Our company undertook a project for a client, FABPulous, to create an IVD Point of Care consumable device. This involved developing a method to accurately collect a specific amount of whole blood, separate the plasma, and transfer a predetermined quantity of buffer and plasma onto a lateral flow strip. We successfully devised a novel technique to separate a small volume of plasma from whole blood in under 10 seconds and created an integrated buffer storage and delivery plunger. To meet CLIA waiver requirements for point of care devices, we employed innovative mechanical design to minimize user steps. Our team completed the project with a design-for-manufacturing approach, which included developing assembly processes and testing protocols for product acceptance and release.