Study Description
The project commenced with the definition of the intended users, use environment, and primary operational function of the inhaler. The target population included adults with varying levels of experience with similar devices, representing a balance of age, education, and gender. A detailed risk analysis was conducted to identify foreseeable hazards and relevant use scenarios. Critical tasks were defined, including dose loading, device orientation, inhalation technique, and maintenance procedures.
Participant recruitment ensured a balanced representation of both experienced and naïve users. User satisfaction was evaluated through structured post-test questionnaires. The study confirmed a high level of safety and ease of use; however, minor interface adjustments were recommended to further optimize usability. A final report, compliant with the requirements of the Medical Device Regulation (MDR), summarized all findings and served as evidence for regulatory documentation.
