Manufacturers of medical devices, IVD medical devices, and combination products must avoid delays in development and approval, lack of market success, and harm due to poor usability. The same applies to internal disagreements over design concepts.
This is exactly where our formative evaluations in all markets around the world help:
The secret of successful devices: User research and formative evaluations help manufacturers elicit user requirements and identify strengths, weaknesses, and risks in design concepts and prototypes, leading to targeted design improvements.
Through targeted evaluation methods and competent moderation, formative evaluations can ensure manufacturers have the insights they need to develop successful devices. Successful devices help users to complete tasks efficiently and offer a good user experience.
Formative evaluations are the prerequisite for legally compliant usability files, for fast and scheduled device approval, and for successful audits and reviews.
Requirements Engineering: Capturing user needs and requirements for a needs-based product design
Planning of the Evaluation: Determination of objectives, success criteria, methods, type and number of test subjects, and evaluation
Design Evaluation: Assessment of design concepts from initial drafts to high-fidelity prototypes
Iterative Tests: Continuous evaluation throughout the development phase for continual improvement
International Evaluations: Conducting evaluations in different countries for global market access
Variant and Competitor Comparison: Tests with different variants and comparison with competitor devices for positioning
Our usability team will help you select the most suitable method for your task and your devices, such as
Heuristic Evaluation: Our team checks the device against heuristics and standards to reliably identify potential usability problems with little effort.
Cognitive Walkthrough: Our team guides representative users through the device to obtain valuable feedback.
Usability Tests: In a usability test, intended users are asked to perform a realistic task with the device in a realistic use environment. This creates the highest level of safety for the subsequent summative evaluation.
A/B and Multi-variant Testing: Users test two or more design variants of the user interface or individual user interface elements. This allows you to choose the demonstrably best variant with certainty.
Contact us now to perform professional formative evaluations and ensure
that your devices meet the expectations of your users and auditors.
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+49 7531 94500 20
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We help you create the prerequisites for the rapid approval of your devices with IEC 62366-1 and FDA compliant summative evaluations.
With our usability labs in Germany and the USA, you create all the prerequisites for successful usability studies and usability tests.
We take over the complete recruitment of healthcare professionals for your usability studies – from search to support on the day of the test.
We help you prove your marketing claims quickly and credibly and thus boost the marketing of your devices.
Need a standard-compliant usability file (human factors engineering file) to pass audits and approvals? We have the know-how! Our customized templates and professional support make it possible.
We analyse and evaluate the usability of your medical devices in everyday use in accordance with MDR after they have been placed on the market.
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