Biosensors & Assay Development

This lecture covers the fundamentals of biosensors and electronic biochips, focusing on bioassay development and validation from a medical device innovation perspective. The instructor emphasizes the importance of listening to market needs, regulatory compliance, and strategic planning in product development. Key topics include identifying high-value needs, concept generation, regulatory requirements, and calibration of ligand binding assays. The lecture also discusses the challenges faced by IVD companies, the impact of regulations on product development, and the critical role of design control in ensuring product quality and competitiveness.