Client/Industry: Medical Devices (Classes I and II)
Problem: Human Factors engineers must confirm patient needs and ensure that medical devices meet FDA safety standards. Internal client teams believe they are on the right track but cannot proceed without following FDA guidelines.
Research: Establish patient profile and potential need or interest in the medical device being studied.
Synopsis: Orman Guidance follows FDA standards of data collection that enable manufacturers to assess and reduce risk in medical devices. Formative evaluations help research teams learn more about challenges they can help solve, and summative studies help confirm that consumers can safely use the device. In all studies, Orman engages a balanced representation of people that may ultimately benefit from the device. Same as above…the Level2 press releases, could we have more than 1?
Related press releases: Innovative New Level2™ Digital Health Therapy Resulted in Better Health for People with Type 2 Diabetes – UnitedHealth Group & UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control | MedTech Dive