Semi-Annual Medical Device Human Factors & Usability Engineering Conference

October 22-23, 2019 | Hilton Alexandria Old Town

December 10-11, 2019 | Andaz San Diego Hotel

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DAY ONE | TUESDAY, OCTOBER 22

7:30 REGISTRATION & WELCOME COFFEE

8:15 CHAIRPERSON’S OPENING REMARKS

8:30 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 frontloading 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 establish 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

Jeff Hockersmith, Director of Quality, CONEXTIONS MEDICAL

 

9:15 MITIGATION OF DESIGN & PROCESS RISKS THROUGH COMPREHENSIVE HUMAN FACTORS ANALYSIS
As medical device manufacturers continue to design and develop groundbreaking medical technologies and products to be integrated into the continuum of healthcare around the world, reducing risks in product design as well as process use are of critical importance. The comprehensive and immersive integration of risk mitigation strategies into human factors and usability testing methods, from study concept and design to the questions asked of participants, provides insights and early identification of potential device risks. Deep analysis of methods behind risk management in human factors will provide participants with insights into how evaluation of design and process risks can act as an early warning sign and can mediate issues prior to approval or commercial launch.

  • Internal evaluation & identification of risks
  • Perceived risks by potential device users
  • Reducing overall risk of device harm

Trevor Dell, R&D Engineering Team Leader, BAYLIS MEDICAL COMPANY

 

10:00 COFFEE & NETWORKING BREAK

 

10:30 PANEL DISCUSSION: PROPELLING USER NEEDS TO THE FRONT OF THE DESIGN PROCESS
The medical device industry is gradually shifting toward greater inclusion of human factors in product development, but the integration of human factors into the design process often occurs in late-stage testing when proposed design changes would be cost and time prohibitive. By incorporating human factors into the early stages of design, companies can establish a thread of human centricity that runs through the entire lifecycle of the device, characterized by clear objectives and experimental rigor in testing as well as utmost prioritization of user needs. This early inclusion not only results in more efficient design cycles and a higher likelihood of successful summative studies leading to device approval, but also ensures that devices are fully equipped to solve problems in a way that satisfies and protects users to the fullest extent.

MODERATOR: Allison Strochlic, Research Director, EMERGO BY UL
with Erin Davis, Associate Research Director, EMERGO BY UL

PANELISTS: Christina Reinhart, ILLUMINA

Erwin Nell, MEDLEVER INC.

Alex Ghesquiere, SENSEONICS INC.

Trevor Dell, BAYLIS MEDICAL COMPANY

 

11:15 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.

Russ Branaghan, Associate Professor, Human Systems Engineering, ARIZONA STATE UNIVERSITY

 

12:00 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

 

1:00 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

 

2:00 CASE STUDY PRESENTED BY MPR ASSOCIATES
Speaker TBD

 

2:45 SMALL GROUP DISCUSSIONS: TARGETED USER RECRUITMENT EXCELLENCE

Group 1: Nurses & Support Staff – Christina Reinhart, ILLUMINA

Group 2: Patients & Caregivers – Alex Ghesquiere, SENSEONICS INC.

Group 3: Physicians & Surgeons – Young Chun, TAKEDA

 

3:30 COFFEE & NETWORKING BREAK

 

4:00 MASTERCLASS: EFFECTIVE MEASUREMENT OF USABILITY IN DEVICE HUMAN FACTORS TESTING
Utilizing an advanced blend of heuristics and research methods, human factors executives are able to gather insightful measures into device use, providing data to support usability as well as feedback on potential design changes to propel future product iteration. Comprehensive measurement of test subjects includes a range of markers, including success vs. failure rates, volume of errors, and time spent on tasks, as well as monitoring of physiological signs indicating cognitive pressure faced by test subjects. In addition to metrics used during usability studies, effective human factors and usability executives will also integrate post-study discussion, gaining even deeper insights into the cognition and perception of test subjects.

Corbin Clawson, Director of Engineering, LONGEVITI NEURO SOLUTIONS

 

4:45 OPPORTUNITIES IN IDENTIFYING & MEASURING BENEFITS OF PRIORITIZED HUMAN FACTORS AND UX
Human factors and usability testing initiatives face more difficulty than other commercial activities in calculating return on investment, particularly where returns stem from benefits that don’t readily link to positive financial outcomes, such as time and risk reduction or increases in customer loyalty and satisfaction. While difficult to accurately measure, effective human factors and usability leaders recognize the need to link activities to positive returns, driving future investment into research through larger budgets, staff resources, and deeper integration of human factors into early product development. With a variety of methods available, multiple presenters will share brief but detailed case studies highlighting the calculated advantages of significant usability testing, through differing areas of research and analysis.

4:45 Case Study 1: Streamlined Development
Stephen Nelson, MEDTRONIC

5:00 Case Study 2:
Elaine McCann, GE HEALTHCARE LIFE SCIENCES

5:15 Case Study 3:
Jerome Canady, US MEDICAL INNOVATIONS, LLC.

 

5:30 CLOSING REMARKS AND DAY 1 CONCLUSION

MD Human Factors Conference

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Alexandria

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