KHI Current Project

Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)

Overview

Accelerated innovation in the kidney community highlights the need for integrating the patient perspective at every step of the product lifecycle. Access to scientifically valid patient preference information could positively inform the decisions of industry and regulators as they design and review new devices for people with kidney failure. This project, a three-year contract with the FDA, collected patient preference information on innovative renal replacement therapies (RRT). This helped Kidney Health Initiative members and the kidney community with the development of safe, effective, and novel RRT devices that target the issues that are important to patients and their care partners.

Deliverable

• Advancing the Use of Patient-Reported, Real-World Evidence for Medical Device Evaluation of Innovative Products for the Treatment of Kidney Failure Using Strategically Coordinated Registry Networks
• Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease
• Incorporating Patient Preferences via Bayesian Decision Analysis
• An Opportunity to Spur Patient-Centered Innovation in Kidney Replacement Therapy Devices
• Legitimization and Incorporation of Patient Preferences: The Arrow that Hit the Achilles Heel of Status Quo Kidney Care
• Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices
• Risk Tolerance in the Setting of Wearable Dialysis Devices: A Patient Preference Study Using the Threshold Technique