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4th Human Factors Engineering & Usability Studies Summit -

4th Human Factors Engineering & Usability Studies Summit
February 4–5, 2019
San Francisco, CA

Designing Medical Devices, Combination Products, and IFUs that Satisfy Regulators, Eliminate Errors, and Improve the User Experience

Agenda – 4th Human Factors Engineering & Usability Studies Summit



Day One

 MONDAY, FEBRUARY 4

8:45AM – 9:00AM

CHAIRPERSON’S INTRODUCTION


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

 UPDATE ON DOMESTIC AND INTERNATIONAL REGULATORY STANDARDS

9:00AM – 9:45AM

POST-BREXIT UPDATE ON INTERNATIONAL STANDARDS AND HARMONIZATION


Ed Israelski, Technical Advisor, Human Factors, ABBVIE

9:45AM – 10:30AM

PANDORA’S BOX IS A LEGACY PRODUCT: WORKING WITH ADD-ONS TO OLDER DEVICES


Janet Lowe, Senior Manager, Device Development, Medical Affairs, ICU MEDICAL

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

GRASP THE LIFECYCLE CHALLENGES FOR DIGITAL THERAPIES AND HEALTH SOLUTIONS


Suraj Ramachandran, Director, Regulatory Affairs, Drug-Device Center of Excellence, MERCK

11:45PM – 12:30PM

Presentation by WORRELL


12:30PM – 1:15PM

SELECT THE IDEAL SCENARIOS FOR RISK ASSESSMENT


Wenjing Wang, Regulatory Affairs Manager, DENTSPLY SIRONA

1:15PM – 2:15PM

Luncheon


 PROPERLY UNDERSTAND YOUR USERS IN TESTS AND THE CLINIC

2:15PM – 3:00PM

WHEN “COMPLIANT” IS THE ENEMY OF “GOOD”: A NEW PERSPECTIVE ON USER EXPERIENCE


Susan McDonald, Senior Human Factors Engineer, XIMEDICA

3:00PM – 3:45PM

PRIORITIZE PATIENT NEEDS AND FEARS TO PRODUCE A BETTER SENSORY EXPERIENCE


James Kleiss, Sensory Quality and Emotional Design Specialist, GE HEALTHCARE

3:45PM – 4:15PM

Networking Break


4:15PM – 5:00PM

PUSH FOR IMPROVED ERGONOMIC SENSORS IN MEDICAL DEVICES IN AN MHEALTH CONTEXT


Didier Clerc, Product Manager, LEMAN MICRO DEVICES

5:00PM – 5:45PM

AVOID REGULATORY INTERVENTIONS BY PROPERLY SITUATING HUMAN FACTORS TESTING WITHIN THE R&D LIFE CYCLE


John Rovnan, Product Manager, ZOLL MEDICAL CORPORATION

5:45PM – 6:30PM

FLAG THE WARNING SIGNS OF SELF-EDITED, MISLEADING USER FEEDBACK


Sami Durrani, Senior Manager, Human Factors, FRESENIUS MEDICAL CARE


Day Two

 TUESDAY, FEBRUARY 5

8:45AM – 9:00AM

CHAIRPERSON’S RECAP OF DAY ONE


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

 BEST PRACTICES IN USABILITY TEST PROTOCOL DESIGN

9:00AM – 9:45AM

DESIGN AROUND CHALLENGES FOR DEVICE INTEROPERABILITY


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

9:45AM – 10:30AM

USE PERCEPTION-COGNITION-ACTION ANALYSIS EFFECTIVELY


John Kruse, Senior Human Factors Specialist, 3M

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

AGREE ON THE BEST TIMEFRAMES WHEN OUTSOURCING TO DESIGN FIRMS AND CONSULTANTS


Marc Stern, Director, Product Management, CERUS CORPORATION

11:45AM – 12:30PM

WHEN A USER INTERFACE BECOMES TOO SMALL: A CASE STUDY


Sean Hagen, Principal, Director of Research & Synthesis, BLACKHAGEN DESIGN

12:30PM – 1:30PM

Luncheon


 OPTIMIZE DESIGN TEAM DYNAMICS, COMMUNICATION, AND LEADERSHIP

1:30PM – 2:15PM

HELP PROJECT MANAGERS SEE THE BUSINESS OPPORTUNITIES RESULTING FROM IMPROVED USABILITY


Ryan Clukey, Senior Manager, System Validation and Human Factors Engineering, PHILLIPS

2:15PM – 3:00PM

MANAGE PROJECT TIMELINES AND WORK WITH AN EYE ON DESIGN FREEZES


Tina Rees, Associate Director, Human Factors, FERRING PHARMACEUTICALS

3:00PM – 3:45PM

CONFRONT THE CHALLENGES AND FALSE ASSUMPTIONS OF HUMAN FACTORS IN START-UPS


Sathya Elumalai, CEO, MULTISENSOR DIAGNOSTICS


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