Presentation
MDD8 - Connected Medical Devices - Key Considerations and Recommended Practices for Safety and Usability
SessionPoster Session 2
DescriptionThe potential of connected medical devices can be transformative, for example enabling remote monitoring, offering real-time feedback, assisting in adherence, and serving as an objective data source. However, various forms of connected technology or accessories offer different advantages and challenges, requiring tailored considerations for safe and effective implementation. Understanding the different forms of connectivity and unique considerations inherent to various approaches is critical for selecting the option that best meets project needs while thinking carefully about user safety and usability.
This presentation will discuss the key considerations manufacturers and designers must address when incorporating connected technologies into medical devices, and how human factors researchers must approach testing for safety and effectiveness with connected products. The following areas will be discussed:
● Examples of connected devices: Connectivity and the various forms in which connected technology may present itself, ranging from integrated technology built into an existing medical device to separate accessories that support, supplement, or augment the performance of a device.
● Why connect my device?: Discussing advantages of connectivity, including as a way to address known use problems or to solve an added objective (e.g., promoting adherence, providing user feedback) not already covered by the device, as well as potential challenges related to connectivity.
● A Use Case for Connectivity: Presenting a use case for connectivity from the perspective of a pharmaceutical manufacturer.
● A Summary of Learnings: Providing an overview of learnings across multiple human factors studies with connected devices, with a focus on both key challenges related to connectivity from a risk-based perspective and important advantages of incorporating connected technologies.
● Recommendations and Takeaways for Connectivity from a Human Factors Perspective: Incorporating strong human factors research to thoroughly document and test connected products, including the importance of building an integrated task analysis for the connected technology and parent device, identifying particular areas of overlap and how new risks may be introduced, and using this to inform design and testing of connected technologies.
By examining these critical aspects of connectivity, this presentation aims to equip the audience with actionable insights to successfully incorporate connectivity into medical devices to foster innovation and improved design while keeping user safety and effectiveness at the forefront.
This presentation will discuss the key considerations manufacturers and designers must address when incorporating connected technologies into medical devices, and how human factors researchers must approach testing for safety and effectiveness with connected products. The following areas will be discussed:
● Examples of connected devices: Connectivity and the various forms in which connected technology may present itself, ranging from integrated technology built into an existing medical device to separate accessories that support, supplement, or augment the performance of a device.
● Why connect my device?: Discussing advantages of connectivity, including as a way to address known use problems or to solve an added objective (e.g., promoting adherence, providing user feedback) not already covered by the device, as well as potential challenges related to connectivity.
● A Use Case for Connectivity: Presenting a use case for connectivity from the perspective of a pharmaceutical manufacturer.
● A Summary of Learnings: Providing an overview of learnings across multiple human factors studies with connected devices, with a focus on both key challenges related to connectivity from a risk-based perspective and important advantages of incorporating connected technologies.
● Recommendations and Takeaways for Connectivity from a Human Factors Perspective: Incorporating strong human factors research to thoroughly document and test connected products, including the importance of building an integrated task analysis for the connected technology and parent device, identifying particular areas of overlap and how new risks may be introduced, and using this to inform design and testing of connected technologies.
By examining these critical aspects of connectivity, this presentation aims to equip the audience with actionable insights to successfully incorporate connectivity into medical devices to foster innovation and improved design while keeping user safety and effectiveness at the forefront.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer