The aim of this course is to introduce the fundamentals of biomedical device design and manufacturing, and evaluate the steps toward complying with medical device regulations.
Course Content
This course contains; Benefit-Risk Determination
,Medical Devices,Classification of Medical Devices,Medical Device Regulation (MDR),Summary of Safety and Effectiveness Data (SSED),Bioelectronics Design Perspective (Biosignal Acquisition and Filtering),Functional Electrical Stimulation,Biocompatibility Perspective (Implantable Neural Interfaces),Biocompatibility Perspective (Implantable Neural Interfaces),Artificial Intelligence for Medical Devices,Clinical Evaluation,Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing,Therapeutic Medical Devices (I),Therapeutic Medical Devices (II).
Dersin Öğrenme Kazanımları
Teaching Methods
Assessment Methods
Classifies the medical devices.
10, 14, 16, 19, 2, 5, 9
A, F
Evaluates the medical device development, testing and marketing processes.
10, 14, 16, 19, 2, 5, 9
A, F
Discusses the design requirements of the medical devices from the bioelectronic, biomaterials and biomechanics perspective.
10, 14, 16, 17, 19, 5, 9
A, F
Evaluates digital signal processing methods in medical devices.
10, 13, 14, 16, 17, 19, 21, 3, 5, 9
A, E
Provides solutions for analog-to-digital and digital-to-analog signal conversion issues in medical devices.
10, 14, 16, 19, 21, 3, 5, 9
A, E
Teaching Methods:
10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 21: Simulation Technique, 3: Problem Baded Learning Model, 5: Cooperative Learning, 9: Lecture Method
Assessment Methods:
A: Traditional Written Exam, E: Homework, F: Project Task
Course Outline
Order
Subjects
Preliminary Work
0
Benefit-Risk Determination
1
Medical Devices
2
Classification of Medical Devices
3
Medical Device Regulation (MDR)
4
Summary of Safety and Effectiveness Data (SSED)
5
Bioelectronics Design Perspective (Biosignal Acquisition and Filtering)
Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing
12
Therapeutic Medical Devices (I)
13
Therapeutic Medical Devices (II)
Resources
1- The European Union Medical Device Regulation of 2017.
2- King PH, Fries RC, Johnson AT, Design of Biomedical Devices and Systems, 4th Edition, CRC Press: Boca Raton, 2019. 3- DeMArco, Medical Device Design and Regulation, ASQ Quality Press: Milwaukee, 2011.
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications
No
Program Qualification
Contribution Level
1
2
3
4
5
1
An ability to apply knowledge of mathematics, science, and engineering
X
2
An ability to identify, formulate, and solve engineering problems
X
3
An ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability
X
4
An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice
X
5
An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice
X
6
An ability to function on multidisciplinary teams
X
7
An ability to communicate effectively
X
8
A recognition of the need for, and an ability to engage in life-long learning
X
9
An understanding of professional and ethical responsibility
X
10
A knowledge of contemporary issues
X
11
The broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context
X
12
Capability to apply and decide on engineering principals while understanding and rehabilitating the human body
X
Assessment Methods
Contribution Level
Absolute Evaluation
Rate of Midterm Exam to Success
30
Rate of Final Exam to Success
70
Total
100
ECTS / Workload Table
Activities
Number of
Duration(Hour)
Total Workload(Hour)
Course Hours
14
3
42
Guided Problem Solving
0
0
0
Resolution of Homework Problems and Submission as a Report
1
20
20
Term Project
0
0
0
Presentation of Project / Seminar
2
15
30
Quiz
0
0
0
Midterm Exam
1
35
35
General Exam
1
45
45
Performance Task, Maintenance Plan
0
0
0
Total Workload(Hour)
172
Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(172/30)
6
ECTS of the course: 30 hours of work is counted as 1 ECTS credit.
Detail Informations of the Course
Course Description
Course
Code
Semester
T+P (Hour)
Credit
ECTS
PRINCIPLES of MEDICAL DEVICE DESIGN
-
Fall Semester
3+0
3
6
Course Program
Prerequisites Courses
Recommended Elective Courses
Language of Course
English
Course Level
First Cycle (Bachelor's Degree)
Course Type
Elective
Course Coordinator
Assist.Prof. Mehmet KOCATÜRK
Name of Lecturer(s)
Assist.Prof. Mehmet KOCATÜRK
Assistant(s)
Aim
The aim of this course is to introduce the fundamentals of biomedical device design and manufacturing, and evaluate the steps toward complying with medical device regulations.
Course Content
This course contains; Benefit-Risk Determination
,Medical Devices,Classification of Medical Devices,Medical Device Regulation (MDR),Summary of Safety and Effectiveness Data (SSED),Bioelectronics Design Perspective (Biosignal Acquisition and Filtering),Functional Electrical Stimulation,Biocompatibility Perspective (Implantable Neural Interfaces),Biocompatibility Perspective (Implantable Neural Interfaces),Artificial Intelligence for Medical Devices,Clinical Evaluation,Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing,Therapeutic Medical Devices (I),Therapeutic Medical Devices (II).
Dersin Öğrenme Kazanımları
Teaching Methods
Assessment Methods
Classifies the medical devices.
10, 14, 16, 19, 2, 5, 9
A, F
Evaluates the medical device development, testing and marketing processes.
10, 14, 16, 19, 2, 5, 9
A, F
Discusses the design requirements of the medical devices from the bioelectronic, biomaterials and biomechanics perspective.
10, 14, 16, 17, 19, 5, 9
A, F
Evaluates digital signal processing methods in medical devices.
10, 13, 14, 16, 17, 19, 21, 3, 5, 9
A, E
Provides solutions for analog-to-digital and digital-to-analog signal conversion issues in medical devices.
10, 14, 16, 19, 21, 3, 5, 9
A, E
Teaching Methods:
10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 21: Simulation Technique, 3: Problem Baded Learning Model, 5: Cooperative Learning, 9: Lecture Method
Assessment Methods:
A: Traditional Written Exam, E: Homework, F: Project Task
Course Outline
Order
Subjects
Preliminary Work
0
Benefit-Risk Determination
1
Medical Devices
2
Classification of Medical Devices
3
Medical Device Regulation (MDR)
4
Summary of Safety and Effectiveness Data (SSED)
5
Bioelectronics Design Perspective (Biosignal Acquisition and Filtering)
Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing
12
Therapeutic Medical Devices (I)
13
Therapeutic Medical Devices (II)
Resources
1- The European Union Medical Device Regulation of 2017.
2- King PH, Fries RC, Johnson AT, Design of Biomedical Devices and Systems, 4th Edition, CRC Press: Boca Raton, 2019. 3- DeMArco, Medical Device Design and Regulation, ASQ Quality Press: Milwaukee, 2011.
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications
No
Program Qualification
Contribution Level
1
2
3
4
5
1
An ability to apply knowledge of mathematics, science, and engineering
X
2
An ability to identify, formulate, and solve engineering problems
X
3
An ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability
X
4
An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice
X
5
An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice
X
6
An ability to function on multidisciplinary teams
X
7
An ability to communicate effectively
X
8
A recognition of the need for, and an ability to engage in life-long learning
X
9
An understanding of professional and ethical responsibility
X
10
A knowledge of contemporary issues
X
11
The broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context
X
12
Capability to apply and decide on engineering principals while understanding and rehabilitating the human body
