$1,885 – $5,675

3rd Human Factors Engineering & Usability Studies Summit (EXL)

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Location

Location

Argonaut Hotel

495 Jefferson Street

San Francisco, CA 94109

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Refund Policy

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No Refunds

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Description

3rd Human Factors Engineering & Usability Studies Summit

It has only been a few years since the FDA released its guidelines for human factors and usability testing for combination products. Compared to medical device companies, dedicated pharma and biotech companies have had to cope with a very high learning curve in order to meet regulatory expectations. For lack of long-term experience on this subject, many companies continue to struggle to build the necessary human factors expertise, whether through outsourcing or intensive team training.

The 3rd annual Human Factors Engineering & Usability Studies Summit is the most specifically focused event on the market for the regulatory and technical needs of combination product sponsors. This year’s program features never-before-heard insights and analysis of the latest FDA regulatory guidelines.

Top Five Reasons to Attend

  1. Updates on the latest regulatory developments, including how to proceed when CDER and CDRH reviewers seem to disagree
  2. Best practice for sequencing validation studies within the product testing life cycle to avoid severe late-stage errors
  3. Device instruction and labeling optimization strategies that reduce user error
  4. Case studies on selecting and working with both trained and untrained user populations
  5. Methods for cultivating in-house expertise on human factors and usability test protocol design

Who Should Attend

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas:

  • Device Development
  • Human Factors
  • Usability
  • Technology
  • Engineering
  • Design Controls
  • Industrial Design
  • Validation
  • Clinical Research
  • Ergonomics
  • Quality Control/Quality Assurance
  • Regulatory Affairs
  • Risk Management
  • Software Engineering/Software Management/Software Development

This event is also of interest to:

  • Human Factors Specialists
  • Device Engineering Specialists
  • Device Trial Specialists
  • Regulatory Consultants/Law Firms
  • Device Software Designers/Testers


Testimonials:

“Great benefits from getting more background on where the industry is now, and how to get others on board for improving usability methods.”
Design Assurance Engineer, BOSTON SCIENTIFIC

Testimonials:
“Very interesting and engaging. Excellent suggestions and advice.”
Senior Quality Engineer, ABBOTT

Testimonials:
“Very engaging, important content.”
Senior Engineer, EDWARDS LIFESCIENCES


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Agenda
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Day One

Monday, Februaury 12

8:00AM – 8:45AM
Registration and Continental Breakfast

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

1:30PM – 2:15PM
Map the Full Range of Errors for Combination Products in At-Home Use

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

5:00PM – Day One Concludes


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

3:00PM – Conference Concludes


Featured Speakers



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


Nick Allen
Global Director, Design and User Experience
GE HEALTHCARE


Ed Israelski
Technical Advisor, Human Factors
ABBVIE


Ling Lu
Senior Principal Scientist,
Biotherapeutics Pharmaceutical Sciences
PFIZER


Natalie Abts
Director, Regulatory CMC,
Combination Products
NATIONAL CENTER FOR HUMAN FACTORS IN HEALTHCARE


Jacques Ginestet
Head, Wearables Development
PROTEUS DIGITAL HEALTH


Gia Rozells
Director, User Experience
BECTON DICKINSON


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

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

Argonaut Hotel

495 Jefferson Street

San Francisco, CA 94109

View Map

Refund Policy

No Refunds

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