BIOMEDE 5902
Transcript Abbreviation:
Med Prod Dev II
Course Description:
Second 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: 5901, or permission of instructor.
Electronically Enforced:
No
Exclusions:
(N/A)
Course Goals / Objectives:
Identify and apply elements of lean-design process (1.2)
Utilize the primary elements of human-centered, usability design (2)
Describe the methods, strategy and process of protecting intellectual property
Analyze the impacts of healthcare costs and reimbursements for a medical product
Produce documentation that meets industrial product requirements and standards
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 |
|---|---|---|---|---|---|
| Business planning and commercialization strategies | 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 |
| Verification and validation of medical product in healthcare market | 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: