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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes”.

The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers.


Date, Time and Location:

This meeting was held September 18 and 19, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Section A of the Great Room)
Silver Spring, MD, 20993

Agenda

September 18, 2013: Patients and Data Collection (methods, tools and validation)
7:30- 8:30 A.M.Registration 
8:30 – 9:15 A.M.Welcoming Remarks 
9:15 – 10:45 A.M.Patient Views on Benefits and Risks of Medical Devices Understanding what patients know about the benefits and risks of medical devices and how they form preferences. Panel Questions:
  • How do patients view the benefits and risks of medical devices?
  • What kind of information do patients use to form their decisions relating to treatment options?
  • What kinds of patient preference information should and should not be collected from patients?
  • How should patient preference information be collected?
Moderator:
Randall Brockman, M.D. (CDRH)
Panel:
Bray Patrick-Lake, B.S., M.F.S (CTTI) 
Lisa Phelps, (NORD)
Jennifer Sheridan, M.P.P. (Parkinson’s Action Network)
Margaret Anderson, M.A.(Faster Cures)
Marjana Marinac (JDRF)
Wendy Selig, M.S. (Melanoma Research Alliance)
10:45 – 11:00 A.M.Coffee Break 
11:00 – 12:30 P.M.State of the Science: Methods to Collect and Use Patient Preference Data Overview of methods to collect patient preference information and active research regarding patient collecting patient preferences. Panel Questions:
  1. What methods and tools can be used to collect patient information?
  2. What are the relative strengths and limitations of these methods and tools?
  3. What approaches should be used to collect patient preference information?
  4. Who should collect patient preference information?
  5. What solutions do you see going forward?
Moderator:
Telba Irony, Ph.D. (CDRH)
Panel:
A. Brett Hauber, Ph.D. (RTI-Health Solutions)
Bennett Levitan, M.D., Ph.D. (Janssen Research & Development/Johnson and Johnson)
Sonal Singh, M.D., Ph.D. (Johns Hopkins University)
Scott Braithwaite, M.D. (SMDM)
12:30 – 1:30 P.M.Lunch: Discussion tables – Methodology 
1:30 – 3:00 P.M.Patient Identification Identifying patients and their preferences and understanding the patient preference paradigm. Panel Questions:
  • How to identify patients and their preferences?
  • Who is a representative patient? What is the average patient? How do you address patient heterogeneity?
  • How can the spectrum of patients be represented?
  • What type of information can/should patients provide?
  • What types of information do patients use to formulate decisions about their treatment options?
  • Where can patient preference information be found?
Moderator:
Martin Ho, M.S. (CDRH)
Panel:
David Hickam, M.D., M.P.H. (PCORI)
Eric D. Agdeppa, Ph.D., M.T.M. (Hill-Rom Company, Inc./AdvaMed)
John Wilbanks (Faster Cures)
Mark Wolff, Ph.D. (SAS Institute)
Sally Okun, R.N., M.M.H.S. (PatientsLikeMe)
3:00 – 3:15 P.M.Coffee Break 
3:15 – 4:00 P.M.Technology Focus: Internet ApproachesModerator:
Anjali Kataria, M.P.P.
Presenters:
David Blaser, Pharm.D. (PatientsLikeMe)
Gregg Rosenberg, Ph.D. (WiserTogether, Inc.)
4:00 – 5:00 P.M.Open Discussion and Wrap Up

