All Features
Katia Savchuk
Since generative AI went mainstream in 2023, it has inspired an equal measure of hype and fear. Boosters of tools such as ChatGPT and DALL-E predict that they will transform our economy, while skeptics worry about their potential to produce inaccurate or harmful results and ultimately replace…
Alonso Diaz, Maria DiBari
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
Mike Figliuolo
By eliminating low-value work from your life, you can focus on more important things. Get rid of difficult customers and focus on driving your business instead.
To get your new year started right, I’d like to share with you what I’ve been taught by homemade bread, lawn mowers, and cheap customers…
ComplianceQuest
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…
Industrial Inspection and Analysis
Unlike the traditional engineering process of designing a part, product, or component from the ground up, many times in life we need to start with an existing item and work backward to solve a problem. It’s a process known as reverse engineering, and it begins by obtaining accurate data about the…
Mike Figliuolo
Your legal department is screwing up. Royally.
You work hard to build relationships with other businesses. How many hours do you invest getting closer to partners, customers, and suppliers? And then that wonderful handshake happens, and it’s time to hammer out the agreements. That’s when Larry the…
Phil Geldart
When it comes to customer service, few companies do it better than the UPS Store, Chick-fil-A, and REI.
That’s not according to me. That’s according to a recently published Best Customer Service list, which was compiled in a partnership between Forbes and HundredX, a data analytics company focused…
Kate Zabriskie
Although a fix-it-the-first-time approach may be the gold standard of customer service, addressing potential issues before they materialize is the true mark of an exemplary user experience.
Consider the pace of our modern world: Customers today want instant solutions, and any hurdle might be a…
Leah Chan Grinvald, Ofer Tur-Sinai
Cars are no longer just a means of transportation. They have become rolling hubs of data communication. Modern vehicles regularly transmit information wirelessly to their manufacturers.
However, as cars grow “smarter,” the right to repair them is under siege.
As legal scholars, we find that the…
Gad Allon
Amazon’s incredible growth over the years has made it a textbook example of what it means for a business to scale, going from a scrappy startup in Jeff Bezos’ garage to a multinational corporation with more than 1.5 million employees.
The retailer recently announced it’s hiring 250,000 full- and…
ISO
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need for…
Mike Figliuolo
I’m going to take over the world! It’s really fun to say that. It’s even more fun to take action toward that goal.
Our world has gotten smaller. Way smaller. Globalization is an unstoppable trend. But as they say, the trend is your friend, so why not take advantage of it? I don’t care how big or…
Kate Zabriskie
“I don’t understand. This hotel has no restaurant, no concierge, and no valet. It’s not at all what I expected. The place had no standards.”—Guest at a roadside motel
“I showed her the picture of Jennifer Aniston and asked for the same haircut. She cut my hair, but I still don’t look a thing like…
Kelley Jacobsen
In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders. Amid supply chain disruptions during the pandemic, hospitals scrambled to find enough devices to keep up with unprecedented demand. The global crisis revealed gaps in standard…
Etienne Nichols
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.
But as anyone in the industry can tell you, consistently getting the products and services you need to manufacture your devices is harder than it sounds. In…
Jennifer Chu
Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination. And in most cases, the wait time has to do with time-consuming steps in sample processing and analysis.
Now, MIT engineers…
NIST
Magnetic resonance imaging (MRI) machines can clearly view non-bony parts of the body—soft tissue such as the brain, muscles, and ligaments—as well as detect tumors, making it possible to diagnose many diseases and other conditions. However, the powerful magnets in conventional MRI machines make…
William A. Levinson
Starbucks’ implementation of artificial intelligence coffee makers1 offers a simple and ideal case study that can illustrate the synergy between efficiency, wages, profits, and inflation. Even if we don’t know the actual cost figures, we can use some hypothetical numbers to demonstrate how higher…
Peter Fader
As an organizational leader, you’ll be very familiar with your company’s key financial statements and monthly management reports. But what do you really know about the people who pull out their wallets and pay for your products and services? In The Customer-Base Audit: The First Step on the Journey…
Adam Zewe
Imagine purchasing a robot to perform household tasks. This robot was built and trained in a factory on a certain set of tasks and has never seen the items in your home. When you ask it to pick up a mug from your kitchen table, it might not recognize your mug (perhaps because this mug is painted…
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Kate Zabriskie
‘Who designed this convoluted process? A monkey could have done a better job.”
“Why do I have to come in and talk to someone? This whole transaction could be handled online. Frustrating!”
“I dread going there. The parking lot is impossible to navigate, you fill out what seems like 8,000 forms…
Etienne Nichols
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.
1. Start by learning about your…
FABTECH
Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them. That’s why the talent shortage in the metal fabrication industry continues to be a pressing concern—and three-quarters of respondents in the National Association of Manufacturers’ 2023 First…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
