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If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device…
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data are directly related to patient care.
Examples of small data include: • Missed clinic appointments…
Limiting work in process (WIP) isn’t easy. Our work is largely invisible, which means it’s hard to notice. It just walks right up, bold and unabashed. It doesn’t have to sneak; we’re simply blind to it. Then, one day, we notice it’s there.
During the last three weeks the Modus Cooperandi team…
(NIST: Gaithersburg, MD) -- JILA researchers have designed a microscope instrument so stable that it can accurately measure the 3D movement of individual molecules over many hours—hundreds of times longer than the current limit measured in seconds.
The technology was designed to track the…
Globally, companies are scrambling to reengineer their performance management processes. Unfortunately, many of these initiatives have the wrong priorities.
Too many leaders rely on convoluted human resources processes and rigid rating systems that are time-consuming and disengaging for managers…
Last month, the ESPN series Outside the Lines reported on baseball pitchers suffering serious injuries from being struck in the head by line drives, and the efforts that Major League Baseball (MLB) is making toward having protective gear developed for pitchers.
You can view the report here if you…
Everyone is gearing up for the challenge of updating their compliance to the requirements of the 2015 version of ISO 9001. Most quality professionals I speak with seem to have digested the new requirements as something very different than past versions. Personally, I don’t see it in quite the same…
This is a continuation of my last column, which I’ve written to honor my late dad who loved golf. As promised, let’s look at the Masters golf tournament final four-round scores for the 55 players who survived the cut. We’ll analyze and then give it a twist based on the ongoing enumerative vs.…
(Banner Engineering: Minneapolis, MN) -- Banner Engineering has expanded the capabilities of its Q4X series of laser distance sensors, allowing them to be used in several new applications. The series now includes an analog model to measure distance and a discrete model with expanded capability to…
To make 3D scanning useful, you really need to understand the types of data files that can be exported or saved from the process. This is particularly important if you’re considering the purchase of a 3D scanner, or are paying for 3D scanning services.
If you’re paying for a service, you might…
In the first part of this series, we looked at how two manufacturers used the Baldrige Criteria to survive the Great Recession and transform their companies. Here we learn more about how the Baldrige can help organizations achieve competitive advantage.
Baldrige Award recipient Lockheed Martin…
(Bruker: Santa Barbara, CA) -- Bruker has released its second-generation Inspire infrared (IR) nanocharacterization system, which features 10-nm spatial resolution infrared chemical mapping in an easy-to-use, laser-safe package. With IR EasyAlign, Inspire simplifies scattering scanning near-field…
During a recent interview with Clint Belinsky, vice president of global quality at Jabil, LNS Research discussed revolutionizing quality management and some of the keys to achieving excellence. Streamlined processes, systems, and technology are important, but without the right people and quality-…
When looking for the best quality management system (QMS) for your business, there are certain traits to take into consideration to ensure you get the most value out of the system in the long run. Here are six of them.
1. Flexibility to make the system your own
Flexibility is an important aspect…
When the recession hit during the early 2000s, Michael Garvey left his fast-paced life trading equities on the floor of the New York Stock Exchange to help save the “family farm,” a bronze foundry in Youngstown, Ohio.
Garvey said his parents and many other manufacturers got caught in the “perfect…
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.
If…
What good is it? Often the mantra of the obsessively practical or the hopelessly cynical, a “what good is it?” response typically indicates disgust, disappointment, or disdain—maybe all three.
Obsessively practical leaders seem to become, well, obsessed, with efficiency. Every act, every task,…
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
(Olympus: Center Valley, PA) -- Olympus, a global technology leader in industrial imaging solutions, will have its experts available for product demonstrations at SEMICON West, taking place July 14–16, 2015, in San Francisco.
The Olympus booth (No. 6040) will be exhibiting the LEXT OLS4100, the …
There’s no doubt that the world becomes more interconnected and technology-centered as each day passes. Driverless cars have taken to the road in pilot projects in several countries; modes of communication are instant and global, whether they’re under 140 characters or above; and medical…
I love my car. Recently, I had to get some major repairs done on it (luckily, they were covered by the warranty). Because it was going to take a while, they provided me with a loaner. This was a really nice car—only 1,200 miles, new-car smell, sunroof, super-quiet, drove like a dream. It made me…
June 11, 2015, marked the fourth anniversary of the passing of someone who, although not typically credited as a “lean” thinker, nevertheless had a profound effect on many lean implementers. Eliyahu Goldratt, or Eli, was an Israeli physicist whose Ph.D. thesis on queuing theory led him and many…
(Konica Minolta: Ramsey, NJ) -- Konica Minolta Sensing Americas (KMSA), provider of advanced optical technology that precisely measures the elements of color and light, will exhibit at the IFT 2015 Food Expo at booth No. 4545. IFT 2015 will take place July 12–14, 2015, at McCormick Place South in…
We need to think about redefining work. Until we—anyone who wishes to bring about organizational change—redefine the actual value-creating work of the business, we haven’t made any changes that are meaningful.
You may be able to create wealth through a variety of business models or ways of…
