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How Does The GVSU aMDI Help Entrepreneurs Negotiate The FDA Approval Process?

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What does it take for a medical device to get approved by the Federal Drug Administration for commercialization? Brent Nowak, PhD, executive director of the Applied Medical Device Institute of Grand Valley State University, explains how the process works.

Nowak is interviewed on this segment of M2 TechCast by Keith Brophy, state director of the Michigan Small Business Development Center, part of a monthly series where Brophy highlights companies and resources available for entrepreneurs through this SBA-backed organization.

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Applied Medical Device Institute launches female catheter

uCol Female Catheter

An external catheter for female hospital patients may be available in the next year, and it will have been created and developed in Grand Rapids.

Brent Nowak said the uCol is one of a handful of medical devices the new applied Medical Device Institute, where he serves as executive director, is working on with its partners.

The aMDI has been operating for just over a year but became an official unit of Grand Valley State University earlier this year. It is housed on the fifth floor of the Cook-DeVos Center for Health Sciences.

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First applied Medical Devices Institute comes to GVSU

Kevin and Brent in Lanthorn

Grand Rapids is known for many things. From craft beers to diverse museums and a continually growing healthcare industry, businesses related to these industries are moving to West Michigan in search of a new and engaged market.

After being approved a year ago following increased interest from the community, Brent Nowak, director of the first applied Medical Devices Institute (aMDI) in West Michigan has been working to serve the healthcare community of the greater Grand Rapids area.

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New center will bring medical devices to market

Kevin and Brent in GVSU Forum

A new institute at Grand Valley is supporting Grand Rapids' growing medical research and biomedical industries by bringing medical device inventions to market. 

The applied Medical Devices Institute (aMDI) — a first of its kind in West Michigan — provides access to researchers, engineers, medical professionals, and business and entrepreneurial professionals. It uses an integrated approach that includes intellectual property, business review and mentoring. The center is located in the Cook-DeVos Center for Health Sciences. 

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