PRINCIPLES of MEDICAL DEVICE DESIGN

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; 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).

1. 1

   Classifies the medical devices.

   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

2. 2

   Evaluates 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

3. 3

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

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

4. 4

   Evaluates digital signal processing methods in medical devices.

   Taught by: Discussion Method, Case Study Method, Self Study Method, Question - Answer Technique, Experimental Technique, Brainstorming Technique, Simulation Technique, Problem Baded Learning Model, Cooperative Learning, Lecture Method · Assessed by: Traditional Written Exam, Homework

5. 5

   Provides solutions for analog-to-digital and digital-to-analog signal conversion issues in medical devices.

   Taught by: Discussion Method, Self Study Method, Question - Answer Technique, Brainstorming Technique, Simulation Technique, Problem Baded Learning Model, Cooperative Learning, Lecture Method · Assessed by: Traditional Written Exam, Homework

WEEKLY PLAN

1. WEEK 0

   Benefit-Risk Determination

2. WEEK 1

   Medical Devices

3. WEEK 2

   Classification of Medical Devices

4. WEEK 3

   Medical Device Regulation (MDR)

5. WEEK 4

   Summary of Safety and Effectiveness Data (SSED)

6. WEEK 5

   Bioelectronics Design Perspective (Biosignal Acquisition and Filtering)

7. WEEK 6

   Functional Electrical Stimulation

8. WEEK 7

   Biocompatibility Perspective (Implantable Neural Interfaces)

9. WEEK 8

   Biocompatibility Perspective (Implantable Neural Interfaces)

10. WEEK 9

    Artificial Intelligence for Medical Devices

11. WEEK 10

    Clinical Evaluation

12. WEEK 11

    Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing

13. WEEK 12

    Therapeutic Medical Devices (I)

14. WEEK 13

    Therapeutic Medical Devices (II)

ASSESSMENT

• Rate of Midterm Exam to Success30%
• Rate of Final Exam to Success70%

WORKLOAD

READING

• 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.

TEACHING STAFF

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