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.
- Gain factual knowledge (terminology, classifications, methods, trends)
- Learn fundamental principles, generalizations, or theories
- Develop specific skills, competencies, and points of view needed by professionals in the field most closely related to this course
July 22-August 6, 2018
DCOM 492/592 Comparative Development and Commercialization of Medical Devices in the United States and Europe, 3 credits (syllabus)
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, you must be enrolled in a minimum of 6 credits during the summer or 12 credits during fall/spring semester.
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. Preference will be given to applicants from Communication Sciences and Disorders and related disciplines.
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 general inquiries, contact the faculty directors (Jessica.Messersmith@usd.edu and Lindsey.Jorgensen@usd.edu) or the Center for Academic & Global Engagement (firstname.lastname@example.org).
To schedule an advising session with Søren Peterson in CAGE, go to http://tinyurl.com/USDabroad-smp.
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.