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Other Track Schedules

Medical and Drug-Delivery Devices Track Schedule

MONDAY, MARCH 6

MDD1 – FDA CDER Perspective on the Role of Human Factors in Combination Product Design and Development
10:30 a.m. to 12:00 p.m.
Location: Grand Ballroom A
Panel Session
Chair: Cheryl Kwinn, Farm Product Development
Cochair: John Gosbee, Red Forest Consulting, LLC
Panelists: QuynhNhu Nguyen, MS, Associate Director for Human Factors; Mishale Mistry, PharmD, MPH, Associate Director (Acting)

MDD2 – Design and Human Factors
1:30 to 3:00 p.m.
Location: Grand Ballroom A
Lecture Session
Chair: Mary Beth Privitera, HS Design/U. of Cincinnati

  • The DNA of Design Excellence
    Bryce Rutter, Metaphase Design Group
  • Amplify Your HFE/UE Outcomes – Insights for Igniting a User-Centered Culture
    Chelsea Wanta and Linda Kohli, GE Healthcare
  • Best Practices of Safety Information Presentation in IFUs
    Eric Shaver, Human Factors MD

MDD3 – Best Practices: Human Factors for Combination Products
3:30 to 4:30 p.m.
Location: Grand Ballroom A
Panel Session
Chair: Tor Alden, HS Design
Cochair: Evan T. Edwards, Kaleo, Inc.
Panelists: Sherri Biondi, Genentech; Molly Story, Sanofi; Valerie Fenster, Amgen, Inc.; Kevin Cluff, AbbVie, Inc.

MDD-POS1 – Medical and Drug-Delivery Devices Posters Session 1
4:30 to 6:00 p.m.
Location: Grand Ballroom E

  1. Are Your User Needs Usable? Writing User Needs That Don't Leave Engineers Scratching Their Heads
    Michael Lau, Insight Product Development
  2. Avoid Repeat Validation: Identifying and Preventing Common Mistakes When Conducting Human Factors for FDA Submission
    Natalie Abts and Rebecca Butler, National Center for Human Factors in Healthcare - MedStar Health
  3. Conducting Cross-Cultural Usability Research
    Arathi Sethumadhavan and Adam Shames, Core Human Factors Inc.
  4. Designing a Device to Administer Multiparticulates to the Pediatric Population – What Do Children Think?
    Claire Lewis, Alexandra Lang, and Jonathan Burley, U. of Nottingham; James McGovern and Joanna Simmons, Pfizer; Joel Segal, U. of Nottingham
  5. Designing Diagnostic Medical Devices for Your Lab Tests
    Ila Elson, Abbott Laboratories
  6. From Phases of Flight to Phases of Care: Translating User Research Into Tools for Design
    Pamela Munro, Feiji Consulting
  7. How Useful Are Handheld ECG Monitors?
    Brad Bonnette, Jeremy Suggs, and Patrice Tremoulet, ECRI Inst.
  8. Novel Techniques for Understanding Connected Device Users in Their Native Environment
    Sherri Biondi, Genentech; Erika Bajars, Matchstick
  9. The Clean and the Dirty of Redesigning Reprocessing Instructions for Use
    Julia Choi, Stephanie Seraphina, and Kate Knudsen, Intuitive Surgical
  10. The Missing Pathway for Human Factors Research
    Mary Beth Privitera, HS Design/U. of Cincinnati; Tor Alden, HS Design
  11. Understanding and Mitigating Use-Related Issues in Home Health-Care Devices
    Limor Hochberg, Stephanie Bassock, and Merrick Kossack, UL-Wiklund
  12. User Experience in Heart Lead Testing
    Arathi Sethumadhavan, Core Human Factors Inc.
  13. Using Data-Driven Research Techniques to Create Better Product Requirements
    Peter Sneeringer and Lindsay Carrabine, Design Science

TUESDAY, MARCH 7

MDD4 – Usability Design Foundations
8:30 to 10:00 a.m.
Location: Grand Ballroom A
Lecture Session
Chair: Beth A. Loring, Loring Human Factors, LLC
Cochair: Tressa Daniels, Illumina

  • Development and Validation of a Usability Metrics for Evaluation of Medical Equipment
    Thomas Looke, Michelle Dolske, and Julie Pepe, Florida Hospital
  • A Rosetta Stone for Standards: Matching Up the Requirements of IEC, FDA, and Other Standards for Medical Devices
    Robert Stephens, Medtronic
  • "Easy to Use" – The Worst Requirement...Ever
    Joe Cesa, Halyard Health Inc.

MDD5 – Applied Usability Engineering Methods
10:30 a.m. to 12:00 p.m.
Location: Grand Ballroom A
Lecture Session
Chair: Joe Cesa, Halyard Health
Cochair: Amanda Hall, Physio-Control

  • New Measurement Tools For Improving Human Factors Work
    Stephen Wilcox, Design Science
  • Multicenter Assessment and Future of Single-Site Surgery
    Bernadette McCrory, U. of Nebraska-Lincoln; M. Susan Hallbeck and Bethany Lowndes, Mayo Clinic; Andrew Christiansen and Chad LaGrange, U. of Nebraska Medical Center
  • Fine Motor Skill Development Using Laparoscopic and Robotic Instruments: How Will Learning One Technique Help Me Learn the Other?
    Asha Dektor, Jane Littau, and Kate Knudsen, Intuitive Surgical, Inc.

