BIOMEDE 5901
Transcript Abbreviation:
Med Prod Dev I
Course Description:
First course in a two-course sequence, focused on taking a medical product or device from concept/prototype to commercialization. Topics include medical product or device testing, IP protection, business models, manufacturability, FDA approvals, and commercialization.
Course Levels:
Graduate (5000-8000 level)
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: 4902, Engr 5902.02H, or equiv.; and permission of instructor.
Electronically Enforced:
No
Exclusions:
(N/A)
Course Goals / Objectives:
make design decisions based on basic design-for-manufacturability principals
understand the financials of a manufacturing company, including cost structure and ROI requirements for new product developments
design, implement, and document testing plans to verify and validate a medical device or product with respect to user needs, design requirements, standards, national and international regulatory pathways, and FDA approvals
collaborate effectively in multidisciplinary teams that include integration between clinical professionals, patients, and product manufacturer
Check if concurrence sought:
No
Contact Hours:
| Topic | LEC | REC out-of-class | REC in-class | Weekly LAB out-of-class | Weekly LAB in-class |
|---|---|---|---|---|---|
| Concept screaning, or taking an initial design concept through to final concept selection | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Professional documentation and communication | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Project management and leadership | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Teamwork | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Time management | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Professional ethics and practice | 0.0 | 0.0 | 0 | 0.0 | 0 |
| Total | 0 | 0 | 0 | 0 | 0 |
Grading Plan:
Letter Grade
Course Components:
Lecture
Grade Roster Component:
Lecture
Credit by Exam (EM):
No
Grades Breakdown:
| Aspect | Percent |
|---|---|
| Oral Presentations | 30% |
| Documentation | 30% |
| Written Reports | 30% |
| Individual Contribuation | 10% |
Representative Textbooks and Other Course Materials:
| Title | Author | Year |
|---|---|---|
| Business Model Generation | Osterwalder, Alexander and Pigneur, Yves | |
| Biodesign: The Process of Innovating Medical Technologies | Yock, Zenios, Makowwer et al |
ABET-CAC Criterion 3 Outcomes:
(N/A)
ABET-ETAC Criterion 3 Outcomes:
(N/A)
ABET-EAC Criterion 3 Outcomes:
(N/A)
Embedded Literacies Info: