Multiple Authors
By: Rachel E. Sherman, Robert M. Califf

Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations surrounding this evidence base.

Multiple Authors
By: Kimberly Watson-Hemphill, Kristine Nissen Bradley

Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.

Duke University’s picture

By: Duke University

Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.

NIST’s picture


Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.

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n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics useless, and that few replacement drugs are in the pipeline. But help may be on the way.

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By: J.D. Power and Associates

According to the recently released J.D. Power 2016 Member Health Plan Study, critical factors of health plan member satisfaction are highest in areas of the country that have more competition between different health plans.

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Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting out the electronics.

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With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices, Eamonn Hoxey, Ph.D., shares his thoughts about the industry, its exponential growth, and why uniform and consistent standards are important.

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By: James Brewton

The healthcare industry is under pressure to improve performance across strategic measures of performance, including delivery cost, operating revenue, employee engagement, patient safety, patient experience, and patient outcomes. A growing number of organizations turn to innovation as a way to survive and succeed in this new healthcare environment. Although many definitions exist for innovation, I like to define it as “the deliberate effort by an organization to find new ways for meeting business challenges.”

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