As noted in previous posts here on the Community Blog, dialysis is a therapy whose time has come, and disruptive innovation is needed. In a first-of-its-kind partnership between the US Department of Health and Human Services and the American Society of Nephrology, the ongoing KidneyX: Redesign Dialysis prize competition is looking to spur medtech innovation that completely disrupts the way kidney failure is treated.
“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has.”
This thought-provoking quote from American cultural anthropologist Margaret Mead characterizes the evolution currently taking place in the stagnant dialysis space. And, in this author’s view, these long-overdue efforts reiterate the theme of everything we do here at the Community Blog: because patients simply deserve better.
As covered in previous Community Blog posts and in our publications, dialysis device innovations currently making their way through development pipelines around the globe are looking to address the problem of maintaining healthy and functional access to the dialysis patient’s lifeline―their bloodstream―and improve the overall treatment experience for patients who depend on it to live, while addressing the enormous healthcare costs associated with chronic kidney disease (CKD; see infographic here). And now, the US Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) have formed a partnership to help catalyze change and expedite the development of innovative new renal replacement therapy (RRT) solutions.
The HHS/ASN partnership has its roots in the June 2016 White House Organ Summit, which called for an increase in breakthrough research and development to improve outcomes for patients needing transplants. In response, the Kidney Health Initiative (KHI) established an initiative to foster a new, multidisciplinary approach to advancing solutions that can improve the lives of millions of kidney patients with end-stage renal disease (ESRD). Last October, KHI published the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy. As noted in the table below, this patient-centered roadmap outlines strategies and research pathways needed to more effectively and efficiently develop commercially viable RRT alternatives to current dialysis treatment.
The roadmap also provides a backdrop for the KidneyX: Redesign Dialysis prize competition, a first-of-its-kind public-private partnership between HHS and ASN, in which the two organizations are committing $2,625,000 in prize money to engineers, scientists, and other innovators, to completely disrupt the way kidney failure is treated.
KidneyX is the first in a series of programs being designed to spur innovative solutions that can prevent, diagnose, and/or treat kidney diseases, according to HHS. The Redesign Dialysis prize will run in two phases. The first, which will award up to 15 prizes of $75,000 each (launched last October and running through February 2019), asks participants to design solutions or components of solutions that can replicate normal kidney functions and improve patient quality of life. What’s especially exciting is that dialysis patients will be on the competition judging panel and are part of the review process.
The second phase, running from April 2019 to January 2020, will ask participants to develop initial prototypes; this phase will award up to three prizes of $500,000 each. Participants may compete in the second phase even if they do not submit a solution in the first phase.
The competition has received a tremendous amount of interest, including from those outside the usual nephrology device and patient care community, says Dr. Sandeep Patel, Open Innovation Manager and KidneyX Program Director at HHS, in a recent interview with the Community Blog.
HHS/ASN Partnership: Looking Beyond What’s Currently Possible in RRT
So how did this partnership come about? ASN leadership became interested in looking for ways they could help jump-start innovative new product development, based on the frustrations experienced by physicians and dialysis patients with current outdated options and the need for truly transformative changes in kidney care, says Rachel Meyer, Director of Policy and Government Affairs at ASN, in a recent interview with Patel and the Community Blog. “It’s really important that ASN has partnered with the federal government to try to achieve these goals of making it possible for more new products to come to market that can benefit patients, because of the unique market dynamics in kidney care,” she says. “The Medicare ESRD Program has a really outsized influence as it is the only program that offers coverage to anyone who is affected by kidney failure, regardless of age or income. In addition, the federal government, via the FDA, is the market regulator for all medical products that come forward.”
“With the first phase of KidneyX, we wanted to bring awareness to the idea that we can do better for dialysis patients, that there are urgent problems to be solved in this space,” explains Patel. “In terms of the medtech community, we wanted to address how we can bring expertise and insights into medical device development from other diverse fields such as nanotechnology, flow systems, and sensors,” he continues.
KidneyX also has a focus on de-risking commercialization by helping prize winners receive input and feedback from patients, investors, business and manufacturing experts, scientists, engineers, and others as needed. By bringing innovators together with government representatives from the FDA, the Centers for Medicare & Medicaid Services (CMS), and the National Institutes of Health (NIH), HHS plans to help KidneyX participants receive useful feedback, to the extent appropriate for each agency, early in the product development process.
We can’t wait to see the forward-thinking ideas that come from this competition! The Community Blog will provide an update on the KidneyX prize winners later this year.
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