High risk medical devices backed by few studies

640_surgeryMany high-risk therapeutic devices get Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market.

Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk devices approved in 2010 and 2011 by the FDA Premarket Approval pathway

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About Peter Coffaro 1426 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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