In this program, you will explore the process of developing durable medical equipment through on-site discussion and exploration of a research lab, development company, and manufacturing facilities located at multiple locations in Europe. DMEs are medically necessary devices prescribed by a health care provider to aid in, contribute to, provide monitoring of, or treatment for a medical condition. As such, health care providers must possess knowledge of DMEs. The process through which a piece of medical equipment becomes available for commercial use in the United States entails several steps from design to development to distribution. The complexity of this process increases when the DME is manufactured outside of the US. The course will be divided into three sections: development, design, and distribution of DMEs. First, we will explore the process through which a medical device is developed, including initial and clinical trials and the mechanisms of product refinement. Second, we will discuss the process for developing candidacy and fitting criteria with particular reference to the US Food and Drug Administration (FDA) labeling and approval processes. Finally, we will investigate the medical and legal requirements for commercialization with respect to both DMEs manufactured within the US and for DMEs manufactured outside of the US. This course will also focus on the differentiation of the three categories of FDA approval classes as well as the difference between these classes and over-the-counter medical equipment.
July 22, 2018
August 6, 2018
DCOM 492/592 Comparative Development and Commercialization of Medical Devices in the United States and Europe
Jessica Messersmith and Lindsey Jorgensen