All Features
Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify data, and it does not control the functions or…
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain,…
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term marketplace success. The related self-assessment questions cover how your organization listens to the voice…
Michael Causey
The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health…
Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets your…
Michael Causey
If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth her salt will tell you it’s often best to let the attacker eat silence rather than draw more…
Ryan E. Day
“We don’t have any binder full of best practices for you. You are it. If you don’t want to change the world—go home.” —Brett Wheatly of Ford Motor Co., to the first candidates for coaches of the fledgling Consumer Experience Movement (CEM) program
When Chris Hunsicker, potential coach to Ford…
AAFP
For the 11th consecutive year, the Agency for Healthcare Research and Quality has released complementary reports that assess the U.S. healthcare system’s performance in the areas of healthcare quality, access, and disparities in care.
The two reports—the 2013 National Healthcare Quality Report and…
Margaret A. Hamburg
The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this important…
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…