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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…
Planning for Project Success
Michelle LaBrosse
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…
Helping the Most of Us
Quality Transformation With David Schwinn
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…
Consult With Humility
Bruce Hamilton
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…
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…
Back to the Beginning With Ohno, Suzuki, and Yoda
Kevin Meyer
As I was researching the remarkable similarities between lean and Zen for my book, The Simple Leader  (Gemba Academy, 2016) one of the most interesting—and meaningful—was the concept of the beginner’s mind. Taiichi Ohno said, “Observe… without preconceptions and with a blank mind.” Zen master…
How to Assess Your Organization’s Quality Culture
Afaq Ahmed, Yves Van Nuland
New technologies have empowered customers to seek out the best products and services at the lowest cost and shortest delivery times. Customers can compare price and delivery information as well as reviews about product quality. Thus, the importance of sustaining outstanding quality in order to…
You Say We’ve Improved? Prove It.
Steve Garbrecht
Here’s a stat that might surprise you—according to LNS Research, 50 percent of manufacturers have implemented or will be implementing cross-functional groups to support their operational excellence journeys within a year. At the same time, only 18 percent have software or processes in place to…
Customer Experience Fuels Innovation
Annette Franz
I was honored recently to be a guest on Innochat, a weekly Twitter chat that takes place every Thursday at noon Eastern time. The show is about innovation and covers a wide range of topics and angles. If you love talking innovation, make time for this chat every Thursday. The topic on July 21 was…
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…
Reducing Wait Times at the Doctor’s Office
MIT News
Ever waited way too long at your doctor’s office for an appointment to start? Those long waits may soon be over. A schedule-optimizing software developed by MIT spinout Arsenal Health gets more patients seen more quickly and could soon be used by thousands of healthcare providers across the…
An Underused Lesson From Ohno and Deming
Harish Jose
Today I’d like to take a look at a lesson from Taiichi Ohno regarding the pursuit of quality. His comment, “The pursuit of quantity cultivates waste, while the pursuit of quality yields value,” struck a chord with me. Among other things, he's referring to the importance of resisting mass-…
How Industrial Firms Can Pivot to Digital Business Models
Knowledge at Wharton
Have you seen the recent commercial where a young son tells his parents that he’s going to work for GE—as a software developer? Their response was one of bewilderment. In their minds, GE is a manufacturer. The commercial exemplifies the idea that the mental models of leaders—their attitudes,…
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…
Twelve Characteristics of Great Leaders
Mike Figliuolo
Sponsored Content M ost of us are good leaders. Most of us aspire to be great leaders. Few are. What does it take to transcend “good” and become “great?” What’s the secret? There isn’t one. The differences between a good leader and a great one boil down to a handful of traits that inspire people…
Feynman and the O-Ring
Denise Robitaille
The great physicist Richard Feynman is best known—at least among laypeople—as the person who solved the mystery of the Challenger space shuttle explosion more than two decades ago. Many of us remember the image of an O-ring suspended in a glass of ice water sitting on a conference table…
Forecasting the Success of Innovation
Henrich Greve
Creators beat managers at predicting an innovation’s success—unless they’re predicting the success of their own work. You probably know someone who owns an Apple Watch, or maybe you own one yourself. Is it a creative product? Well, the multifunction watch was creative the first time it appeared…
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…
Lean by Doing
Bruce Hamilton
Early along, as a student of the Toyota Production System (TPS), now referred to as lean, I struggled with some of the concepts and systems. For example, Shigeo Shingo’s claim that a four-hour machine setup could be reduced to less than 10 minutes made me a skeptic. “Perhaps, when Mr. Shingo…
Four Tips for Picking the Perfect Business Partner
Micki Vandeloo
It’s so important for manufacturers to find and cultivate valuable partnerships. They can help manufacturers expand their service or product offerings, make their processes more efficient, and help specify and procure just the right equipment. When manufacturers launch a new product or are making…
Lean Leadership: Go and See for Yourself
Annette Franz
I recently came across the Japanese terms genchi genbutsu and gemba; they’re both key principles of the Toyota Production System, which comprises Toyota’s management philosophy and best practices. Although they’re (lean) management principles and concepts, they apply not only to the employee…
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…
Tie the Rope
Jason Furness
For the sake of argument, let’s say you’re aware of an issue that’s holding your enterprise performance back, and you know what to do about it. At that point, there are seven key actions you can take to rapidly implement change, which in turn will allow you to respond to market changes with short…
Performance, Not Policy
Kevin Meyer
Few people realize how employee policy manuals, usually given to you on your first day and then mostly forgotten, shape an organization’s culture and thereby its fundamental performance. To give you a reference point, one company I worked for had an employee manual of 40+ pages. Every section…

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