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As my busy and productive trip to India drew to a close, I had the opportunity for one final meeting and one last memory with a group of some of the country’s most extraordinary women. The occasion was a women’s roundtable in Mumbai, organized by the Confederation of Indian Industry (CII).
It…
We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association.
The study found that the FDA used a range of clinical trial evidence when approving…
You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes.
The Institute of Medicine (IOM), already working with more than a dozen drug makers, the…
PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give presentations in some form or fashion at various points in our careers. If you’d like to succeed in those efforts, there are three things you should never…
Those of us in and around Washington D.C. like to tell folks in the days leading up to a president’s State of the Union (SOTU) address that the speeches rarely matter and are generally forgotten while the teleprompter’s still warm.
Then we analyze them to death for a few days. I don’t mean to…
This past November, three winners of the 2013 Malcolm Baldrige National Quality awards were announced, one in education and two in healthcare. Quality Digest Daily is fortunate that one of the winners, Sutter Davis Hospital (SDH) is practically in our back yard. This gave us an opportunity to meet…
Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea. It gets a little trickier after that.
In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen other…
Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls. However short, these two sections outline some of the…
Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.
With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014.
CDRH’s Office of Compliance…
Last week, I accompanied my father to an eye hospital to get his eye examined for a suspected cataract. The hospital examined his eye and confirmed the presence of a cataract. They recommended surgically implanting an artificial lens in his eye—a fairly common procedure these days for cataract…
It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes.
Where I live in the Washington, D.C. area, the new express road program in Northern…
At GBMP’s recent Northeast Shingo Prize Conference in Hyannis, Massachusetts, the Center for Comparative Medicine (CCM) displayed adaptations of lean to biomedical research in its Community of Lean Lounge. Conference attendees were drawn in by the wacky display of dangerous animals and props, but…
A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT).
The guidance, issued Nov. 14…
You probably have seen many consumer advertisements for prescriptions drugs—on TV, in magazines, or online. Although those ads are expensive, did you know that in 2010, pharmaceutical companies actually spent more money advertising to healthcare professionals than they spent advertising to…
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.
International food inspections will surely be a focus area…
A recent news story here in Ontario detailed how health officials were reviewing the results of 3,500 CT scans and mammograms at two Toronto-area hospitals because of potential errors caused by a radiologist’s “performance issue.” Although the results of that review are still pending, the story…
My colleagues and I at LNS Research have spoken to numerous companies during the past several years that have done an admirable job of building compliance into production processes. However, there are still many companies, particularly in the manufacturing sector, that struggle to meet product and…
There are many good reasons to go to Arkansas in September: to visit Little Rock, America’s No. 1 most livable city; or attend the annual Eureka Springs Antique Automobile Festival, to name two. But neither of these reasons are why more than 100 scientists, researchers, government regulators, and…
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much guidance about product design control, particularly concerning sections 820.30 and 820.40 of the…
Moore’s Law predicts that every two years the cost of computing will fall by half. That’s one reason why tomorrow’s gadgets may be better, and cheaper, too. But in American hospitals and doctors’ offices, a very different law seems to hold sway: Every 13 years, spending on U.S. healthcare doubles…
Hospitals are facing ever-increasing pressure to evaluate and cut costs. This isn’t surprising. Medical supplies represent as much as 30 percent of an average hospital’s total operating expenses. Regulatory and economic changes, and initiatives such as value-based purchasing, are also pushing…
School bells have sounded the death knell of summer across the land. But as we’ve noted before, the U.S. Food and Drug Administration (FDA) didn’t take much time off to enjoy surf and sand. The agency capped a busy season last week by issuing a new guidance aimed at investigational review boards (…
Increasing product recalls, regulatory fines, and penalties have made product-safety compliance a top priority for many manufacturers. The Consumer Product Safety Improvement Act (CPSIA) and other global and regional product-quality regulations have subjected consumer-product companies to…