Workshop Descriptions

2019 HFES Health Care Symposium Workshop Sessions

 

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The 2019 Health Care Symposium will be offering seven workshops at this year's meeting.

Click on the links to learn more about each of these workshops below:





 

Improving the Safety and Effectiveness of Medical Devices Through Human Factors Considerations:  An Interactive Workshop

March 24, 2019 - 8:00 AM - Noon 
Presented by: Human Factors Pre-Market Evaluation Team, CDRH, FDA

This workshop provides a forum for an interactive dialog between FDA/CDHR human factors team and sponsors, consultants and other interested persons regarding human factors (HF) validation of a variety of medical device and systems. Participants will have opportunities to ask questions to the presenters.  

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Human Factors Validation of Combination Drug Products:  An Interactive FDA Workshop

March 24, 2019 - 1:30 PM - 5:30 PM
Presented by:  Irene Z. Chan, Pharm.D., BCPS and additional presenters, Division of Medication Error Prevention and Analysis, FDA (CEDR)

This workshop provides a forum for an interactive dialog between the FDA/CDER human factors team and sponsors, consultants and other interested persons regarding human factors (HF) validation of combination drug products. Participants will have opportunities to ask questions to the presenters.

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Designing for Safe Use

March 27, 2019 - 1:30 PM - 5:30 PM

Presenters:
Michael Wiklund, CHFP, MS, PE
General Manager, Human Factors Research & Design, EMERGO by UL

Cory Costantino, CHFP, MS
Design Director, Human Factors Research & Design, EMERGO by UL

Alix Dorfman, MS
Senior Human Factors Specialist, Human Factors Research & Design, EMERGO by UL

Description & Learning Objectives:
This workshop is designed to deliver a “booster shot” of knowledge about how to design medical technology for safe use. To supplement an attendee’s knowledge about good human factors engineering practices (per FDA guidance, per IEC62366-1:2015), the workshop will focus on user interface design elements that help ensure proper product use and prevent potentially harmful use errors. In other words, it is focused on creating risk mitigations (also called risk control measures) that help drive a successful product development outcome; one that helps ensure a safe and satisfying product, successful summative usability test and, subsequently, regulator acceptance of product safety claims.

Workshop attendees will receive practical advice and be expose to many examples of ways to design for safe use, such as the following ten:Workshop attendees will receive practical advice and be expose to many examples of ways to design for safe use, such as the following ten:

  • Add a warning label that conforms to the best practices described in ANSI Z535 and other authoritative sources.
  • Guard a design element to prevent accidental actuation or one that could cause harm, such as a pinch point or sharp point.
  • Evacuate smoke and other airborne particles to prevent clinician and patient inhalation.
  • Add padding to avoid pressure points and to lessen harm due to incidental contact.
  • Add an interlock mechanism (hardware- or software-based) to ensure that a critical action is deliberate versus accidental.
  • Damp the motion of device parts that could cause harm should they otherwise move quickly and strike the user with significant force.
  • Make key information (e.g., expiration date, dosage) conspicuous to ensure effective communication.
  • Make text, numbers, and graphical information (e.g., waveforms) legible to ensure correct reading and interpretation.
  • Use various types of coding (e.g., color, shape, texture, sound, text size) to differentiate information and controls as well as ensure proper matching of components (e.g., a tube to a port).
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Moderating Studies: Discipline, Flexibility, Counseling

March 27, 2019 - 1:30 PM - 5:30 PM

Presenters:
Bryant Foster, M.S.
Vice President, Research and Design, Research Collective

Emily Hildebrand, Ph.D.
Director, Human Factors, Research Collective

Description & Learning Objectives:
User research studies are carefully designed to collect objective data from participants. At a minimum, the moderator is responsible to conduct the study in a way that does not introduce bias. Skilled moderators are able to obtain additional insights that can make a huge impact on a project’s success. For example, only the moderator can ask follow up questions that can reveal the root cause of a use error. The skills that make a good moderator can be learned, practiced, and perfected. 

This workshop will use examples from actual studies to teach attendees the skills that make a good moderator. Attendees will have the opportunity to practice their moderating skills in role playing exercises. Moderating skills that will be taught include:

  • Moderating styles that should be used in generative research, formative studies, and validation usability studies
  • Effective methods to uncover root causes of use errors and difficulties
  • Tips for determining if an error was made because it was not perceived or it was not comprehended
  • Strategies to avoid leading participants
  • How to avoid participants’ questions without being rude 
  • Tips for encouraging participants to act as they would in real life
  • How to explain a device without teaching participants how to use it
  • Strategies to help participants feel comfortable
  • How to encourage participants without introducing bias
  • When to answer questions and when to ask questions
  • How to avoid bias through body language and voice
  • Study design strategies to provide a realistic experience for participants
  • Guidelines for determining which tasks should be simulated and which can be evaluated through comprehension questions
  • Tips for conducting effective research with children
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Mining Device Post-Market Databases for Usability Problems: Tips, Techniques, and Lessons Learned

