All Features
Janet Woodcock
In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many…
Robert Fangmeyer
What does healthcare in the United States need? Well, according to a report released May 29, 2014, by the President’s Council of Advisors on Science and Technology (PCAST), U.S. healthcare organizations need “systems engineering.”
In their letter to President Obama, PCAST co-chairs John Holdren…
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the…
Howard Sklamberg
To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.
As the Food and Drug Administration’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee…
Enterprise Innovation Institute at Georgia Tech
Two major noncommercial health information technology organizations are working together in a new vendor-neutral health IT innovation network designed to stimulate development of new ideas and shorten the time required to bring new solutions into practice.
The Department of Veterans Affairs (VA)…
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
University of Arizona
To keep hospitalized patients safer, University of Arizona (UA) researchers are working on new technology that involves a small, wearable sensor that measures a patient’s activity, heart rate, wakefulness, and other biometrics—data that can predict a fall before it happens.
More than 500,000…
Ryan E. Day
Last month I, along with millions of other people around the world, celebrated Easter. For myself, a religious observance, for others a celebration of seasonal renewal. I think for most people, Easter is a time that elicits reflection on what matters most in the world. The state of the global…
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…