Semi-Annual Medical Device Human Factors & Usability Engineering Conference

December 10-11, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY ONE | TUESDAY, OCTOBER 22

7:30 REGISTRATION & WELCOME COFFEE

8:15 CHAIRPERSON’S OPENING REMARKS
Merrick Kossack, Research Director, EMERGO BY UL

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 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

 

10:15 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: Rachel Aronchick, 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 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.

1:00 Case Study 1: Recent Trial Insights
Jerome Canady, US MEDICAL INNOVATIONS, LLC.

1:30 Case Study 2: Streamlined Development
Stephen Nelson, MEDTRONIC

1:45 Case Study 3: UX and the “New Product” Opportunity
Elaine McCann, GE HEALTHCARE LIFE SCIENCES

 

2:00 SYSTEMS PERSPECTIVE ON USABILITY ENGINEERING
Usability engineering must be viewed as a product life-cycle process and must be effectively integrated with an overall systems engineering approach. With this systems perspective, teams can see users and their needs, environments, constraints, and risks as components of the product or device under development. An exploration of this systems perspective on usability engineering, the method by which such a perspective is integrated in an overall development process, and its scalability based on a product’s risk profile will allow human factors and usability teams rethink product development.

Kathleen McHugh, Project Manager, Systems Lead Engineer, MPR ASSOCIATES INC.

 

2:45 SMALL GROUP DISCUSSIONS: TARGETED USER RECRUITMENT EXCELLENCE

Group 1: Patients & Caregivers – Alex Ghesquiere, SENSEONICS INC.

Group 2: Physicians & Surgeons – Young Chun, TAKEDA

 

3:30 COFFEE & NETWORKING BREAK

 

4:00 CASE STUDIES: TRANSFORMING AN UNSUCCESSFUL HUMAN FACTORS VALIDATION TEST INTO DEVICE EXCELLENCE
An unsuccessful human factors validation test is an unfortunate setback in the development of a device, but the information obtained from such a test can be channeled into a clear roadmap for device and process improvements. Having a plan in place for the eventuality of a failed test can prepare teams to recover as quickly and cost-effectively as possible, pinpoint and isolate the risks revealed in the test, and tighten focus to make the necessary improvements with correct documentation and attention to regulatory requirements.

  • Case Study 1: Administration Kit
  • Case Study 2: Nth Generation Drug Delivery Device

Young Chun, Human Factors Lead, R&D, Medical Devices, TAKEDA

 

4:45 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 Manager, BAYLIS MEDICAL COMPANY

 

5:30 CLOSING REMARKS AND DAY 1 CONCLUSION

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