I remember when I first discovered the work of Mark Graban. The year was 2008, and I was preparing to speak to the Massachusetts Hospital Association, an audience of about 400 hospital CEOs and administrators. They wanted me to tie my work with Toyota to healthcare, which I had no firsthand…

The United States spends $2.5 trillion for healthcare. Healthcare spending is expected to reach $4.5 trillion by the end of the decade. With Obamacare becoming a reality, we need to find a way cut the cost of healthcare to help pay for these increasing costs. The Institute of Medicine (IOM)…

At hospital shift changes, doctors and nurses exchange crucial information about the patients they’re handing over—or at least they strive to. In reality, they might not spend enough time talking about the toughest cases, according to a study led by the University of Michigan. These quick but…

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.…

I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA consumer updates, which are news stories posted on www.fda.gov designed to give consumers important…

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…

Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no interstate sales). This means that compounding pharmacies…

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…

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…

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…

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…

During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were four years previously. It worked for Reagan, so we’re going to try a variation of it here. Is the Food and Drug administration (FDA) better off than it was four or five…

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…

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…

The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more George Smiley and John le Carré types than we’d ever imagined. According to reports in The New York…

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…

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…

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,…

Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union. They apparently aren’t happy that the Food and Drug Administration (FDA) is writing…

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…

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…

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 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…

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…

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…