College of

1) Where will the medical devices industry find the technical expertise to solve challenging industry issues such as device development, manufacturing, multi-firm collaboration, process improvement, and quality assurance?

2) What is the best way to address the lack of a skilled workforce in the highly regulated medical devices industry?

3) How will government regulation and public policy affect the medical devices industry?

4) Can we forecast how a variety of powerful economic forces at work today will change the future economic environment facing the medical devices industry?

5) What are the affects of global competition and U.S. Food and Drug Administration (FDA) regulation and what are appropriate public policy responses?

The educational component of CareMed includes a 15-hour graduate certificate program in regulatory affairs (with an explicit emphasis on medical devices). This certificate program was developed with input from local medical device companies and faculty in the Regulatory Affairs Program at San Diego State University. Moreover, this certificate program is expected to evolve into a formal Master’s degree option in the near future. In order to become a Master’s degree program, new courses must be added. One of the planned new courses is a course in the economics of regulation and antitrust, and a second is the economics of healthcare. Both of these courses already exist in the College of Business Administration at USF.

CareMed will require and encourage close, direct interaction with practitioners and key constituents within the medical devices industry who can offer a rich understanding of the workings of the industry and the issues it faces, both in the short run and in the long run. In fact, operating partnerships have already been established with the Florida Medical Manufacturers’ Consortium (FMMC) and the U.S. Food and Drug Administration (FDA).

One centerpiece of CareMed that integrates our three-pronged mission is an active learning and virtual manufacturing laboratory. This lab will facilitate research on advanced manufacturing and prototyping techniques, promote collaboration between academia and industry in medical device and equipment design and manufacturing, and provide opportunities for hands-on learning by our engineering students.

The CareMed industry center is consistent with the five competitive strategies put forth by the College of Engineering which make it viable for other state and federal funding.

The proposals are not limited to an individual project, but seek to fund the development of a major area of research that lends itself to emerging as a research center)
The proposals will be viable in multiple competitions, including the Legislative Budget Requests (LBR), Congressional Plus Ups, Centers of Excellence, and World Class Scholars competitions).

The proposed effort represents a significant unmet need that will be attractive to legislators.
The proposed effort is interdisciplinary, involves several disciplines within the College of Engineering, and promotes collaboration with other colleges in the university.

The proposed effort has the potential to win competitive federal grants.

The findings of the recent National Academy of Engineering (NAE) study indicates the importance of the MDE industry at the local, national, and international levels, coupled with the research interests and resource capabilities of USF, make a strong case for developing CareMed as a national research center at the University of South Florida.