All Features
NIST
Stain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have found…
Mike Figliuolo
Many people proclaim they are gurus, ninjas, and other silly titles. Giving yourself such a title can cause people to lose respect for you, and it can cost you credibility.
Titles matter. A lot. So do email addresses and signature blocks. As unfortunate and as shallow as it is, people make a first…
Stephanie Ojeda
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
Melissa Burant, Marc Schneider
As a manufacturer, you understand that supply chain disruptions happen all the time. What you don’t know is when or how they will affect your operation and business. But assessing your supply chain risks and implementing good supply chain management practices can be daunting. This is especially…
Michael King
In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.
Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them to elevate…
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Mike Figliuolo
Is the customer really always right? We throw that comment around haphazardly without truly considering the ramifications of such an approach. I’d submit that they’re not. There are plenty of times the customer is wrong (and sometimes, very much so).
First, let’s explore the implications of a “…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Mike Figliuolo
If you have a new business idea, I’m excited for you. If you ever want to get it off the ground, however, be sure you have a problem. A real problem. I know that sounds cryptic. Allow me to explain.
When I hear a new pitch, the first question I ask is, “What’s the problem?”
You would be surprised…
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…
