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

 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?

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

• Creating Value: Criteria and Considerations for the Development of a Sustainable National System? – Heather Colvin (10 Minutes)
• Report from ROI on UDI work group (what we learned about framing the analysis) – Kade Etter (10 Minutes)
• Framing the ROI for better evidence generation by the National Evaluation System – Gregory Pappas (10 Minutes)

Discussion (1 Hour, 15 Minutes)

10:15-10:30   Break

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

Moderator:   Mitchell Krucoff

• TVT case study: evidence for better, faster, cheaper – Kathleen Hewitt (10 minutes) Discussion (20 minutes)
• VQI case study: evidence for better, faster, cheaper – Philip Goodney (10 minutes) Discussion (20 minutes)
• Ortho case study: evidence for better, faster, cheaper – Patricia Franklin (10 minutes) Discussion (20 minutes)
• Coronary case study: evidence for better, faster, cheaper – David Kong (10 minutes) Discussion (20 minutes)

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