Technology Roadmap for Innovative Approaches to Renal Replacement Therapy
Projects
Portfolio:
Devices
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Education and Resources, Toolkits
In October 2018, the Kidney Health Initiative (KHI) published The Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy (KRT), which aimed to stimulate the innovation needed to move toward this goal. The goals of the roadmap are to:
- Spur innovation in the KRT field
- Create opportunities to attract industry and academic investment in developing KRT solutions
- Encourage an internationally oriented multidisciplinary approach to solution development
- Accelerate the availability and adoption of commercially viable solutions
- Ensure that patient and care partner preferences are incorporated throughout the KRT solution development life cycle
- Optimize models of reimbursement
As part of the roadmapping process, KHI incorporated input from patients, researchers, health care professionals, care partners, product developers, entrepreneurs, regulatory agencies, and payers.
Publications & Resources
The roadmap has inspired several KHI-driven projects that extend the work of the roadmap:
- A patient edition of the roadmap
Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy: Patient Edition
- Fostering Innovation in Fluid Management: A supplement to spur innovation in fluid management devices and techniques
Today’s innovators can change the status quo in fluid management for people with kidney failure. Despite the potential for severe complications, current fluid management methods amount to trial and error, and there are no approved devices for objectively measuring volume status. This document provides guidance to spur innovation in fluid management devices and techniques that will improve the quality of life of people with kidney failure.
- Clinical Trial Design to Support Innovative Approaches to Renal Replacement Therapy: A set of FDA resources for the developer community related to clinical trial design for innovative approaches to KRT
To bring innovative treatment alternatives to people with kidney failure, innovation in clinical trial design and endpoints must keep pace with innovation in products. This project facilitated coordination between regulators and the nephrology community to streamline the clinical development pathway. It defined terminology for future KRT products and identified the most appropriate trial designs and endpoints for a variety of RRT products.
Defining Common Renal Replacement Therapy Terminology
FDA Resources for Developers of Innovative Approaches to Renal Replacement Therapy
- Fostering Innovation in Fluid Management: A supplement to spur innovation in fluid management devices and techniques
- Human Centered Design Toolkit for Treating Kidney Failure
This toolkit provides pre-clinical innovators and early-stage start-ups developing kidney replacement therapies with empathy tools to facilitate their interactions with people with kidney failure, enable market segmentation, and provide a framework for a customer requirements document.
Human Centered Design Toolkit: Treating Kidney Failure, Version 1
Human Centered Design Toolkit: Treating Kidney Failure, Version 2
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- Drugs, Education and Resources
- Clinical Trial Endpoints, Drugs
- Clinical Trial Infrastructure, Drugs
- Devices, Patient Preferences
- Devices, Patient Preferences
- Patient and Family Engagement, Patient Preferences