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Examining Colorado’s Covid-19 Outbreak Using Control Charts
Jay Arthur—The KnowWare Man
Story update 5/6/2020: The charts and some data have been updated to reflect the data available on the date this article was published. During the Covid-19 stay-at-home order in Colorado, I've become increasingly frustrated by Covid-19 charts. Most of what I see are cumulative column charts, which…
Waiting for the Covid-19 Peak
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
Break the Curve and Keep It Broken
William A. Levinson
The phrase “flatten the curve” means to slow the transmission of the coronavirus (Covid-19) in order to spread the total number of cases out over a longer period of time. This will avoid overwhelming the healthcare system.1 The model is accurate as presented throughout the internet, but it also…
Do You Have a Coupon?
Bill Kalmar
Have you noticed that coupons have become a major part of our lives? There are always coupons for restaurants or stores in most of the newspapers these days. And it seems that every day, we receive an email about a deal at a local store, but it requires a coupon. Last month was my birthday month,…
How Does Covid-19 Telehealth Expansion Affect Providers?
Clinton Ballew
Telehealth services have become even more critical in caring for patients as the Covid-19 pandemic quickly evolves. To temporarily remove barriers to practice telehealth, the federal government and many states have made sweeping changes in telehealth waiver provisions. As HORNE continues to…
Using Layered Process Audits to Close the Loop on Safety
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety. Companies conducting layered process audits (LPAs) can help get the United States get…
What the Trump Administration Could Do Now to Remedy the Ventilator Shortage
James Anderton
While healthcare professionals globally struggle to contain the Covid-19 pandemic, acute care patients are taxing ICU units worldwide. Critical to the care needed for the most serious cases is breathing support through mechanical ventilators. In Italy, the worst-hit nation in Europe, the lack of…
The Power of Customer Access
Chip Bell
The “camp” where we board our cat is fantastic. Our cat gets “tree time”—a giant climbing structure with tunnels and carpeted “trees” to climb and scratch. She gets the best of tender loving care, complete with brush-outs and nail trims. But try and contact the camp hands-free from your car, and…
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…

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