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|ED 5311||Medical Device Innovation|
Definition and classification of medical devices, Introduction to new medical device development- Case studies from successful medical device start-ups.
Medical device: needs finding and need statement development; Stake holder analysis, Preliminary market analysis and disease state understanding; Needs filtering, Need validation through market analysis and disease state analysis.
Intellectual property fundamentals and patenting procedures, Regulatory fundamentals.
Concept generation, concept selection and concept development, IP and Regulatory strategy for new product, Provisional patent filing.
R&D strategy, Medical device reliability and quality assurance, Design control and documentation, Prototyping, Business plan development.
Stefanos Zenois, Josh Makower, Paul Yock, Biodesign: The Process of Innovating Medical Technologies, Cambridge University Press, 2009
1. Richard C. Fries, Handbook of Medical Device Design, CRC press, 2001
2. Myer Kutz, Standard Handbook of Biomedical Engineering and Design,: McGraw Hill, 2003