BIOMEDICAL ENGINEERING
Bachelor	TR-NQF-HE: Level 6	QF-EHEA: First Cycle	EQF-LLL: Level 6

Course Introduction and Application Information

Course Code	Course Name	Semester	Theoretical	Practical	Credit	ECTS
BME3001	Biomedical Device Design II	Fall	1	4	3	6

This catalog is for information purposes. Course status is determined by the relevant department at the beginning of semester.

Basic information

Language of instruction:	English
Type of course:	Departmental Elective
Course Level:	Bachelor’s Degree (First Cycle)
Mode of Delivery:	Face to face
Course Coordinator :	Prof. Dr. ALİ YEKTA ÜLGEN
Course Objectives:	The goal of this course is to learn and execute the design process by developing an innovative technical solution to a clinical need. By the end of the Spring Semester, students should be able to: - plan and execute an engineering and design project plan; - design and implement a proof-of-concept controlled experiment; - incorporate engineering and clinical feedback into your project plan; - communicate your project motivation and status to experts and a lay audience; - understand the basic components of a patent; and - develop and maintain a design history file

Learning Outcomes

The students who have succeeded in this course;
Students will work in a team on a client-centered biomedical engineering design project to learn concept generation, product analysis, specifications, eveluation, clinical trials, regulation, liability, and ethics and apply the design process to produce a physical prototype.
The design teams initially consists of 2 students : a 2nd year 1st semester student paired with a 3rd year 1st semester student. The 3rd year students serve as peer mentor in the design process.
Four such teams (a total of 8 students) will be competing for the same client based design problem, for 7 weeks, using different conceptual approaches. A winner design concept will be selected and all (8) students will work together using the winning design concept during the remaining 7 weeks to complete the project and implement a protype.

Course Content

Fundamentals of medical device design, design methodology, project management, engineering ethics, scientific report writing.

Weekly Detailed Course Contents

Week	Subject	Related Preparation
1)	Medical Device Definition, Classifying Medical Devices.
2)	Discovering Needs, Medical device Design Development.
3)	Grouping the students, forming the groups and selecting the design topics.
4)	Medical Device Innovation
5)	Risk Management in Medical Devices
6)	Rapid Prototyping
7)	Preliminary Design Concept Presentation: teams will make presentations for their device concepts. The winning concepts will be selected and all (8) students will work together using the winning design concept during the remaining 7 weeks to complete the project and implement a protype. Results will be posted on the website.
8)	Reliable Design, Testing and Ageing.
9)	Medical Device Alarm Design
10)	Designing Home Care Devices
11)	Warranty Period Cost
12)	Medical Device Patent and Useful Model Basics
13)	Testing our idea by Bench Testing and Animal Testing
13)	Electrode Design
14)	Progress Reports: Each design team will present their progress and submit a progress report.

Sources

Course Notes / Textbooks:	Webster, John G. “Encyclopedia of Medical Devices and Instrumentation”, 2nd Edition, (2006) Medical Instrument Design and Development: From Requirements to Market Placements, by Claudio Becchetti, Alessandro Neri July 2013, ©2013, Hardcover
References:	Webster, John G. “Encyclopedia of Medical Devices and Instrumentation”, 2nd Edition, (2006) Medical Instrument Design and Development: From Requirements to Market Placements, by Claudio Becchetti, Alessandro Neri, July 2013, ©2013, Hardcover

Evaluation System

Semester Requirements	Number of Activities	Level of Contribution
Attendance	10	% 10
Presentation	1	% 10
Project	1	% 40
Final	1	% 40
Total		% 100
PERCENTAGE OF SEMESTER WORK		% 20
PERCENTAGE OF FINAL WORK		% 80
Total		% 100

ECTS / Workload Table

Activities	Number of Activities	Duration (Hours)	Workload
Course Hours	14	1	14
Study Hours Out of Class	14	6	84
Project	1	20	20
Final	14	3	42
Total Workload			160

Contribution of Learning Outcomes to Programme Outcomes

No Effect	1 Lowest	2 Low	3 Average	4 High	5 Highest

	Program Outcomes	Level of Contribution
1)	Adequate knowledge of subjects specific to mathematics (analysis, linear, algebra, differential equations, statistics), science (physics, chemistry, biology) and related engineering discipline, and the ability to use theoretical and applied knowledge in these fields in complex engineering problems.
2)	Identify, formulate, and solve complex Biomedical Engineering problems; select and apply proper modeling and analysis methods for this purpose	5
3)	Design complex Biomedical systems, processes, devices or products under realistic constraints and conditions, in such a way as to meet the desired result; apply modern design methods for this purpose.	5
4)	Devise, select, and use modern techniques and tools needed for solving complex problems in Biomedical Engineering practice; employ information technologies effectively.	5
5)	Design and conduct numerical or physical experiments, collect data, analyze and interpret results for investigating the complex problems specific to Biomedical Engineering.	5
6)	Cooperate efficiently in intra-disciplinary and multi-disciplinary teams; and show self-reliance when working on Biomedical Engineering-related problems.	5
7)	Ability to communicate effectively in Turkish, oral and written, to have gained the level of English language knowledge (European Language Portfolio B1 general level) to follow the innovations in the field of Biomedical Engineering; gain the ability to write and understand written reports effectively, to prepare design and production reports, to make effective presentations, to give and receive clear and understandable instructions.	5
8)	Recognize the need for life-long learning; show ability to access information, to follow developments in science and technology, and to continuously educate oneself.	5
9)	Having knowledge for the importance of acting in accordance with the ethical principles of biomedical engineering and the awareness of professional responsibility and ethical responsibility and the standards used in biomedical engineering applications	5
10)	Learn about business life practices such as project management, risk management, and change management; develop an awareness of entrepreneurship, innovation, and sustainable development.	4
11)	Acquire knowledge about the effects of practices of Biomedical Engineering on health, environment, security in universal and social scope, and the contemporary problems of Biomedical Engineering; is aware of the legal consequences of Mechatronics engineering solutions.	5