Attention to the innovation deficit in treatments for kidney failure is increasing. As development of next generate kidney replacement therapy begins to accelerate, the perspectives of people with kidney failure must not be overlooked. To bridge this gap, the Kidney Health Initiative published a conceptual framework for patient reported outcomes regulators and device developers can use to incorporate the patient perspective into the total product lifecycle.

A workgroup convened to review exiting patient-reported outcome measures (PROMs), synthesize existing data on patient preferences, and develop a framework for future PROMs that could be used in the evaluation of transformative renal replacement therapy devices. Such a framework can be used to catalyze patient-centered innovation by incorporating patient perspectives into both the development and regulatory evaluation stages of the total product life cycle.