All Features
Johns Hopkins University
Computational medicine, a fast-growing method of using computer models and sophisticated software to figure out how disease develops—and how to thwart it—has begun to leap off the drawing board and land in the hands of doctors who treat patients for heart ailments, cancer, and other illnesses.…
Gallup
The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country. And as many health systems adopt new strategies to reduce patient readmission rates and improve Hospital Consumer…
Michael Causey
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of…
Tefen Management Consulting
One of the many hidden challenges in hospital systems is to ensure required supplies are readily available and in the right quantity. Significant manpower is invested in material management so that patients receive care without interruption. An optimized supply system that uses modern technology…
Tefen Management Consulting
When a medical institution aspires toward excellence and patient safety, quality enhancement proves to be a key factor essential to the process.
It goes without saying that there are countless risks in the healthcare system, and that it is always a priority to minimize these. There is nothing new…
Institute of Medicine
America’s healthcare system has become too complex and costly to continue business as usual, according to the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” from the Institute of Medicine.
Inefficiencies, an overwhelming amount of data, and other…
Tracey Lynn King, Brian A. Stockhoff, Mary Beth Edmond
Editor’s note: This is the third of a three-part series on quality in healthcare. Part one described the Juran Model for Patient Safety, and part two identified elements of a patient safety officer program.
With between 44,000 to 98,000 patients dying each year in hospitals as a result of medical…
Mike Roberts
Adverse food safety events can have disastrous effects on branding and profitability. Because information today can go viral in a matter of hours, companies in the food and beverage industry are faced with increasing pressures to operate seamlessly, with little or no room for error…
Mary Beth Edmond, Jonathan Flanders
Editor's note: Part one of this three-part series on patient safety, "Establishing a Patient Safety Culture," offered an overview of the Juran Model for Patient Safety. Part Two takes a closer look at Juran's patient safety curriculum and certification.
It has been 22 years since the Institute of…
Mary Beth Edmond, Jonathan Flanders
Ensuring patient safety is one of the most vital and challenging roles in health care. Public reporting of preventable medical errors has forced hospitals to report their medical error numbers accurately and to improve the quality of care. Organizations such as the Institute of Medicine recommend…
Patrick Stone
Speed up approval for new health care products and minimize a major drug shortage. Sounds good so far, right? Let’s hope lawmakers get this right with a new bill designed to speed delivery and avert shortages of life-saving medicines.
Throughout the Food and Drug Administration’s (FDA) history,…
Alberto Gutierrez
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched…
Mark Graban
As the Supreme Court debates the fate of “Obama Care,” we should recall the formal name of the law: the Patient Protection and Affordable Care Act (PPACA). Most of the public debate has been about the cost of health care, losing sight of the urgent need to fix the ongoing crisis of quality and…
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…
