Kidney Health Initiative (KHI)

Understanding Patients' Preferences: Stimulating Medical Device Development in Kidney Disease

Wednesday, August 12 - Thursday, August 13, 2015

Patients and care partners experience life with their device every day or nearly every day. Yet, as new medical devices are being designed or tested, patients and care partners are often not involved in communicating what they like or will work best for them. A new program at the U.S. Food and Drug Administration (FDA) called the “Patient Preference Initiative” is interested in finding ways to match patients’ choices with the approval of new medical devices.

This workshop brought together patients, care partners, scientists, doctors, nurses, technicians, and companies to hear what is important to patients, and to think about how those ideas can be measured and used by the companies that are developing new medical devices. The workshop balanced education and teaching with small group discussion.

KHI is pleased to announce that over 110 individuals attended this important workshop, including over 70 patients, care partners and family members.

The workshop was sponsored by the Kidney Health Initiative — a public, private partnership between the American Society of Nephrology, the US Food and Drug Administration and over 70 organizations and companies.

Workshop Program

Due to the high demand, 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.

Wednesday, August 12

3:30 PM          Registration Opens

4:30 PM - 6:15 PM       Opening Session

Moderators:
Dolph Chianchiano, JD, MPA
National Kidney Foundation, KHI Board of Directors Member

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

Welcome Remarks
Frank Hurst, MD, FASN

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

6:15 PM - 7:00 PM     Dinner

7:00 PM - 8:20 PM     Innovation Forum

Moderators:
Celeste Castillo Lee
Patient Advocate for the Vasculitis Foundation,
KHI Board of Directors Member and Chair of KHI Patient and Family Partnership Council

Melissa Threlkeld, MHA, FACHE
Austin, TX

Finding ways for kidney disease patients to be included in the medical device development process was one of the main goals of this workshop. The Innovation Forum showcased this idea by using existing or upcoming medical devices as examples. Presentations were made by Nx Stage Medical, Inc., W. L. Gore & Associates, NeoKidney- A Dutch Kidney Foundation Initiative, AWAK Technologies, Humacyte Inc., Dr. Victor Gura - Wearable Artificial Kidney (WAK), and Dr. Shuvo Roy- The Kidney Project.

8:20 PM - 9:00 PM     Informational Tables

Individuals were able to visit with and ask questions to the companies and individuals that presented during the Innovation Forum at their informational tables.

Thursday, August 13

7:15 AM          Continental Breakfast/Registration

8:00 AM - 10:30 AM     Session 1: How can patients and care partners assist in developing new medical devices?

Moderators:
Benjamin Fisher, PhD
Center for Devices and Radiological Health, FDA

Linda Upchurch, MBA, MHA
NxStage Medical, Inc.

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

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

9:10 AM - 9:45 PM      Breakout Discussions

Background information will be presented before small group discussions. Questions for the small groups may include:

  1. In ESRD care, what are some gaps that new devices may help?
  2. What technologies are in need of improvement?
  3. What function or components of medical devices are important to patients and care partners?
  4. How can device developers obtain input from patients and care partners for design issues?

9:45 AM - 10:00 PM      Coffee Break

10:00 AM - 10:30 PM     Summary of the Breakout Discussions

Moderators:
Benjamin Fisher, PhD

Linda Upchurch, MBA, MHA

10:30 AM - 1:30 PM      Session 2: How can patients and care partners help ensure the success of future clinical trials?

Moderators:
Jennifer Flythe, MD, MPH, FASN
University of North Carolina, Chapel Hill

Celeste Castillo Lee

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

Patient and Care Partner Engagement in Clinical Research (Slides)
Celeste Castillo Lee

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

11:30 AM - 12:15 PM     Lunch Buffet

12:15 PM - 1:00 PM     Breakout Discussions

Moderators:
Jennifer Flythe, MD, MPH, FASN

Celeste Castillo Lee

Background information will be presented before small group discussions. Questions for the small groups may include:

  1. Why do individuals choose to participate or not to participate in clinical trials?
  2. What are some ways patients and care partners can help in the design of a clinical trial?
  3. How can we increase patient involvement in clinical trials?
  4. What study factors are important to patients and care partners?
  5. Can we assess patient preferences during clinical trials?
  6. What is a patient reported outcome and how can it be used in clinical trials?

1:00 PM - 1:30 PM     Summary of Breakout Discussions

1:30 PM - 3:45 PM     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?

Moderators:
Carolyn Y. Neuland, PhD
Center for Devices and Radiological Health, FDA
KHI Board of Directors Member

Terri Bonadio, BSHA, RN, CNN
Fresenius Medical Care

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

2:30 PM - 2:45 PM     Coffee Break

2:45 PM - 3:30 PM     Breakout Discussions

Background information will be presented before small group discussions. Questions for the small groups may include:

  1. How can patients and care partners participate in the FDA process to “approve” a new medical device? What problems could arise?
  2. Who should collect the patient preference information?
  3. What is benefit versus risk and how to patients and care partners think about these topics?
  4. What is a medical device label?
  5. Using the idea of benefit/ risk and a medical device label, how will patients determine what medical device is right for them?

3:30 PM - 3:45 PM     Summary of Breakout Discussions

Moderators:
Carolyn Y. Neuland, PhD

Terri Bonadio, BSHA, RN, CNN

3:45 PM - 4:00 PM     Wrap-Up / Closing

Location

Hilton Baltimore BWI Airport
1739 West Nursery Road
Linthicum Heights, MD, 21090

Webcast Information

Due to the high demand, KHI captured portions of the workshop and have included links to them in the presentation titles above.

Background Webinar

We ask that all workshop attendees view a brief recorded webinar on the patient preferences and the medical device total product lifecycle. To view the webinar, please visit the webinar’s webpage by clicking here.

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 Patient Network.

FDA Brings Patients Into the Process.

FDA Draft Guidance - Patient Preference Information.

PCORnet, the National Patient-Centered Clinical Research Network.

Vasculitis Patient Powered 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)