News and Insights

Written by Sam Sye Recently, I was working on a project where the product under research involved removable components. During the study, it became increasingly apparent that many users encountered difficulty recognizing the need to remove such components, or how such a task could be accomplished. Color is a magnificent way to catch users’ attention and direct them to a course of action. However, as we soon discovered, color may carry unintended connotations for end users, which may ultimately backfire. In particular, this product used black arrows to indicate how to remove certain components of the device. The rationale for this particular choice of hue was that it provided the greatest contrast to the white background of the device. Under this criterion, the color of the arrows worked fabulously. Participants indicated this design was eye-catching, easy to see and understand. In the US, the design was vastly preferred to other alternatives. When we tested the same de...

Written by Arathi Sethumadhavan This guidance   was issued by the FDA last month and provides answers to the following: What is Patient Preference Information (PPI)? Refers to patients’ experiences with a disease or condition and its management Can also include the assessments of care partners Can be quantitative or qualitative What will PPI be used for? PPI may be used to understand a disease and the impact it has on patients PPI may be used to understand the risk-benefit tradeoffs for treatment from the patient’s viewpoint. Specifically, if a large number of well-informed patients believe that the benefits of the product far outweigh the risks, FDA can use this information to influence their decision PPI may be used to understand how different sub-groups of the patient population view a product PPI will be useful for devices with a direct patient interface, devices with an impact on patient’s quality of life, life-saving devices with a high risk profile,...