Audience Polling
Open Public Comment Session
Moderators:
Phil Desjardins, J.D. (CDRH)
Nada Hanafi, M.P.H., M.Sc. (CDRH)
September 19, 2013: Incorporating patient preference information into the Medical Device Total Product Life Cycle (TPLC) regulatory paradigm
8:30 – 9:00 A.M.Keynote SpeakerWilliam Murray
(Medical Device Innovation Consortium)
9:00 – 9:45 A.M.Technology Focus: Surveys
FDA-RTI Weight-loss Device Survey – Pilot Study
F. Reed Johnson, Ph.D. (RTI Health Solutions)
Telba Irony, Ph.D. (CDRH)
9:45 – 10:00 A.M.Coffee Break 
10:00 – 12:00 P.M.Patient Preference in the Total Product Life Cycle (TPLC) Patient preference data can be pre-market and post-market data. Discuss where in the TPLC patient preference information can be included to impact/improve medical devices for the public. Topics to discuss include clinical trial design, current collaborations, and novel external approaches. Panel Questions:
  1. Where do you start in integrating patient preferences?
  2. How do you integrate patient preferences into clinical trial design?
  3. How could patient preference data be collected and used for post-market and compliance issues?
  4. What disease areas or device types are best suited for the patient preference approach?
  5. What additional safe guards should FDA consider when including patient preference information into its regulatory decision-making?
  6. What do you propose as the first steps for the patient preference approach?
Moderator:
Kelly Slone (MDIC)
Panel:
Andrea Furia-Helms, M.P.H. (OHCA)
Bray Patrick-Lake, B.S., M.F.S. (CTTI)  
Danica Marinac-Dabic, M.D., Ph.D (CDRH)
David Hickam, M.D., M.P.H. (PCORI)
Jack Lasersohn, J.D. (Vertical Group)
Jonathan Morris, Ph.D.(Medtronic, AdvaMed)
12:00 – 1:15 P.M.Lunch: Hands-on website demonstrationsPatientsLikeMe
SAS
WiserTogether
1:15 – 2:15 P.M.Validation of the Patient Preference Data FDA reflects on the previous panels regarding patient identification, methodology, limitations, and how patient preference information can be validated to be used for regulatory submissions. Panel Questions:
  1. How to validate patient preference data and information?
  2. What methods and tools can be used for validation?
  3. Who should validate patient preference information?
  4. How will reviewers judge the validity of patient preference data?
Moderator:
William Maisel, M.D., M.P.H.(CDRH)
Panel:
Carolyn Neuland, Ph.D. (CDRH)
Greg Campbell, Ph.D. (CDRH)
Juan Marcos Gonzalez, Ph.D. (RTI Health Solutions)
Randall Brockman, M.D. (CDRH)
Sahar Dawisha (CDRH)
Scott Braithwaite, M.D. (SMDM)
2:15 – 2:30 P.M.Coffee Break 
2:30 – 3:15 P.M.Shared Clinical Decision Making PresentationMichael J. Barry, M.D.
(Informed Medical Decisions Foundation)
3:30 – 4:30 P.M.
Strategies Going Forward
Summaries of the panels from the workshop and discussion of strategies for FDA, industry, and patients going forward regarding patient preference. Audience Polling Strategies to Consider:
  • How to incorporate patient preference information in the regulatory process?
  • How can FDA use patient preference data within the Total Product Life Cycle regulatory paradigm?
  • In what ways should patient preference data not be used?
  • Where along the TPLC continuum can patient preference information be incorporated?
  • What additional safe guards should FDA consider when including patient preference information into its regulatory decision-making?
  • How should patient preference information be incorporated into the medical device research paradigm?
TBD

Presentations

DayTitleWebcast VideoSlides (PDF)
Day 1CDRH Welcome, Patient Views on Benefits and Risks of Medical DevicesWebcast VideoSlides (711kb)
State of the Science: Methods to Collect and Use Patient Preference DataWebcast VideoSlides (1.7MB)
Patient IdentificationWebcast VideoSlides (1.3MB)
Technology Focus: Internet ApproachesWebcast VideoSlides (2.1MB)
Day One Discussion and Wrap UpWebcast VideoSlides (77kb)
Day 2MDIC and FDA-RTI Weight-loss Device SurveyWebcast VideoSlides (2.5MB)
Patient Preference in the Total Product Life Cycle (TPLC)Webcast VideoSlides (786kb)
Validation of Patient Preference DataWebcast VideoSlides (271kb)
Overview of Shared Decision Making, Strategies Going Forward and Day Two Wrap UpWebcast VideoSlides (2.3MB)

Transcripts

Public Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.

Workshop Details

Food and Beverages will be available for purchase during the breaks.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact Mimi Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5437, Silver Spring, MD 20993-0002, 301-796-4125, email: Mimi.Nguyen@fda.hhs.gov.

Or

Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3623, Silver Spring, MD 20993-0002, 301-796-5427, email: Nada.Hanafi@fda.hhs.gov.