- Determine an intuitive, quick and cost efficient method to collect a precise quantity of whole blood, separate the plasma and deliver a specified quantity of buffer and plasma to a lateral flow strip.
- Design a complete point of care device that accomplishes the above, including the sample collection and processing module, and the lateral flow cartridge.
Unique Features and Accomplishments
- Researched and developed a novel method to separate a specified small volume of plasma from whole blood in less than 10 seconds by using a custom flow through filter stack and a dispensing method that prevents hemolysis.
- Developed an integrated buffer storage and delivery plunger that utilizes a foil heat seal and overmolded elastomer features that control flow during use.
- Utilized creative mechanical design in order to minimize the number of required user steps, and make them intuitive enough to meet CLIA waiver requirements for point of care devices.
- Started with a basic list of product requirements and finished the project with a complete design-for-manufacturing, including assembly processes and testing protocols for product acceptance and release.