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FDA
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?
Scientists at the U.S. Food and Drug…
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Dawn Bailey
In health care settings, clinical integration is a fairly new concept that means coordinating patient care across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-focused.
According to Becker’s Hospital Review, “clinical…
Michael Causey
It’s March 2014, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing occurred last year, which could slow product innovation down the line.
Also there was a drop in 2013…
The QA Pharm
There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases they are made when new company standards are deployed to remain current with…
Steve George
The implementation of the Affordable Care Act (ACA) will stress a healthcare system that is already under the strain of an aging baby boomer population. New patients are expected to flood the system starting in early 2014, part of the 25 million uninsured Americans projected to get health coverage…
Margaret A. Hamburg
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…
Margaret A. Hamburg
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…
Michael Causey
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…
Mike Figliuolo
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…
Michael Causey
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…
Dirk Dusharme
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…
Michael Causey
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…
Dennis Payton
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…
Michael Causey
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…
Arun Hariharan
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…
Michael Causey
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…
Gerry Cronin
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…
Michael Causey
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…
Thomas Abrams
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…
Grant Ramaley
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,…
Patrick Stone
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…
Stewart Anderson
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…
Mike Roberts
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…
Margaret A. Hamburg
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…