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.
- Discuss DME concept development and refinement
- Describe how a durable medical product becomes commercially available
- Define and differentiate the FDA approval process for durable medical equipment manufactured within and outside of the US
- Compare and contrast the DME approval process within the US to international approval processes
- Discuss how differences in DME approval processes around the world impact global health care and global standards of practice
- Discuss the impact of DME development, design, and distribution on a medical professional's clinical practice patterns (undergraduate)
- Discuss the impact of DME development, design, and distribution on their future clinical practice patterns, decisions processes, and prescriptions/recommendations (graduate)
- Demonstrate awareness of multiple perspectives of DME within the global community
- Investigate and analyze contemporary issues, phenomena, and ideas with global impact, considering their effect on the individuals, communities, and social or natural environments involved
- Course Term: Summer
- Travel Dates: July 20-August 4, 2019
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Title: DCOM 492/592 Comparative Development and Commercialization of Medical Devices in the United States and Australia
Download syllabus: DCOM 492/592
After admission to this program, CAGE will register you in the course you indicate on the Course Registration Form in your application. You will not be able to register yourself in WebAdvisor.
Participants will stay in shared hotel accommodations arranged by the program.
Wondering how much it's going to cost? See Budget Sheet for information about total program costs, payment schedule, and the withdrawal and refund policy.
Scholarships and Financial Aid
How am I going to pay for it? See our Financial Assistance page for a list of USD and external scholarships.
To inquire about using federal financial aid to help toward the expense of this program, contact the Office of Financial Aid as early as possible (non-USD students should contact the financial aid office at their home institution). NOTE: To be eligible for federal financial aid for this program, you must be enrolled in a minimum of 6 credits during the summer.
Are you a senior planning to graduate in May prior to participating in this program? To be eligible for USD scholarships—such as the Arts & Sciences International Opportunity Fund or Farber Fund—or other financial aid, you will need to change your graduation date to the end of summer.
Applications—including all required pre-decision materials and recommendations—must be submitted online by the deadline specified in the Dates/Deadlines section on this page. Incomplete applications cannot be considered. To start an application, click the Apply Now button on this page. If the Apply Now button does not appear, applications are either not open yet, or it is past the deadline.
If you have started an application already, use the LOGIN (USD applicants) or NON-USD LOGIN (non-USD applicants) link on this site to return to the materials.
This program is open to students of all majors.
This program is open to applicants from any institution, although preference will be given to USD students.
All applicants must be in good academic and judicial standing at their home institution. For other eligibility requirements, including minimum GPA and any language prerequisites, refer to the Fact Sheet on this page.
Jessica Messersmith received a Ph.D. in Human Sciences from the University of Nebraska in 2008 and is an Associate Professor in the Department of Communication Sciences and Disorders at USD. Dr. Messersmith's teaching interests include psychoacoustics which is the psychophysical study of acoustics, and multiple facets of cochlear implants including but not limited to cochlear implant signal processing, and post-implant performance. Her research focuses on practices in the cochlear implant clinic and improving outcomes of children with cochlear implants through these practices.
Lindsey Jorgensen holds a Ph.D. and an Au.D. from the University of Pittsburgh and is an Assistant Professor in the Department of Communication Sciences and Disorders at USD. Her research interests include amplification, hearing loss, aging, traumatic brain injury, hearing aid use, dementia, geriatric and veteran populations.
For questions about the course content and program site, contact the faculty leaders, Jessica Messersmith or Lindsey Jorgensen.
For general inquiries and questions about the application process, course registration and billing, contact Søren Peterson in the Center for Academic & Global Engagement. To schedule an advising session with him, visit Coyote Connections (Get Assistance -> Study Abroad -> Faculty-Led Programs).
For information about immunizations and health precautions, refer to the Centers for Disease Control and Prevention (CDC). After you have been admitted to this program, you will be required to complete a travel physical with a healthcare provider such as Sanford Vermillion.