intended users. Together, we develop the list of mandatory requirements for your product.
Of course, we also pay attention to the necessary documentation of the results and the process according to IEC 62366-1 and FDA.
Design, test and iterate
We implement the defined requirements in a user interface design. In such a way that all already known risks are excluded during use.
Then the user interface design is iteratively tested and evaluated with real users using a prototype. Iterations follow until the medical device or IVD no longer has any critical use errors.
Of course, this is also always documented so that at the end you have a complete usability engineering file or a complete human factors report.
Summative Evaluation / HF Validation
If no more critical use errors occur in the previous step, it’s time for the final step: In a summative evaluation, we prove that your product can also be used provably safely – and by real users in accordance with its intended purpose.
At the end of the process, you will have a complete usability engineering file or a complete human factors report with all the evidence you need according to MDR and FDA regarding the usability of your product.
Learn more about Medical Usability
We regularly write expert articles on the topic of medical usability and usability engineering for IVDs and medical devices. We also offer pragmatic tips for implementing regulatory requirements in your product design.
What is your specific case? We would be happy to find out together in a free, no-obligation, get-to-know-you meeting what challenges we can help you with. We look forward to hearing from you!