Healthcare Features

NIST's picture
NIST
A newly released study comparing 34 U.S. healthcare organizations that received the Baldrige National Quality Award with their 153 geographically closest competitors found that the Baldrige Award...
Russ King's picture
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of...
Michael Causey's picture
Michael Causey
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us...
Michael Causey's picture
Michael Causey
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto...
Michael Causey's picture
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget...
Thomas Prewitt Jr.'s picture
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data...
Alex Morris's picture
Alex Morris
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation. We’re talking documentation to demonstrate you have a compliant quality...
Michael Causey's picture
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem...
Alexandra Brown's picture
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's picture
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...
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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...
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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...
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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...
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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's picture
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's picture
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...
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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's picture
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's picture
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,...
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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...