Post-Baccalaureate Certificate in Medical Product Design and Device Development
Certificate Level: Graduate
Admission Requirements: Bachelor's degree
Certificate Type: Post-baccalaureate Certificate
Minimum Number of Credits to Completion: 15.0
Instructional Delivery: Online
Calendar Type: Quarter
Expected Time to Completion: 1 year
Financial Aid Eligibility: Not aid eligible
Classification of Instructional Programs (CIP) code: 14.0501
Standard Occupational Classification (SOC) code: 17-2031
About the Program
Over the past 50 years, the practice of medicine has become increasingly driven by technological innovations; however, simply being able to design and develop a new technology is no guarantee that the technology will reach its intended audience, whether that audience be made of medical professionals or patients. To reach the goal of introducing a medical technology into the marketplace, a biomedical engineer must run the gauntlet of regulations, attitudes, and financial considerations that make up the United States healthcare system.
Medical devices are subject to extensive FDA regulations. Thus, biomedical engineers who design medical technologies must be proficient in the regulatory and economic components of introducing a new medical device into the US health market. Knowledge of intellectual property law is also a prerequisite for those who plan to develop novel medical technologies. Because the cost of obtaining FDA is steep, obtaining intellectual property protection for extended periods of time is necessary to recovering project costs. Along similar lines, biomedical engineers must also appreciate the role of Medicare and other insurers and their requirements for reimbursement.
This certificate program is designed to prepare biomedical engineers to understand the environment into which their innovations will be placed and the users who will interact with them. Professionals enrolled in the certificate will develop an understanding of critical regulatory, economic, and legal issues in addition to the project management skills that facilitate the development of new medical devices and positive working relationships with intellectual property lawyers, insurance companies, and the federal government.
Program Requirements
| Required Courses | ||
| BMES 509 | Entrepreneurship for Biomedical Engineering and Science | 3.0 |
| BMES 538 | Biomedical Ethics and Law | 3.0 |
| BMES 588 | Medical Device Development | 3.0 |
| BMES 821 | Medical Instrumentation | 3.0 |
| or BMES 534 | Design Thinking for Biomedical Engineers | |
| BMES 822 | Medical Instrumentation II | 3.0 |
| Total Credits | 15.0 | |
Sample Plan of Study
| First Year | |||||
|---|---|---|---|---|---|
| Fall | Credits | Winter | Credits | Spring | Credits |
| BMES 821 | 3.0 | BMES 822 | 3.0 | BMES 588 | 3.0 |
| 3 | 3 | 3 | |||
| Second Year | |||||
| Fall | Credits | Winter | Credits | ||
| BMES 538 | 3.0 | BMES 509 | 3.0 | ||
| 3 | 3 | ||||
| Total Credits 15 | |||||
Additional Information
For more information, contact:
Carolyn Riley
Associate Director of Professional Programs
215-895-2215
cr63@drexel.edu
