| MATHEMATICS (TURKISH, PHD) | |||||
| PhD | TR-NQF-HE: Level 8 | QF-EHEA: Third Cycle | EQF-LLL: Level 8 | ||
| Course Code | Course Name | Semester | Theoretical | Practical | Credit | ECTS |
| BME4008 | Human Factors in Medical Device Design | Fall | 3 | 0 | 3 | 6 |
| The course opens with the approval of the Department at the beginning of each semester |
| Language of instruction: | En |
| Type of course: | Departmental Elective |
| Course Level: | |
| Mode of Delivery: | Face to face |
| Course Coordinator : | Prof. Dr. ALİ YEKTA ÜLGEN |
| Course Objectives: | Learn how to accomplish a Medical Device Prototype Design by applying tools of human factor engineering; principles of design verification and validation studies. |
|
The students who have succeeded in this course; The student will learn about medical device requirements, standards, human factor and usability engineering skills in device-user interface, FDA model, verification and validation concepts in design prototype evaluation and compliance with medical device directives. |
| Designing the right device, Design input requirements Compliance matrix, Applying human factors and usability engineering to optimize medical device design and minimize the risks, Product design and development with DHF, Deliverables and milestones, Methods of organizing a DHF, How to maintain the DHF after design transfer. |
| Week | Subject | Related Preparation | |
| 1) | HF (preliminary) Analysis Requirements in the early stages of device development, FDA User-Device Model | ||
| 2) | Formative Evaluation and Design Modification | ||
| 3) | Planning and executing HF/Usability validation studies | ||
| 4) | HF/Usability Report | ||
| 5) | Overview of Human Factors Medical Device Standards | ||
| 6) | Planning and Conducting HF for Medical Devices | ||
| 7) | Midterm Exam | ||
| 8) | FDA and ISO 13485 Design Control Requirements, Design and Development Planning Continues | ||
| 9) | Design Input, Risk Management and Design Output | ||
| 10) | Design Review, Design Verification and Validation | ||
| 11) | Design Transfer | ||
| 12) | Software Validation | ||
| 14) | Pilot Production and Volume Production | ||
| 14) | Design Changes and Design History File | ||
| Course Notes: | Power Point Presentations, Design for Biomedical Engineers J. Webster R. Pallas-Areny, e-book, 2015; Design and Development of Medical Electronic Instrumentation, D. Pruychi and M. Norris, John-Wiley and Sons, 2005. |
| References: | Standards ANSI/AAMI HE 75 and EN 62366-1; Design Control Requirements and Industry Practice, AAMI corse e-notebook, 2016;Human Factors for Medical Devices, AAMI course e-notebook, 2013; Overview of International Medical device Human Factors Standards,, K. İsraelski, Abbott; An Introduction to Human Factors in MEdical DEvices, Do It By Design, D. Sawyer, CDRH, FDA. |
| Semester Requirements | Number of Activities | Level of Contribution |
| Attendance | 0 | % 0 |
| Laboratory | 0 | % 0 |
| Application | 0 | % 0 |
| Field Work | 0 | % 0 |
| Special Course Internship (Work Placement) | 0 | % 0 |
| Quizzes | 0 | % 0 |
| Homework Assignments | 5 | % 30 |
| Presentation | 0 | % 0 |
| Project | 0 | % 0 |
| Seminar | 0 | % 0 |
| Midterms | 1 | % 30 |
| Preliminary Jury | 0 | % 0 |
| Final | 1 | % 40 |
| Paper Submission | 0 | % 0 |
| Jury | 0 | % 0 |
| Bütünleme | % 0 | |
| Total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 60 | |
| PERCENTAGE OF FINAL WORK | % 40 | |
| Total | % 100 | |
| Activities | Number of Activities | Duration (Hours) | Workload |
| Course Hours | 14 | 3 | 42 |
| Laboratory | 0 | 0 | 0 |
| Application | 5 | 0 | 0 |
| Special Course Internship (Work Placement) | 0 | 0 | 0 |
| Field Work | 0 | 0 | 0 |
| Study Hours Out of Class | 14 | 8 | 112 |
| Presentations / Seminar | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework Assignments | 0 | 0 | 0 |
| Quizzes | 0 | 0 | 0 |
| Preliminary Jury | 0 | 0 | 0 |
| Midterms | 1 | 4 | 4 |
| Paper Submission | 0 | 0 | 0 |
| Jury | 0 | 0 | 0 |
| Final | 1 | 2 | 2 |
| Total Workload | 160 | ||
| No Effect | 1 Lowest | 2 Low | 3 Average | 4 High | 5 Highest |
| Program Outcomes | Level of Contribution |