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 the product can be reproduced easily, if it will stay stable for a long time, and if it is allowed according to the rules. This review compares the dominant manufacturing paradigms-roll-to-roll printing, and semiconductor-derived microfabrication-and shows how the respective strengths and limitations match the different targets, costs, and risk class. This is more about making manufacturing an upstream optimization problem than treating processes as defects and quality as assurance, rather than making it an upstream optimization problem. And it does this by looking at some other big pathways for regulations in the U.S., EU, and China as well, where we get to see how those differences in classification requirements, what kind of proofs you should have, and different ways about running those quality management systems affect how quickly things can come out after developing them, and what your flexibility with customers is like when those products are already out there in the world. The study looks at some case studies: disposable glucose strips, cartridge-based blood analyzers, and new continuous monitoring systems are used to show how the exact same electrochemical ideas can result in very different commercialization issues based on the clinical context and system integration. Synthesizing those angles creates a review that can give a system level map of matching research design to industrial and regulatory realities, with the goal of making it easier for electrochemical biosensors to go from lab prototypes to ready-for-market diagnostic tools.