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...
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...
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...
Taha A. Kass-Hout
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...
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...
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...
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...
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...
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The FDA recently released a new draft guidance document for medical device data systems (MDDS).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...
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...
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 market...
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...
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...
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...
William Anderson
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...
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...
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...
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,...
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,...
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...
