Healthcare Features

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...
Katherine Watts's picture
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling...
Robert M. Califf's picture
Robert M. Califf
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The...
Dara Corrigan's picture
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this...
Davis Balestracci's picture
Davis Balestracci
Those of you familiar with W. Edwards Deming know that his Funnel Experiment ultimately shows that a process in control delivers the best results if left alone. Funnel Rule No. 4, also known as a “...
Vijay Iyer's picture
Vijay Iyer
As the director of the structural heart team at Kaleida Health’s Gates Vascular Institute in Buffalo, New York, I perform minimally invasive, endovascular surgeries to repair structural defects of...
AssurX's picture
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes...
Suzanne Schwartz's picture
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to...
Joel Bradbury's picture
Joel Bradbury
Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale...