The In Vitro Diagnostics (IVD) industry focuses on developing methods for the diagnosis, screening, monitoring, and prognosis of human diseases and to aid in therapy selection. IVDs identify and quantify biomarkers that can entail small molecules, proteins, DNA/RNA, or pathogens as well as cells and tissues of a certain phenotype. Developing diagnostic assays, instrumentation and devices requires input from many disciplines such as biochemistry, molecular biology, engineering, and computer science. This course provides an overview of the in vitro diagnostics industry and will enable students to acquire the basic knowledge and skills needed to understand and ultimately design diagnostic assays and devices. The course also features aspects of user research, marketing / competitor analysis, device regulatory affairs and program management. Through a semester long project that involves the entire section, students will learn how to develop an IVD in a complex team environment.
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