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. CDRH chose to pilot the Innovation Pathway 2.0 (IP 2.0) with ESRD device manufacturers. This pilot, also referred to as the “Innovation Challenge: End-Stage Renal Disease,” was announced in January of 2012.
ESRD was chosen as the focus 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.
CDRH received 32 applications for the ESRD Challenge — more than anticipated. This indicated to us that there is a desire or need from device innovators for early and efficient collaboration with the FDA.
FDA subject matter experts, management, and members of the Innovation Subcommittee of the Center Science Council rated candidates on the following factors:
- 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?
- 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?
In April 2012, the FDA announced its selection of the following three products:
- 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.
The selected developers for this pilot program had an opportunity to participate in IP 2.0 and collaboratively discuss their technology with CDRH reviewers and work with the Center on the development of a benefit-risk profile to help guide future studies and map out a regulatory path forward (a Data Development Plan) for their product. IP 2.0 also supported communications and interactions between the sponsors, FDA and Centers for Medicare & Medicaid Services (CMS). The Innovation Challenge and IP 2.0 program successfully concluded in November 2014 with all three participating developers reporting that the program established an environment of trust that stimulated technical enhancements and significantly shortened their devices pathway to market.