All Features
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…
Mark Graban
Given all of the problems that exist in our American healthcare system, it’s encouraging that most healthcare organizations are endorsing or practicing some form of process improvement or operational excellence strategy. Under the banner of different labels and using different combinations of…
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is something we tend…
Patrick Runkel
It’s been called a “demographic watershed.” During the next 15 years alone, the worldwide population of individuals aged 65 and older is projected to increase more than 60 percent, from 617 million to about 1 billion, according to a U.S. Census Bureau report.
Increasingly, countries are asking…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Katherine Watts
The HORNE Healthcare team has been blogging recently about the necessary business model changes we think are inevitable to healthcare transformation. We’ve focused on the macro level, urging healthcare organizations to take action. Although I believe our advice is sound for large systems, I am…
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
