THERAPEUTIC MEDICAL DEVICES

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.

CONTENT

This course contains; Medical Devices - Overview,Classification of Medical Devices,Medical Device Regulation (MDR),Summary of Safety and Effectiveness Data (SSED),Bioelectronics Design Perspective (Signal Acquisition and Filtering),Functional Electrical Stimulation,Biocompatibility Perspective (Abiotic Characterization),Biocompatibility Perspective (Biotic Characterization),Digital Signal Processing for Medical Devices,Clinical Evaluation of Medical Devices,Therapeutic Medical Devices (I),Therapeutic Medical Devices (II),Artificial Intelligence for Medical Devices,Statistical Analysis for Medical Devices.

1. 1

   Discuss the design requirements of the medical devices from the bioelectronic, biomaterials and biomechanics perspective.

   Taught by: Discussion Method, Question - Answer Technique, Experimental Technique, Project Based Learning Model, Simulation Technique, Cooperative Learning, Experiential Learning, Lecture Method · Assessed by: Traditional Written Exam, Homework, Project Task

2. 2

   Classify the medical devices.

   Taught by: Discussion Method, Self Study Method, Question - Answer Technique, Brainstorming Technique, Project Based Learning Model, Cooperative Learning, Experiential Learning, Lecture Method · Assessed by: Traditional Written Exam, Homework, Project Task

3. 3

   Perform the effectiveness analysis of medical devices.

   Taught by: Discussion Method, Self Study Method, Question - Answer Technique, Project Based Learning Model, Cooperative Learning, Experiential Learning, Lecture Method · Assessed by: Traditional Written Exam, Project Task

4. 4

   Evaluate the medical device development, testing and marketing processes.

   Taught by: Discussion Method, Self Study Method, Question - Answer Technique, Brainstorming Technique, Project Based Learning Model, Cooperative Learning, Lecture Method · Assessed by: Traditional Written Exam, Project Task

5. 5

   Evaluates the working principles of biomedical devices for signal recording and stimulation.

   Taught by: Discussion Method, Problem Solving Method, Self Study Method, Question - Answer Technique, Experimental Technique, Cooperative Learning, Flipped Classroom Learning, Lecture Method · Assessed by: Traditional Written Exam, Homework

WEEKLY PLAN

1. WEEK 1

   Medical Devices - Overview

2. WEEK 2

   Classification of Medical Devices

3. WEEK 3

   Medical Device Regulation (MDR)

4. WEEK 4

   Summary of Safety and Effectiveness Data (SSED)

5. WEEK 5

   Bioelectronics Design Perspective (Signal Acquisition and Filtering)

6. WEEK 6

   Functional Electrical Stimulation

7. WEEK 7

   Biocompatibility Perspective (Abiotic Characterization)

8. WEEK 8

   Biocompatibility Perspective (Biotic Characterization)

9. WEEK 9

   Digital Signal Processing for Medical Devices

10. WEEK 10

    Clinical Evaluation of Medical Devices

11. WEEK 11

    Therapeutic Medical Devices (I)

12. WEEK 12

    Therapeutic Medical Devices (II)

13. WEEK 13

    Artificial Intelligence for Medical Devices

14. WEEK 14

    Statistical Analysis for Medical Devices

ASSESSMENT

• Rate of Midterm Exam to Success50%
• Rate of Final Exam to Success50%

WORKLOAD

READING

• 1- The European Union Medical Device Regulation of 2017. 2- Medical Instrumentation: Application and Design, John G Webster, 4th ed. John Wiley & Sons, 2010. 3- Journal articles presented during the lecture.

TEACHING STAFF

• Assist.Prof. Mehmet KOCATÜRKCOORDINATOR
• Assist.Prof. Mehmet KOCATÜRK