Healthcare Features

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...
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...
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 “...
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...
Michael Causey's picture
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a...
Brooke Pierce's picture
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at...
Michael Causey's picture
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part...
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Theresa M. Mullin
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has...
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Scott Rader
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-...
Kade Moody's picture
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your...
Andrew Maynard's picture
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94...
GBMP's picture
GBMP
Ellis Medicine is a 438-bed community and teaching healthcare system serving New York’s capital region. With four main campuses, five additional service locations, more than 3,300 employees,...
The Un-Comfort Zone With Robert Wilson's picture
The Un-Comfort Zone With Robert Wilson
Over the years, I’ve beaten myself up over business breakdowns, lost relationships, and countless other failures. I would only look at what I’d done wrong and where I was at fault. And, of course,...
Christine Schaefer's picture
Christine Schaefer
Every year a new cohort of Baldrige Executive Fellows gains intensive knowledge about leading organizations to excellence through cross-sector, peer-to-peer learning hosted at the sites of Baldrige...
Anthony Harris's picture
Anthony Harris
The proliferation of Accountable Care Organizations (ACO), spurred by the healthcare industry’s shift from fee-for-service to pay-for-performance, has focused healthcare executives’ attention on...
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Marschall Runge
While commanding four vessels sailing between England and India in 1601, Capt. James Lancaster performed one of the great experiments in medical history. Each of the seamen on just one ship—...
Knowledge at Wharton's picture
Knowledge at Wharton
Steve Klasko, president of Thomas Jefferson University and CEO of Jefferson Health, is the co-author of We Can Fix Healthcare (Mary Ann Lieber Inc., 2016) with Wharton adjunct professor Gregory P....
William A. Levinson's picture
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “...