Kidney Health Initiative Seeks Patient Input into Medical Device Development

The Kidney Health Initiative (KHI) continues to make advances toward addressing the needs of the kidney community and fulfilling its mission through member-driven, multidisciplinary projects. This public-private partnership between the American Society of Nephrology (ASN), the US Food and Drug Administration (FDA), and over 70 member organizations and companies is coordinating 10 different projects focused on enhancing patient safety and fostering innovation in kidney disease.

One project focuses on the importance of incorporating patient preferences into product development programs and into regulatory decision-making. The KHI workgroup, “Workshop to Elucidate Role of Patient Preferences in Support of CDRH Regulatory Actions in Kidney Disease,” has been charged with addressing this issue by seeking input from patients and their families on new treatment options to reduce the burden of kidney disease, which affects more than 20 million Americans.

The workgroup recently developed and launched a short animated video to engage patients and encourage them to attend one of three webinars held in April 2015. The video has since been viewed over 1200 times, resulting in more than 160 patients expressing interest in attending one of the workgroup’s webinars (245 total registrants).

The webinars served to educate patients on device product lifecycle, the role of the FDA/Center for Devices and Radiological Health (CDRH) in device development, and how the agency is seeking patients’ ideas to help guide new treatments and products that meet their needs through the CDRH Patient Preferences Initiative. The webinars also sought to collaboratively increase patient interest and knowledge of this area, before their invitation to participate in the workgroup’s upcoming workshop.

The workgroup’s animated video and webinar slides can be viewed in the Patient Info section of the KHI website: www.kidneyhealthinitiative.org

In phase II of this project, the KHI workshop will build on the lessons learned at the FDA Public Workshop held September 18-19, 2013, on patient preferences, and will provide a forum for interactive discussions between FDA regulators and other stakeholders to find practical solutions to address patient preference issues relevant to kidney health. Patients will be able to share their ideas directly with the FDA, scientists, doctors, nurses. and technicians. The workshop will be held August 12-13, 2015, at the Hilton Baltimore, BWI Airport. More information about the program, how to register, and the application process for travel support for patients, family members, and care partners is available at the Patient Info section of the KHI website: www.kidneyhealthinitiative.org.

Following the workshop, the workgroup will generate a white paper that will concisely define the major barriers and solutions to developing patient preference tools for medical devices within therapeutic areas relevant to individuals with kidney disease.

KHI hopes that this workgroup will be an important step forward in its efforts to develop a more patient-centric approach to drug and device development and looks forward to continued success of this project, “Workshop to Elucidate Role of Patient Preferences in Support of CDRH Regulatory Actions in Kidney Disease.” For additional information or to discuss KHI and its projects, please contact the KHI staff at KHI@asn-online.org.