All Features
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…
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…
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…
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…
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…
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.…
Jeffrey Eves
Sponsored Content
There are many paths for organizations to become good, sustainable, low-footprint citizens of the business world. Production processes can be redesigned to be more efficient, corporate campuses can be located so as to reduce employees’ dependence on fossil fuels, and buildings…
NIST
Recently on the Taking Measure blog, we asked Tara Lovestead, a recipient of the 2016 Presidential Early Career Award for Scientists and Engineers (PECASE), a few questions about her life and work. She was recognized for her extensive application of new methods to rapidly and inexpensively detect…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this time, we may need to fasten our seatbelts and actually read the card in the seat pocket.
A bill under…
Tim Lozier
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…
Jon Speer
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—…
Ken Miller
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),…
Bruno Scibilia
Sponsored Content
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…
Jill Hartzler Warner, Thinh Nguyen
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…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
Gilles Hilary
Phil used to be a very senior financial executive. When asked for a number, he would typically provide with a rough ballpark answer, such as, “It’s about 5 percent.” He’d then be peppered with questions about how he had arrived at that figure.
After a while, he got tired of this questioning and…
Dan Jacob
Airbags, ignition switches, and even emissions software; although large recalls make the news at a regular pace, these are surrounded by scandal. News reports include claims of illegal or unethical activity executed by individuals or larger groups of people. Unfortunately, as new reports expose…
Mike Micklewright
When considering any effort toward performance improvement, you should always start by looking at the organization’s principles and culture, and making sure these are aligned so they not only permit positive changes to occur, but also ensure that the changes will be sustained over the long run. By…
Manufacturing Extension Partnership MEP
Whether it’s for performance management or for risk, it’s important to know who your suppliers are and have a close business relationship with them.
It’s a given you should already have a strong relationship with your key suppliers, but how often does your supplier request the following items? •…
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
