About the Program

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.

The Role of Design in Medical Products & Devices

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.

How do you Design a Medical Device?

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.

Program Requirements

Sample Plan of Study