Biomedical Engineering Innovation and Entrepreneurship

Catalog description

This course is designed to teach students how to develop a biomedical technology-based product or service, not in a controlled company environment, with specifications provided, but in an ultra-competitive global marketplace where the only tests of success are whether value is created and a profit is made. The course will begin by examining entrepreneurship as a career choice. It will then cover the entire biomedical technology start-up process, from idea generation to product development to successful harvest. This includes value proposition and business model development, intellectual property, regulatory bodies and processes (The Food and Drug Administration and other biomedical product regulatory agencies, including IEC, ISO and ASTM), finance and accounting, and fundraising, including venture capital. Biomedical technologies studied will include medical devices, medical imaging, biologics, and tissue-engineered and regenerative medicine products. The principals and tools of innovation and entrepreneurship can apply equally well to a start-up company or a large.