MDD6 – Ethical Challenges With Usability Testing
1:30 to 3:00 p.m.
Location: Grand Ballroom A
Lecture/Panel Session
Panel Chair: Rebecca Butler, National Center for Human Factors in Healthcare - MedStar Health
Lecture Chair: Laurie Reed, Farm Design, Inc.
Lecture Cochair: Eric Shaver, Human Factors MD

  • Panel: Does the FDA Human Factors Guidance Help Curb Ethical Dilemmas in Health-Care Usability Testing?
    Panelists: Lawrence Wolpert and Natalie Abts, National Center for Human Factors in Healthcare - MedStar Health; John Gosbee, Red Forest Consulting, LLC; Xin Feng, FDA; Sara Waxberg McNew, Eli Lilly and Company; Joshua Singer, National Center for Human Factors in Healthcare - MedStar Health
  • Lecture: Recruiting Patients With Rare Diseases and Their Caregivers
    Beth Loring, Loring Human Factors, LLC; Jacquelyn Wan, Radius Innovation & Development

MDD7 – Health-Care Facility Access Challenges for User Research
3:30 to 4:30 p.m.
Location: Grand Ballroom A
Panel Session
Chair: Sean Hagen, BlackHagen Design
Cochair: Sami Durrani, Fresenius Health Care
Panelists: Beth Loring, Loring Human Factors, LLC; Mary Beth Privitera, HS Design/U. of Cincinnati; Susan Feldman and Ryan McDowell, Children's Mercy Kansas City; Stephen Wilcox, Design Science; Keith Karn, Human Factors in Context LLC

MDD-POS2 – Medical and Drug-Delivery Devices Posters Session 2
4:30 to 6:00 p.m.
Location: Grand Ballroom E

  1. A Controlled Clinical Trial Testing the Effectiveness of a Mindfulness Training Video Game
    Paul Barclay, Nicholas James, and Clint Bowers, U. of Central Florida
  2. A Research Consortium for Human Factors in Medical Devices and Combination Products
    Frank Drews, U. of Utah
  3. Can Health Care Learn From the Other Industries Like Aerospace and Automotive?
    Russell Branaghan, Research Collective; Jen Donahue, Beckman Coulter; Dean Barker, Optum Health; David Mitropoulos-Rundus, Hyundai Motor Company; Bryant Foster, Research Collective
  4. In Situ Infusion Pump Usability Assessment: Do Active User Surveys Provide Future Design Insights?
    Mary Gordon and Krisanne Graves, Texas Children's Hospital; Courtney Titus, Baylor College of Medicine; Curt Braun, Benchmark Research & Safety
  5. Incorporating Diverse Patient Preferences Into a Medical Device Offering
    Sarah Baer and Megan Lan, BD Medical - Pharmaceutical Systems
  6. Medical Device Design: Applying a Human-Centered Design Methodology
    Gina Taylor Matthew Bowman, U. of Illinois at Urbana-Champaign
  7. Optimizing Medications Arrangement Inside the Intensive Care Ambulance: Improving Prehospital Emergency Care and Safety
    Avi Parush, Irit Demri, Noa Brotman, Shmuel Traub, and Asher Hen, Israel Inst. of Technology; Eli Jaffe, Magen David Adom
  8. Out-of-Box Device Failures: One Institution's Experience and MAUDE Data
    Michael Tanner, Beaumont Health
  9. Role of Human Factors in the Design of Infusion Pumps
    Sunitha Narendra Babu and Dan Nathan-Roberts, San Jose State U.
  10. Strategic Sample Sizes for Summative Testing
    Sarah Creasy and Graham Barrett, Medtronic
  11. Strategies for Successful Human Factors Collaboration With Medical Device Development Teams
    Eric Shaver, Human Factors MD
  12. The Blurring of the Line Between Medical and Consumer Products
    Russell Branaghan and Bryant Foster, Research Collective; Jessica Crosby, SynCardia; Mark Palmer, Lextant
  13. The Use of Eye-Tracking in Usability Testing of Medical Devices
    Thomas Koester, Jesper BrÝsted, and Jeanette Jakobsen, FORCE Technology
  14. UI Form Design Considerations for Ergonomists Evaluating Computer Workstations
    Allen Yagjian, British Standards Inst.

WEDNESDAY, MARCH 8

MDD8 – Bridging the Industry/Regulatory HF/E Gap: Honoring Ron Kaye's FDA Leadership
8:30 to 10:00 a.m.
Location: Grand Ballroom A
Panel Session
Chair: Robert A. North, Human Centered Strategies
Cochair: Adam Schames
Panelists: Rollin J. (Terry) Fairbanks, National Center for Human Factors in Healthcare - MedStar Health

MDD9 – Medical Device Human Factors: FDA CDRH Panel
10:30 a.m. to 12:00 p.m.
Location: Grand Ballroom A
Panel Session
Chair: Anthony D. Andre, Interface Analysis Assoc./San Jose State U.
Cochair: Sean Hagen, BlackHagen Design
Panelists: Shannon Hoste, Xin Feng, and Hanniebey Wiyor, FDA Human Factors Premarket Evaluation Team

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