DAY ONE | TUESDAY, DECEMBER 10
7:45 REGISTRATION & WELCOME COFFEE
8:30 CHAIRPERSON’S OPENING REMARKS
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 PANEL DISCUSSION: 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.
Homayoon Kazerooni, SUITX
Enid Montague, DEPAUL UNIVERSITY
12:15 LUNCHEON FOR SPEAKERS, SPONSORS & ATTENDEES
1:30 HIGHLIGHTING THE ROLE OF COGNITIVE SCIENCE IN HUMAN FACTORS AND USABILITY ENGINEERING
Cognitive processes underlying human behavior play an indispensable role in human factors and usability engineering, dictating everything from a user’s perception and emotional response to decision making and motor function. To thoroughly understand the ability of the mind and body to interact with a medical device, human factors teams can study and utilize the principles of cognitive science through academic research and lessons learned from other industries, ensuring that design inputs align closely with holistic user requirements. Continued education on the structure of the human mind is a valuable tool in creating and validating devices that are straightforward, safe, and functional.
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
Christina Reinhart, 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 WORKSHOP: DEVELOPMENT OF PRECISE & INSIGHTFUL QUESTIONS IN USABILITY TESTING
Well-crafted questions can push human factors and usability studies beyond the limits of observation and into the perceptive and cognitive processes that lead to observed actions. While the specifics of writing and ordering questions vary from study to study, there are principles that can be utilized to reduce bias, avoid the collection of redundant or useless information, and choose the shortest path to relevant and useful insights that will inform design inputs. In this interactive workshop, small groups will receive a hypothetical product and study goal, and will work together to author a set of questions that have the potential to accurately pinpoint user needs, with efficiency of words and built-in safeguards against bias.
Russ Branaghan, Associate Professor, Human Systems Engineering
ARIZONA STATE UNIVERSITY
5:00 CLOSING REMARKS AND DAY 1 CONCLUSION