Medical Device Design
•We can advise and support you in generating concepts, detailed design, and prototypes at any point in the whole design and development process. Typically, the device should go through an iterative design process before released to the market.
•We collaborate with you to produce refined designs by generating many concepts, prototyping and user testing the most promising concepts, and converging on the best solution.
•A good user interface (UI) is essential for users, such as healthcare professionals and patients, to interact correctly with a medical device. The UI may comprise displays, controls, and other touchpoints and be found on devices as large as an MRI scanner or as small as a blood glucose meter. Regardless of device type and scale, poor design can be the root cause of use errors and risks.
•We can support your hardware and software user interface design. For your UI design process we can:
produce user research
produce a user-related risk analysis
develop design specifications
according to user research and your requirements, product design concept(s)
develop and detail the concept(s)
build prototype(s) with you
produce a human factors and usability formative study (see HUMAN FACTORS AND USABILITY)
develop and refine to a final design
a human factors and usability validation study for the final design
document the final design
Labelling and Packaging Design
The FDA and CE regulations and standards require medical devices (including combination products) to include validated labelling; this normally includes on-product labels, instructions for use, and packaging. Poorly designed labelling can cause use errors and risks even if the device’s physical and/or computer-based user interface elements are well designed.
•We can help you communicate to your target users how to properly operate your device by designing easy-to-understand and follow labelling that incorporates optimised features, such as user-oriented terminology and symbols, coherent and task-oriented information layouts, visually pleasing compositions, and simple infographics.
We also help you design and develop effective and user-friendly labelling by defining user requirements and developing optimised concepts. The result is validated labelling solutions that help ensure your device is safe, effective, and satisfying use.