Lecture
This lecture covers the fundamentals of biosensors and electronic biochips, focusing on bioanalytic assay development and validation from a product development perspective. The instructor, Fabien Rebeaud, aims to provide insights into good practices in in vitro diagnostics (IVD) product development, state-of-the-art bioassay development, and nanofluidic biosensors for near-patient testing. The lecture emphasizes the importance of understanding market needs, regulatory requirements, and planning in product development. It also discusses the challenges faced by IVD companies, such as technology not meeting clinical needs and issues with product prototypes and manufacturing. Regulatory aspects, including the impact on patient safety and the consequences of regulatory non-compliance, are highlighted.