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My first exposure to manufacturing was nearly 21 years ago. My on-the-job training was brief and mainly consisted of general safety, machine operating, and maintenance instructions with little focus on problematics or quality requirements. After all, I wasn’t forming sheet metal for an airplane; I…
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
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…
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…
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(FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date.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—…
Although it’s bad to ignore a crisis, more serious problems for leaders arise when they try to rouse the collective will to address or prevent organizational emergencies. Heads nod around conference tables as well-laid-out rationales and action plans for strategic change are presented. Months…
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.…
(ISO: Geneva) -- When is a good deal really a lemon? Sometimes the biggest bargains come with the heaviest hidden costs, thanks to unclear warranties that cover little when things go wrong. Faulty goods and ambiguous warranties are one of the greatest bugbears for consumers and retailers. A new…
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),…
(H. G. Schaevitz: Moorestown, NJ) -- H. G. Schaevitz LLC, Alliance Sensors Group has solved the age old problem of cross talk between sensors even if the master signal conditioner fails.
When linear variable differential transformer (LVDT) signal cables are bundled together or laid close to each…
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…
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…
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…
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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…
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…
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…
(Humantech: Ann Arbor, MI) -- Whether your goal is to comply with local regulations, meet company standards, or develop a world-class ergonomics process, you must determine “where you are” and “where you want to be.” It is necessary to understand the gaps before devoting time and energy to…
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…
(NCTech: Edinburgh, UK, and Houston, TX) --NCTech, the developer of reality imaging systems, announces two new developments for its industrial-grade iSTAR panoramic camera. The company will be demonstrating these developments at the SPAR 3D Expo & Conference, April 11–14, 2016, in The…
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…
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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…
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…
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…
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…
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…
