Kidney Health Initiative (KHI)

KHI Current Project

Workshop to Elucidate Role of Patient Preferences in Support of CDRH Regulatory Actions in Kidney Disease

Patient Care Issue:

Although patients are the final consumer, they rarely have an opportunity to influence products that come to market. The success of a new product is based on many factors, including the usability by patients. Finding appropriate and fulfilling ways for patients to participate in the development of new products is a vital goal.


The Center for Devices and Radiological Health (CDRH) at FDA has emphasized the importance of incorporating patient preferences for risk over benefit into product development programs and into regulatory decision making. However, the relevant stakeholders (patients, health professionals, industry, and federal agencies) have an imperfect understanding of best practices for creating the tools to capture and analyze data related to patient preferences.

KHI Solution:

The workgroup hosted a workshop on the topic of patient preferences for medical devices at the Hilton Baltimore BWI Airport on August 12-13, 2015. Click here to review the agenda or presentations.

In addition, the workgroup developed and launched a short animated video to engage patients and encourage them to attend one of three educational webinars held in April 2015. Click here to view the video or learn more about the webinars.


The workgroup is drafting 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.


Workshop and Publication.

Timeframe for Completion

Workshop-Completed in August 2015; Publication-Spring 2017.


Dolph Chianchiano
National Kidney Foundation
(KHI Board of Directors Member)

Frank Hurst, MD
Center for Devices and Radiological Health (CDRH), FDA


Terri Bonadio
Director of Marketing, Home Hemodialysis
Fresenius Medical Care, North America

Deborah J. Brouwer-Maier, RN, CNN
Director of Dialysis Access Initiatives
Fresenius Medical Care, North America
Liaison for Vascular Access Society of the Americas

Diana Clynes
Director of Program & Services
American Association of Kidney Patients
Liaison for American Association of Kidney Patients

Maria Ferris, MD, MPH, PhD
Associate Professor
University of North Carolina, Chapel Hill
Liaison for American Society of Pediatric Nephrologists

Jennifer Flythe, MD, MPH
Brigham and Women’s Hospital Renal Division

Martin Ho, MS
Center for Devices and Radiological Health (CDRH), FDA

Celeste Castillo Lee
Patient Advocate, the Vasculitis Foundation
(KHI Board of Directors Member, KHI PFPC Chair)

Lillian Pryor, MSN, RN, CNN
Nursing Supervisor
Fresenius Medical Care, Jersey City, NJ
Liaison for American Nephrology Nursing Association

Bradley Roynon, RAC
Manager-Renal Global Regulatory Affairs
Baxter Healthcare Corp.

Melissa Threlkeld, MHA, FACHE
Austin, TX

Linda Upchurch, MBA, MHA
Director of Public Policy
NxStage Medical, Inc.

KHI Board of Directors Liaison:

Carolyn Y. Neuland, PhD
Chief, Gastroenterology and Renal Devices Branch (GRDB)
Center for Devices and Radiological Health (CDRH), FDA

Conflict of Interest

To view KHI's Conflict of Interest and Disclosure Policy please click here.

To view the Workgroup Disclosures please click here.