Presentation
MDD2 - "Start Here" Packaging as a Risk Control Measure
SessionPoster Session 1
DescriptionIn the development of medical devices, regulatory standards emphasize the importance of identifying and addressing potential risks early in the design process. As part of this process, medical device manufacturers perform formative usability testing of the device user interface with intended users to identify potential use issues. Depending upon the potential harm severity, these identified use issues may necessitate the implementation of additional controls to mitigate risks effectively. Traditionally, risk control measures have primarily focused on the device's direct user interface or labeling, specifically the accompanying instructions for use (IFU). However, it is important to recognize that user interactions are influenced by the entire system, which includes the device, labeling, and packaging. Medical device packaging is the first user interface of the medical product that users interact with and therefore has a crucial role in communicating intended use.
This poster provides an overview of a case study on how innovative labeling solutions on packaging emerged as effective risk control measures. The case study highlights the use of packaging of a medical device-drug combination product as an introduction to its intended use. By implementing graphic and packaging design affordances, users were guided through a series of information that directed them from the packaging, to the IFU, and ultimately to device use. The case study demonstrates that thoughtful packaging design can significantly contribute to the overall safety and effectiveness of medical treatments, serving not just as a container, but as an integral component of risk management.
This poster provides an overview of a case study on how innovative labeling solutions on packaging emerged as effective risk control measures. The case study highlights the use of packaging of a medical device-drug combination product as an introduction to its intended use. By implementing graphic and packaging design affordances, users were guided through a series of information that directed them from the packaging, to the IFU, and ultimately to device use. The case study demonstrates that thoughtful packaging design can significantly contribute to the overall safety and effectiveness of medical treatments, serving not just as a container, but as an integral component of risk management.
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)