Tandem Diabetes Care recently announced that it is expanding a voluntary recall of specific lots of insulin cartridges used with its t:slim insulin pump. ...

Aging, molding, and leaching present challenges for medical device engineers.

Sticking a plastic medical device part or some plastic packaging in an oven to figure out how it will age years from now--it sounds like a good idea.But there are plenty of ways to botch up the testing, says Karl Hemmerich, president of Ageless...

A medical device designer might look up a polymer's physical properties and game out how a part made of the polymer will withstand stress. But start molding the part, and it might not hold up anyway.Molding adds an entirely new dimension to what...

Thor Rollins frets about things that most average people, even most average medical device professionals, don't think about: "Some people don't understand that there is a difference between extractables and leachables," says Rollins, a...

Strangled babies and irradiated patients provide some recent examples of why medical device designers cannot assume their products will be used the way they think they are going to be used, says Edith Folger, senior software quality engineer at...

Angelcare Monitors is engaging in a voluntary recall to provide cord covers for 600,000 baby monitors with potential strangulation risk, the U.S. Consumer Product Safety Commission recently announced. It turns out cords can be a lethal problem...

Next-generation genetic sequencing, the idea of cheap and accessible testing, is one of the trendy areas in the medical device industry and a potential game-changer in the testing equipment sector...