Fri, Jun 17 | FDA White Oak Bldg 32

Building the National Evaluation System for Medical Devices: Making a Case for a Return on Investment (ROI)

BUILDING THE NATIONAL EVALUATION SYSTEM FOR MEDICAL DEVICES: MAKING A CASE FOR A RETURN ON INVESTMENT (ROI) FOR USE OF REAL-WORLD EVIDENCE
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Time & Location

Jun 17, 2016, 8:00 AM
FDA White Oak Bldg 32, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

About the Event

 RECORDING LINKS

https://collaboration.fda.gov/p6811gb4p7c/

https://collaboration.fda.gov/p1c7m75jpvj/

https://collaboration.fda.gov/p879zktkkhd/

https://collaboration.fda.gov/p1l2n1g58v6/

AGENDA

08:15-08:30    Opening Remarks:  Objective of meeting and logistics – Jesse Berlin

Demonstration that NES will create a platform for better, faster and cheaper studies and data for regulatory decision making

08:30-10:15   Session 1:  Where are we?

ModeratorProvide overview regarding need for this meeting as it developed out of value proposition work – Danica Marinac-Dabic

Discussion (1 Hour, 15 Minutes)

10:15-10:30   Break

10:30-12:30   Session 2:  Case studies of ROI

Moderator:   Mitchell Krucoff

12:30-13:30  Working Lunch – Britt Barham

  • Creation of small groups (volunteers)
  • Review questions that will guide small groups
  • Introduction of chairs and rapporteurs for each small group (chairs will be presenters of case studies)

Rapporteurs TVT group:  Perry Bridger VQI group:  Gary Thompson Ortho group:  Paul Haisman Coronary group:  Mitchell Krucoff

13:30-14:30   Session 3 – small group discussion:  The purpose is to reach agreement on questions posed by the meeting.  Example, come to consensus about what investments should be included in the studies in question. Each group should internally select a chair person and a rapporteur.         

  • TVT
  • VQI
  • Ortho
  • Coronary

14:30-14:45  Break

14:45-16:30  Session 4:  Report Out

  • Report out of small groups on consensus and further questions.
  • Discussion of cross cutting questions
  • Discussion of draft work plan for proposed manuscript – writing teams for each section identified

16:30-17:00   Closing Session:  Jesse Berlin

  • Finalization of plans to compete work of small groups, as needed
  • Review of proposed outline for a White Paper
  • Discussion
  • Creation of work group to develop first draft of White Paper
  • Note how the output from this meeting feed into the broader work on value propositions
Registration is Closed

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