All Features
Jon Speer
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971,…
Alan Rudolph, Raymond Goodrich
We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.
This process is used for the treatment of blood products such as plasma, platelets, and…
Amber Dance, Knowable Magazine
This story was originally published by Knowable Magazine.
As Covid-19 cases fill the hospitals, among the sickest and most likely to die are those whose bodies react in a signature, catastrophic way. Immune cells flood and attack the lungs they should be protecting. Blood vessels leak; the blood…
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…
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…
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…
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…
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…
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…
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…
Donald J. Wheeler, Al Pfadt, Kathryn J. Whyte
Based on the professional literature available, there are some inconvenient truths about Covid-19 that are not always considered in the chorus of confusion that exists today. Here we summarize what is known, what has already happened, and what is to be expected based on the analysis of the data and…
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…
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…
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…
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…
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…
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,…
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…
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…
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…
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…
Dirk Dusharme @ Quality Digest
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…
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…
Anat Amit-Eyal
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man…
Michael Millenson
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.
The “To…
