Medical Device Assembly

Short reports on issues affecting medical device manufacturers.

ARTICLES

Design controls help prevent medical device failures

By John Sprovieri
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 Medical device engineers are great at designing innovative, life-saving gizmos.  


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Failure Modes Analysis Aids Design of Medical Devices

By John Sprovieri
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In 2011, the U.S. Food and Drug Administration received more than 400,000 reports of adverse events related to medical devices. More than 12 percent of those events resulted in hospitalization.


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New Conformal Coating Has Antimicrobial Properties

The new coating produced a log 5 reduction on 14 common microorganisms.
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The conformal coating Parylene has long been known for its excellent dielectric strength, high thermal stability (up to 450 C), dry-film lubricity and outstanding chemical resistance. Those properties have made the material a staple for coating printed circuit boards and electronic devices exposed to environmental extremes.


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Usability Tests Lend Insight Into Medical Device Design

Engineers sometimes fail to account for who will be us-ing the device and where it will be used.
By John Sprovieri
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Each year, the U.S. Food and Drug Administration logs some 100,000 reports of adverse events related to medical devices. More than a third of those are due to human error.


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Opposition Mounts to Tax on Medical Devices

By John Sprovieri
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“Implementation of the medical device tax will cost our economy thousands of high-paying jobs.” —Gail Rodriguez, MITA


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Clean Room Robots Assemble Medical Devices

By John Sprovieri
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EPSON’s new robot can withstand exposure to vapor-ized hydrogen peroxide gas.


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Prototyping Improves Design Of Medical Devices

By John Sprovieri
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Doctors rarely make house calls, but if you give them a chance to see their technology ideas become reality, they won’t hesitate to pay you a visit.


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Medical Device Assemblers Pin Down Savings

By Christie L. Jones
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Simple changes saved the manufacturer more than $2.3 million annually.


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Medical Device Assembly:Top 10 Reasons Medical Devices Fail

By John Sprovieri
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More than 90 percent of electronic medical devices initially fail to comply with standards.


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Medical Device Assembly: Laser Welds Plastic Parts for Infusion Pump

By John Sprovieri
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A European medical device manufacturer uses a laser welding system from Leister Process Technologies to assemble a new infusion pump.
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Behind the Scenes at Ford's Michigan Assembly Plant

People are the heart and soul of the 2012 Assembly Plant of the Year. This slideshow shows some of the men and women who build three different types of electrified vehicles alongside traditional gas-powered cars on the auto industry’s most flexible assembly line—Ford’s Michigan Assembly Plant in Wayne, MI. Photos courtesy Ford Motor Co.

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