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Tracking Covid-19: Update
Donald J. Wheeler, Al Pfadt, Kathryn J. Whyte
This article is an update to “Tracking Covid-19” that Al Pfadt, Kathryn Whyte, and I wrote last week. In that article we summarized what is known about Covid-19, what has already happened, and what is to be expected based on the analysis of the data and the epidemiological models. Over the past…
When Restaurants Close, Americans Lose Much More Than a Meal
Rebecca Spang
Arnold Schwarzenegger tweeted a video of himself on March 15, 2020, saying: “No more restaurants.” Seated in his palatial kitchen with two miniature horses, Whiskey and Lulu, beside him, the former California governor pronounced: “We don’t go out; we don’t go to restaurants. We don’t do anything…
Doing Business in a Post-Pandemic World
Ryan E. Day
Although Covid-19 shelter-in-home edicts usually use the terms “essential” and “nonessential,” most business owners think of doing business as essential for survival. Many organizations don’t have the resources to temporarily suspend business. They must find new ways to get it done. In a Think…
Three Myths Engineers Believe About Quality
Jon Speer
Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that improve the lives of end users. Still, many medical…
The One Huge Mistake Quality Professionals Make in Preparing for Covid-19
Gleb Tsipursky
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
Unable to Exhibit Due to Trade Show or Conference Cancellations?
This is supposed to be trade-show season. The time when companies send their employees to industry tech shows and user-group meetings to see and experience the latest offerings in their field. A time when companies expend a good portion of their budget on booth space, shipping costs, and hotel and…
On the Front Lines of Developing a Test for the Coronavirus
David Pride
‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States…
Leverage Learning Environments to Create Customer Value
Kevin Meyer
A couple weeks ago a consultant friend of mine, who coincidentally focuses his practice on lean in healthcare, was complaining about issues with his healthcare providers. It’s a story we hear often: doctors running late, very short and often superficial consultations, a rush to diagnosis, and a…
FDA Form 483 Observations and Warning Letters: What’s the Difference?
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article. The unfortunate truth of the matter is…
Deep Learning AI Discovers Surprising New Antibiotics
Sriram Chandrasekaran
Imagine you’re a fossil hunter. You spend months in the heat of Arizona digging up bones only to find that what you’ve uncovered is from a previously discovered dinosaur. That’s how the search for antibiotics has panned out recently. The relatively few antibiotic hunters out there keep finding…
Critical Data Elements and Data Quality
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of…
Manufacturing Standards for Biopharmaceuticals
Sheng Lin-Gibson, Vijay Srinivasan
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…
Handling Product Recalls and Product Liability Lawsuits
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are…
Fourteen Leadership Principles That Drive Amazon to Be Customer-centric
Ian Golding
During the last five years, a small number of organizations have been featured multiple times in my writing. In the vast majority of cases, I have used these businesses as a way of bringing to life global best practices in the field of customer experience management. It is inspiring to be able to…
Hospital Rankings Hold Up
Peter Dizikes
Given the complexities of healthcare, do basic statistics used to rank hospitals really work well? A study co-authored by MIT economists indicates that some fundamental metrics do, in fact, provide real insight about hospital quality. “The results suggest a substantial improvement in health if you…
Technique Reveals Whether Models of Patient Risk Are Accurate
Anne Trafton
After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics. While these models are useful in most cases, they do not…
Bridging the ‘Valley of Death’ for U.S. Biomanufacturing
Kelvin Lee
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills…
The Four Yokes of the Change Agent
Jim Benson
‘It’s the shoes!” Spike Lee yelled into the camera on the Air Jordan ads. But it was never the shoes. Michael, Magic, and LeBron would have outplayed their leagues in golf cleats. It was never the shoes. But it was us, the salespeople. In our case, the intelligencia that “trains” people to be…
Just Add Engineers to the Mix
Michael Baxter
You would expect a building where vinegar is made to have a sour smell, highly pungent, perhaps with a whiff of apple. World Technology Ingredients (WTI) smells nothing like this. Their manufacturing facility, off a county two-lane in Jefferson, Georgia, has a vaguely mineral aroma. More dry than…
Five Ways Brands Are Changing Their Playbooks to Win
Knowledge at Wharton
Have you heard of a media company called T-Series? Chances are, you probably haven’t. Gulshan Kumar, whose résumé up to 1983 read, “Fruit juice seller, streets of New Delhi,” founded it that year. Since its inception, T-Series has become an unlikely media powerhouse—its YouTube channel has 119…
Recent Legislative Impacts to Telemedicine in Care Delivery
Clinton Ballew
Legislative support is growing for the reimbursement of care delivery via telemedicine. The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General have recently made final and proposed rule changes to stimulate greater use and access for telemedicine delivery. These…
Quality Has a Role to Play in Pricing and Should Claim a Seat at the Table
Patrick Moorhead, Gabriel Smith
According to the Journal of Consumer Research, a high price indicates either bad value or good quality, whereas a low price indicates either good value or poor quality. At the heart of this dichotomy is the role that quality plays in both the actual and perceived price of the product. To…
How to Use Your Data to Drive Real-Time Customer Experiences
Vaishali Gopi
Data, analytics, surveys, IoT, artificial intelligence, and automation are the leading buzzwords in retail and customer service. But what is the point of having all these data about our customers? The business implications can be overwhelming and never lead to anything meaningful. However, for…
Quality Is Everything
Dirk Dusharme
What a year. No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
Quality Digest Top Stories for 2019
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this…

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