All Features
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 to help patients gain timely access to breakthrough technologies.
Consider Second Sight Medical…
Debashis Sarkar
The cheating at Kobe Steel shook not just Japan but the entire manufacturing world. As Kobe Steel CEO Hiroya Kawasaki revealed, about 500 companies had received its falsely certified products, which affected not only those companies but also its entire supply chain. However, the issue at Kobe was…
Chip Bell
The coolest birthday present I ever received was a gift from my wife a number of years ago; it was a white 1962 Mercedes-Benz 220 sedan reasonably well-restored. But the classy antique car, with its deep fenders and leather seats, turned out to be a real lemon. That’s about all I remember about…
Annette Franz
Do you feel like you’re not making the progress in your customer experience (CX) transformation efforts that you thought or hoped you would by now?
You started years (not months—it’s a journey) ago, but you don't think your organization has evolved.
What’s the reason for that?
I’ve seen several…
Ian Setliff, Amyn Murji
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 seasonal influenza vaccine. But H3N2 viruses, like the one that’s infecting many people this year, are…
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 diagnosis needs to come into a sleep lab and be attached to a number of devices. This setting is hardly…
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. It can also save you a major side trip into the swamp of unnecessary calculation minutiae,…
Curt Redden
We all seem to get it by now—more engaged employees perform at a higher level. The organizations that get their strategy right in this area provide a superior customer experience, have lower levels of employee churn, higher morale, and ultimately much higher financial performance. Their customers…
Willie L. Carter
What differentiates a lean-thinking organization from a traditional one? Basically, the lean-thinking organization is grounded in the answers to two simple questions: “What do my customers value?” And, “What organization and work processes inside my company will most directly deliver that value?”…
Stephen McCarthy
Cost of quality (CoQ) is certainly not a new topic. It was first described in 1956 by American quality control expert Armand V. Feigenbaum in a Harvard Business Review article. As you likely already know, CoQ consists of four categories: internal and external failures, and appraisal and prevention…
Knowledge at Wharton
When Tide and other detergent manufacturers developed colorful, convenient pods designed to be tossed into washing machines and dishwashers, they never expected teenagers would try to eat them. But what was dubbed the “Tide pod challenge” quickly went viral, with teens posting videos of themselves…
Morten Wendelbo, Christine Crudo Blackburn
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 mortality caused by the virus is already double that of last year’s.
One reason the flu is so severe…
George Hall
Every year, would-be suitors spend lots on cards, nice trinkets, flowers, and even chocolates, trying to win the attention of their sweetheart or crush. It can be a dangerous game of risk and chance, quite often resulting in disappointment for one or both parties.
This is, I believe, most likely…
John Bell
I have written more than a 100 blog posts about leadership, strategy, and culture. Within that portfolio are several accounts of business reinvention and transformation. Yet it was only a few months ago that I composed my first post on another type of reinvention: personal reinvention. My own. …
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, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug…
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 about maximizing employee engagement and productivity, and even happiness.
Promoting health habits is…
Julia Russell
Retailers and brands convened in New York recently to experience the National Retail Federation’s Retail’s Big Show, and one of the biggest topics on attendees’ minds was technology. From automation to personalization to social marketing, the growing importance of technology in the shopping…
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…