|
Credit: 1 course unit
Elective course
Catalog Description
This course explores the transition from discovery of fundamental
knowledge to its ultimate application in a clinical device or drug.
Emphasis is placed upon factors that influence this transition and upon
the integrative requirements across many fields necessary to achieve
commercial success. Special emphasis is placed upon entrepreneurial
strategies, intellectual property, financing and the FDA process of
proving safety and efficacy. Current public companies in the medical
device and drug industry are studied in detail and critiqued against
principles developed in class.
Prerequisites:
Senior standing in Bioengineering, or permission of the instructor
Textbook(s) and/or
Other Required Materials:
Material posted on the course Blackboard website.
Course objectives:
To understand biomedical product development, with emphasis on
entrepreneurial strategies, intellectual property, financing and the FDA
process of proving safety and efficacy.
Topics Covered:
- The process of
discovery
- Introduction to the
Marketplace
- Getting
started
- Protection of intellectual
property
- Financing the Venture and the Business
Plan
- The Regulatory (FDA)
Process
- Good Manufacturing
Practices
- Marketing Strategies for New
Products
-
Class/Laboratory
Schedule:
Lecture: 3 hr/week
Contribution
towards Program Outcomes:
|
Multidisciplinary
Ability
|
High
|
|
Problem Solving
Approach
|
Med.
|
|
Problem Solving
Methods
|
Med.
|
|
Experimentation
|
Low
|
|
Design
|
Med.
|
|
Professional
Orientation
|
High
|
Person(s) Preparing
Description and Date:
Paul Ducheyne
July 2007
|
