Healthcare Features

AssurX's picture
AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on...
Wesley McGrew's picture
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile...
AssurX's picture
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to...
Rob Mitchum's picture
Rob Mitchum
People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter...
Brooke Pierce's picture
Brooke Pierce
As high deductibles and escalating costs drive patients to take a more active role in their healthcare, providers are waking up to the fact that they need to pay attention to what buyers want. But...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In last week’s Quality Digest Live: design digital assistance instead of digital assistants, how to make better beer, and closed-loop manufacturing. “How Digital Media Will Bring Out Our Best Selves...
Laurel Thoennes @ Quality Digest's picture
Laurel Thoennes @ Quality Digest
Traffic crawled. Ahead of me was a pickup, its bumper thick with stickers. From the one most cracked and faded, I saw the word “welfare.” Just before the driver switched lanes, I made out the rest...
Azadeh Shoaibi's picture
Azadeh Shoaibi
The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful,...
Brenda Stodart's picture
Brenda Stodart
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development. We may...
Mike Richman's picture
Mike Richman
On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap: “SAE Institute Creates Webisodes to Benefit STEM...
Michael Causey's picture
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been...
Greg Anderson's picture
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital...
AssurX's picture
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. In December 2016, Director Janet Woodcock laid out some of the...
Michael Causey's picture
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will...
William A. Levinson's picture
William A. Levinson
‘Sitting is the new smoking” is a common new adage. James Levin, M.D., of the Mayo Clinic explains, “Too much sitting also seems to increase the risk of death from cardiovascular disease and cancer...
Tom Scaletta's picture
Tom Scaletta
Quality improvement initiatives are a mainstay for hospital care teams. They can also offer a fresh approach for raising patient satisfaction scores. To achieve maximum effectiveness, however, they...
Jon Speer's picture
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not...
Greg Anderson's picture
Greg Anderson
Like it or not, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is here. MACRA created the new Quality Payment Program, comprised of two pathways to higher quality: the Merit-Based...
Laura Gillenwater's picture
Laura Gillenwater
I recently had the privilege of attending the Health Care Advisory Board’s National Meeting in St. Louis. One of the topics that really struck me was the last presentation about the importance of...
Anna Nagurney's picture
Anna Nagurney
When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally...