Master program will focus on bringing healthcare technology to market #WhyMFG

Washington, D.C. – The George Washington (GW) University, located in the nation’s capital, has developed a new master of engineering degree in regulatory biomedical engineering (rBME). This first-of-its-kind program seeks to produce graduates who can successfully navigate the regulatory environment and help bring new products to market faster by providing training in regulatory science, biomedical innovation, and entrepreneurship.

The average length of time for premarket approval of a new medical device in the United States is four and a half years, which is nearly five times longer than in Europe, according to the university.

“Our new master of regulatory biomedical engineering program addresses the important role that innovation, entrepreneurship, and product approval play in getting technologies into the market, where they actually can improve healthcare and save lives,” said Igor Efimov, chair of the Department of Biomedical Engineering, in a GW press release. “Ultimately, product approval is key to getting the technologies into the market, and this program is designed to prepare engineers to understand the product approval process and the process of translating their research to the bedside.”

The 30-credit program offered through GW’s Department of Biomedical Engineering in partnership with the School of Medicine and Health Sciences Regulatory Affairs Program includes courses in biomedical engineering, regulatory issues, and patent law, as well as a practicum.

According to GW, graduates of the interdisciplinary rBME program will “acquire skillsets comparable to those of an engineer with five to seven years of experience,” helping equip them for jobs within medical device companies, government agencies, and compliance institutions.

“We’re within walking distance of many patent law firms on K Street and only a Metro ride from the U.S. Patent and Trademark Office and the Food and Drug Administration,” Efimov said. “That proximity gives us the opportunity to develop a one-of-a-kind regulatory engineering program.”

The new program will begin in the spring of 2016.

Source: GW