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, Technical Advisor, Human Factors, ABBVIE

9:45AM – 10:30AM

Create the Ideal Templates to Show Compliance With Engineering Expectations


Tressa Daniels, Senior Manager, User Experience Design, Infusion Division, 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


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

11:45AM – 12:30PM

Key Human Factors Considerations From an Interview With CDRH at FDA


Melissa Lemke, Director, Human Factors Engineering, AGILIS CONSULTING

12:30PM – 1:30PM

Luncheon


 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

Update Your Risk Management Protocols to Better Anticipate Product Misuse


Barbara Young, Quality Engineer, SIEMENS HEALTHCARE

4:15PM – 5:00PM

Embrace Holistic Design Methodologies for Breakthroughs in User Experience


Nick Allen, lobal 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

Keep Design Validation Centered in Your HF Studies


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

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Quantify the ROI of Human-Centered Design


Gia Rozells, Director, User Experience Design, BECTON DICKINSON

11:45AM – 12:30PM

Properly Sequence All of the Validation Tests for Device Software


Jonathan Avedikian, Human Factors Engineer, ABBOTT

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

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


Kristen Stebbins, Clinical Researcher, WELCH ALLYN

2:15PM – 3:00PM

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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