All Features
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an internationally recognized quality…
Thomas Prewitt Jr.
I am concerned about the rush to consolidation we are seeing in the hospital industry. It seems all too tidy and easy, and if there is anything I have learned from my 30+ years in clinical medicine, it is that nothing in healthcare is easy.
Larger hospitals began acquiring smaller hospitals in…
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
Dawn Bailey
In a recent column, I shared insights from the 2013 Baldrige Award recipients’ leaders as they fielded questions related to their journeys to excellence. There was so much thoughtful reflection that it couldn’t fit into just one column.
More answers to questions follow:
How did you convey to…
Carly Barry
Via Christi Health, the largest provider of healthcare in Kansas, operates a Center for Clinical Excellence that’s made up of a team of quality practitioners; all have had lean and Six Sigma training. I recently had the opportunity to talk with the team about the types of projects they’re working…
The QA Pharm
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call…
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…