BTEC 681 - Discovery and Development of Medical Devices

BTEC 681 ia a comprehensive study of the scientific and commercial practices used to deliver healthcare products to the market. Commercial development timelines are long and expensive, manufacturing is complex, and products are subjected to regulatory scrutiny to protect safety of users. The new IT revolution has empowered biotechnology and has reduced the time and cost of the product development process, providing biotechnology products with market advantages and ability to meet public needs and market demands faster and less costly than other suppliers can. This course aims to introduce students to the biotechnology industry in healthcare, in the area of medical devices. Topics covered will focus on assessment of market needs, and product discovery and development to meet those needs. Students will learn the whole process from generating an idea, elaborating a concept, and producing a prototype to a medical device product. Topics will also include manufacturing, market research, regulatory issues, and financing. Each student will deliver an oral presentation and submit a written project in the format of an SBIR Phase-1 grant application. Gaining new knowledge, skills and abilities will help students to advance in their current positions, or to transition to a new career that involves biotechnolgy and the pharmaceutical industry, hospitals and/or universities, public health and/or governmental agencies.
Components: Lecture
Grading Method: R