In Vitro Diagnostics: Product Development

This lecture by the instructor provides insights into good practices in medical device product development, state-of-the-art bioassay development, and the challenges in the in vitro diagnostics (IVD) industry. It covers topics such as market needs, regulation, product positioning, and the importance of design control. The lecture delves into the failures of IVD companies, emphasizing the importance of understanding customer needs and proper product design. It also discusses nanofluidic biosensors for near-patient testing and the regulatory requirements governing medical devices. The presentation concludes with a focus on assay development, including key performance parameters, calibration of ligand binding assays, and method comparability.