All Features
Stephen M. Hahn, Amy P. Abernethy
During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds,…
Gleb Tsipursky
Should quality professionals be worried about the new Covid strains originating in the United Kingdom, South Africa, and elsewhere, and recently identified in the United States?
Authorities have focused on downplaying concerns about vaccine effectiveness against these new variants. While some…
Richard Harpster
As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…
Jane Bianchi
Let’s pretend, for a moment, that you’re a primary care physician and you refer one of your patients to another doctor for a colonoscopy. Will the patient follow through? If not, how will your team know to remind him or her? If the patient does receive a colonoscopy, will your team be alerted so…
Bahar Aliakbarian
The two major U.S. developers of the early Covid-19 vaccines are Pfizer/BioNTech and Moderna. They both developed mRNA vaccines, a relatively new type of vaccine. A major supply-chain issue is the temperature requirement for these vaccines.
The Pfizer vaccine needs to be stored at between –112° F…
Sanjay Mishra
As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical…
Nader Moayeri
I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to…
Steve McCarthy
The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Rich Press
Researchers at the National Institute of Standards and Technology (NIST) have produced synthetic gene fragments from SARS-CoV-2, the virus that causes Covid-19. This material, which is noninfectious and safe to handle, can help manufacturers produce more accurate and reliable diagnostic tests for…
Merilee Kern
As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or…
Tinglong Dai, Guihua Wang, Ronghuo Zheng
The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes.
It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can…
Jeb Banner
As the current pandemic unfolds, organizations’ boards of directors—especially in the healthcare industry—must continue leading and guiding. But gathering board members for in-person meetings is no longer an option.
In response, board engagement has gone digital. Planning, hosting, and following up…
Donald J. Wheeler
On Sept. 29, 2020, the recorded worldwide death toll from Covid-19 reached 1 million. Six days earlier the United States reached 200,000 Covid-related deaths. So how did the United States with only 4 percent of the world’s population manage to capture 20 percent of the world’s deaths in this…
Gleb Tsipursky
Although deeply fulfilling, establishing and growing a quality-oriented startup poses serious dangers for the mental health of quality leaders. During the expansion stage, a founder will often face brutally long work weeks, pressure from different sources to manage the startup while raising funding…
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.
Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Jennifer Mallow
Covid-19 has led to a boom in telehealth, with some healthcare facilities seeing an increase in its use by as much as 8,000 percent. This shift happened quickly and unexpectedly, and has left many people asking whether telehealth is really as good as in-person care.
During the last decade, I’ve…
Donald J. Wheeler
This article tracks the progression of Covid-19 over the past six months on a state-by-state basis and provides a framework for interpreting these curves by including curves for seven other countries. While 52 states and territories are covered here, it turns out that there are just three basic…
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints…
Jon Speer
Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you. Generally, patients trust clinicians’ expertise and seldom wonder if the products being used have undergone rigorous testing and are proven to be safe…
Jennifer Lauren Lee
While awaiting full access to their labs due to Covid-19 restrictions, scientists at the National Institute of Standards and Technology (NIST) have taken this rare opportunity to report the technical details of pioneering research they conducted on the disinfection of drinking water using…
Stephen M. Hahn, Anand Shah
Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an…
Donald J. Wheeler
In past articles I have used graphs to provide perspective on how the Covid-19 pandemic is progressing around the world. In this article I shall update some of those graphs and use these historical data to make projections on what may be expected in the United States in the fall.
The worldwide…
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine.
Infectious disease expert Anthony Fauci. Coronavirus response coordinator Deborah Birx. County health officials across the United States. The Covid-19 pandemic has led to the emergence of a new set of household names: those in the media…
