BME G6700 Biodesign 3: Translational Solutions

The third course of a three course sequence in which a yearlong group project will be undertaken to design and construct a biomedical engineering device or system. This third course focuses on the implementation of the conceptual design solution defined in Capstone 2 course. The conceptual design and prototype will be transformed into a product that can be marketed and used at the bedside to treat patients. The content of this course will focus on final product development, testing and clinical validation methods as well as preparation of documents for regulatory submission. Students will learn to develop a translational solution to a biomedical need within the constraints of a real world problem including quality and process management, reimbursement strategy, marketing and stakeholder strategy, sales and distribution strategy, competitive advantage and business strategy, operating plan and financial model, business plan development, funding sources, and licensing and alternate pathways.

Credits

3

Prerequisite

BME G6600.

Contact Hours

1 hour lecture and 2 hour lab/week