Evaluating Medical Devices in Nephrology Using Patient-Reported Outcome and Experience Measures

Abstract

Incorporating the patient's perspective into the entire product life cycle of medical device development is paramount for ensuring patient-centric evaluation. By prioritizing patient-centric evaluation, medical device developers can better address patient needs and enhance the quality and effectiveness of health care solutions. Patient-reported outcomes (PROs), patient preference information (PPI), and qualitative inquiry are methodologies to incorporate and amplify the patient's voice. In nephrology, unlike in other clinical domains, the utilization of PROs, PPI, and qualitative inquiry in medical device development has been notably sparse. Consequently, a glaring absence of patient involvement in the development of devices leaves the impact of these devices on patient well-being and functionality largely unexplored. Many forward-thinking programs as well as Food and Drug Administration guidance on the use of PROs and PPI are effectively bringing PROs into nephrology device development. Many resources exist to help researchers select high-quality PROs. There are unique considerations for using PROs and PPI to support regulatory decision-making, including fit-for-purpose, concepts of interest, context of use, and least burdensome selection. The rapid evolution of patient-centric initiatives in nephrology will serve to ensure that medical devices meet the needs of people with kidney disease and improve the quality of care.

Keywords: Medical device; patient preference information; patient-reported outcome; regulatory decision-making.