All Features
Ryan E. Day
As a journalist in the quality improvement field, I try to keep an eye on emerging technology that can help us do things better, faster, and more efficiently. Naturally, the internet of things (IoT) is cropping up more often. IoT is all about connected devices, that is, connected to the internet,…
Michael Armstrong, Kenneth Klassen
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 Canada ranks behind other developed countries in healthcare quality.
In the United States, waits are…
Scott Gottlieb, Jeffrey Shuren
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 instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance…
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 biotechnology.
Three years ago, MIT spinout Zaiput Flow Technologies launched a novel continuous-flow liquid-…
Brian Rogers, Karel Cool, Christophe Angoulvant
Disruptive ventures arise from mobile device ubiquity, data-powered AI, and digital platforms that connect buyers and suppliers in new ways. They are reshaping industries such as transportation (e.g., Uber, Lyft, and Didi Chuxing), hospitality (e.g., Airbnb and FlipKey), payment services (e.g.,…
Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…
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 on once a medical device has reached the market, and it can be challenging to keep up with…
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 you end up with is going to be what you want? Documenting your requirements should be obvious, right…
Kostya Kimlat
A sale, like a great magic trick, occurs inside the customer’s mind. And it is there where it is replayed, remembered, and redefined continually afterward. Because magicians are masters of perception, they understand how to get into the heads of their prospects better than anyone else. That’s why…
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 work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
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 drug-benefit programs for health plans. CVS/Caremark is one of the three largest PBMs in the United…
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 under development or review throughout the federal government. For the U.S. Food and Drug…
Carrie Van Daele, Ronee Franklin
The key to being an explorer lies in what you do with your creative thinking and attitude, which allow you to consider different points of view. Like the explorer, you look for probabilities and possibilities. This is what is known as creative thinking skills: having the ability to create…
Jenna Gallegos, Jean Peccoud
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 remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…
Debashis Sarkar
We all know the famous quote, “The customer is always right.” It was coined more than a century ago. In the United States, it was popularized by Marshall Field during the early 1900s. In the United Kingdom, it was popularized by Harry Gordon Selfridge of luxury retailer Selfridge’s fame. Since…
David Schwinn
I was recently reminded of a fundamental statement about continual improvement. In Out of the Crisis (Massachusetts Institute Center for Advanced Engineering, 1986), W. Edwards Deming stated, “I should estimate that in my experience, most troubles and most possibilities for improvement add up to…
Chip Bell
I do not at all understand the mystery of grace—only that it meets us where we are but does not leave us where it found us. —Anne Lamott
Howard Perdue was the owner, manager, and spiritual leader of the Ford tractor dealership in McRae, Georgia, during the 1950s and 1960s. In that era, about 185…
Lou Valdez, Dara Corrigan, Peter Stein
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 fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified…
Taran March @ Quality Digest
I loved my Honda. Is it OK to cling to that emotion, even after a car takes its final drive and lands in a dissection yard to be pulled to pieces so other old Hondas can stay on the road? Are there counselors out there specializing in car grief who might advise? ’Tis the Christmas season, so I can…
Trevor Blumenau
How does one define quality in the context of a warehouse? The perfect warehouse is clean, has everything in its place, and is easy to access. Your warehouse looks like the one below, right?
You have a perfectly accurate database table that tells you exactly where everything is, correct? And…
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 after being discharged; readmissions also hurt hospital bottom lines.
Readmissions cost hospitals $…
William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
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 Toilet Day” ISO truly has a standard (or at least a standard in development) for everything. World Toilet…
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 rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
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 concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…