BIOMEDE 5639
Transcript Abbreviation:
Med Device Design
Course Description:
Basic principles and essential steps for medical device design and commercialization.
Course Levels:
Undergraduate (1000-5000 level)
Graduate
Designation:
Elective
General Education Course:
(N/A)
Cross-Listings:
(N/A)
Credit Hours (Minimum if “Range”selected):
3.00
Max Credit Hours:
3.00
Select if Repeatable:
Off
Maximum Repeatable Credits:
(N/A)
Total Completions Allowed:
(N/A)
Allow Multiple Enrollments in Term:
No
Course Length:
14 weeks (autumn or spring)
Off Campus:
Never
Campus Location:
Columbus
Instruction Modes:
In Person (75-100% campus; 0-24% online)
Prerequisites and Co-requisites:
Prereq: Sr or Grad standing in Engineering, or permission of instructor.
Electronically Enforced:
No
Exclusions:
(N/A)
Course Goals / Objectives:
Distinguish between primary and secondary market research, to identify marketing resources in medical device industry, and to convert clinical needs into engineering specifications
Identify methods for intellectual property protection and to carry out the patent search for medical devices
Utilize engineering and management tools for medical device design, project management, progress reporting, and documentation
Itemize the essential components for medical device regulation, to differentiate between PMA and 510k pathways for FDA approval, and to emphasize safety, human factor, and research ethics in medical device development
Check if concurrence sought:
No
Contact Hours:
| Topic | LEC | REC | LAB | LAB Inst |
|---|---|---|---|---|
| Clinical needs and market analysis | 4.5 | 0.0 | 0.0 | 0 |
| Product definition and QFD analysis | 4.5 | 0.0 | 0.0 | 0 |
| Computer-Aided Design and Manufacturing | 4.5 | 0.0 | 0.0 | 0 |
| Design and fabrication of biomedical devices and micro devices | 4.5 | 0.0 | 0.0 | 0 |
| Design management and project plan | 3.0 | 0.0 | 0.0 | 0 |
| Human factors, safety and ergonomics | 3.0 | 0.0 | 0.0 | 0 |
| Prototyping, testing and quality control | 4.5 | 0.0 | 0.0 | 0 |
| Software programming, verification, and validation | 3.0 | 0.0 | 0.0 | 0 |
| Benchtop, animal, and clinical testing | 4.5 | 0.0 | 0.0 | 0 |
| Regulation and FDA | 3.0 | 0.0 | 0.0 | 0 |
| Research ethics | 1.5 | 0.0 | 0.0 | 0 |
| Funding and business plan | 1.5 | 0.0 | 0.0 | 0 |
| Total | 42 | 0 | 0 | 0 |
Grading Plan:
Letter Grade
Course Components:
Lecture
Grade Roster Component:
Lecture
Credit by Exam (EM):
No
Grades Breakdown:
| Aspect | Percent |
|---|---|
| Class participation and quizzes | 20% |
| Home works | 30% |
| Mid term examination | 20% |
| Final project | 30% |
Representative Textbooks and Other Course Materials:
| Title | Author | Year |
|---|---|---|
| Design of Biomedical Devices and Systems, 2003 | King, P.H. and R.C. Fries |
ABET-CAC Criterion 3 Outcomes:
(N/A)
ABET-ETAC Criterion 3 Outcomes:
(N/A)
ABET-EAC Criterion 3 Outcomes:
(N/A)
Embedded Literacies Info:
Attachments:
(N/A)
Additional Notes or Comments:
(N/A)
Basic Course Overview:
BIOMEDE_5639_basic.pdf
(10.74 KB)