KHI Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies

With the aid of patients, care partners, and multiple academic, private, and public communities, the Kidney Health Initiative’s newly developed technology roadmap is catalyzing innovative approaches to kidney replacement therapy (KRT). The roadmap provides guidance for innovators and entrepreneurs who are working to redesign dialysis and provide better care for those with kidney disease.

With the aid of patients, care partners, and multiple academic, private, and public communities, the Kidney Health Initiative’s newly developed technology roadmap is catalyzing innovative approaches to kidney replacement therapy (KRT). The roadmap provides guidance for innovators and entrepreneurs who are working to redesign dialysis and provide better care for those with kidney disease.

The Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and the US Food and Drug Administration, has convened a multidisciplinary group to create a technology roadmap for innovative approaches to KRT to address patients’ needs. The Roadmap is a living document. It identifies the design criteria that must be considered to replace the myriad functions of the kidney, as well as scientific, technical, regulatory, and payor milestones required to commercialize and provide patient access to KRT alternatives. Various embodiments of potential solutions are discussed,   Roadmap is agnostic to any particular solution set. System enablers are identified, including vascular access, biomaterial development, biologic and immunologic modulation, function, and safety monitoring. Important Roadmap supporting activities include regulatory alignment and innovative financial incentives and payment pathways. The Roadmap provides estimated timelines for replacement of specific kidney functions so that approaches can be conceptualized in ways that are actionable and attract talented innovators from multiple disciplines. The Roadmap has been used to guide the selection of KidneyX prizes for innovation in KRT.

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“KHI has developed the Technology Roadmap for Innovative Approaches to KRT with a primary focus on the professed needs and preferences of patients with advanced kidney disease. With increased awareness by disparate technological communities of opportunities to make transformative contributions, together with additional interest and investment from the corporate, philanthropic, and venture capital communities, it is hoped that this Roadmap will facilitate the achievement of brighter future for the growing population of patients worldwide with kidney disease.”

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