All Features
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…
Klaus Wertenbroch
From a customer perspective, the only thing more frustrating than being denied a product or service is when that denial comes without a satisfactory explanation. As humans, our ability to deal with disappointment depends on understanding why it happened. Without an acceptable rationale, we’re apt…
Anju Dave Vaish
T his year’s unprecedented lockdown happened just as we started moving forward with our 2020 goals. There has been a lot of speculation about Covid-19 and its consequences, much of it dire, but there has also been something that has kept us all rolling: the human mindset. With constraints come new…
Jon Speer
The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks.
That’s why, when Greenlight Guru released its “…
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…
Gleb Tsipursky
‘It’s not going away, and we have to face that reality.” That’s what the CEO and founder of a quality-centered high-tech manufacturing startup with 180 employees told the leadership team in early July 2020 to convince them of the need to do a strategic pivot to address Covid-19.
Previously, the…
Chip Bell
He stood on a platform in the early afternoon of a cold November day only a few feet from the edge of Soldier’s National Cemetery. He was dizzy and feverish, suffering with the beginning of smallpox. It had been four months since the end of the bloody Battle of Gettysburg. And he delivered a two-…
Mark Williams
One of the favorite aspects of my career in the insurance industry is delivering a positive outcome to someone in the midst of a personally challenging situation. Whether it’s giving someone the means to provide for care when health starts to fail, or a cushion to ease financial burdens after the…
Ryan E. Day
In our ultra-connected world, user experience (UX) can be a life-or-death matter for consumer-facing businesses. User experience is so critical that savvy leaders integrate UX/UI (user interface) design with product development and even consider UX when shaping business strategy. Madeline Fraser,…
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…
Ryan E. Day, Dirk Dusharme, Taran March @ Quality Digest
In order to best illustrate how enterprisewide SPC software can help address shop-floor problems and then funnel the captured data to the corporate level where strategic issues can be analyzed, here is a case study of a hypothetical manufacturing facility. In it, the company makes effective use of…
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.…
Tom Taormina
After more than 50 years as a quality control engineer and having worked with more than 700 companies, it is my observation that the vast majority of quality professionals hold their prime directive to be reducing defects to the lowest acceptable level by minimizing process variability. Most of us…
Annette Franz
I recently read a Recruiterbox article that stated: “Culture can either immunize or infect a company. Good culture can revitalize and motivate. Negative culture increases employee absences and turnover while decreasing their overall productivity while at work.... Employee turnover alone can cost a…
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…
Dallas Crawford
Manufacturers know the value of automation on the plant floor. The world is more interconnected, with more competitors, and consumers are more informed and thus more selective with purchasing decisions. With increased competition and disruption, manufacturers must leverage automation to achieve…
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…
James J. Kline
In today’s coronavirus environment, governments at all levels are under greater fiscal pressure. For instance, Oregon’s governor has told state departments to prepare for a 12-percent reduction in their budgets. Given this environment, perhaps it is time to reexamine an established approach to…