Abstract

Inputs and Outputs in Product Engineering

Leanna M Levine, Founder & President, ALine, Inc.

Point-of-care product development can be thought of like the layers of an onion. On the outside is the industrial design for the product and all the human factors considerations that make a product successful in the marketplace. Just below the surface is the electromechanical controls and the software that manage the cartridge function, including controls and calibrations. Another layer down is the cartridge itself, and its interface to the instrument to provide all the needed electromechanical supplies, be it light, heat, pneumatics, or other mechanical subsystems. Then at the heart of this product is the assay itself which is engineered into the cartridge and drives the overall cartridge requirements.

A unique aspect to point of care product development is to determine how the biological or chemical test will perform in a microfluidic system often before the rest of the product concept is thoroughly fleshed out. This means the programmatic priorities are focused on translational research before developing design inputs for a regulated product with an instrument. ALine’s new partnership with Nectar Product Development will enable us to support not just the assay implementation in a microfluidic cartridge, but also create the entire product development roadmap, including the path to regulatory approval.