Live Chat Software
January 22 - 24, 2018
United States

MAIN CONFERENCE DAY TWO

8:00 am - 9:00 am REGISTRATION AND MORNING JUMPSTART

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Julian Goldman

Director of the Program on Medical Device Interoperability
Massachusetts General Hospital, Harvard Medical School



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Anthony Watson

(Former Director, Division of Anesthesiology, General Hospital Infection Control, and Dental Devices, FDA) Associate Vice President, Regulatory Affairs - Devices
Sanofi

•Join leading regulatory experts at this panel to evaluate Issues related to strategic implications of FDA device regulations
•Hear best practices for compliance with ISO 13485:2016
•Prepare yourself for the new EU Medical Device Regulations (EU MDR)
•Evaluate how MDUFA IV would impact the path to FDA approvals 
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Pat Baird

Head of Global Software Standards
Philips

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Robert Ezzell

Associate Director , Global Regulatory Affairs - Medical Devices
Sanofi

10:45 am - 11:00 am MORNING MINGLE

•Experience that both quality and safety are improved when the software  development team is agile, and that regulatory requirements can still be met

•Delve into several key areas for applying Agile methods in the medical device context

•Fit together hardware and software development, and being Agile in both
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Nancy Van Schooenderwoert

President and Managing Partner
Lean-Agile Partners

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Brian Shoemaker

Principal Consultant
ShoeBar Associates

12:00 pm - 1:00 pm NETWORKING LUNCHEON

1:00 pm - 1:45 pm MEDICAL DEVICE SOFTWARE - REQUIREMENTS AND CONFIGURATION MANAGEMENT


1:45 pm - 2:30 pm EXPLORE WHAT’S NEXT IN HUMAN FACTORS ENGINEERING FOR MEDICAL DEVICE MOBILE APPS AND IOT

Ed Israelski - Advisor on Human Factors, Combination Product Development, Former Director Human Factors, AbbVie
•Evaluate Chances and Risks of Mobile Health Apps
•Delve into best practices in Human Factors for Medical Device Mobile Apps
•Uncover IoT Opportunities and hear examples of potential features  for Medical Device Mobile apps
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Ed Israelski

Advisor on Human Factors, Combination Product Development, Former Director Human Factors
AbbVie

2:15 pm - 2:45 pm Afternoon Recharge - Network over Refreshments

2:15 pm - 3:00 pm Actionable Data Collection and Analytics to Reduce Operating Costs

Patrick Schenkel - Business Intelligence Manager, Zimmer Biomet


· Understand the value of passively collected data
·Implement a predictive analytics approach
·Reduce operating costs, increasing inventory turns, and identifying risks turns, and identifying risks


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Patrick Schenkel

Business Intelligence Manager
Zimmer Biomet

3:15 pm - 4:00 pm INCORPORATE IOT AND INTEROPERABILITY TO ENABLE DATA FOR YOUR MEDICAL DEVICE SOFTWARE

David Arney - Lead Engineer, MD PnP Program, Massachusetts General Hospital

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David Arney

Lead Engineer, MD PnP Program
Massachusetts General Hospital

4:00 pm - 4:05 pm CHAIRS’ CLOSING REMARKS