All Features
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 the technology we rely on every day, including helping patients remain confident in the safety of…
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 realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a…
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 firm grip on quality management processes—especially document management and change control—will be…
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 risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
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 of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San…
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 worked intensively to explore ways to enhance the patient’s voice in drug development. Recently the FDA…
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-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
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 organization, but I think for many healthcare systems, the answer is false.
If you have already started…
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 percent of the crashes that caused these injuries and fatalities are attributable to human choice or error…
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, and more than 700 medical staff, Ellis Medicine offers an extensive array of inpatient and outpatient…
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, this would only make me feel worse.
People would tell me, “Rob, you need to love yourself.” Wow,…
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 Award recipients. Every Baldrige Fellow completes a capstone project as part of the executive…
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 clinical outcome metrics. Yet the greatest barriers—individual clinician practices—remain difficult to…
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—his own, of course—was required to sip three teaspoons of lemon juice per day. By the midpoint of the voyage…
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. Shea and Michael Hoad. In the book, the authors propose 12 disruptive transformations to the…
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, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
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 about $94 for a two-pack of injectable epinephrine to more than $600 in just nine years, has members…
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 satisfaction, and reduced cost.
In the fee-for-service environment, hospitals, physicians, and other…
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 considering. You might have also wanted to know what features were standard on the various makes and…
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 Lisa. • It took Michelangelo four years to paint the ceiling of the Sistine Chapel. • It took Leo…
Thinh Nguyen, Rachel E. Sherman
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 product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
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 back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
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 are still some good lessons about understanding the ever-present, insidious, lurking cloud of…
MIT News
Ever waited way too long at your doctor’s office for an appointment to start? Those long waits may soon be over. A schedule-optimizing software developed by MIT spinout Arsenal Health gets more patients seen more quickly and could soon be used by thousands of healthcare providers across the…
John Elliott
In 1978, REO Speedwagon released the single “Roll with the Changes,” a song that never fails to give me an adrenaline rush, especially as I run or bike. I think it’s pertinent to what healthcare professionals are experiencing since health reform became law in 2010 and the Centers for Medicare…
