1. What Kind of Aspects can Physicians Look Forward To? US Physician View
Ron Waksman, MD
Director, Cardiovascular Research Advanced Education
Professor of Medicine, Georgetown University
MedStar Heart Institute

2. Ron Waksman, MD Consulting: Biotronik, Inc. Abbott Laboratories
Boston Scientific Corporation
Medtronic, Inc.
Merck and Company, Inc.
Honoraria:
Abbott Laboratories,

3. US IS BIG But the The ‘OUS’ Market is Bigger
World Population
95.5%
4.5%
United States
Rest of The World
2013

4. U.S. Population by Race/Ethnicity 2005
7/3/2018
U.S. Population by Race/Ethnicity 2005
Native Hawaiian/ Pacific Islander
0.1%
American Indian/
Alaska Native
0.7%
Asian Only 4%
Two or More Races 1%
African American (Non-Hispanic)
12%
White
(Non-Hispanic)
67%
Hispanic
14%
Total = million
Data excludes Puerto Rico, Guam, U.S. Virgin Islands, Northern Marina Islands.
SOURCE: Table 3: annual Estimates of the Population by Sex, Race and Hispanic or Latino Origin for the United States: April 1, 2000 to July 1, 2005 (NC-EST ). Population Division, U.S. Census Bureau.

5. Distribution of U.S. Population by Race/Ethnicity 2000 and 2050
Total = million
Total = million
SOURCE: Kaiser Family Foundation, based on U.S. Census Bureau, 2004, US Interim Projections by Age, Sex, Race, and Hispanic Origin.

6. Across America, Differences in How Long and How Well We Live
7/3/2018
Across America, Differences in How Long and How Well We Live

7. Comparative Populations (2010)
Population (millions)
Area (km2 x 103)
*EU potentially expands to 29 countries if Turkey and Croatia join (557.5 million)

8. Global Healthcare Scrutiny…

9. Speed is important, but…………..
The most important is“to deliver safe and effective devices to market, through the correct review process in the timely manner”
Safety
&
Efficacy

10. Comparative Approval Times
Japan
10m EU
11m US
22m 12 24 36
Time (months)

12. The Global Picture Variable requirements for clinical studies
Variable end points and follow-up times US EU
Japan
Variable application of guidance by Notified Bodies
Both Pre- and Post-Market requirements increasing
Adding time, money and need for resources
Need for further alignment and standardization

13. Why Undertake a Global Device Study?
With a larger sample to enroll goals can be achieved more expeditiously
Assess device outcomes in different geographies, populations, ethnicities
Accelerate diverse regulatory pathways
Early granting of country-specific reimbursement
Faster to marketing opportunities

14. Limited Knowledge

15. HBD: Proof of Concept (POC) Trials
Bridging studies (ca. 2003)
Poolability – poolable registries
Single protocols
Global randomized trials

18. Difficulties in Running a Global Trial
Working across multiple time zones
Multiple languages, cultures
Investigator training
Multiple IRBs/ECs
Inventory control
Etc.

19. Is it worth it?
YES!

20. An Artery is an Artery…
No matter which country it is from.

21. What does the US physician expect?
Be part of the investigational device.
Faster access to cutting edge technology
It works for pharma it should work for devices
Assurance of safety and efficacy across all global population ethnicities
Reliable post marketing data
Predictable and uniform regulatory process
Predictable reimbursement process