Commercial Translation of Electrochemical Biosensors: Supply Chain Strategy, Scale-Up Manufacturing, and Regulatory–Quality Considerations

Electrochemical biosensors have reached a high degree of analytical maturity; however, only a small portion of laboratory demonstrations actually progress to commercial products. In this review, we looked non-analytically at the factors which are in place with respect to this translational gap, specifically looking into supply chain design, scale-up manufacturing strategy, regulatory-quality, and more. Based on a wide range of academic and industrial literature, the paper considers how decisions about what kind of material to use, especially for material that recognizes living things, conductive material made from ink, and the material that is the actual product being made, can make a big difference in whether…