3rd Human Factors Engineering & Usability Studies Summit - San Francisco, CA

3rd Human Factors Engineering & Usability Studies Summit
February 12 - 13, 2018
San Francisco, CA
San Francisco, CA

Complying with the Latest Regulatory Guidelines, Updating the Design and Validation Testing Protocols for Medical Devices and Combination Products, and Optimizing the User Experience

Agenda – 3rd Human Factors Engineering & Usability Studies Summit



Day One

 Monday, Februaury 12

8:45AM – 9:00AM

Chairperson’s Opening Remarks


Nick Allen, Global Director, Design and User Experience, GE HEALTHCARE

 ADAPTING TO NEW REGULATIONS

9:00AM – 9:45AM

Craft the Proper Industry Response to Draft HF Guidelines on Biosimilar Interchangeability


Ed Israelski, former Director, Human Factors, ABBVIE

9:45AM – 10:30AM

Create the Ideal Templates to Show Compliance With Engineering Expectations


Tressa Daniels, Senior Manager, User Experience Design and Human Factors Engineering, BECTON DICKINSON

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Update on the Progress and Priorities of the Combination Product Coalition HF Working Group


Robert Nesbitt, Director, Human-Centered Design and Human Factors, ABBVIE

11:45AM – 12:30PM

Key Human Factors Considerations From an Interview With CDRH at FDA


Patricia A. Patterson, President, AGILIS CONSULTING

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

Clarify the Use of Design Controls in Device Development


Darin Oppenheimer, Executive Director, Head, Drug Device Center of Excellence, MERCK

 SELECTING AND WORKING WITH USER GROUPS

2:15PM – 3:00PM

Drive Device Usability and Procurement Decisions With Healthcare Provider Involvement


Natalie Abts, Program Manager, Usability Services, NATIONAL CENTER FOR HUMAN FACTORS IN HEALTHCARE

3:00PM – 3:30PM

Networking Break


3:30PM – 4:15PM

Adjust Your Processes to Fringe Research Scenarios


Katie Hansbro, CEO, DESIGN SCIENCE
Pete Sneeringer, Director, Human Factors, DESIGN SCIENCE

4:15PM – 5:00PM

Update Your Risk Management Protocols to Better Anticipate Product Misuse


Barbara Young, Risk Manager, SIEMENS HEALTHCARE

5:00PM – 5:45PM

Embrace Holistic Design Methodologies for Breakthroughs in User Experience


Nick Allen, Global Director, Design and User Experience, GE HEALTHCARE


Day Two

 Tuesday, Februaury 13

8:00AM – 8:45AM

Continental Breakfast


8:45AM – 9:00AM

Chairperson’s Recap of Day One


Nick Allen, Global Director, Design and User Experience, GE HEALTHCARE

 UPDATING YOUR TEST DESIGNS

9:00AM – 9:45AM

Re-Evaluate the Statistical Underpinning of HF Analysis


Jacques Ginestet, Head, Wearables Development, PROTEUS DIGITAL HEALTH

9:45AM – 10:30AM

Case Studies: Uncover User Needs That Can Translate Into Design Inputs


Serge Dubeau, Vice President, Design and Human Factors, WORRELL

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

PANEL: Is There a Better URA Tool Than the uFMEA?


Moderator:
Sean Hagen, Principal, Director of Research and Synthesis, BLACKHAGEN DESIGN

Panelists:
Ed Israelski, former Director, Human Factors, ABBVIE
Jeffrey Morang, Usability Leader, SANOFI
Jonathan Avedikian, Human Factors Engineer, ABBOTT

11:45AM – 12:30PM

Human Factors Validation Vs. Design Validation in Combination Products


Ling Lu, Senior Principal Scientist, Combination Product Design Control Group Lead, PFIZER

12:30PM – 1:15PM

Quantify the ROI of Human-Centered Design


Gia Rozells, Director, User Experience Design, BECTON DICKINSON

1:15PM – 2:15PM

Luncheon


2:15PM – 3:00PM

Properly Sequence All of the Validation Tests for Device Software


Jonathan Avedikian, Human Factors Engineer, ABBOTT

3:00PM – 3:45PM

Maximize Output and Minimize Time and Cost When Recruiting Human Factors Study Participants


Kristen Stebbins, Clinical Researcher, WELCH ALLYN

3:45PM – 4:30PM

Integrate Patent/Trademark Concepts Into Medical Device V&V for Enhanced Performance


Matthew Doyle, Systems Verification and Validation Engineer, VARIAN MEDICAL SYSTEMS


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