2018 Annual Public Forum

2018 MDIC Annual Public Forum
Wednesday, September 5, 2018 | 8:30 a.m. – 6:00 p.m.
Center for Total Health
700 2nd St NE, Washington, DC 20002

Gathering industry, government, and nonprofit partners to advance the regulatory science of medical devices.

The 2018 Annual Public Forum will celebrate MDIC’s 5th Anniversary by gathering MDIC members and the broader medical device and diagnostics community to discuss current trends in regulatory science and spotlight MDIC’s leadership in the development of innovative regulatory science tools.  Hear from FDA Commissioner Scott Gottlieb and other industry and community innovators on a range of regulatory topics from cybersecurity and real-world evidence to patient input, quality and data analytics and innovative medical device clinical trial design.

Welcome

Pamela Goldberg | President and CEO MDIC

Fireside Chat

Scott Gottlieb, MD | Commissioner, FDA
Mike R. Minogue | ABIOMED, President, CEO, and Chairman; MDIC Board Chairman

MDIC Celebrates 5 Years

Pamela Goldberg | President and CEO MDIC

NESTcc: Developments Over the Last Year

Rachael Fleurence, PhD | Executive Director, NESTcc, MDIC
Kathleen Blake, MD, MPH | VP, Healthcare Quality, American Medical Association
Jeff Shuren, MD, JD | Director, CDRH, FDA
Michelle McMurry-Heath, MD, PhD | WW VP Regulatory and Clinical Affairs, Johnson & Johnson

Cybersecurity: Coordinate Vulnerability Disclosure Reporting

Randy Schiestl | VP, R&D and Global Technology, Boston Scientific
John deCraen | Sr. Director, Global Cyber Risk Services, Alvarez & Marsal
Paul Rubin, JD | Partner, Debevoise & Plimpton
Seth Carmody, PhD | Cybersecurity Project Manager, CDRH, FDA
Greg Garcia | Executive Director for Cybersecurity, Health Sector Coordinating Council
Zach Rothstein, JD | Associate VP, Technology & Regulatory Affairs, AdvaMed
Luke Dembosky, JD | Partner, Debevoise & Plimpton
Dana-Megan Rossi, JD | Product Security Policy & Strategy, BD

MDIC Founders Recognition

Pamela Goldberg | President and CEO MDIC

Lunch + Keynote: Innovation and Modern Monopolies

Alex Moazed | Founder and CEO Applico

Science of Patient Input:  Influencing Device Development

Barry Liden, JD | VP Patient Engagement, Edwards Lifesciences
Brett Hauber | Sr. Economist and VP, Health Preference Assessment, RTI Health Solutions
Mike Otleweski | Clinical Program Scientist, Med Institute
Michelle Tarver, MD, PhD | Director, Patient Science & Engagement, CDRH, FDA
Donnette Smith | National President and Board Chair, Mended Hearts, Patient
Adam Amdur | Chief Patient Ofcer, American Sleep Apnea Association, Patient
Tonya Roney Moore | Champion, South Atlantic District Support Leader, WomenHeart of Cone Health

Safety Signal Transparency: Using the Power of Data

Jeff Shuren, MD, JD | Director, CDRH, FDA
JiJo James, MD | Chief Medical Ofcer, Medical Devices, Johnson & Johnson
Heather Hawley | Executive Director, Health Innovation, Modernization, and Safety, MITRE
Harlan Krumholz, MD, SM | Professor of Medicine and Epidemiology & Public Health at Yale University, and Director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE)

Keynote: CDRH Updates

Jeff Shuren, MD, JD | Director, CDRH, FDA

 

Closing Remarks

Pamela Goldberg | President and CEO MDIC