Biodesign Innovation: Concept Development and Implementation
Milroy Craig Brinton Todd Yock Paul
This course is the second component of a two-course series on medical device innovation focused on how to take initial concepts forward into the development of actual medical technologies used in the clinic. The class will show how early concepts can be filtered through a rigorous evaluation process based on the regulatory, reimbursement, and business model requirements.
Students will learn how to develop R&D and clinical strategic plans, work through a template for developing a financial plan, learn the format for writing a business plan for a medtech start-up, and understand different approaches for attracting venture funding or licensing partnerships.
This part of the course focuses on commercialization strategy via a series of faculty lectures and industry insights. There are a number of case studies presented that show how successful medtech companies started, what they did right from a product development, regulatory and clinical perspective, and what they could have done better. Faculty and invited lecturers provide in-depth analyses from their own experiences at both large and small medical device companies.