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

Health Law: Life Science Research Institutions & Companies

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Health Law: Life Science Research Institutions & Companies
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Path " Intellectual Property : General does not include this course.
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BIOE 374B

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

School of Engineering

Recommended for route(s):

[ Academia ] Health Law: Life Science Research Institutions & Companies

Why it is relevant for ...

[ Academia ] as a Relevant Course outside SLS for those interested in Lifesciences: Innovations : Students interested in lifesciences should consider taking 1 or more courses on the market and regulatory issues raised by innovation in the health care industry. Both the regulatory and payer environment in the U.S. and abroad are critical considerations in the development of business models for new health care products and services. This course examines innovation in the life sciences industry, from an assessment of clinical needs and the potential market for a new concept to the development of a business plan, including patentability, financing and licensing strategies.

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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