Human Factors Engineering & Usability Studies Congress

December 7-8, 2020

Online Livestream

What To Expect

The Human Factors Engineering & Usability Studies Congress is the only event specifically focused on the needs of medical device and combination product professionals responsible for avoiding use errors and medication errors while building a positive user experience. As your combination product matures, are you ready to address more involved questions of practical design, troubleshooting, and answering involved questions from regulators? This unique event will empower HF professionals to grow more confident in their skills, guide their teams toward the right insource/outsource decisions, and set new strategies for device software.

Hilton East Brunswick

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3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson

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Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers

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Craig Lipset

Head of Clinical Innovation
Pfizer

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Jeff Kingsley

Chief Executive Officer
IACT Health 

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Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

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Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

  • Latest updates on domestic and international regulatory developments
  • Ideal metrics for judging the ROI in human factors engineering and usability testing
  • Innovative methods for selecting the best comparator devices and study designs
  • Detailed insight on the design, testing, updating, and cybersecurity precautions required for medical device software and apps
  • Unequaled access and networking opportunities with the life science industry’s leaders in usability testing

Who Should Attend?

This conference is designed for senior leaders and executives in pharmaceutical, biotech, and medical device companies responsible for:

  • Human Factors / Human Factors Engineer
  • Usability
  • User Experience / User Interface / UX / UI
  • Patient Experience
  • Customer Experience
  • Medical Device
  • Combination Products
  • Device Development / Device Technology
  • Labeling
  • Packaging
  • Instrumentation
  • Design Assurance Engineer
  • Product Development
  • Device Design
  • Industrial Design
  • Design Controls
  • Wearables
  • Mobility
  • Software Engineering
  • Quality / Quality Control / Quality Assurance / Quality Engineer

Monday

December 7th, 2020 | Day 1

8:00 AM - 8:45 AM

Login

8:45 AM - 9:00 AM

Introduction from Chairperson

Joseph Purpura - Associate Vice President, Medical Device Safety
ALLERGAN

PART 1: HUMAN FACTORS ENGINEERING AFTER COVID-19

9:00 AM - 9:45 AM

Anticipate FDA Reactions to New Summative and Validation Test Designs

HF professionals must find new ways to recruit staff, maintain regular schedules, and interact with users – especially users who are in high risk groups for COVID-19. In addition to maintaining HF credibility, future test designs will need to address new concerns about liability, risk, and patient privacy.

  • Explore tests involving mobile labs and remote product shipping
  • Gather input from legal, regulatory, and compliance team members
  • Understand what novel study designs FDA will find credible and acceptable

Gia Rozells - Director of User Experience Design
BD

Natalie Abts - Head, Human Factors Engineering
GENENTECH

9:45 AM - 10:30 AM

Position your Pipeline for a Future of Remote Testing

The COVID emergency has allowed for rapid upgrading of remote testing protocols, which are often faster and less expensive. Once the social distancing imperative fades, will FDA allow remote testing to remain in place?

  • Visualize the logistical hurdles of training and delivering devices to all test participants
  • Adapt home use testing methods to devices that could cause harm if used improperly or if not returned
  • Determine whether the data and perspectives from remote testing will be sufficient

10:30 AM - 10:45 AM

Networking Break

10:45 AM - 11:30 AM

Explore the Most Practical Options for Virtual User Interface Testing

Whereas graphical user interfaces and vision-oriented products are easily tested remotely, other device aspects are far more challenging.  New approaches in augmented reality, virtual reality, and puppet testing can all be achieved in the short term and can bridge COVID’s gaps.  

  • Review data collection through virtual reality and other new methods
  • Establish a visual brand language that fits with product iconography and workflow
  • Fuse the expertise of research groups and designers

John Staton - Director, Human Factors, User Research, and Experience Design
THERMO FISHER

11:30 AM - 12:15 PM

PANEL: Modify Protocol Development Around Presubmission Timeframes

Getting answers to a presubmission can take over 2 months – for a study you’re actively trying to plan. Direct interactions with FDA can be used to help refine your questions and increase the likelihood of precise answers.

  • Limit the scope of questions to improve feedback speed and relevance
  • Focus on clarifying the acceptability of specific testing aspects
  • Compare and contrast different presubmission methodologies

Jonathan Amaya-Hodges - Associate Director, Regulatory Affairs CMC, Combination Products and Medical Devices
BIOGEN

12:15 PM - 12:45 PM

Lunch

12:45 PM - 1:30 PM

CASE STUDY: Monitor for Signs of Anchoring Bias and Cherrypicking Favorable Data

Outsourced testing partners want sponsor companies to be happy – but what sponsors need is accuracy, even if the results are disappointing. The sooner you get bad results, the faster you can fix problems.

