Healthcare Features

Jon Speer's picture
Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized...
Matthew M. Lowe's picture
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace...
Jon Speer's picture
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for...
AssurX's picture
AssurX
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the...
Matthew M. Lowe's picture
Matthew M. Lowe
Despite the life science industry’s infatuation with modernity and trend chasing, even its most forward-thinking organizations have struggled to fully digitize and integrate their operations. Yet,...
Robyn Metcalf's picture
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal...
NIST's picture
NIST
A new measurement approach proposed by scientists at the National Institute of Standards and Technology (NIST) could lead to a better way to calibrate computed tomography (CT) scanners, potentially...
Bruce Hamilton's picture
Bruce Hamilton
Last February I had the opportunity to observe healthcare providers up close and personal at one the world’s premier hospitals. “Who Cares for the Caregivers?” was written from the perspective of a...
Shobhendu Prabhakar's picture
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also...
Hubert Gatignon's picture
Hubert Gatignon
Health and economics are linked in more ways than just health insurance. When we look past the obvious, research shows us how brain scans, the gig economy, or even hospital queues are all part of the...
Jon Speer's picture
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms. The doctor looks at those symptoms,...
Zach Y. Brown's picture
Zach Y. Brown
Imagine there was a store where there were no prices on items, and you never knew what you’d pay until you’d picked out your purchases and were leaving the shop. You might be skeptical that the store...
Stephen McCarthy's picture
Stephen McCarthy
I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences...
Mike Richman's picture
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article...
Quality Digest's picture
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where...
Laurel Thoennes @ Quality Digest's picture
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business? 1988: Food and Drug...