DAY TWO | WEDNESDAY, DECEMBER 11
8:30 REGISTRATION & MORNING COFFEE
9:00 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
Saher Bishara, Senior Principle Human Factors and Usability Engineer, User Experience
9:45 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.
Serena Oaks, BREG
Christina Reinhart, ILLUMINA
Saher Bishara, MEDTRONIC
10:30 COFFEE & NETWORKING BREAK
11:00-12:00 MULTI-PART CASE STUDY: OPPORTUNITIES IN IDENTIFYING & MEASURING BENEFITS OF PRIORITIZED USABILITY TESTING
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.
11:00 INTRODUCTION TO TOPIC:
Tressa Daniels, Associate Director, UXD & Human Factors, BD
11:20 CASE STUDY 1: DESIGN THINKING
Nikhil Joshi, Senior R&D Engineer, AURIS HEALTH INC
11:40 CASE STUDY 2: RISK MITIGATION
12:00 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS
1:00 FDA PERSPECTIVES ON MEDICAL DEVICE HUMAN FACTORS REGULATION
With the mandate of ensuring medical products are safe and effective for use, regardless of the use scenario, the Agency is increasingly focused on human factors and usability testing to validate that new and existing medical products are designed and commercialized in a user friendly, low-risk manner. Increasingly sophisticated technology including the adoption of robotic aides in surgery, machine learning in imaging equipment and mobile applications which assist in monitoring health. All pose new and unique risks which must be assessed and mitigated under the careful eye of the FDA.
Jacob Nardone, Staff Regulatory Affairs Specialist, DEXCOM
1:45 CREATING A STRONG POST-MARKET HUMAN FACTORS AND USABILITY FEEDBACK LOOP
In real-world, post-market settings, medical devices cleared for commercial use encounter a far wider spectrum of users and use scenarios, providing unique and unanticipated insights beyond the controlled environment of human factors and usability tests. Forward-thinking medical device firms are combining human factors with post-market surveillance and quality teams in order to collect and effectively analyze use feedback, which is then used in design modifications and the development of next generation products. Additionally, post-market feedback collected assists in satisfying regulatory demands for risk mitigation and long-term product safety, further affirming the importance of strong post-market feedback loops.
- Overcoming barriers to post-market research
- Review of regulatory guidance on post-market testing
- Collection and analysis of post-market usability data
- Creation of data-collection timetables
- Strategies for implementing feedback
- Equipping persons at point-of-contact to collect useful data
Chris Nocera, Manager, Engineering, CELONOVA BIOSCIENCES INC.
2:30 UNDERSTANDING AND RECOVERING FROM VALIDATION FAILURE
An unsuccessful human factors validation study can be a major setback for any device developer on the critical path to regulatory submission. However, a failed study can still produce rich data that can be used a tool to reexamine the device design and generate a roadmap for the path forward. Having a contingency plan for this outcome can help teams to recover as quickly and cost-effectively as possible.
- Robust documentation
- Failure prevention
- Accurate root cause analysis
- Identifying risk mitigation gaps
- Consideration of cost and timeline
- Determining risk acceptability
Natalie Abts, Head of Human Factors Engineering, GENENTECH
3:30 CLOSING REMARKS & CONFERENCE CONCLUSION