  • Firmly set expectations for clinical usability trial partnerships
  • Ensure studies are executed and interpreted with integrity
  • Look for warning signs in trial completion time

Joseph Purpura - Associate Vice President, Medical Device Safety
ALLERGAN

1:30 PM - 2:15 PM

Differentiate Between Preference and Usability to Ensure you Follow the Right Signals

Patients may prefer not to use a device even if they understand how to do it. It is critical both to gather data about patient preference and adoption, and to separate that data from usability itself.

  • Interpret use data about devices that may be confusing or embarrassing
  • Recognize that patients may be able to use a device but choose to cease using it – and why
  • Learn from both data sets while keeping them distinct

Jenn Zuba - Risk Management Engineering Leader
W.L. GORE

2:15 PM - 2:30 PM

Networking Break

2:30 PM - 3:15 PM

Make Your Case About Leveraging Existing Data to Reduce Summative Testing Requirements

Drug delivery device combination product sponsors often want to leverage existing data to reduce complexity and scope of summative testing, and sometimes they are successful! What are key considerations and methodologies to keep in mind when making this case?

  • Understand recent health authority guidance and expectations
  • Identify situations where data may be leveraged
  • Synthesize an approach to evaluate applicability of existing data
  • Translate into proposals for reduced testing requirements

Rachel Poker - Human Factors Engineering Manager, Device Development
ASTRAZENECA

3:15 PM - 4:00 PM

Adapt to Regulatory Perceptions of Bias

Your test protocols get judged by regulators who might not have specific HF training, requiring a careful touch as you explain what is commonplace. FDA wants to avoid any appearance of overtraining or bias – but what do they really mean by this, and what is necessary to avoid it?

  • Review past complaints about the use of spoken or written descriptions
  • Work through FDA expectations regarding overtraining and learning decay
  • Retrain your teams to stop using potential intervention trigger words such as “familiarize”

Ed Israelski - Technical Advisor, Human Factors
ABBVIE

Tuesday

November 17th, 2020 | Day 2

8:00 AM - 9:00 AM

Login

8:45 AM - 9:00 AM

Chairperson’s Recap of Day One

Joseph Purpura - Associate Vice President, Medical Device Safety
ALLERGAN

PART 2: SMOOTHER TEAM MANAGEMENT FOR A BETTER USER EXPERIENCE

9:00 AM - 9:45 AM

Merge the Perspectives of Diverse Teams and Departments to Meet Design Goals

Your device design team covers multiple backgrounds, and it can be a challenge to guide diverse viewpoints into a common solution that meets HF requirements and creates a pleasant user experience. Managing and focusing the input from so many disciplines requires a careful, diplomatic approach.

  • Review leadership techniques that help in uncovering mistakes while avoiding blame
  • Refocus the input from engineering, marketing, and clinical research colleagues to emphasize HF outcomes
  • Build a close rapport with your lead engineers and clinical specialists

Young Chun - Associate Director, Lead, Human Factors and User Research
TAKEDA

9:45 AM - 10:30 AM

Resolve Organizational Disputes over Acceptance Criteria

Regulators don’t want medical device sponsors to use quantitative acceptance criteria, but that is not always clear to device manufacturers who may not have a historic focus on HF. If companies or teams struggle to understand how usability engineering differs from other types of engineering, HF managers must prepare to win internal arguments.

  • Summarize how usability engineering is different in terms of risk management, testing, validation, and acceptance criteria
  • Get leadership on your side
  • Rally the full set of standards as evidence

Joe Cesa - Manager, Human Factors Engineering, Surgical Robotics
MEDTRONIC

10:30 AM - 10:45 AM

Morning Networking Break

10:45 AM - 11:30 AM

Design Error-Resistant Medical Devices with an Advanced Heuristic Approach

Ten key heuristics can be used during formative design, device evaluation, and competitive benchmarking. Through these heuristics, you can achieve faster design integration, and reduction and mitigation for use errors, leading to a safer, more effective device design.

  • Use heuristics to evaluate the usability of a medical device
  • Distinguish between varieties of use errors
  • Categorize and establish the root cause of use errors

Tim Goldsmith - Staff Human Factors Engineer / User Experience Designer
ILLUMINA

11:30 AM - 12:15 PM

Fully Align Expectations and Understandings with Outsourced Partners

Writing the guides for screening and moderating is just the beginning of the oversight necessary for good relationships with outsourced partners. If you haven’t clearly defined what you expect regarding use errors and critical tasks, you’re just wasting your time and money.

