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The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted…
John Hunter
I am amazed how difficult it is to convince organizations to adopt quality improvement practices. I look at organizations that I interact with and easily see systemic failures due to faults that can be corrected by adopting management improvement strategies that are decades old. Yet executives…
Venkatesh Shankar
A quarter of a century ago, on July 5, 1994, a company that shared a name with the world’s largest river was incorporated. It sold books to customers who got to its website through a dial-up modem.
It wasn’t the first bookstore to sell online. (Books.com launched in 1992.) But it behaved like a…
Manfred Kets de Vries
David was extremely gratified when he was named businessman of the year. He felt he deserved the recognition. Many articles had portrayed him as an entrepreneur who had reframed his industry, which gave him the courage to make his boldest move yet: taking over his largest competitor.
Some analysts…
Steven Brand
Manufacturing Day, an initiative designed to inspire the next generation of manufacturers, arrives Oct. 4, 2019. The annual MFG Day (which can be held anytime during the month) involves thousands of manufacturers across the country holding events, tours, activities, and more. Last year, in…
Ryan E. Day
Industrial Custom Products (ICP) is a world leader in prototyping, developing, and manufacturing high-quality OEM and custom thermoformed and vacuum formed plastic components, as well as die cut and dieless knife-cut parts. What makes ICP unique among its competitors is its award-winning quality,…
Jesse Lyn Stoner
Positive thinking can do wonders for your attitude. But it won’t make a difference in achieving your goals. Instead of just thinking positively (and vaguely) about what you want to accomplish, use mental imagery to ensure your success. These five tips show how to get the most from mental imagery.…
Caroline Preston
There’s a lot of anxiety out there about robots gobbling up our jobs. One oft-cited Oxford University study predicts that up to 47 percent of U.S. jobs are vulnerable to automation. Other research suggests the share is much lower. But while the exact numbers may be debated, there’s little question…
Hearing aids, dental crowns, and limb prosthetics are some of the medical devices that can now be digitally designed and customized for individual patients, thanks to 3D printing. However, these devices are typically designed to replace or support bones and other rigid parts of the body, and are…
Rohit Mathur
Whatever the process or type of data collected, all data display variation. This is also true in software development. Any measure or parameter of interest to our business will vary from time period to time period, e.g., number of incidents per week or month, time taken in resolving incidents,…
Annette Franz
There’s a lot of bad press out there about journey mapping. And there’s a lot of bad journey mapping (or what people think is journey mapping). A few months ago, I shared my six-step journey mapping process. Remember, journey mapping isn’t just a tool; it’s also a process. Know the tool and create…
Knowledge at Wharton
For decades, relatively easy access to space and the big profits to go with it have dangled elusively just over the horizon. With a little more R&D money and a few more advances in the technology, the thinking went, space would be ours.
Are we there yet? More than a few signs are pointing in…
Victor Prince
If you work long enough, you will have a micro-managing boss or two. These bosses think they know your job better than you do. Maybe they had your job before they got promoted to management. They focus on how you do your job instead of on the results you produce. They think that because you are…
Gwendolyn Galsworth
We have been examining motion and moving without working, the footprint of the invisible enemy: missing information. Added up, motion—in all its thousand and perverse forms—can steal 10 percent to 30 percent of our usable workday. Its impact is huge. We know the cure: Replace recurrent questions…
Caroline Rook
Toby Gould was both excited and petrified on the morning of Dec. 12, 2018. He and the three other nonprofessional rowers in his team were due to set off from La Gomera in the Canary Islands in a rowing boat equipped with only as much kit and freeze-dried food as a 29 × 6 ft boat can carry. Ahead of…
NIST
Ordinarily, you won’t encounter a radiation thermometer until somebody puts one in your ear at the doctor’s office, or you point one at your forehead when you’re feeling feverish. But more sophisticated and highly calibrated, research-grade “noncontact” thermometers—which measure the infrared (heat…
Barrett Thompson
A hot topic of conversation for many B2B industrial companies is the talent and skills gap due to the generational shift in the workforce from baby boomers to millennials. According to Ben Willmott, head of public policy at the Chartered Institute of Personnel and Development, “Too many employers…
Sarah Webb, Knowable Magazine
This story was originally published by Knowable Magazine.
What you see in the image below is a lobe of a liver, times two. On the right, a flesh-and-blood one, removed from a transplant donor; and on the left, one created from plastic to represent bile ducts, arteries, and veins, which were laid…
Donald J. Wheeler
During the past three months James Beagle and I presented columns that made extensive use of analysis of means techniques. Since these techniques may be new to some, this column explains when to use each technique and where to find tables of the appropriate scaling factors.
In 1967, Ellis R. Ott…
Brooke Kuei
A technique developed by researchers at the Department of Energy’s (DOE) Lawrence Berkeley National Laboratory (Berkeley Lab), in collaboration with Dow and Eindhoven University of Technology in the Netherlands, is providing atomic-resolution details about magnesium chloride, a material involved…
Harry Hertz
This blog, “Blogrige,” is about organizational performance, but first I need to set the stage.
One of the most prized commodities in many organizations, including mine, is space. Space is tight. Organizational (business) units are always looking to keep their current space and grab more space from…
Stephen Rice, Scott Winter
As driverless cars become more capable and common, they will change people’s travel habits not only around their own communities but across much larger distances. Our research has revealed just how much people’s travel preferences could shift, and found a new potential challenge to the airline…
Romesh Saigal, Abdullah AlShelahi
Soon after the Great Recession, the U.S. stock markets plunged—and rebounded within 36 minutes. The Dow Jones Industrial Average dropped more than 9 percent, losing more than 1,000 points before suddenly recovering.
This May 6, 2010, event was the first recorded “flash crash.” Although it didn’t…
Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region…
Jose R. Costa
Few people would deny the crucial role agility plays in helping a person succeed in today’s ever-changing business environment. The best leaders read the shifting marketplace and course-correct to help their businesses stay ahead of the curve. Yet while “agility” may be a trendy concept, the key to…
