Alexandra Brown
Being a hospital leader is more difficult than ever in today’s changing healthcare environment. It can be easy to stray off course while dealing with regulatory compliance and financial constraints...
Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is...
Akhilesh Gulati
The dynamics of the healthcare environment are changing rapidly. Small primary care practices are confronting a host of regulatory, technological, and practice challenges, not the least of which is...
Jim Bevier
A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day...
Thomas Prewitt Jr.
One of our major problems with healthcare reform is that we are doing it from the top down.
At the top, a bloated bureaucracy works in an environmental context of regulations and finance that...
ASQ
Strengthening communication between caregivers and patients should be a top priority for reducing healthcare costs and improving patient experience, according to a new poll of U.S. healthcare...
Alexandra Brown
Physician alignment is vital to driving the changes necessary in our shifting healthcare environment. On the hospital side, physicians are the frontline experts needed to increase quality and...
Patrick Stone
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles...
Jon Speer
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All...
Alexandra Brown
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons.
Many hospital...
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements,...
Kelly Kuchinski
Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250...
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
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
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.
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
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
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...
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
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...
