Healthcare Features

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, “...
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Timothy Holbrook
The rising price for the EpiPen, a drug delivery system that is crucial for persons experiencing potentially life-threatening allergic reactions, has resulted in outrage. The price increase, from...
Greg Anderson's picture
Greg Anderson
Government and commercial insurers are transforming payment systems from a fee-for-service reimbursement model to arrangements that include incentives for quality, outcomes, improved patient...
Brooke Pierce's picture
Brooke Pierce
Think back to your last car, truck, or SUV purchase. What did you want to know before spending so much money? More than likely, you first wanted to know the price range of the type of car you were...
John Maxwell's picture
John Maxwell
Have you ever considered the time investment required of some of the world’s greatest achievements? • It took 26 months to build the Eiffel Tower. • It took Da Vinci four years to paint the Mona...
Thinh Nguyen's picture
Thinh Nguyen
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination...
Jon Speer's picture
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent...
Davis Balestracci's picture
Davis Balestracci
I hope this little diversion into design of experiments (DOE) that I’ve explored in my last few columns has helped clarify some things that may have been confusing. Even if you don’t use DOE, there...