Presentation
MDD29 - The Intersection of Innovation and Regulation: Designing and Testing Medical Devices for Multiple Patient Groups
SessionPoster Session 1
DescriptionWe’re seeing an increase in medical devices that are being cleared for use for multiple patient groups due to the growing adoption of digital health solutions, increasing reliance on data sharing in health systems, and the efficacy of digital solutions for treatment. This presents unique challenges for developing an approach to product design, risk identification, and a validation pathway that is both cost effective and efficient, but that also satisfies the distinct user needs of specific patient populations. This joint presentation from the Tidepool Project, a 501(c)(3) nonprofit organization dedicated to developing innovative technologies in the diabetes space, and Core Human Factors, human factors experts specializing in medical devices, will explore potential avenues, questions, and considerations for designing digital technologies that support distinct and nuanced patient needs amidst regulatory requirements that can sometimes pose challenges to designing the most tailored products. With this returning collaboration between Tidepool and Core Human Factors, we come at this question from two unique perspectives: real-world industry challenges and a snapshot of current strategies from a leading human factors consulting group.
This Presentation Will Cover:
- A discussion of different approaches to recruitment, screening, and user group definition designed to identify cross-sections of overlapping patient needs across disparate populations.
- Exploring different strategies for designing a modular system that can accommodate distinct user groups, including tailored approaches to labeling, access to in-app features, and training that consider health literacy, language, and comprehension levels.
- Leveraging both adaptive usability and research tools to design studies that evaluate both usability and safety for a broad range of users.
This Presentation Will Cover:
- A discussion of different approaches to recruitment, screening, and user group definition designed to identify cross-sections of overlapping patient needs across disparate populations.
- Exploring different strategies for designing a modular system that can accommodate distinct user groups, including tailored approaches to labeling, access to in-app features, and training that consider health literacy, language, and comprehension levels.
- Leveraging both adaptive usability and research tools to design studies that evaluate both usability and safety for a broad range of users.
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)