Michael Causey’s picture

By: Michael Causey

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.

Christine Forcier’s picture

By: Christine Forcier

The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets. For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively should also have in place a properly implemented and maintained quality management system.

Grant Ramaley’s picture

By: Grant Ramaley

One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time. It shows how small medical-device companies are making major contributions to health care, and begins another story that explains how one standard is threatening to undo these gains.

Guidon Performance Solutions LLC’s picture

By: Guidon Performance Solutions LLC

Industry experts at Guidon Performance Solutions’ Second Annual Virtual Healthcare Summit agreed that health care organizations’ ability to survive their increasingly demanding and changing environment will require a new agility and adaptability. Consensus from the speakers signaled that most health care systems are unprepared to cope with the ongoing change.

Stanford News Service’s picture

By: Stanford News Service

For 50 years, scientists searched for the secret to making tiny implantable devices that could travel through the bloodstream. Engineers at Stanford University have demonstrated just such a device. Powered without wires or batteries, it can propel itself though the bloodstream and is small enough to fit through blood vessels.

Texas A and M News and Information Services’s picture

By: Texas A and M News and Information Services

In an era of soaring medical costs, providing health care to employees at or near their workplace is gaining new momentum, according to an article in the Winter 2012 issue of MIT Sloan Management Review.

Dale Hallerberg’s picture

By: Dale Hallerberg

There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.

News-Medical.Net’s picture

By: News-Medical.Net

Japanese vehicle manufacturer, Toyota, is well-known for developing the principles of lean manufacturing. Research published in the International Journal of Technology Management suggests that the lean approach might also be beneficial to medical procedures, making hospitals more efficient and cutting waiting lists.

Davis Balestracci’s picture

By: Davis Balestracci

I recently attended the annual forum of the Institute for Healthcare Improvement (IHI), which is probably the leading health improvement organization in the world. The forum has grown from under 100 attendees in 1989 to almost 6,000 this year—half of whom were there for the first time—with now thousands more virtual participants. It has become a cliché that invokes my gag reflex when participants say, “Oh, I go to get my batteries charged.” And I always wonder, on hearing this, Why were they drained?

UC Berkeley NewsCenter’s picture

By: UC Berkeley NewsCenter

A nurse refuses to help an ailing alcoholic who is upset to find a hospital detox unit closed. A hospital clerk brushes off a deceased woman’s grieving family as they try to pay her bills and claim her belongings. A charge nurse keeps the mother of gunshot victim from seeing her son, saying the emergency room is “too busy.”

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