All Features
Sam Manzello
I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science.
As a fire researcher, or more colloquially, a dragon wrangler, my job is to help protect people and property from fire’s devastating effects.…
Knowledge at Wharton
I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.
Now, the Oldsmobile division and its iconic vehicles are…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Fred Schenkelberg
A fault tree analysis (FTA) is a logical, graphical diagram that starts with an unwanted, undesirable, or anomalous state of a system. The diagram then lays out the many possible faults, and combinations of faults, within the subsystems, components, assemblies, software, and parts comprising the…
More than 313 million global work-related accidents occur each year, according to the International Labour Organization, with a high percentage of those accidents resulting in significant time away from work. Each accident bears a personal and financial cost for the worker and the employer. Yet,…
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
Gilles Hilary
President Obama has been injured in a terrorist attack on the White House. A tweet released by the Associated Press (AP) attests to this. It carries the company’s “verified” stamp of authenticity. The S&P 500 just lost more than $130 billion. Well, not quite.
The AP’s tweet was the byproduct…
James Olthoff
I’m a physicist, and as anyone who watches the popular TV series The Big Bang Theory knows, it’s a commonly held conception that there is a strong connection between being a scientist and being enthralled with all things science fiction, fantasy, and superheroes. Anyone who walks into my office at…
The QA Pharm
Aquality management review of data with responsible company leadership is a current good manufacturing practices requirement. Quality management review procedures vary, but there seems to be a struggle with presenting data from across the quality management system in a meaningful and consistent…
NIST
Anyone who has ever covered a wall with sticky notes to clearly map all of the steps in a process knows how valuable that exercise can be. It can streamline workflow, increase efficiency, and improve the overall quality of the end result. Now, a public-private team led by the National Institute of…
Mike Figliuolo
Work is a convenient excuse for not taking care of yourself. Not exercising, poor diet, and stress are a bad combination. You’ve got to make time for you. Work will always be there when you get back.
Just over a year ago, I had a heart attack. My second heart attack. Yep. Two. The first one…
Jeffrey Phillips
The tone of this article is a bit tongue in cheek, but the point is quite serious. Innovators go through a number of phases as they accept the reality of innovation based on what executives and corporate culture allow. Growing as an innovator is something like experiencing the seven stages of…
Rachel Tracy
Two things are true when it comes to making important decisions that affect your company: You need a way to quantify risk to make the best choice, and you need to be able to explain that choice. A risk matrix helps you do both.
Calculating risk across various outcomes can give you clear…
Brian Stanton
Doors that are obviously meant to be pushed not pulled, footprints painted on the floor telling you where to stand at the airport—these are examples of good design and usability. You don’t have to think too hard about what to do because someone else put a lot of thought into how to get across the…
Chad Kymal
The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. Many of us close to the standard expected it to be released in May 2016 after the April International Aerospace Quality Group (IAQG) meeting in Singapore. However, this was not the case; the IAQG decided…
Stephan Manning, Marcus M. Larsen
One of the big themes in the current presidential race is how decades of free trade have dealt a heavy blow to the U.S. worker as millions of jobs were shipped overseas to take advantage of cheap labor.
That’s even turned some pro free-trade Republicans into protectionists. As a result, the…
Harry Hertz
I recently read an HBR blog by Sunnie Giles that reported the results of a study of 195 leaders representing 30 global organizations. The leaders were asked to identify the most important competencies for leadership. The study reminded me of a complementary article in Forbes, written by Glen…
Jennifer Marshall
For as long as we have had automobiles, we have had traffic accidents. Even the vehicles that we depend on to take care of us in the event of an accident—ambulances—get into accidents nearly every day. Because ambulances are basically a small emergency room on wheels, the occupants in the back are…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Mark Esser
Depending on whom you ask, May (or August or April—it would be great if someone were to standardize this, but we’re going with May) is National Inventor’s Month. Lots of people have dreams of being a famous inventor. Even I’ve had “ideas” for inventions before.
For instance, during the 1990s,…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…
Richard Gates
Put your hands together. Now move them back and forth to rub them against each other. Feel that heat? That’s from friction. No matter if it’s between siblings or the gears of an engine, we usually think of friction as a bad thing, and often it is. Friction can cause things to heat up, wear down,…