Healthcare Article Features

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...
Ann Brady's picture
Ann Brady
Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s...
Jamie Steiner's picture
Jamie Steiner
Ultra-low temperature freezers became popular due to the storage of Covid-19 vaccines, but they have been important components of laboratories for many years. There’s a lot, however, to think about—...
Prashant Yadav's picture
Prashant Yadav
During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines,...
David Stevens's picture
David Stevens
The United States has more than 6,000 hospitals, and each one has thousands, if not tens of thousands, of clinical assets, such as imaging machines, ventilators, and IV pumps. Managing this equipment...
Kari Miller's picture
Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality...
William A. Levinson's picture
William A. Levinson
Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from...
The Un-Comfort Zone With Robert Wilson's picture
The Un-Comfort Zone With Robert Wilson
In a recent column, I wrote about the power of suggestion. I stated, “When our subconscious mind is exposed to a constantly repeated message, it’s going to penetrate unless we are cognizant of it.”...