From bench to market: Regulatory and commercial challenges in clinical point-of-care biosensors

Biosensors are powerful tools for supporting the rapid, simple, and accurate diagnosis of diseases. Over the past decades, numerous biosensors have been developed, incorporating innovative technologies to enhance analytical performance and to enable miniaturization, usability, and connectivity. However, the successful translation of these devices from the laboratory to the market remains limited. This gap is largely due to challenges in meeting regulatory requirements and addressing critical factors for commercialization. As a result, many promising biosensors never progress beyond the research stage or patent filing. In this review, we discuss the regulatory pathway of the U.S. Food and Drug Administration (FDA), outlining device classification and the mandatory performance tests. Furthermore, we examine key commercialization aspects, including manufacturing scalability, supply chain management, and logistics for storage and distribution. Our goal is to provide practical guidance for researchers and companies aiming to bring point-of-care (POC) biosensors into clinical use.