All Features
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…
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…
Sameer Hasija, Vivek Choudhary
One fine morning in 1909, Henry Ford made a surprise announcement during a company meeting. In the future, Ford Motor would stick to a single car model, the Model T, in black only. No other choices, or as he said, “Any customer can have a car painted any color that he wants so long as it is black…
Knowledge at Wharton
CEOs are stepping forward to confront public policy issues that often extend beyond their core business, in part at the urging of their employees, write Caroline Kaeb and David Scheffer in this opinion piece. Kaeb is co-chair of the Business and Human Rights Pillar and a senior fellow of the…
Chad Kymal, Gregory F. Gruska
During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late…
Jyoti Madhusoodanan, Knowable Magazine
A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “sustainable…
Boris Liedtke
‘Any customer can have a car painted any color that he wants,” said Henry Ford in 1909, “so long as it’s black.” Ford’s strategy of standardization and efficiency made a runaway success of the Model T car and built Ford Motor Co. into one of the world’s biggest automakers. But 110 years on,…
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the Gates …
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that…
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
If your…
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have…
Ryan E. Day
In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this article, we’ll outline four points that can help your organization integrate standards into your…
Kevin Price
In the world of risk management, maintenance of mission-critical equipment drives priorities and budgets. It is the ultimate test of proactive maintenance and smart decision making. Managing assets that “cannot be allowed to fail” is more than an emotionally charged mandate that forces managers…
Venkat Viswanathan, Shashank Sripad, William Fredericks
As electric cars and trucks appear increasingly on U.S. highways, it raises the question: When will commercially viable electric vehicles take to the skies? There are a number of ambitious efforts to build electric-powered airplanes, including regional jets and planes that can cover longer…
Shobhendu Prabhakar
Someone recently asked me why quality failures and safety incidents continue to occur despite organizations communicating their quality and safety visions to the workforce, developing and implementing quality and safety management systems, and campaigning day in and day out about quality and safety…
Ronda Culbertson
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk…