Kidney Health Initiative (KHI)

Understanding Patient Preferences for Medical Device Development

In August 2015, the Kidney Health Initiative (KHI) convened a workshop where the FDA, clinicians, the device industry, and patients, care partners or patient advocacy groups came together to discuss the barriers and solutions to device development. At the times, there were few tools available to incorporate patient preferences into product development. Additionally, FDA was interested in hearing patients' ideas to help their regulatory decision making for medical devices in kidney disease, including – but not necessarily limited to – dialysis, vascular access, and transplantation.

Prior to the workshop, a KHI workgroup developed and launched a short animated video to engage patients and encourage them to attend educational webinars held in April 2015. The webinars educated patients on the product lifecycle and the role of the FDA, specifically the Cetner for Device and Radiological Health. The workgroup wanted to increase patients’ interest and knowledge before participating in the workshop. The workgroup's video and webinar slides can be viewed below:

Patient Engagement Video
Educational Webinar
Understanding Patients' Preferences: Stimulating Medical Device Development in Kidney Disease

The KHI workshop provided a forum for interactive discussions between FDA, patients and other stakeholders to find practical solutions to address patient preference issues relevant to kidney health.

Workshop Executive Summary and Summary Slide Deck

The workgroup produced an Executive Summary of the workshop that can be viewed here.

The workgroup developed a short slide deck that summarizes the workshop and asks that attendees and interested parties share this information with their community (fellow patients at local dialysis clinics, patient groups, or community groups).

View the downloadable and printable workshop summary slide deck.

KHI captured portions of the workshop and have included links to them in the presentation titles below.

Please note, that some presenters have given us permission to post their slides online as PDFs for downloading. In order to view available slides, please click on the link to the immediate right of the presentation.

Understanding Patients' Preferences: Stimulating Medical Device Development in Kidney Disease
August 12-13, 2015
Hilton Baltimore BWI Airport
Baltimore, MD
Wednesday, August 12

Welcome Remarks
Frank Hurst, MD, FASN
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Patients and Their Government: Shared Expectations and Responsibilities Determine High Impact Engagement (Slides)
Paul T. Conway
Kidney Transplant Recipient, President of the American Association of Kidney Patients

Opening Remarks
Robert Califf, MD
Deputy Commissioner of Medical Products and Tobacco, FDA

Panel Discussion
Panelists: Paul T. Conway and Robert Califf, MD

FDA's Patient Preference Initiative for Medical Device Development(Slides)
Kathryn M. O'Callaghan
Center for Devices and Radiological Health, FDA

The Science of Measuring Patient Preferences (Slides)
John F. Bridges, PhD
John Hopkins Bloomberg School of Public Health

Patients' Preferences in Dialysis: What Do We Know?
Francesca Tentori, MD
Arbor Research Collaborative For Health

Panel Discussion
Panelists: Kathryn M. O'Callaghan, John F. Bridges, PhD, and Francesca Tentori, MD

Thursday, August 13

Session 1: How can patients and care partners assist in developing new medical devices?

Engaging Patients in the Development of Medical Devices
Linda C. Upchurch, MBA, MHA
NxStage Medical, Inc.

Determining Acceptable Benefits and Risks of Emerging Therapy: A Patient Community's Approach (Slides)
Holly L. Peay, PhD, CGC
RTI International and Duchenne Connect Network, a program of Parent Project Muscular Dystrophy

First Things First! Prioritizing Patient Preferences (Slides)
F.P. Wieringa, PhD
Delegated by the Dutch Kidney Foundation and Dutch Kidney Patient Association

Panel Discussion
Panelists: Linda Upchurch, MBA, MHA, Holly Peay, PhD, CGC, and F.P. Wieringa, PhD

Breakout Discussions: Summary of the Breakout Discussions

Session 2: How can patients and care partners help ensure the success of future clinical trials?

Clinical Trials in Kidney Disease: Where are all the Patients? (Slides)
Jennifer Flythe, MD, MPH, FASN

Patient Informed Clinical Trials
Sally Okun, RN, MMHS
PatientsLikeMe, Inc.

Patient-reported Outcomes Instruments in Dialysis: Are We Measuring the Right Outcomes? (Slides)
Jennifer Flythe, MD, MPH, FASN
University of North Carolina, Chapel Hill

Patient and Care Partner Engagement in Clinical Research (Slides)
Celeste Castillo Lee
Patient Advocate for the Vasculitis Foundation
KHI Board of Directors Member and Chair of the KHI Patient and Family Partnership Council

Panelist Discussion
Panelists: Jennifer Flythe, MD, MPH, FASN, Sally Okun, RN, MMHS, and Celeste Castillo Lee

Breakout Discussions: Summary of Breakout Discussions

Session 3: How can patients and care partners help with the decision to make a new device available as well as improve a device once it is on the market?

The Patient Voice and the FDA
Steve L. Morin, RN, BSN
Office of Health and Constituent Affairs, FDA

FDA Regulatory Decision Making: Obesity Study as a Potential Tool (Slides)
Anindita Saha, BSE
Center for Devices and Radiological Health, FDA

Patient Impact on Benefit-Risk
Dalia Jacob, MD Baxter Healthcare, Inc.

Panel Discussion
Panelists: Steve L. Morin, RN, BSN, Anindita Saha, BSE and Dalia Jacob, MD

Breakout Discussions: Summary of Breakout Discussions

Wrap-Up / Closing

Relevant Links and Information

The workshop focused on how patients' preferences can be measured and used when developing new medical devices. The following links were highlighted as additional resources at the workshop.

FDA: What We Do

FDA Patient Network

FDA Brings Patients Into the Process

FDA: Clinical Trials - What Patients Need to Know

FDA Draft Guidance - Patient Preference Information

Vasculitis Patient Powered Research Network

PCORnet, the National Patient-Centered Clinical Research Network

PatientsLikeMe

Medical Device Innovation Consortium's Patient Centered Benefit-Risk Assessment

"Paient Uprising: With technology as a tool, more people are taking the lead when it comes to their own health care", Kendall Morgan, American Way Magazine (May 2015)

Workgroup Members

KHI would like to thank the workgroup member's for their efforts and work to host a successful workshop:

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

Dolph Chianchiano (Workgroup Co-chair)
National Kidney Foundation
KHI Board of Directors Member

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
University of North Carolina

Frank Hurst, MD (Workgroup Co-chair)
Center for Devices and Radiological Health (CDRH), FDA

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

Celeste Castillo Lee
Patient Advocate, the Vasculitis Foundation
KHI Board of Directors Member, Chaif of KHI PFPC

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

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.