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The Kidney Innovation Accelerator (KidneyX) is a partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). HHS and ASN plan to hold a series of KidneyX prize competitions to develop innovative solutions that can prevent, diagnose, and/or treat kidney diseases. Every KidneyX prize competition will define a problem, without a pre-conceived notion of what the solution(s) should be, and ask participants to find solutions. Think better, think bold, think big.
The initial KidneyX prize competition is "KidneyX: Redesign Dialysis," which has two phases. Phase 1 (submissions open now) asks participants to design potential solutions or components of solutions, while Phase 2 asks for the demonstration of a prototype solution or component. Both phases will be open to all eligible participants. Participants do not have to submit a Phase 1 entry in order to submit a Phase 2 entry.
The Redesign Dialysis prize seeks solutions or components of solutions that offer patients significant alternatives to dialysis as it is generally practiced today. The competition is intended to attract a wide range of ideas and participants and thus to catalyze development of new, improved classes of renal replacement therapeutic options. Of particular interest is applying advanced technologies currently used in non-kidney areas to current or potential renal replacement therapy technologies. We seek ideas and participants from outside the field of kidney health as well as from within it. Many potential prize competition participants may have applicable technologies, concepts, or expertise from domains that have not previously been considered in improving renal replacement therapy. Similarly, there may be innovators working on component technologies or discrete concepts that may have utility as one part of a novel renal replacement therapy solution.
This prize competition will be run in two phases; participants may submit a solution in Phase 2 even if they did not participate in Phase 1. Phase 1 is a design phase that asks participants to submit their ideas and solutions related to renal replacement therapy. Up to 15 Phase 1 winners will be selected, with each eligible Phase 1 winning submission receiving a $75,000 cash prize. Winners may also be invited to present their ideas at an open public meeting with an audience expected to include stakeholders from across government, investors, patients, industry representatives, academics, and non-profit organizations. Eligibility rules are described in "Terms and Conditions." Participants do not have to submit a Phase 1 entry in order to submit a Phase 2 entry.
Phase 1: Design
Phase 1 participants should ensure that their submission provides sufficient detail and information to allow judges to evaluate the submission in accordance with the following Phase 1 evaluation criteria:
Potential to significantly improve or add to the landscape of solutions to manage kidney failure
Clearly demonstrates a vision for medical product development, which should include a clear articulation of the problem being addressed/solved.
Clearly demonstrates that the proposed design includes new components, technologies, or approaches that have not previously been part of renal replacement therapies
Nature and extent of anticipated benefit(s) to patients,
Clearly demonstrates efforts to incorporate patient feedback into the design
Clearly addresses one or more of the “Improving Patient Quality of Life” objectives discussed in Section D, above
Feasibility of producing a functional prototype (including scientific and technological rigor)
Clear descriptions of technological or scientific needs, if any, for potential development of a prototype (e.g., what gaps in the proposed solution exist, how might your design fit with existing approaches to create a solution, where do you need additional input?), to better inform and position HHS and ASN to offer assistance if appropriate
Clear explanation of additional challenges or potential pitfalls that need to be considered or addressed
Feasibility of development milestones over one year
Feasibility of regulatory approval of the proposed solution
Clear explanation of the knowledge or expertise the participant/participant team brings to the development of the proposed solution.
Quality of evidence supporting the design
Phase Two: Prototype Demonstration
Phase 2 of the prize competition asks participants to build their proposed solution into a prototype. Participants may also submit a prototype solution in Phase 2 even if they have not submitted a design solution in Phase 1.At the end of Phase 2, judges will review submissions and an authorized official will select up to 3 winners, with each eligible winning submission receiving a cash prize of $500,000. Eligibility rules are described in "Terms and Conditions."
Phase 2 participants should ensure that their submission provides sufficient detail and information to allow judges to evaluate the submission in accordance with the following Phase 2 evaluation criteria:
Demonstration of at least the first iteration of a prototype solution whose function addresses one or more elements of the prize competition scope described in Section D, above (testing in animals or humans is not required, but some demonstration or documentation of the prototype’s operating capacity is necessary).
Demonstration of patient input in the design of the prototype.
Degree to which input from patients has informed the development of the prototype
Estimated patient quality of life impact if the prototype solution were to be broadly implemented
Prototype addresses one or more of the "Improving Patient Quality of Life" objectives discussed in Section D, above
Degree of innovation from past approaches or solutions
Potential for prototype to significantly advance towards readiness for animal or human studies (if applicable)
Long-term vision for product development of the prototype solution, including potential pathways for commercialization
Collaborations or planned collaborations, if any, with industry or other entities (participants may choose not to disclose all such collaborations if they wish)
Next steps and potential challenges envisioned/proposed for product development, potentially including gaps in existing technologies, manufacturing, regulatory, or payment hurdles (the purpose of this information is to better inform and position HHS and ASN to offer assistance if appropriate)
Blood Filtration (filtering blood to remove waste and excess fluid)
Electrolyte Homeostasis (maintaining appropriate levels of key minerals in the blood)
Fluid Regulation (regulating the amount of and/or removing excess fluid)
Toxin Removal and Secretion (removing, limiting or preventing toxins in the bloodstream)
Filtrate Drainage and Connectivity (removing excess filtrate after processing; connectivity issues for filtration, processing, and exterior drainage)
Improving Patient Quality of Life:
Minimizing burden on the family and care partner(s)
Improving ability to work, travel, and engage in recreational activities
Increasing mobility and physical activity
Improve upon vascular/peritoneal access to limit needle sticks, physical alterations to patient
Reducing disease and treatment complications
Providing more choices for treatment
Liberalizing diet and fluid regulation
Reducing medication burden
Improved renal replacement therapy access (vascular or peritoneal access needed for treatment)
Addressing engineering challenges (e.g., preventing clotting, bleeding, and infection in vascular circuit and associated devices)
Biological and Immunological modulation
Biosensor development and other safety monitoring functions
Use Challenge.gov to submit your solution.
For Phase 1: Participants are asked to submit designs for potential solutions or components of solutions. A participant’s Phase 1 submission (due February 28, 2019) must be 6 pages or less, 8.5 x 11 inch page, 10-point font or greater and one inch margins. Additionally, participants must include a publicly shareable abstract (not longer than 1 page) describing the proposed solution or component technology. By submitting an entry, all Phase 1 participants automatically agree to allow this abstract to be published on the KidneyX.org site. Participants may, but are not required to, submit a visual supplement as part of their Phase 1 submission (e.g., a link to video, a website, or design specs)
For Phase 2: Participants are asked to demonstrate a prototype solution or component of a solution. A participant’s Phase 2 submission, must be 10 pages or less, 8.5 x 11 inch page, 10-point font or greater and one inch margins. Phase 1 winners that wish to participate in Phase 2 must submit a separate Phase 2 application. The participant must also submit a visual (photographic or video) presentation demonstrating the actual prototype. Finally, Phase 2 participants must include a publicly-shareable abstract summary (no more than one page) of the prototype solution. By submitting an entry, Phase 2 participants automatically agree to allow this abstract to be published on the KidneyX.org site
HHS Competes was established after the signing of the America COMPETES Act, to invest in innovation through research and development, and to improve the competitiveness of the United States. HHS Competes is a way for HHS employees to draw on external talent and ideas to solve critical problems.
HHS has sponsored over 100 challenges and awarded 4 million dollars in prizes, leading to the development of many novel solutions to address complex problems.