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Course Descriptions

Biomedical Device Innovation I / II

‣ The bioInnovate I / II course sequence will utilize a planned, multidisciplinary team approach to teach medical device design and documentation within the regulatory framework of the FDA. Students will be required to develop design inputs (requirements, specifications), design outputs (prototype, testing), and a business plan for commercial translation. Business plan development will include an assessment of critical business aspects including financials, markets, marketing, sales, and business models. Teams will develop requirements towards subsequent development of business plan for a medical device venture. In addition, funding sources will be identified for potential future development. There will be two laboratory sessions per week: one focused on prototyping and design, another focused on manufacturing and testing. Course lecture topics include: FDA QSR, intellectual property, project management, documentation, mechanical drawing, risk management, verification testing, design validation, business plans, funding, and ethics. bioInnovate I syllabus can be found here (bioInnovate I.pdf) . bioInnovate II syllabus can be found here. (bioInnovate II.pdf)

Clinical Problem Solving Through Strategic Analysis I / II

This is a two semester graduate level course focused on the process of strategic analysis of complex clinical problem solving through evaluation of diagnostic processes, current therapeutic approaches and clinical outcomes. Students will learn to critically evaluate real-world clinical problems from a global perspective, and then identify diagnostic and therapeutic deficiencies that can be addressed through process of innovating medical technologies. The academic-based lectures in clinical problem solving through bioinnovation will be reinforced through applied application of course material in clinic-based workshops. The course will provide the academic foundation for mastery of the entire spectrum of the problem solving process from clinical needs finding to needs analysis, concept generation and refinement to prototyping, intellectual property protection, and business planning. The text-based lecture series will be complimented with interactive lectures that provide real-world examples of the medical innovation process given by guest lecturers who have successfully navigated the strategic bioInnovate process and impacted healthcare through innovating technologies. Clinical Problem Solving I syllabus can be found here (Clinical Problem Solving I.pdf). Clinical Problem Solving II syllabus can be found here. (Clinical Problem Solving II.pdf)