All Features
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years.
Now,…
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives.
These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Scott Trevino
The pandemic promises ongoing challenges for healthcare providers in 2022 as they cope with nursing shortages and cybersecurity threats amid shifts previously underway for the industry. How they manage their clinical assets, however, can present opportunities to overcome those challenges while…
Maggie Overfelt
Machine learning has the potential to drastically improve efficiency and the quality of care in hospitals by tackling hard-to-predict problems like ICU occupancy or which patients are likely to be readmitted.
Yet, a big barrier to any technology working optimally is getting full buy-in from its…
Sankesh Abbhi
Life science organizations play a vital role in healthcare’s technology revolution, with a key focus on identifying the right opportunities to scale digital transformation. Currently, life sciences leaders are leaning into areas such as automation, which was discussed at length at ArisGlobal’s…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Bill Marler
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
Kari Miller
In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).
The primary goal of post-market…
Prashant Yadav, Antoine Désir
The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…
John Colmers, Sherry Glied, Knowable Magazine
This story was originally published by Knowable Magazine.
The way the United States typically finances hospitals isn’t working. The coronavirus laid this bare, along with many other long-standing societal problems.
Before Covid-19, most hospitals were operating on a standard “fee-for-service”…
Dawn Bailey
‘We didn’t get here on our own,” said Brian Dieter, president and CEO of Baldrige Award-recipient Mary Greeley Medical Center (MGMC), speaking at the 32nd Baldrige Quest for Excellence Conference. “We think we are very much better as a result of having learned from [other Baldrige Award recipients…
Rich Tree
Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to start up as soon as possible once the project is completed but also to achieve steady-state throughput as quickly as possible after the startup begins. This type…
Dirk Dusharme @ Quality Digest
Like it or not, work-from-home (WFH) is here to stay. This is not just a perk that employers might offer, but a requirement on which many employees, current and future, are demanding. According to several surveys, between 30 and 50 percent of employees surveyed said they would leave their jobs if…
Jay Arthur—The KnowWare Man
There are many control chart rules to detect special causes (i.e., out-of-control conditions). Although most of these rules are clear, the one that seems to befuddle most people is the rule about trends. Is it six points (including the first point), six points (excluding the first point), or seven…
Taran March @ Quality Digest
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a…
Ravi Anupindi
Inoculating the planet from Covid-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison, but in this case, the enemy is invisible and everywhere.
Some of the vaccines require super-cold storage at virtually all…
Sara Adams
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.
For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS)…
Dawn Bailey
‘What would be important to you in the care of your daughter?” John Chessare, president and CEO of Baldrige Award-recipient GBMC HealthCare (GBMC), asked a virtual Quest for Excellence conference audience.
“The No. 1 answer is always that people want the best possible health outcome for their…
Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen
For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.
Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for healthcare…
Zach Winn
This story was originally published by MIT News.
For small healthcare groups like dentist’s offices, one sick staff member can mean a day’s worth of cancelled appointments. Such offices can either continue short-staffed, which could negatively affect patient care, or reschedule appointments,…
Tom Siegfried, Knowable Magazine
This story was originally published by Knowable Magazine.
From the earliest days of their evolution, guts and brains have been the best of friends.
It’s a mutually beneficial relationship. Guts prepare nourishment for delivery to the brain. And brains guide the behaviors needed to fill the gut…
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