  • Unify essential definitions
  • Highlight expectations for regulatory submission
  • Dedicate the time necessary to training

Tressa Daniels - Global Director, Human Factors Engineering
TELEFLEX

12:15 PM - 12:45 PM

Lunch

12:45 PM - 1:30 PM

PANEL: Take a Full-Sensory Approach to Build a More Pleasant Patient Experience

The patient experience is a sliding scale, not a good/bad binary, and removing problems doesn’t necessarily make device use more pleasant for them. When designing the communications systems for large medical devices, you can gain a market advantage by focusing on a pleasant or even ideal patient experience.

  • Analyze the factors and impacts of acoustics in large imaging devices (i.e. MRIs)
  • Recognize that there is more to patient perception than getting rid of complaints
  • Tally whether the market will pay for a better user experience

James Kleiss - Research Architect, User / Patient Experience
GE HEALTHCARE

Jay Duhig - Director, Patient Integration, Pharmacovigilance and Patient Safety
ABBVIE

1:30 PM - 1:45 PM

Networking Break

1:45 PM - 2:30 PM

Avoid Overestimating and Overburdening Users with Medical Training

When using complicated hardware, medical professionals are just as prone to error as laymen. Assuming that people with advanced degrees are better at learning than others is a serious, and often unrecognized, error that can plague design teams.

  • Recognize that learning is a potential burden for all users
  • Ensure a consistent approach to labeling and training regardless of user background
  • Interrogate your own assumptions

Mary Pat Cottengim - Principal Usability Engineer, Medical Devices
BAUSCH & LOMB

2:30 PM - 3:15 PM

Validate the Usability of Disposable Wireless Products

The advantage of using the Internet-of-Things to connect multiple devices is creating cheaper, disposable devices with simpler interfaces. But some devices can be too simple, causing user confusion and introducing risk of error.

  • Study the decision to withdraw wireless EKG devices due to usability challenges
  • Highlight the constraints of tiny disposable reusable devices
  • Apply proper skepticism to the IOT promises of service providers

John Kruse - Senior Human Factors Specialist
3M

Vera Shuman - Human Factors Product Development Specialist
3M

FEATURED SPEAKERS

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Natalie Abts

GENENTECH

Head, Human Factors Engineering

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Jonathan Amaya-Hodges

BIOGEN

Associate Director, Regulatory Affairs CMC, Combination Products and Medical Devices

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Joe Cesa

MEDTRONIC

Manager, Human Factors Engineering, Surgical Robotics

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Young Chun

TAKEDA

Associate Director, Lead, Human Factors and User Research

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Mary Pat Cottengim

BAUSCH & LOMB

Principal Usability Engineer, Medical Devices

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Tressa Daniels

TELEFLEX

Global Director, Human Factors Engineering

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Tim Goldsmith

ILLUMINA

Staff Human Factors Engineer / User Experience Designer

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Ed Israelski

ABBVIE

Technical Advisor, Human Factors

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John Kruse

3M

Senior Human Factors Specialist

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James Kleiss

GE HEALTHCARE

Research Architect, User / Patient Experience

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Joseph Purpura

ALLERGAN

Associate Vice President, Medical Device Safety

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Gia Rozells

BD

Director of User Experience Design

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Vera Shuman

3M

Human Factors Product Development Specialist

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John Staton

THERMO FISHER

Director, Human Factors, User Research, and Experience Design

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Jenn Zuba

W.L. GORE

Risk Management Engineering Leader

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Rachel Poker

ASTRAZENECA

Human Factors Engineering Manager, Device Development

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Jay Duhig

ABBVIE

Director, Patient Integration, Pharmacovigilance and Patient Safety

CONFERENCE REGISTRATION

LIVESTREAM PRICING

EARLY BIRD

$796


Before 10/30/20

STANDARD

$896


Anytime

Register 2 Attendees, Get 1 Complimentary Registration!*

Interested in registering groups of 7 or more? Contact us directly for pricing.

SPONSORED BY

Scarritt Group - Official Media Partner

OFFICIAL LIVESTREAM PROVIDER

MEDIA PARTNERS

PM360 - Media Partner

PREMIER MEDIA PARTNER


SPONSOR THIS EVENT

Contact Amy Chapman at (561) 571-7687achapman@dgeconfs.com