MAIN CONFERENCE DAY TWO
8:00 am - 9:00 am REGISTRATION AND MORNING JUMPSTART
9:00 am - 9:15 am CHAIRS’ RECAP OF DAY ONE
Julian Goldman
Director of the Program on Medical Device InteroperabilityMassachusetts General Hospital, Harvard Medical School
9:15 am - 10:00 am KEYNOTE: REGULATORY PERSPECTIVES ON DIGITAL HEALTH
Anthony Watson
(Former Director, Division of Anesthesiology, General Hospital Infection Control, and Dental Devices, FDA) Associate Vice President, Regulatory Affairs - DevicesSanofi
10:00 am - 10:45 am WHAT’S NEW IN THE REGULATORY?
•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
10:45 am - 11:00 am MORNING MINGLE
11:15 am - 12:00 pm REVISIT AGILE ADOPTION FOR REGULATED MEDICAL SOFTWARE?
•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
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
•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
Ed Israelski
Advisor on Human Factors, Combination Product Development, Former Director Human FactorsAbbVie
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
· 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
