Usability Engineering
Regulatory usability in line with design development
The usability of a product is only as good as its integration into the development process!
In order for usability methods such as context analysis or formative evaluations to lead to an actual improvement of the product, they must be anchored in the project at the right time and with the appropriate questions. We have made it our goal to effectively incorporate the needs of the user into the overall development by synchronizing usability engineering and design development.
Why you should integrate usability into your process
Differentiation from competitors
Securing the Summative Evaluation
Safeguarding decisions
Fulfillment of the MDR
Risk minimization of the medical device
Basis for the accompanying documentation
Usability identifies, design solves
In our understanding, design and development create solutions within the problem space identified and defined by usability. Through coordinated processes of technical development, design and usability engineering, the disciplines complement each other optimally and through the right interface methods from our medical design process, usability engineering becomes an effective tool for your development and not just an elaborate accessory for the medical device file.
Usabilityfrontend & backend
The accessibility of findings and results from usability activities is, in addition to process integration, another decisive factor for the effectiveness of usability engineering. Often, project participants first have to fight their way through bulky usability documents, i.e., the "usability backend", in order to access the information relevant to them. For the usability file required by MDR and FDA, these formal documents are of course relevant. However, they are not always suitable for the daily work of project teams or product managers.
A "usability front end" in which content and findings are made usable for the respective needs of the project participants is therefore the key to success. In this way, usability can be made into a common communication basis and interface between the various stakeholders.
Usability Engineering Services
Usability integration into the design process
Usability from the very first idea! We offer continuous support of the design process through usability engineering, allowing usability findings to be integrated as early and directly as possible into your product development.
To this end, our design services mesh seamlessly with usability activities to help capture and develop human-machine interaction in a structured way.
In this way, usability becomes a living part of the development process, facilitating decision-making and safeguarding conceptual and technical development.
Usability Strategy & Management
The usability strategy as a secure foundation for your project. Together with you, we plan and accompany your precisely fitting and interlocking process as the cornerstone for effective and goal-oriented usability activities that support your development.
User Research & Context Analysis
Know your users and understand their problems! By involving users and methodically capturing the context of use, we support you in gaining objective insights and defining the usage requirements for your product.
Usability Engineering File & Documentation
In addition to an effective implementation of usability, we also support you with the corresponding regulatory documentation of, for example, evaluations, use scenarios or the use specification.
Formative & summative evaluation
The proof of the pudding is in the eating - testing is the best way to ensure the quality and functionality of a product. That's why we work with you to conduct in-process formative and final summative evaluations in accordance with the MDR and FDA.
"A product that inspires in its use - effective process integration makes usability a powerful tool in your product development."
Your contact person for usability engineering
Anna-Lena Gölz
Head of Usability Engineering
+49 89 780 196 50
annalena.goelz@wilddesign.de