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BIOE Biodesign Innovation: Concept Development and Implementation (ME 368B, MED 272B)

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BIOE 374B

Biodesign Innovation: Concept Development and Implementation (ME 368B, MED 272B)

School of Engineering

General course Description:

(Same as OIT 385) Two quarter sequence. How to take a medical device invention forward from early concept to technology translation and development. Topics include prototyping; patent strategies; advanced planning for reimbursement and FDA approval; choosing translation route (licensing versus start-up); ethical issues including conflict of interest; fundraising approaches and cash requirements; essentials of writing a business or research plan; strategies for assembling a development team. Prerequisite: MED 272A, ME368A, OIT 384 or BIOE 374A.

Course Style: A Substantive course teaches the law, theory, and policy in a particular area of law

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