BIOEN 6082 - Biomedical Device Innovation II

Second semester of a two semester graduate level project based learning class focused on medical device design and documentation within the regulatory framework of FDA QSR, business plan development, and business startup concepts. This course will bring together students in medicine and medical residency, traditional engineering students, business, and law students for a multidisciplinary experience in medical product innovation. During the second semester (design output phase), prototypes are reined and tested to ensure requirements are met. In addition to device development, students will develop a business plan around the medical device to understand commercial translation concepts including financials, markets, marketing, sales, competition, risk, and business models. Students will develop business plan requirements and subsequently a full business plan throughout the semester. Business plans will be entered into business plan competitions and funding sources will be identified for future company formation. This course includes two lab sessions per week one focused on medical device testing and another on business plan development. Two lecture sessions per week will cover topics including: verification testing, design validation, clinical trails, technology commercialization, ethics, business concepts, and company formation. Outputs of is semester include: medical device prototype, design and testing documentation, business plan, and competition entry.