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NIST
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to horizontal, and…
Michelle LaBrosse
Most people begin with the great intentions to eat well, exercise, do their best at work, and get along with co-workers. Unfortunately, good intentions don’t always impel us to actually do what we say we’ll do. Why is this? Let’s explore the answers to this question and how to align our actions…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Marc Silverstein
Every day, new technology creates smaller and smaller materials and components. In many industries these parts require high magnification, sometimes up to 1,000X, to see submicron features. This is accomplished using a compound or upright microscope, where the user can select the objective lens.…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Jesse Lyn Stoner
Traditionally, career paths have been based on the idea of “moving up the ladder.” Success is measured by how high you get. A lateral move is usually not seen as a smart career move. Even when changing jobs to increase your skills, the expectation is the new position will be a step higher up the…
April Lemois
Whether it’s budgeting season, or you’re preparing for the future, you need to make strategic decisions about where your allocations will go. As planning commences to replace your current coordinate measuring machine (CMM) or to add a new one, important business considerations such as prior-year…
Ken Levine
One poorly understood concept in lean Six Sigma is how much to “stretch” when setting S.M.A.R.T. goals. These letters are defined as S—specific; M—measureable; A—assignable, attainable, or achievable; R—realistic, reasonable, or relevant; and T—time-based or time-bound. Regardless of the different…
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Kimberly Watson-Hemphill, Kristine Nissen Bradley
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Duke University
Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.
A new report from the planning board for a national medical device evaluation system (NMDES) describes how the…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Manfred Kets de Vries
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wenty-five years ago, corporations and business schools were preoccupied with models of the rational economic man, not realizing that executives are anything but rational decision makers. The emotional aspects of leadership and the importance of corporate culture were all but ignored. At that…
Joby George
Driven by market expansion, financial pressures, and the need to accelerate innovation, today’s manufacturers have expanded their global operations and supply partners. This evolution has only amplified the manufacturer and supply-chain relationship, which is often characterized by a delicate…
GBMP
Hub Pen Co., located in Braintree, Massachusetts, imports specialty writing instruments and imprints them with company logos and other customized inscriptions. In 2013, the company received a grant for training in lean and continuous improvement, which was delivered by the Greater Boston…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Davis Balestracci
In part one yesterday, we looked at stats of the Boston Red Sox bullpen, a typical example of baseball’s tendency to find special cause in just about anything. The Boston Globe article on which these two columns are based has been a gold mine for teaching many useful, basic concepts about…
Davis Balestracci
In honor of baseball season, I’m going to apply some simple statistical thinking to my favorite sport in a two-part series today and tomorrow. I want anyone to be able to enjoy this, so I’ll mark any technical statistics as optional reading. For those of you interested only in the interpretations…
Giles Hutchins
Globalization, disruptive technologies, pressure on finite resources, increasing social disparity, and demand for business transparency: Enter the age of uncertainty. These transformative times are reshaping the workplace in profound ways, demanding the crossing of thresholds at myriad levels. …
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
Tonianne DeMaria
I recognize that the title of this column might stir up some controversy, especially among fellow coffee enthusiasts. Not to mention it puts me at risk of getting exiled from my beloved adopted home, Seattle. And yes, perhaps “Clarity > Coffee” even seems a tad hypocritical, considering that I’…
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
Jim Frost
P -values have been around for nearly a century, and they’ve been the subject of criticism since their origin. In recent years, the debate over p-values has risen to a fever pitch. In particular, there are serious fears that p-values are misused to such an extent that it has actually damaged…
Niranjan Deodhar
Previously in this series, we looked at applying the principles of process improvement (PI) to itself. We identified metrics that help define effective and efficient PI, and then analyzed some work practices that help drive these metrics. Here, we move on to analyze more work practices, this time…
