Certificate in Medical Product Design and Device Development

Certificate Level: Graduate
Admission Requirements: Bachelor's degree
Certificate Type: Graduate Certificate
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 Program (CIP) Code: 14.0501
Standard Occupational Classification (SOC) Code: 17-2031

 

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 health care 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.


Required Courses
BMES 509Entrepreneurship for Biomedical Engineering and Science3.0
BMES 538Biomedical Ethics and Law3.0
BMES 588Medical Device Development3.0
BMES 821Medical Instrumentation3.0
Select one of the following:3.0
Introduction to Medical Science
Medical Instrumentation II
Total Credits15.0

Additional Information

For addition information, please contact Carolyn Riley (Professional Programs, cr63@drexel.edu) or Professor Kambiz Pourrezaei (Program Coordinator, pourrezk@drexel.edu).
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