Presentation
MDD22 - Navigating Human Factors Challenges: Lessons Learned From Combination Product Acquisitions
SessionPoster Session 1
DescriptionThe acquisition of new combination products from other companies pose unique challenges for organizations. This poster aims to share valuable lessons learned from a large pharmaceutical organization's perspective, especially when navigating the human factors landscape during these acquisitions. We will delve into the specific considerations and elements that teams look for when integrating these assets into their portfolios, considering unique requirements at different stages of development. This also includes what human factors considerations to "triage" based on different phases of acquisition, data and development history, the user interface elements, as well as the impacts of any identified problems. It is important to note that some small biotech firms may lack the expertise and resources to address human factors issues effectively in their products. Therefore, it becomes crucial for pharmaceutical organizations to understand and navigate these challenges successfully. Drawing from industry standards and regulatory guidelines, we will explore the key factors that need to be addressed during the integration process. This may include leveraging vendor data, developing the user interface design encompassing the device constituents, instructions for use, packaging, labeling, and training, as well as effective risk management strategies. Two real-world case studies and examples will be utilized to showcase practical strategies for the integration of new combination products into existing portfolios, featuring one case on a co-packaged kit that was acquired during ongoing pivotal clinical trials and a case on an injectable product that was acquired a few months prior to a pivotal clinical trial. Each of these cases require different approaches and strategies. The poster will demonstrate the variety of challenges teams may face and how to best overcome them.
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)