All Features
Britta Voss
When you email friends, you don’t have to worry about whether they use Gmail, Outlook, Yahoo, or some other email provider. You just enter their email address, write your message, and hit send. The reason this works is because there are layers of standardized protocols that all the email clients…
Sharona Hoffman
A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.
That should worry all of us. The…
Jon Speer
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device quality…
Jill Barshay, Sasha Aslanian
When Keenan Robinson started college in 2017, he knew the career he wanted. He’d gone to high school in a small town outside Atlanta. His parents had never finished college, and they always encouraged Robinson and his two older siblings to earn degrees. Robinson’s older brother was the first in the…
Ekim Saribardak
Transporting cargo over long distances has always been a logistical nightmare, but when the goods are of a delicate nature, the whole operation becomes significantly more challenging. Perishable foods, chemicals, pharmaceutical products, and other delicate goods all need special treatment during…
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and…
Knowledge at Wharton
From a lone statistician toiling over narrowly defined problems for the marketing department, to a C-level executive overseeing a mission-critical area impacting every function of the company, the meaning of “data and analytics professional” has changed a lot in recent years. A. Charles Thomas’s…
Natasha Gilbert, Knowable Magazine
This story was originally published by Knowable Magazine.
Alfalfa, oats, and red clover are soaking up the sunlight in long narrow plots, breaking up the sea of maize and soybeans that dominates this landscape in the heart of the U.S. farm belt. The 18 by 85 meter sections are part of an…
The Un-Comfort Zone With Robert Wilson
When I was 7 years old, I went into the woods behind my house, built a fire, then fried an egg over it in an old pie tin. When the egg was done, I ate it. I didn’t even like eggs, but because I had cooked it on my own, it was delicious.
I was so proud of my achievement that I ran inside and told…
Eric Weisbrod
In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization. But when you have multiple, disparate plants around the country or the globe, standardization can…
David Blustein
On the surface, the well-being of the American worker seems rosy. Unemployment in the United States hovers near a 50-year low, and employers describe growing shortages of workers in a wide array of fields. But looking beyond the numbers tells a different story.
My new book, The Importance of Work…
Ziv Carmon
Counterfeiting is widespread and rapidly expanding. In 2015, the value of fake and pirated products globally was estimated at $1.7 trillion, equivalent to the GDP of Canada. The scope of this phenomenon is vast. In both developing and developed countries, counterfeiting affects many sectors,…
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…
Jim Benson
Responsibility. It’s a hard word to come to grips with. What is the responsible thing to do right now? What is my personal responsibility? What is my responsibility as a team, family, company, state, or country member? What do I expect from others?
The world now is in transition, from being…
William A. Levinson
The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities…
Jennifer Lopez
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug…
Ben Brumfield
For decades, Krishan Ahuja tamed jet noise, for which the National Academy of Engineering elected him as a new member this year. Today, Ahuja is an esteemed researcher at the Georgia Institute of Technology, but he got his start more than 50 years ago as an engineering apprentice in Rolls Royce’s…
Michael D. Williams
As I spoke recently with colleagues at a conference in Florence, Italy, about healthcare innovation, a fundamental truth resurfaced in my mind: the U.S. healthcare industry is just that. An industry, an economic force, Big Business. It is a vehicle for returns on investment first and the success of…
Gabriel Hawawini
Given the recent, renewed intensification of the shareholder vs. stakeholder debate, the concept of value creation has become more ambiguous. On whose behalf should organizations generate value? For owners, employees, upstream and downstream partners, or local communities immediately affected by…
ISO
Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published.
Innovation is an increasingly…
Barnaby Lewis
Put in the terms of this article’s title, most of us would run a mile, whatever the proposition. But the popularity of online reviews, and the trust we place in persons unknown when making major decisions about where to stay, what to eat, and how to get the most from a trip, tells a different story…
Rob Matheson
In the Iron Man movies, Tony Stark uses a holographic computer to project 3D data into thin air, manipulate them with his hands, and find fixes to his superhero troubles. In the same vein, researchers from MIT and Brown University have now developed a system for interactive data analytics that runs…
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…
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…
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…