All Features
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…
Annette Franz
Last month, I wrote about the concept of lean management and what that means not only for your company but also for your customers.
If company leadership wants to transform the culture of the organization and become a lean company, they’ve first got to understand what comprises lean leadership,…
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…
William A. Levinson
ISO 9001:2015 clause 4.2—“Understanding the needs and expectations of interested parties” requires the organization to determine the “requirements of these interested parties that are relevant to the quality management system.” The recent two-day conflict that Facebook lost to F.B. (Fluff Busting…
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…
Annette Franz
I was honored recently to be a guest on Innochat, a weekly Twitter chat that takes place every Thursday at noon Eastern time. The show is about innovation and covers a wide range of topics and angles. If you love talking innovation, make time for this chat every Thursday.
The topic on July 21 was…
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…
Harish Jose
Today I’d like to take a look at a lesson from Taiichi Ohno regarding the pursuit of quality. His comment, “The pursuit of quantity cultivates waste, while the pursuit of quality yields value,” struck a chord with me. Among other things, he's referring to the importance of resisting mass-…
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…
Micki Vandeloo
It’s so important for manufacturers to find and cultivate valuable partnerships. They can help manufacturers expand their service or product offerings, make their processes more efficient, and help specify and procure just the right equipment.
When manufacturers launch a new product or are making…
Annette Franz
I recently came across the Japanese terms genchi genbutsu and gemba; they’re both key principles of the Toyota Production System, which comprises Toyota’s management philosophy and best practices. Although they’re (lean) management principles and concepts, they apply not only to the employee…
Ryan E. Day
Sponsored Content
In today's hyper-competitive, fast-paced manufacturing world, there is rarely anything like a "routine" day at the office—especially when you're a tier-one supplier for some of the largest aerospace companies in the world. To make the grade and satisfy this kind of demanding…
Chad Kymal
In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their management…
Ruth P. Stevens
A
s the document and imaging industry evolves, imaging workflows become more sophisticated, and products increase in complexity. But with innovation, the industry has faced a new problem: customer confusion. Workflow management now involves both traditional end users in the office as well as IT…
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
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…
The Un-Comfort Zone With Robert Wilson
I carefully filled the cake cone from the frozen custard machine, pushing it up at just the right moment to create a perfect ball. Then as I shut off the machine, I pulled the cone away with a circular motion to give it the company’s signature curl on top. It was beautiful, and I was proud of the…
Day in, day out, business leaders are reminded that digital disruption is coming for their customers, for their talent, and for their bottom lines. CEOs of traditional companies consistently rate digital upstarts disrupting their business models as their No. 1 concern.
And it’s no wonder. We’re…
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…
Knowledge at Wharton
I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.
Now, the Oldsmobile division and its iconic vehicles are…