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Building the National Evaluation System for Medical Devices The Role of MDEpiNet PPP J. Matthew Brennan, MD, MPH Interventional Cardiology Duke Triangle Heart Associates Assistant Professor of Medicine Duke University School of Medicine

Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

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Page 1: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

Building the National Evaluation

System for Medical Devices

The Role of MDEpiNet PPP

J. Matthew Brennan, MD, MPH Interventional Cardiology

Duke Triangle Heart Associates

Assistant Professor of Medicine

Duke University School of Medicine

Page 2: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Overview

Page 3: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Eroom’s Law. The number of new drugs approved by the FDA per billion US dollars (inflation-adjusted) spent on research and development

(R&D) has halved roughly every 9 years since 1950.

Scannell et al., Nature Reviews Drug Discovery 11:191, 2012

Product Development in the U.S. Increasingly Slow & Expensive

Page 4: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

4

Product Development in the U.S. Ineffective

Page 5: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

The Digital Revolution An Opportunity for Regulatory Reform

5

Page 6: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

The Digital Revolution

Impediments to Change

Page 7: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

The Digital Revolution

Impediments to Change

Clinical

Research Clinical

Practice

Slide with permission from M Krucoff, DUH

Page 8: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

MDEpiNet Public-Private Partnership

“You can’t break down silos,

but you can connect them.” Christiaan W. Lustig

Page 9: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

MDEpiNet Public-Private Partnership Who are we?

PARTNERS AHRQ, ACC-NCDR, Avalere, Canadian Agency for Drugs and

Technologies in Health Cardiovascular European Research Center (CERC),

Centers for Medicare and Medicaid Services (CMS), IDEAL Collaboration,

Johnson & Johnson, Lahey Health, MedTech Intelligence, Medtronic, Mercy,

Northgate Public Services, National Center for Health Research, National

Institute for Health and Care Excellence (NICE), Phillips, Phillips Innovation

and You, Society for Vascular Surgery Patient Safety Organization, The TMJ

Association, LTD…. And, GROWING!

Page 10: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

MDEpiNet Public-Private Partnership The Mission

Page 11: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

MDEpiNet Organizational Structure

MDEpiNet Coordinating Center (Duke)

MDEpiNet Science & Infrastructure Center

(Cornell)

MDEpiNet Methodology Center

(Harvard)

MDEpiNet Stakeholder Council

Cardiovascular WG

Orthopedic WG

Additional WGs

Disease-Based Working Groups

Executive Operations Committee

Stakeholder Engagement and Sustainability Committee

International Committee

Publications Committee

Public Programs Committee

Scientific Oversight Committee

From D Marinac-Dabic

Page 12: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

National Evaluation System (NESMD) Building Blocks

Infrastructure

Analytics

Implementation

Page 13: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

National Evaluation System (NESMD) Infrastructure

Page 14: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Identify & Access Global Data Streams

Page 15: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Coordinated Registry Networks (CRNs)

A. Linked complementary registries B. Multiple source structured data extraction

C. Distributed data networks

Page 16: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Create a Unified Syntax

Page 17: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

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Incorporate Unique Device Identifier(UDI)

Page 18: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

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Validate Data Accuracy

‘Big Data’

Page 19: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

National Evaluation System (NESMD) Data Analytics

Page 20: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

Data Extraction and Longitudinal Trend

Analysis (DELTA)

Uniform Stratified Risk Adjusted

Frequentist Statistical

Process

Control

(SPC)

Stratified

SPC

CUSUM

Logistic Models

SPRT

Propensity Match

Survival Analysis

Bayesian Bayesian

Updating

System

(BUS)

Stratified

Bayesian

Hierarchical

(Bayesian)

Logistic

Regression(HLR)

Page 21: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

MDEpiNet Strategic Projects Redesigning the Pipeline

App 1 Late-Phase Pre-Market Clinical Trials

App 2 Label Extension & Post-Approval Studies

App 4 Claims-based ‘Performance Goals’

App 3 ‘Dedicated’ Post-Approval Analyses

App 5 Automated Safety Surveillance

Page 22: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

National Evaluation System (NESMD) Redesigning the Pipeline

Page 23: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

MDEpiNet PPP A Shared Philosophy

Contact Information

[email protected]

Duke Coordinating Center

Project Manager

Page 24: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell

All Rights Reserved, Duke Medicine 2007

THANK YOU

J. Matthew Brennan, MD, MPH Interventional Cardiology

Duke Triangle Heart Associates

Assistant Professor of Medicine

Duke University School of Medicine