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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…
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…
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…
‘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…
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-…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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.…
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…
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…
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…
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…
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…
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…
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…