A multidisciplinary judging panel will evaluate Phase 1 submissions using the equally weighted criteria. Depending on the volume of submissions received, an expert panel may conduct an initial review of eligible submissions and determine a subset for judge evaluation.
Phase 1 evaluation criteria
The degree of confidence in the enabling solution to safely replace or support one or more kidney functions, and the ability to sustain continuous functionality over time. (See the Kidney Health Initiative 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy for specific targets by functionality.)
The degree to which the submission demonstrates potential utility in serving as a foundational enabling element of an artificial kidney, and clearly outlines plans to collaborate with other innovators and experts in further development.
The likelihood based on bench or animal testing results or other justification that the enabling solution could integrate with nascent artificial kidney solutions or receive approval to begin first-in-human clinical trials within 3-4 years from submission.
The potential for the solution to improve quality of life and clinical outcomes for a broad spectrum of patients (e.g., those with differing access to care or comorbidities).
The level of advancement beyond established scientific methods and technology (e.g., advances in materials, biocompatibility, power utilization, size/weight, sensors, long-term patency).
Development progress and plan
The amount of progress completed relative to funding received, the rigor of plans for continued development in Phase 2, and confidence in the team to execute.
The potential and timeframe for the enabling solution as part of an integrated artificial kidney to attract external investment, be produced sustainably at scale, and obtain payer reimbursement once commercialized.
To achieve KidneyX programmatic goals, HHS and ASN may consider the diversity of solutions when selecting winners from the top-scoring submissions recommended by the judging panel.