Healthcare Features

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...
Eric Cooper's picture
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house...
Mike Richman's picture
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at...
Sharona Hoffman's picture
Sharona Hoffman
CVS operates 9,700 pharmacies and 1,000 MinuteClinics. A decade ago, it also purchased Caremark and now operates CVS/Caremark, a pharmacy benefits manager (PBM), a type of business that administers...
Scott Gottlieb's picture
Scott Gottlieb
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations...
Jenna Gallegos's picture
Jenna Gallegos
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists...
Quality Transformation With David Schwinn's picture
Quality Transformation With David Schwinn
I was recently reminded of a fundamental statement about continual improvement. In Out of the Crisis (Cambridge MA: Massachusetts Institute Center for Advanced Engineering, 1986), W. Edwards Deming...
Lou Valdez's picture
Lou Valdez
Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to...
Patrick Horine's picture
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly...
Mike Richman's picture
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look: “World...
Jay Desai's picture
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout...
Jon Speer's picture
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key...
Grant Ramaley's picture
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the...
Davis Balestracci's picture
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-...