Healthcare Features

Janet Woodcock's picture
Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our...
Mohammad Jalali's picture
Mohammad Jalali
Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data...
Bruce Hamilton's picture
Bruce Hamilton
Last month I joined Eric Buhrens, CEO at Lean Enterprise Institute (LEI), to host a leadership team from Tel Aviv’s Sourasky Medical Center. They were on a study mission to many of Boston’s fine...
Jon Speer's picture
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission...
Ryan E. Day's picture
Ryan E. Day
So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at...
Marin Hedin's picture
Marin Hedin
Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life...
Knowledge at Wharton's picture
Knowledge at Wharton
America’s healthcare system has been on the examining table lately: from the tortuous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from...
Mike Richman's picture
Mike Richman
During this past Friday’s episode of Quality Digest Live, our weekly web TV show, QD editor in chief Dirk Dusharme and I covered stories about the gig economy and the skills gap and workforce...
Chad Kymal's picture
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and...
Malvina Eydelman's picture
Malvina Eydelman
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act...
Ian Setliff's picture
Ian Setliff
The current 2017–2018 flu season is a bad one. Hospitalization rates are now higher than in recent years at the same point, and infection rates are still rising. The best line of defense is the...
Mary Beth O’Leary's picture
Mary Beth O’Leary
Matt Bianchi had a problem. As chief of the division of sleep medicine at Massachusetts General Hospital, he needed a better way to diagnose sleep disorders. Typically, a patient seeking a...
Davis Balestracci's picture
Davis Balestracci
The Individuals chart is the “Swiss Army knife” of control charts. It usually approximates the supposedly “correct” chart under most conditions, and its use is much easier to understand and explain...
Morten Wendelbo's picture
Morten Wendelbo
Flu season in the United States typically peaks in February, but this year’s outbreak is already one of the worst on record. As of Jan. 6, 2018, 20 children have died from the flu, and overall...
AssurX's picture
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017,...
Wendy Wood's picture
Wendy Wood
Employers have a stake in their staff’s health. It’s not just a matter of keeping health insurance premiums in check which is a consideration in countries without universal healthcare. It’s also...
Michael Armstrong's picture
Michael Armstrong
Patients often wait weeks or months for medical appointments. Canada’s Fraser Institute recently reported that Canadians typically wait 10 weeks to see specialists. Long wait times are one reason...
Scott Gottlieb's picture
Scott Gottlieb
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For...
Rob Matheson's picture
Rob Matheson
Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and...
Jon Speer's picture
Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going...