analyze - The basis for user-centered design
The analysis takes the users, the specific context of use, and potential risks into consideration. Thus, this phase forms the basis of all subsequent phases, e.g. successful design and evaluation.
Extensive analysis...
For Medical Safety Design, experts first collect information on the market and make a comparison with similar products. The collected context of use such as user profile, task description, or work environment serves to understand the users and their requirements. This may be the basis for typical use case scenarios. Potential risks when using the product properly are described and evaluated.
...documented requirements...
The "analyze" phase documents requirements of the medical product to be designed. The documented use case scenarios, tasks, and objectives of the users serve as a set of criteria in subsequent phases.
...and risk management
A risk analysis checks the product safety, use safety, production safety, and maintenance management. Based on this analysis, additional requirements for the design of the medical product are defined.