Principal Drew Degentesh, and Carolynn Johnson, Human Factors & User Research Manager, recently spoke at the 3rd Annual Human Factors Excellence for Medical Device Design conference in Minneapolis.
Drew moderated a highly interactive panel, encouraging the audience to participate as much as panel members, in a discussion of best practices for identifying and mitigating user-related risks and hazards in medical device design, touching on topics such as:
- Assessing risks by conducting usability testing before prototypes are developed.
- Reducing risk by conducting continual risk evaluation throughout product stages
- Avoiding risks through proactive involvement of human factors
- The importance of accurately describing the use error and harm when conducting a use error risk assessment
- Considering how identified use risks will be tested during validation while performing risk assessment.
Meanwhile, Carolynn presented a case study articulating the need for design research—beyond human factors and usability research—to ensure medical devices are useful and engaging, in addition to merely being useable. Her topics included:
- Exploring the relationship between usability and usefulness in user experience design
- Why usability and human factors studies fail to reflect product use in everyday life
- Mitigating potential validity risks through the application of design research
- Executing 62366-compliant design research with tight budget and tighter timelines
Other speakers included leading human factors and product management experts from the FDA, Intuitive Surgical, GE Healthcare, Medtronic, and Insulet, among others.