Healthcare Article Features

Adrian Hernandez's picture
Adrian Hernandez
T he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs...
Gleb Tsipursky's picture
Gleb Tsipursky
When the Covid pandemic swept through the country last year, companies rapidly transitioned employees to working from home (WFH). However, this shift led to growing challenges of WFH burnout and Zoom...
Jon Speer's picture
Jon Speer
Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will...
Wade Schroeder's picture
Wade Schroeder
Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key...
Ariane Ollier-Malaterre's picture
Ariane Ollier-Malaterre
This story was originally published by Knowable Magazine. Working from home—formally known as telework—is here to stay. A 2021 survey of approximately 30,000 Americans concluded that, after the...
David L. Chandler's picture
David L. Chandler
This story was originally published by MIT News. Two MIT professors have proposed a new approach to estimating the risks of exposure to Covid-19 under different indoor settings. The guideline they...
Jon Speer's picture
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design,...
Janet Woodcock's picture
Janet Woodcock
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19...
Edmund Andrews's picture
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.”...
Graham Freeman's picture
Graham Freeman
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food...
Gleb Tsipursky's picture
Gleb Tsipursky
Have you or your employees been feeling work-from-home burnout (WFH) and Zoom fatigue these past months despite the supposed convenience of working from home and using video conferences to meet? Due...
Rita Men's picture
Rita Men
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no...
Sharona Hoffman's picture
Sharona Hoffman
Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities...
Dave Klumpe's picture
Dave Klumpe
Recent surveys point to increasing frustration and, frankly, exhaustion among nurses across the country. Although attending to patients during the pandemic has exacerbated the challenges of the...
Tinglong Dai's picture
Tinglong Dai
More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the...
Anne Trafton's picture
Anne Trafton
In the era of social distancing, using robots for some healthcare interactions is a promising way to reduce in-person contact between healthcare workers and sick patients. However, a key question...
Ryan E. Day's picture
Ryan E. Day
In an article published by Quality Digest, Julias DeSilva addresses recent declines in ISO certification and poses the question, “Does quality matter anymore?” His conclusion is that even if you don’...
Clare Naden's picture
Clare Naden
It’s been about a year since the Covid-19 pandemic turned our world upside down, and that includes the world in which we work. Certainty has hung up its hat, normality looks unlikely to return, and...
Denis Bergeron's picture
Denis Bergeron
From the earliest days of radioactivity research, radiation and cancer therapy have gone together like peas and carrots. But Zach Levine covered peas and carrots in an earlier blog post, so I...
Gleb Tsipursky's picture
Gleb Tsipursky
Stakeholder engagement is one of the more critical aspects of leadership, whether you’re a team leader or a member of a cross-functional team trying to lead team members to focus on quality....