March 27, 2019 - 1:30 PM - 5:30 PM

Presenters:
Robert A. North, Ph.D.
Human Centered Strategies, LLC

Steven D. Harris, CDR USN (ret.)
Rational LLC

Description & Learning Objectives:
Understanding usability and use error causes once a device is marketed can be a dilemma for human factors practitioners in the healthcare industry. Usability problems often go underreported, yet many human factors insights lie within these adverse event reports. Categorization of adverse event causes seldom point to the real problem – mismatches between user interfaces and user mental models of how a device works. Adverse event reporting and complaint files may contain helpful data concerning usability problems, but sorting through these reports can be time consuming and frustrating for the HF practitioner.

The workshop author team has developed linguistically based data manipulation and search techniques that have proved beneficial in mining for usability issues using standard System Query Language (SQL) approaches. In this half-day workshop, we will provide an introduction to the structure of the FDA’s Manufacturer and User Device Experience database, and how HF practitioners can obtain and manipulate adverse event narratives to identify usability issues.

The workshop will include:

  • Live demonstrations of how data is downloaded from the FDA MAUDE database and manipulated, including obtaining frequencies of terms entered in a dataset of interest (i.e. particular infusion pump over a certain time period)
  • Analysis of these frequently entered terms for their usability connotation, and how search terms can be used to sort reports to identify those with high affinity with usability related terminology.
  • A tutorial on the MAUDE database records, structure of the database, isolating records of interest, and use of the existing public domain on-line search capability.
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Co-Designing Methods to Study and Improve Patient-At-Work

March 24, 2019 - 1:30 PM - 5:30 PM

Presenters:
Shanqing Yin, Ph.D.
Senior Principal Human Factors Specialist, KK Women's & Children's Hospital, Singapore

Dan Nathan-Roberts, Ph.D.
Professor, San Jose State University

Paul Barach, M.D., MPH
Professor, Wayne State University School of Medicine

Description & Learning Objectives:
In this workshop, participants start off with an introduction to the concepts of human factors and patients at work. Each presenter will then share human factors approaches and methods they have used to study clinical and patient work processes, followed by hands-on activities and demonstrations among participants on these human factors methodologies. Lastly, we will address patient experience through the lens of one of our presenters who recently underwent cancer surgery, and participants will be invited to reflect as past and future patients, brainstorm and co-design (as patients and as researchers) methods to quantify the effort of patients at work (Batalden et al., 2016).

During this 3-hour interactive workshop, participants will:

  • Explore the concept of patient-at-work, patient effort, and patient workload
  • Be introduced to applied human factors methods used to study clinical process in a complex social technical system
  • Participate, experience, and discuss the challenges and potential solutions in addressing the workload of being a patient
  • Brainstorm and co-design methods for studying and improving patients at work
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Raise the Bar: Fostering a High Performing Medical Device Human Factors Practice

March 27, 2019 - 1:30 PM - 5:30 PM

Presenters:
Sami Durrani, Ph.D.
Fresenius Medical Care

Robert Stephens, Ph.D.
Medtronic

Eric Bergman, Ph.D.
Fresenius Medical Care

Description & Learning Objectives:
Developing a high performing human factors program within a new or existing business can be challenging. This workshop will illuminate best practices for initiating programs and raising exsiting programs "to the next level" within medical device and combination product development companies. The workshop will solicit examples of current challenges faced by attendees to facilitate the discussion regarding best practices and strategies for building HF programs tailored to the interests of workshop participants. Workshop findings will be compiled into a "toolkit" relevant for those establishing an HF program or looking to expand the size or influence of current programs. These findings will be shared via an article in a HFES journal and/or at next  year's conference.

Topics to be covered will include:
  • Team
    • Staff retention & recruitment in a competitive job market
    • Leveraging external consultants v. hiring additional internal staff
    • Diversity of expertise: Designers v. HF v. combination skillsets
    • Identifying professionals from non-medical industries with transferrable skills
    • Identifying non-HF professionals who could be trained as supporting staff
    • Team roles and organizations
  • Process
    • Integrating with existing quality management system
    • Making human factors a "default" part of the R&D process
    • Moving human factores earlier into the design cycle
    • Optimizing procedures, work instructions and templates
  • Organizational Effectiveness
    • Expanding HF influence and impact beyond project boundaries
    • Using HF to steer business strategy
    • Strategies for obtaining management support
    • Communication with upper level management and internal stakeholders
    • Overcoming the most common organizational challenges
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