2013 Schedule *

WEDNESDAY, MARCH 20, 2013
8:00am-
9:00am
 Registration and Continental Breakfast
9:00am-
9:15am
Welcome Remarks
Scott Colburn, U.S. Food and Drug Administration
Carol Herman, AAMI
9:15am-
10:00am
 China and the Growing Importance of the Global Standards Market
Joe Bhatia, President & CEO, American National Standards Institute ( ANSI)
10:00am-
11:15am
 Update and Discussion on the European Medical Device Directive Changes and Their Impact on Medical Device Manufacturers
Oliver Christ, Prosystem AG
Elisabeth George, MD, Philips Healthcare
Jürgen Stettin, Prosystem AG and University of Applied Sciences, Hamburg
11:15am-
11:30am
 Break
11:30am-
12:30pm
Update and Discussion on Priorities and Activities of the FDA's Center for Devices & Radiological Health (CDRH)
William Maisel, MD, U.S. Food and Drug Administration
12:30pm-
1:30pm
Networking Luncheon
1:30pm-
2:45pm
 A Discussion on Interoperability Challenges with Medical Devices and What Is Being Done with Standards to Overcome these Challenges
Heather Agler, PhD, U.S. Food and Drug Administration
Terenzio Facchinetti, PharmD, Underwriters Laboratories Inc.
Joe Lewelling, AAMI
Dan Ryan, Underwriters Laboratories Inc.
2:45pm-
3:00pm
 Break
3:00pm-
4:00pm
 Human Factors and Usability Considerations in Designing Medical Devices
Ed Israelski, PhD, AbbVie
Molly Follette Story, PhD, U.S. Food and Drug Administration
4:00pm-
5:00pm
 A Review of the FDA' s New Innovation Pathway Initiative
Murray Sheldon, MD, U.S. Food and Drug Administration
5:00pm-
6:00pm
 Reception
 

THURSDAY, MARCH 21, 2013
8:30am-
9:00am
Continental Breakfast
9:00am-
10:30am
Medical Device Cybersecurity Considerations
Sherman Eagles, SoftwareCPR
Kevin Fu, PhD, University of Michigan
Mark Olson, Beth Israel Deaconess Medical Center
Bakul Patel, U.S. Food and Drug Administration
10:30am-
11:15am
 An Update on the International Medical Device Regulators Forum (IMDRF) and Sunsetting of the Global Harmonization Task Force (GHTF)
Kimberly Trautman, U.S. Food and Drug Administration
11:15am-
11:30am
 Break
11:30am-
12:30pm
 Systems Engineering Considerations in Device Design
Ken Hoyme, Boston Scientific
Meaghan O’Neil, Accenture
Al Taylor, U.S. Food and Drug Administration
12:30pm-
2:00pm
 Luncheon Program: Quality Metrics and Their Impact on Medical Device Manufacturing
David Classen, MD, Chief Medical Information Officer, Pascal Metrics
2:00pm-
3:00pm
 A Review of Amendment 1 (2012) to ANSI/AAMI/IEC 60601-1:2005: Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance
David Osborn, Philips Healthcare
Mike Schmidt, Strategic Device Compliance Services
3:00pm-
4:00pm
 Managing Multiple Quality Management Systems when Producing Combination Products
 Venky Gopalaswamy, PhD, Johnson & Johnson, Inc.
Alberto Velez, Johnson & Johnson, Inc.
John Barlow Weiner, JD, U.S. Food and Drug Administration
4:00pm
Conference Adjourns

* Times and topics are subject to change.