Open Forum: Human Factors Usability Testing Q&A

Usability testing is one of the most important activities you can perform during the development of your medical device. Usability testing results can help you determine user needs, better understand use-related risks, inform your design process, and demonstrate safer and more effective use. But there is no single best usability test method that applies to all situations. Often there are questions related to usability testing, and the answer to those questions is quite often “it depends.” Let us help you gain a better understanding of effective usability testing practices. 

During this session, we’ll share our insights on such usability testing topics as:

• Regulatory expectations for usability testing 
• Scaling of usability testing efforts 
• Linkages between usability testing and use-related risk analysis 
• Tips for conducting usability testing, including moderating, data collection, team testing and more

What you learn during this session will also depend on the questions you and your fellow attendees ask.

About our presenters

Merrick Kossack, senior research director 

Merrick Kossack is a senior research director with Emergo by UL’s Human Factors Research & Design team. A leader of the team since 2016, Kossack assists customers with developing their processes and strategies to address their human factors engineering needs, particularly for complex and high-risk systems. In addition, he helps customers develop their use-related risk analyses, human factors reports and other key documents required for regulatory submissions. He has developed and taught courses on human factors in medical device development and delivered numerous presentations on the subject. He is a contributing author to the book Applied Human Factors in Medical Device Design (2019).

Kossack is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee as well as IEC TC 62/SC 62A JWG4, both responsible for the creation of human factors-related standards and guidance. He is also a member of the AAMI faculty staff responsible for teaching their Human Factors for Medical Devices course. 

Andrea Dwyer, M.S., Associate Research Director – Human Factors  

Andrea Dwyer is an Associate Research Director with Emergo by UL’s Human Factors team. She has been with the team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical and drug delivery device development. She helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses, and guides clients in engaging with the FDA on clients’ HFE strategies. She frequently conducts workshops, speaks at industry events and advises clients on how to implement HFE in the medical device development process. Andrea is a co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.

Frauke Schuurkamp, managing human factors specialist 

Frauke Schuurkamp is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design team. She has been with the team since 2013. She has experience delivering HFE services to the medical device industry. More specifically, Schuurkamp leads and oversees research activities such as user research and usability testing. Furthermore, she helps customers develop key HFE documents for their design history files, including use-related risk analyses, and advises customers on how to apply HFE during product development to meet regulators' expectations. She holds a B.S. in Applied Psychology and an M.S. in Human Factors & Media Psychology.