Healthcare Features

Alexandra Brown's picture
Alexandra Brown
Hospital leaders are feeling increasing pressure to find ways to thrive in our changing healthcare system. A C-suite that is removed from daily hospital operations is a liability in this era of...
The QA Pharm's picture
The QA Pharm
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a...
Alexandra Brown's picture
Alexandra Brown
A big challenge facing academic medical centers is how to maintain a focus on patient care in an artificially divided environment. Most academic medical centers were developed in a system with...
Thomas Prewitt Jr.'s picture
Thomas Prewitt Jr.
As we begin the journey to value-based healthcare, the relationships between a hospital and its medical staff are changing. For decades, these relationships were straightforward: Doctors admitted...
Michael Causey's picture
Michael Causey
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a...
Dawn Keller's picture
Dawn Keller
Juvenile idiopathic scoliosis. That was the diagnosis given to my then 8-year-old daughter last January. In short, it means that she’s young (under 10), she exhibits an abnormal amount of spinal...
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Ron Shoop
As more physicians are integrating their patient electronic medical records (EMRs) with third-party patient portals, they’re looking for clarifications on many issues to stay within the various...
Michael Causey's picture
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of...
Michael Causey's picture
Michael Causey
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America. Almost across the...
Tripp Babbitt's picture
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and...
Michael Causey's picture
Michael Causey
A s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based...
Alexandra Brown's picture
Alexandra Brown
My husband and I both like to run. I run about three miles once or twice a week—if the weather’s not too bad, and if I don’t have something else going on. Keith, on the other hand, runs half...
Jeff Mazik's picture
Jeff Mazik
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year,...
Margaret A. Hamburg's picture
Margaret A. Hamburg
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens...
Gary Minks's picture
Gary Minks
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be...
Michael Causey's picture
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and...
The QA Pharm's picture
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying...
Dave Cranmer's picture
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a...
Johns Hopkins University's picture
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,...
The QA Pharm's picture
The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations...