The in vitro diagnostics industry focuses on developing methods for the diagnosis, screening, and monitoring of human diseases based on identification and quantification of small molecules, proteins, oligonucleotides, or of cells and tissues of a certain phenotype. Developing diagnostic assays, instrumentation and devices requires input from many disciplines such as biochemistry, molecular biology, engineering, physics 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. Students will become familiar with the fundamentals of biomolecular recognition, assay development, engineering design, device fabrication, optics, fluid mechanics, and laboratory automation. The course also features aspects of market research, project management, and device regulatory affairs.
After completing this course, students should be able to:
- Describe the major diagnostic assay types and their applications
- Correctly interpret metrics used in bioassay development and validation
- Assess the technical merit and competitive position of current IVD technologies
- Develop a preliminary design of a diagnostic device using a requirements driven engineering approach
- Apply fundamental project management tools to implement an interdisciplinary team-based effort