DAY ONE | TUESDAY, DECEMBER 10
7:45 REGISTRATION & WELCOME COFFEE
8:30 CHAIRPERSON’S OPENING REMARKS
Natalie Abts, Head of Human Factors Engineering, GENENTECH
8:45 BOLSTERING USABILITY TESTING WITH PROACTIVE FRONT-END STUDY DEVELOPMENT
Improvements to the usability of a device often result from user feedback collected during formative studies or post-market surveillance, but front-loading research before usability testing begins can help human factors teams anticipate and correct for many issues that may arise in later tests. A solid groundwork of data derived from focus groups and interviews, contextual inquiry and ethnographic research, and post-market feedback from previous device iterations can establishing a foundation for tests and increase efficiency throughout the process. Such research defines the scope of the study, quickly identifies potential risks and challenges, and closely examines personal user behavior in a way that is difficult to replicate in a lab environment.
- Informal methods for pre-study data collection
- Focus groups & interviews
- User or customer surveys
- Comprehensive risk factor identification
- Ethnographic research strategies
- Translation of research into design inputs
Bart Peterson, Principal Industrial Designer, BD
9:30 ALIGNMENT OF HUMAN FACTORS TESTING WITH IEC-62366 TO ANALYZE, SPECIFY, DEVELOP & EVALUATE USABILITY
As medical device human factors and usability testing becomes increasingly relevant on a global scale, executives look to international standards harmonized with FDA regulation for a comprehensive guide to ensuring tests meet the needs of various regulators. Long considered the gold standard in Europe, IEC 62336-1: 2015 provides guidance on evaluating use risk in correct and normal uses and when applied, and aligns with FDA guidance to ensure robust regulatory compliance.
- Utilizing FDA guidance to interpret IEC 62366-1
- Practical implementation of 62366-1 in usability tests
- Focus on User Interfaces of Unknown Provenance
- Insights into the application of IEC 62366-2
Daniel Mabini, Usability Lead, GE HEALTHCARE
10:15 COFFEE & NETWORKING BREAK
10:45 TAILORING USABILITY FOR LAYPERSONS OPERATING DEVICES OUTSIDE OF MEDICAL ENVIRONMENTS
Patients and caregivers utilize a diversity of medical devices outside of medical contexts to manage personal health outcomes, and human factors and usability teams are tasked with designing devices that are compatible with a wide variety of personal characteristics and use environments. While some basic aspects of usability are relatively consistent across user groups, certain design factors must be carefully tailored toward the mental processes, health literacy, and physical capabilities of laypersons in order to mitigate risk, ensure device effectiveness, and maximize ease of use.
- End-user identification and usability testing
- Devices used by both HCPs and laypersons
- Switching between basic and expert modes
- Anticipating stress levels in emergency situations
- Migration of medical devices from institution to home
- Authoring appropriately intuitive IFUs for laypersons
Homayoon Kazerooni, CEO, SUITX
11:30 MODULE: HUMAN FACTORS AND USABILITY TESTING FOR INNOVATIVE, DISRUPTIVE TECHNOLOGIES
Current guidelines, best practices and regulatory standards apply to a broad range of existing medical devices, but rapid and constant technological breakthroughs continue to advance the device industry into unknown territory. Unprecedented developments in AI and machine learning, robotic surgical tools and systems, and nanotechnology continue to redefine the limits and functions of human factors in medical devices, and vigilant forecasting of trends will prepare human factors teams to utilize the full breadth of future innovations.
11:30 CASE STUDY: Enid Montague, DEPAUL UNIVERSITY
11:40 PANEL DISCUSSION
Nikhil Joshi, AURIS HEALTH INC.
Homayoon Kazerooni, SUITX
Enid Montague, DEPAUL UNIVERSITY
12:15 LUNCHEON FOR SPEAKERS, SPONSORS & ATTENDEES
1:30 HIGHLIGHTING THE ROLE OF EXPERIENCE MAPPING IN USABILITY ENGINEERING
Cognitive processes underlying human behavior play an indispensable role in human factors and usability engineering. Consideration of and empathy for the user’s perception and emotional response to decision making enables development of a safer and more effective device interface. Mapping the specific touch points that a user encounters throughout the experience provides strong insights into design inputs that align closely with holistic user requirements. An experience map is a valuable tool for identifying pain points and opportunities to make efficient improvements to an existing product or to create complementary products.
Yasmine Haddad, Senior Systems Engineer, THINK SURGICAL
2:15 SMALL GROUP DISCUSSIONS: TARGETED USER RECRUITMENT EXCELLENCE
Observation of the ways in which users interact with a device is essential for viable usability studies, and accurate identification and recruitment of these users is a step toward collecting valuable insights. However, barriers to recruitment such as lack of interest or availability, narrowness of study parameters, or job title specialization can jeopardize the representativeness and compliance of otherwise well-designed tests. Whether offering creative incentives or utilizing outside partners to source leads, human factors personnel can explore and apply tested strategies for recruiting relevant users in numbers needed to satisfy regulations.
GROUP 1: NURSES & SUPPORT STAFF
Charles Weaver, ILLUMINA
GROUP 2: PHYSICIANS & SURGEONS
Nikhil Joshi, AURIS HEALTH INC
GROUP 3: PATIENTS & CAREGIVERS
Michelle Hatch, GENENTECH
GROUP 4: STERILIZATION TECHNICIANS
Lee Haugen, EISENHOWER MEDICAL CENTER
3:00 COFFEE & NETWORKING BREAK
3:30 HUMAN FACTORS AT HOME: DESIGN CONSIDERATION OF IN-HOME USE
Designing devices for in-home use is more challenging than designing for clinical environments. The users at home are patients, family and caregivers rather than trained healthcare providers. These users are often older or in poor health, with diminished perceptual, cognitive or motor abilities. Further, the home is usually designed for comfort and family rather than healthcare. This presentation discusses how to accommodate these differences in medical device design.
Russ Branaghan, Associate Professor, Human Systems Engineering
ARIZONA STATE UNIVERSITY
5:00 CLOSING REMARKS AND DAY 1 CONCLUSION