KidneyX and the Redesigning Dialysis Prize

Creating breakthrough innovations

The US Department of Health and Human Services, the American Society of Nephrology and the National Kidney Foundation have completed Phase 1 of their Redesigning Dialysis Prize. They are looking for solutions that help kidney patients with alternatives to dialysis as it is practised today. 47

They have awarded fifteen finalists from the first stage $75,000 each for their designs. These designs had to replicate normal kidney functions and improve patient quality of life. The solutions improve treatment in a numbers of ways from improving patient mobility to better engineering to avoid risks like blood clotting. 48

Phase 2 challenges participants to build and test prototype solutions, or components of solutions, that can replicate normal kidney functions or improve dialysis access. The most successful three prototypes in Phase 2, which could include entrants who did not take part in Phase 1, will each receive $500,000.

The emphasis on understanding patients’ needs is part of the design of this prize; it is about re-orientating effort to support those on dialysis rather than looking for alternatives like growing organs from scratch, which might be decades away from widespread use. More than 100,000 patients in the United States each year start either temporary or permanent dialysis. Last year there were just over 21,000 donor organs available for transplant. 49 There will be many people who live for a long time relying on a dialysis machine. With this in mind there is a fund for patients to design their own solutions alongside the main prize, offering small grants up to $2,000. There is also a requirement for entrants to the main prize to engage with patient groups.

The federal government in December 2019 allocated $5 million in public funds for KidneyX. Given the $35 billion spent annually in the US on dialysis, this prize has an economic motivation as well. 50 There will be more follow-on prizes under the umbrella of KidneyX after the current phase two is over.

Entrants into this prize were given a detailed roadmap for the goals of the project and the kinds of solutions that the sponsors are interested in. But unlike the DARPA or Ansari prizes, this was not a technical specification for how to win the prize. It focused more on explaining why, for them, better renal care means new forms of dialysis, wearable devices, implantable devices or steps towards regenerated kidneys. They want to move the community away from incremental changes to current machinery, which has become the norm thanks to low funding for kidney medicine. But they also wanted to avoid too much focus on technologies that are decades away like synthetic organs.

One of the first round winners, a team led by Shuvo Roy from UC San Francisco ultimately wants to produce an implantable biomechanical kidney. 51 But the prize led them to design a small home dialysis unit based on their preliminary designs for the implantable one. The focus on improving quality of life now rather than waiting for a full solution helped redirect their attention.

Help innovators thrive

The required patient engagement for all entries comes with introductions to patient groups that have already signed-up to support the prize: ‘We know that many KidneyX applicants will be entering the kidney space for the first time and will not have direct access to patients. As such, we have developed a list of contacts at reliable partner patient organizations that could help identify patients that would be interested in providing direct feedback to KidneyX applicants.’ 52

This appears to have changed the narrative for some of the entries, with demonstrable awareness of improving quality of life in the winners of phase one, including the UC San Francisco team above.

The Department of Health and Human Services divisions participating in KidneyX include the Centers for Medicare and Medicaid Services, the Food and Drug Administration and the National Institutes of Health . This combination offers new access to – and a sympathetic ear from – large patient populations, regulators and research funders.

KidneyX preceded, and perhaps helped make the argument for the Executive Order signed by President Trump in 2019 to launch Advancing American Kidney Health. The initiative provides specific solutions to deliver on three goals: fewer patients developing kidney failure, fewer Americans receiving dialysis in dialysis centres, and more kidneys available for transplant. In particular, it is pushing for regulatory change to make home dialysis possible for more patients – led by the regulators who will need to make that change. 53

The winners of Phase 1 of this competition have received an additional $75,000 to support their prototypes for Phase 2. Moreover, they now each have confirmation that their idea is viable from the panel of 40 experts that judged that round, as well as online videos showcasing their work from the US Government. This should help support their case for additional investment. One company, Outset Medical, recently closed a round of $125m funding for its solution. It was established in 2003, so some of its technology and reputation predates the prize. But the win in Phase 1 is central to its promotional information, and with the momentum of the additional government funding for KidneyX, will likely have helped it secure that funding.