The alleged heartlessness of the medical device industry was decried by its critics in late February when Medtronic won a U.S. Supreme Court case over federal preemption of premarket approval (PMA) products that are not in violation of FDA requirements. The decision means that patients injured by PMA devices cannot sue manufacturers in state courts if the devices are not adulterated or misbranded.
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Direct welding of plastics can be used in place of adhesives and other bonding methods for joining a variety of medical devices, particularly disposables. An article in the May issue explores the methods of laser welding for sealing plastic seams in medical devices.
We’ll also explore the ins and outs of testing. Medical devices must undergo a number of physical, biological, and chemical characterization tests. The testing requirements for those being implanted in the body are more stringent. Find out what some of these additional tests entail.
As always, May features our coverage of MD&M East. The exclusive guide will help you prepare for your attendance to the trade show and conference sessions.
