All Features
Michael Causey
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification is…
Banner Medical
Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry. The company believes this investment achieves multiple payoffs—in relationship-building with customers, in risk mitigation, and in…
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.
The…
Davis Balestracci
In my March 7, 2012, column, “An Elegantly Simple but Counterintuitive Approach to Analysis,” I suggested the necessity to formally assess the stability of the process producing any data—a step not usually taught in most academic statistics courses. This is done by plotting the data in their…
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…
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…
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…
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…
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.
A 2011 study by the professional-services company Towers Watson and the nonprofit National…
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.
This article explains the philosophy behind the major changes in the standard, how these changes will affect…
Mark R. Hamel
During a recent trip to the great state of Texas, I heard some down-home wisdom: “Before you season your food, why don’t you taste it first?” The person who uttered that question was not talking about food. Rather, he was challenging someone who was a little too hell-bent on changing something…
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…
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…
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…
Mark Graban
To improve quality, the most effective hospitals and leaders focus on processes and systems, instead of just lecturing and cajoling their employees and physicians to do better. W. Edwards Deming famously stated that the problem with posters and exhortations was that “they take no account of the…
William A. Levinson
Hospital-acquired infections, ventilator-acquired pneumonia, patient falls, and similar events are (hopefully) rare enough to promote discussion of control charts for rare events. A Google search will, for example, turn up the application of u charts to falls per 1,000 patient days (u being…
William A. Conway M.D.
As a 2011 recipient of the Malcolm Baldrige National Quality Award, the Henry Ford Health System in Detroit has achieved recognition as a top-performing organization for excellence in innovation, efficiency, and quality improvement. The highest priority of our quality improvement work is to…
As You Sow
A first-of-its-kind framework released Dec. 6, 2011, offers recommendations to food and food packaging companies on how to identify and evaluate nanomaterials in products. Not only is this technology unregulated and untested for its implications on public health but companies may not even be…
ASQ
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization.
The survey results also show that experience…
Bill Kalmar
The 2011 Malcolm Baldrige National Quality Award winners were announced last week, and for the first time, three recipients are in the health care category.
The recipients of the 2011 Baldrige Award are:
• Concordia Publishing House, St. Louis (nonprofit)
• Henry Ford Health System, Detroit (…
Stanford News Service
A readily portable miniature microscope weighing less than 2 grams and tiny enough to balance on your fingertip has been developed by Stanford University researchers. The scope is designed to see fluorescent markers, such as dyes, commonly used by medical and biological researchers studying the…
The Advisory Board Co.
In our current health care environment, hospitals face increasing urgency to strengthen relationships with physicians. Among the concerns are an aging population driving increased demand for health care (as well as a growing Medicare population), reimbursement reductions and changes, and…
The Ohio State University
Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland United States, a new study suggests.
Researchers found that drugs produced at plants located in Puerto Rico that are owned and operated by U.S…
When the Japanese word kaizen entered the language of quality improvement via Masaaki Imai’s seminal book, Kaizen: The Key to Japan’s Competitive Success, (McGraw-Hill/Irwin, 1986), the author defined kaizen as “ongoing improvement involving everyone.” In a 2011 video posted on YouTube, Imai…
Mark R. Hamel
First, the introduction. This post was earnestly written by my friend, Jeff Fuchs. He’s the director of the Maryland World Class Consortia, a lean nonprofit assistance organization in the mid-Atlantic. He’s also president of Neovista Consulting, which works with large and small organizations on…
