MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R - PowerPoint PPT Presentation

MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R g Rema marks Harlan M. Krumholz, MD Yale School of Medicine Yale-New Haven Health System Twitter: @hmkyale 1

“Toward Collective, Collaborative Intelligence via Continuum of Evidence Generation” Twitter: @hmkyale 2

Status quo is woefully inadequate to keep up with the information needs of patients, clinicians, administrators, payors, and policy makers Twitter: @hmkyale 3

Too slow, too expensive, too uninformative Twitter: @hmkyale 4

Errors of false negatives and false positives Twitter: @hmkyale 5

Opportunities: We do not learn from experience. Twitter: @hmkyale 6

Opportunities: We do not work together. Twitter: @hmkyale 7

Opportunities: We are polarized. Twitter: @hmkyale 8

Learning from experience Collaboration across disciplines and stakeholders Twitter: @hmkyale 9

Putting the interest of patients and the public first Twitter: @hmkyale 10

Th Themes… Device and technology lifecycle Twitter: @hmkyale 11

Th Themes… FDA has a greater freedom to consider a large range of methods and approaches Twitter: @hmkyale 12

Th Themes… Devices and technologies evolve in their use and performance Twitter: @hmkyale 13

Th Themes… Devices and technologies evolve in their use and performance What changes: population, application, expertise, context, software Twitter: @hmkyale 14

Th Themes… Technology, computational power, digital transformation, consumerism, and business models are positioning us to create platforms for learning from experience and translating that knowledge into benefit for patients and the public. Twitter: @hmkyale 15

ICOR, ICCR, ICVR, ICTVR, Ortho CRN, VISION, SPARED, Robotic Surgery, DAISI, Women’s Health Registry Initiative, SMART, BUILD, AUDI, IDEAL-D, PASSION, DELTA, BD2K, Claims Validation, CBRI, HIVE, TMJ, AEDs, Methodology Twitter: @hmkyale 16

Twitter: @hmkyale 17

NE NEST and and MD MDEpiNet Coordination, Integration, Progression Demonstration, Investigation, Invention Twitter: @hmkyale 18

NEST T and MD MDEpi piNet Complementary and Essential Twitter: @hmkyale 19

Jou Journey y to o a Critical Ju Junct cture Untenable Status Quo Ample Opportunities Infrastructure to Support Change Twitter: @hmkyale 20

Fu Future Innovation Iteration Impact Value Twitter: @hmkyale 21