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Revolution by Design: The Materials Genome Initiative
James Warren
Creating a new material has long been either an accident or a matter of trial and error. Steel, for instance, was developed over hundreds of years by people who didn’t know why what they were doing worked (or didn’t work). Generations of blacksmiths observed that iron forged in charcoal was…
Three Causes of Security Breaches
British Assessment Bureau BAB
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error. The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent of the breaches…
FDA Introduces the Pre-RFD Process
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…
Six Tips to Make Sure Your 510(k) Submission Is Accepted
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…
A Network Model for IoT
NIST
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,…
What You Can Learn From Startups
Peter J. Sherman
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…
Staying Ahead of the Curves
Jennifer Huergo
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs. Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded in the shaft and…
Machine Learning for Risk Management
Gilles Hilary, Sivakumar Viswanathan
It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades. Shortly afterward, David and John realized they had just become victims of the rise of…
First the Innovation, Then the Persuasion
Andrew Maynard
Elon Musk, CEO of Tesla Motors, recently revealed the second part of his master plan for the company, and it’s a doozy. Not content with producing sleek electric cars (which to be fair, were only a stepping stone to greater things), Musk wants to fundamentally change how we live our lives. But the…
ISO 14971 or FMEA: Which Should You Use?
Jesseca Lyons
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA). As an engineer, there’s a good…
Going the Distance on National Tape Measure Day
Dan Sawyer
Whether they’re made of leather or metal, tape measures have been used by people for a long time. The first spring-loaded metal tape measure was invented and patented in England in 1829. Alvin Fellows of New Haven, Connecticut, made improvements to that design, including the locking mechanism that…
Moving From Volume to Value
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…
How Do We Uncouple Global Development From Resource Use?
Heinz Schandl
The world is using its natural resources at an ever-increasing rate. Worldwide, annual extraction of primary materials—biomass, fossil fuels, metal ores, and minerals—tripled between 1970 and 2010. People in the richest countries now consume up to 10 times more resources than those in the poorest…
Managing Thrill Seekers
Manfred Kets de Vries
Thrill-seeking employees’ addiction to risk can create havoc in the workplace. Managed correctly, however, their fearlessness can be a great advantage to any organization. People who knew Lawrence Devon, a VP of sales in a large retail group, viewed him as the quintessential sensation seeker—a…
Organizational Excellence in the Cyber-Risky Age
Robert Fangmeyer
In August 1987, Congress created the Baldrige Performance Excellence Program, a public-private partnership that spawned a global movement. This small program was given a great big purpose: to improve the quality and performance of U.S. businesses so as to improve our national competitiveness. As a…
ISO/TS 16949 Piles on the Requirements This Year
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…
From Automotive to Aerospace
Mark Whitworth
Quality is, for every organization and across all industries, a key competitive differentiator. This is especially true in the highly competitive automotive industry, where cost pressures have pushed automakers and their suppliers toward global sourcing and distributed supply-chain operations.…
Registration of Food Facilities
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…
If I Had a Hammer...
Right now, scientists all over the world are trying to understand how we get injured when our bodies are subjected to strong, dynamic loads—a hard body-check on the hockey rink, a tackle on the football field, a car crash, or even a bomb blast. Fortunately, I haven’t had any experience with bomb…
Despite 35+ Years of Evidence to the Contrary...
Davis Balestracci
Today I want to concentrate on the foundation of what is most commonly taught as design of experiments (DOE)—factorial designs. Elsewhere I’ve mentioned three of C.M. Hendrix’s “ways to mess up an experiment.” After 35 years of teaching DOE, I’ve concluded that he pretty much captures the…
‘OSHA-Proofing’ Your Business
Jonathan Jacobi
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential people, and…
Four Signs That Your Industry Is Ripe for Digital Disruption
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…
Do You Trust the Food You Eat?
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…
NIST’s Newest Watt Balance Brings World One Step Closer to New Kilogram
NIST
A high-tech version of an old-fashioned balance scale at the National Institute of Standards and Technology (NIST) has just brought scientists a critical step closer toward a new and improved definition of the kilogram. The scale, called the NIST-4 watt balance, has conducted its first measurement…
Is the Time Ever Right to Flout Procedure?
Loic Sadoulet, Thomas Hinterseer
It’s a tragic irony that the day before the 2010 Deepwater Horizon oil well disaster, executives from BP and the rig’s operators, Transocean, visited the platform on a “management tour” that included a number of specific safety-related purposes. During the tour, there were already signs that all…

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