Healthcare Article Features

Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than...
Alex Waddell's picture
Alex Waddell
Emergency medical workers, already at increased risk for burnout compared to other professions, continue to be challenged by the fallout of Covid-19. Stretched to the breaking point by increased...
James Gaines's picture
James Gaines
In 2004, the United States’ Defense Advanced Research Projects Agency (DARPA) dangled a $1 million prize for any group that could design an autonomous car that could drive itself through 142 miles of...
Jon Speer's picture
Jon Speer
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate...
Laurie Flynn's picture
Laurie Flynn
AStanford Medicine-led study has found that borrowing certain billing- and insurance-related procedures from other countries could lead to policies that drastically lower healthcare costs in the U.S...
Bendta Schroeder's picture
Bendta Schroeder
The first step in choosing the appropriate treatment for a cancer patient is to identify their specific type of cancer, including determining the primary site: the organ or part of the body where the...
Dwayne Duncum's picture
Dwayne Duncum
The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing. If we take any lesson from the...
Etienne Nichols's picture
Etienne Nichols
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no...
Catherine Barzler's picture
Catherine Barzler
Falls are a serious public health issue that result in tens of thousands of deaths annually while racking up billions of dollars in healthcare costs. Although there has been extensive research into...
Jennifer Chu's picture
Jennifer Chu
Ultrasound imaging is a safe and noninvasive window into the body’s workings, providing clinicians with live images of a patient’s internal organs. To capture these images, trained technicians...
Grant Ramaley's picture
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different...
Claudine Mangen's picture
Claudine Mangen
Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it...
Gregory Way's picture
Gregory Way
Drugs don’t always behave exactly as expected. While researchers may develop a drug to perform one specific function that may be tailored to work for a specific genetic profile, sometimes the drug...
Adam Zewe's picture
Adam Zewe
Physicians often query a patient’s electronic health record for information that helps them make treatment decisions, but the cumbersome nature of these records hampers the process. Research has...
Karina Montoya's picture
Karina Montoya
Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer. On average, a...
Tom Rish's picture
Tom Rish
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its...
Patricia Santos-Serrao's picture
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply...
Mike John's picture
Mike John
This article has been republished with permission from Medical Plastics News. While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is...
Gleb Tsipursky's picture
Gleb Tsipursky
The pandemic has made organizations aware of the need for a new C-suite leader, the CHO, or chief health officer. This has been driven by recognizing the importance of employee health for engagement...