Medical device companies launch products overseas

Published: October 10, 2011 6:00 am ET

Related to this story

Topics Medical, Public Policy

CHICAGO (Oct. 10, 1:25 p.m. ET) — The time-consuming process and high cost of getting medical devices approved in the United States is prompting the majority of medical device and diagnostic companies to launch their products overseas first.

An online survey of 350 medical device companies funded by the medical technology industry’s Institute for Health Technology Studies found that more than 75 percent of device manufacturers seek regulatory approval overseas first for new medical devices.

The study was conducted for InHealth by Northwestern University.

Almost two-thirds of the companies surveyed, 63 percent, said they sought approval overseas first because of the unpredictably of the 501 (k) review and approval process of the Food & Drug Administration.

Another 22 percent said the high costs of FDA review sent them overseas, and 14 percent said they first sought approval overseas for new medical devices because of the lengthy and complicated U.S. review process, which they said was twice as long as in the European Union.

Small companies surveyed said they experienced an average total review time by the FDA of 330 days compared to the average review time by the FDA of 177 days reported by large companies.

The online survey also found that the medical device development process for small companies—which are involved with new products twice as often as large companies—is 50 percent longer than for large companies, 26. 6 months versus 17.7 months.

More than three-quarters of respondents—76 percent—said they found the preparation requirements for a 510(k) submission to be uncertain or unclear, and 72 percent said they felt that the information requests from FDA reviewers went beyond the requirements established in guidance documents.

Not surprisingly, only eight percent of survey respondents said that they viewed the FDA’s 510(k) product review process as the most predictable regulatory system. Some two-thirds of respondents said that Europe’s CE marking process is the most predictable regulatory system for medical device approval.


Comments

Medical device companies launch products overseas

Published: October 10, 2011 6:00 am ET

Post Your Comments


Back to story


More stories

Image

German molder picks North Carolina for US manufacturing plant

February 26, 2015 4:21 pm ET

German medical goods company Raumedic AG has chosen Mills River, N.C., for its first U.S. manufacturing site and U.S. headquarters.    More

Image

Expert says more action needed to solve ocean plastics problem

February 25, 2015 5:59 pm ET

DALLAS — Private companies are going to have to step up to the plate and open their wallets if the world ever wants to solve the growing...    More

Image

Medical compounder adding two extrusion lines

February 25, 2015 3:49 pm ET

Compounding Solutions LLC plans to add two new co-rotating twin-screw extruders this year to raise its capacity and provide more flexibility.    More

Image

Referendum on bag ban going to California voters

February 24, 2015 6:34 pm ET

California's voters, not legislators, will be the ones to ultimately decide on the state's plastic bag ban.    More

Image

Leader calls on Mexico’s plastics industry to spend more to defend plastics

February 24, 2015 6:13 pm ET

MEXICO CITY — Mexico’s plastics industry must spend more on recycling, advertising and lobbying to stave off anti-plastics legislation, a ...    More

Market Reports

Flexible Packaging Trends in North America

North America represents about 30 percent of the global consumption of flexible packaging. Annual growth in this region is forecast at 4 percent during the next 5 years.

For more insight on growth opportunities, drivers of growth and the outlook for 2015, download this report.

Learn more

Plastics Recycling Trends in North America

This report is a review and analysis of the North American Plastics Recycling Industry, including key trends and statistics based on 2013 performance. We examine market environment factors, regulatory issues, industry challenges, key drivers and emerging trends in post-consumer and post-industrial recycling.

Learn more

Plastics in Mexico - State of the Industry Report

This report analyzes the $20 billion plastics industry in Mexico including sales of machinery & equipment, resins and finished products.

Our analysts provide insight on business trends, foreign investment, top end markets and plastics processing activity. The report also provides important data on exports, production, employment and value of plastics products manufactured.

Learn more

Upcoming Plastics News Events

June 2, 2015 - June 3, 2015Plastics Financial Summit - Chicago 2015

September 16, 2015 - September 18, 2015Plastics Caps & Closures - September 2015

More Events