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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…
In a rapidly changing business environment, it’s sometimes hard just to keep up with everyday demands—never mind having time to develop new and better approaches to changing requirements, needs, or markets. Staying ahead of the curve sounds as if it might demand working longer hours, hiring more…
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…
(Wiley: Hoboken, NJ) -- Entrepreneur Nigel Collin’s book, Game of Inches (Wiley, 2015) dispels the myth that success must come from disruption, and provides an actionable blueprint for real-world business achievement. Collin interviewed more than 80 successful Australian entrepreneurs and leaders…
Color is a big differentiator in the world of 3D scanning, but when it comes to inspection or reverse engineering, it’s usually not mandatory and sometimes not even important. However, color is paramount in applications such as heritage preservation, which is the 3D scanning and digitization of…
The world needs leadership, and there’s no better way to lead than to listen. A leader who listens controls the conversation, and has the power to build bridges instead of barriers.
Listening requires you to be present, to set aside your own agenda, to use discernment.
When someone says, “Black…
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hose of you at a certain age (meaning old) will no doubt remember the song, “Does Your Chewing Gum Lose Its Flavour?” It was a single released in 1959 and sung by Lonnie Donegan. It’s an irritating song but not as irritating as the thousands of people who prefer to leave their chewing gum at the…
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…
Running as fast as I could, I zigzagged across the field. I dodged and ducked, and stayed just out of reach from the grabbing hands. I stumbled and fell, but quickly rolled away from my pursuer and bounced back onto my feet before he could catch me. I charged toward a short stone wall and leapt…
Hexagon Manufacturing Intelligence recently released the latest system in its 3D optical scanner portfolio, the BLAZE 600M. The solution is similar to structured light but comprised of a blended combination of technologies that allow it to be faster and more accurate than traditional structured-…
A new publication from the National Institute of Standards and Technology (NIST) provides a basic model aimed at helping researchers better understand the internet of things (IoT) and its security challenges.
Examples of IoT systems include a smart electric grid, a home controlled by sensors,…
(DeFelsko: Ogdensburg, New York) – DeFelsko Corp., a U.S. manufacturer of coating-thickness gauges and inspection instruments, has been selected to host five Society for Protective Coatings (SSPC) training events beginning in November 2016. at its headquarters in Ogdensburg, New York.
These…
(Sensaphone: Aston, PA) -- Detecting vibration fluctuations in machinery early on prevents equipment failure and secondary damage. The 4–20mA vibration sensor from Sensaphone, designer of remote monitoring technology, can be permanently mounted on equipment to continuously monitor vibration…
Before you can do a project well, you must first make sure it’s the right one for you at that time. A project is “right” when it moves you closer to your long-term goals, aligns well with your unique strengths, and is achievable given the resources and people you have available. Once you’ve…
It’s hard these days to miss the passion of people who support Donald Trump or Bernie Sanders, the steadfastness of the Tea Party, the outrage of the Occupy Wall Street group, and the frustration of young people who have so given up on the system that they choose not to vote. Most grievous is the…
(FARO: Lake Mary, FL) -- FARO (NASDAQ:FARO), the world’s most trusted source for 3D measurement and imaging solutions for metrology, factory automation, product design, public safety, BIM/CIM, and 3D solutions and services, announces the launch of the FARO Forensic ScanArm solution, a tailored…
(InnovMetric: Quebec, Canada) -- InnovMetric Software Inc., the leading provider of universal 3D metrology software solutions, today announced that worldwide demand for the PolyWorks universal 3D metrology software platform in fiscal year 2015 (ending March 31, 2016) led to a 35% global sales…
Understanding the benefits of having sound knowledge, perspective, and the appropriate skill sets in metrology is just as crucial in today’s technological world as it was 50 years ago. The same goes for key decision making based on solid processes, procedures, methods, and data analysis. Taking…
(Hexagon Manufacturing Intelligence: North Kingstown, RI) -- Hexagon Manufacturing Intelligence North America today announced that its Integrated Solutions Business group will unveil a new-to-the-market Automation solution at the International Manufacturing Technology Show (IMTS) 2016, taking…
A year ago, at the 2015 Coordinate Metrology Society Conference (CMSC), the PrecisionPath Consortium for Large-Scale Manufacturing started its journey toward building a sustainable, industry-driven coalition that continues to attract the brightest minds in manufacturing and metrology. The recent…
(Third Dimension, Bristol, UK) -- Executive TV is excited to announce Manufacturing Change, the latest addition to their ongoing series of industrial documentaries exploring the United Kingdom’s manufacturing sector and its future. This program features Bristol-based Third Dimension, experts in…
Although it sank more than 150 years ago, the USS Monitor has an everlasting place in history.
As one of the first of the so-called "ironclads," the Monitor, along with its Confederate Army foe, the CSS Merrimack, fought to a draw at the Battle of Hampton Roads, VA, on March 9, 1862. From that…
Dimensional measurement has been used as a part of manufacturing systems for many years. However, although shop floor measurement equipment can be used next to a manufacturing machine and its measurement data can be digitally interfaced to change some manufacturing parameters, machine tools…
A friend and colleague remarked to me that “the lean market has become mature,” implying a depth and breadth of lean understanding in industry that I have rarely seen myself.
Standardized work, for example, almost always looks like time setting to me, an occasional and cursory exercise by…
As organizations become successful and grow, uncertainty is generally the enemy. Thriving organizations seek to eliminate variation and increase efficiency. They identify best practices and policies, and design standard operating procedures. Such efforts can make a business wildly efficient at…
