Course Title                                       



Course Number

BME 415


Tentative Opening Date

Fall 2010 semester


Course level

3rd or 4th year students with a genuine interest in new biomedical device development and entrepreneurship (Prerequisite: None)



Prof. Dr. A. Cüneyt Taş

Dept. of Biomedical Engineering

Yeditepe University


Course Objectives

This course focuses on the real-life practices and challenges of translating scientific discovery into commercial products. More specifically, its scope is limited in most circumstances to situations where some knowledge of biomedical engineering, electrical engineering, chemistry, physics and related disciplines may prove to be particularly useful. The course primarily uses case studies of real-world new product development challenges to simulate the industrial challenges that will confront fresh engineers in the field.


Course content

Descriptions of “state-of-the-art” and “innovation;”

From prototype to industrial up-scaling in biotechnology;

Industrial manufacturing requirements (Case studies on biomedical devices; Class I, Class II or Class III devices);

Importance of FDA approval and CE marks for biomedical devices;

ISO standards governing biomedical device development & quality assessment;

Descriptions of discovery, patentable ideas, and intellectual property;

How do patent institutes work and protect your invention;

Assignment of inventors in a patent application;

Advantages and disadvantages of patents;

Trademark registration and Copyright versus Patents;

When and how to apply for a patent;

Utility patents and design patents;

Transforming a “patent” into a “product-on-the-market:” Technology Transfer.


Total credit hours: 3

Lab hours: 0

Lecture hours: 3


Online Text

Title:  “Inventor’s Handbook”

Publisher:  Lemelson Foundation & Massachusetts Institute of Technology

Online source:



Title: “Robert’s Rules of Innovation”      

Authors: R.F. Brand & M.J. Kleinman

Publisher: John Wiley & Sons, Inc., 2010   ISBN 978-0-470-59699-9



Term Project                   (30%)

Homeworks                     (30%)

Final exam                     (30%)

Classroom participation (10%)