Innovation Challenge: End-Stage Renal Disease

The application period for the Innovation Challenge
is now closed.

Sponsors Participating in the ESRD Challenge
How the FDA Selected Sponsors for the ESRD Challenge

In January 2012, the FDA announced the Innovation Challenge — a pilot program for innovative devices that address end-stage renal disease (ESRD).

Applicants from the ESRD Innovation Challenge will participate in Innovation Pathway 2.0, allowing the FDA assess the strengths and weaknesses of the Pathway's features and fine-tune them for broader application.

End stage renal disease (ESRD) is a condition that occurs when kidneys are no longer able to work at a level needed for day-to-day life. Patients with ESRD require life-supporting treatments such as maintenance dialysis or kidney transplantation.

The Innovation Challenge focuses on devices that may have a significant impact on public health. We chose ESRD as a focus for Innovationa Pathway 2.0 for a number of reasons:

• ESRD is managed almost entirely using medical devices, such as dialysis systems, vascular access systems, and diagnostic tests.
• ESRD management is costly, and it negatively impacts the patient's quality of life. Most patients must undergo dialysis treatment in clinics several times a week in sessions that can last several hours.
• ESRD is a growing public health care concern in the U.S.
• ESRD could benefit from innovative devices and transformative improvements.

Sponsors Participating in the ESRD Challenge

CDRH received 32 applications for the ESRD Challenge — more than we anticipated. This indicates to us that there is a desire or need from device innovators for early and efficient collaboration with the FDA.

The FDA chose three products to participate in Innovation Pathway 2.0:

• An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco,
• A Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif., and
• A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

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How the FDA Selected Sponsors for the ESRD Challenge

The FDA encouraged interested to contact us for more information and to submit an application for the program. A copy of the application form is provided here.

FDA subject matter experts, management, and members of the Innovation Subcommittee of the Center Science Council discussed each application internally, and held an initial teleconference with each candidate to better understand the device technology, its public health impact, possible regulatory impact, and stage of development.

After speaking with each applicant, the FDA rated candidates on the following factors:

Innovation

• Does the product involve an innovative technology?
• Does the product use a novel approach to solve a technological problem?
• Could FDA's in-house technical/clinical expertise be advanced by partnering with the sponsor this project?

Regulatory Impact

• Does this project challenge an existing regulatory framework or give the FDA an opportunity to re-evaluate earlier precedents?
• Does this project give the FDA an opportunity to create or influence new models for regulation?

Public Health Impact

• Does this product target a vulnerable patient population?
• Does it have the potential to draw meaningful clinical impact relative to the current state of the art?
• Does it appear to have the potential for a favorable Benefit-Risk profile?
• Does it have the potential to improve patient access to healthcare?

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