In this program, you will explore the process of developing durable medical equipment through on-site discussion and exploration of research lab, development, and manufacturing facilities located in Sydney, Australia. 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 labeling and approval processes of both the US Food and Drug Administration (FDA) and the European CE mark used in Australia. 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 20, 2019
August 4, 2019
DCOM 492/592 Comparative Development and Commercialization of Medical Devices in the United States and Australia
Lindsey Jorgensen and Jessica Messersmith