All Features

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…
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…
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…
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 Is Everything
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…
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…
An Action Plan for Work-Family Balance
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…
Medical Errors Still Harm Too Many People, But There Are Glimpses of Real Change
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…
Weekly Quizzes for Current Good Manufacturing Practices Training Credit
The QA Pharm
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit! This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups. Also, each quiz will have one…
FDA’s Fast-Track Model for Software As a Medical Device Requires a Cuture of Quality
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies. Medical device…
Turning the Pharmaceutical Model Upside Down
The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup. The company’s…
The Food Safety Modernization Act in a Nutshell
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12…
Big Food Is Ripe for a Revolution
Boris Liedtke
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German…
Measuring Surgical Quality
Lola Butcher, Knowable Magazine
Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better. Nearly three decades of research have made clear that some hospitals and surgeons have significantly better outcomes than others. Exactly how to measure the quality of a…
Putting the Customer First in Prosthetic Device Development
David Moser
Technology companies are frequently driven by their engineering processes. Of course product quality is regarded as most important, and that quality can be tested and measured with numbers and data. Such companies also frequently align their core identity with the engineering that belies their…