All Features
David Hall Rode
In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters. A notable enforcement surge occurred in September 2025 when the FDA released 80 warning letters in a single week. Although…
Troy Harrison
Here’s something nobody saw coming: The generation most skeptical of AI isn’t the one that doesn’t understand it. It’s the one that understands it best.
Every new technology faces resistance. The internet? A fad. Smartphones? Unnecessary. Social media? A waste of time. But tech skepticism has…
Stephen Russek
In the evenings, after patients have left for the day, our research team visits the radiation oncology offices at the University of Colorado Anschutz Medical Campus to talk to medical physicists about how our research can help cancer patients. We also run experiments in their radiation suites.
The…
Felicitas Stuebing
At the corner of quality and assembly, design engineers are frequently confronted with unexpected, complex fluid process issues in the prototyping phase. These obstacles are reflected in voice-of-customer sprints and surveys revealing that medical devices companies in particular stall out in the…
ISO
In 2021, container ships idled for weeks outside the Port of Los Angeles, a stark visual reminder of just how fragile modern supply-chain reliability had become. The backlog sent shockwaves across industries. Factories stalled, shelves emptied, and businesses scrambled for alternatives. It was a…
Elizabeth Weddle
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they…
Stephanie Ojeda
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…
Nimax
The global coding- and marking-equipment market is on a clear growth path. As shown in a recent Grand View Research report, the market was worth $17,528 million worldwide by the end of 2024.
Furthermore, GVR’s projections estimate the market value will reach $24,927 million by 2030, with a…
Adam Grabowski
To stay profitable as a manufacturer, you have to run a tight ship. I’ve been lucky enough to visit with owners and key people at thousands of manufacturers all over the world. My main goal during these visits is to listen and learn what makes them so good at what they do.
It turns out that the…
Chip Bell
One hour after takeoff from London’s Heathrow Airport on an intercontinental flight to the U.S., the pilot announced the aircraft was returning, “because my windshield just shattered.” After gasps from passengers, he calmly announced there was no danger, but there would be a long delay to secure…
Creaform
In motorsport, performance isn’t defined by a single factor. It’s the sum of countless details, each playing a decisive role when pushing speeds up to 200 mph (320 km/h). From how a driver sits in the car to how the bodywork complies with strict regulations, accuracy can mean the difference between…
Stephanie Ojeda
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting there can be a misstep. Without the right…
William A. Levinson
My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason for warning letters, and also introduces the role of failure mode effects analysis (FMEA) in preventing trouble in the first place. The U.S. Food and Drug…
Lexi Sharkov
We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily…
Dolf van der Haven
When businesses talk about customer experience, the conversation almost always focuses on the end user. That’s understandable, but dangerously narrow. In modern service ecosystems, particularly those governed by service integration and management (SIAM), the customer experience depends just as much…
Troy Harrison
A recent company meeting revealed what management called a “handoff problem.” The sales team would close deals, then toss them over the wall to the service team, which would promptly fumble the relationship because they didn’t understand what had been promised or why the customer bought in the…
Maartje van Krieken
Your market is shifting, your competitor just pulled ahead, and the one person who could execute the next move has resigned. You can’t get more data fast enough, yet the window to act is closing. In today’s volatile, uncertain, complex, and ambiguous (VUCA) world, this is the moment that defines…
Global Shop Solutions
Small to midsize manufacturers are facing mounting pressure from unpredictable supply chain disruptions. From fluctuating customer demand to reshoring operations and diversifying suppliers, maintaining efficiency and protecting cash flow have never been more critical.
Global instability, shifting…
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.
One notable…
Annie Wilson, Professor Ryan Hamilton
Nano Tools for Leaders, a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management, are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success and the engagement and…
Frank King
At Ramirez & Co., a midsize business with decades of wins, leadership thought its biggest challenges were competitors, technology, and the market. Close, but no cigar. The real problem was stress, the silent drain that doesn’t show up on a Gantt chart but still wrecks your timeline.
Deadlines…
Judy Fainor
What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?
It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet. What we do have is…
Mike Regan
In July 2024, CrowdStrike rolled out a software update that crashed more than 8 million Windows systems worldwide. The faulty release disrupted hospitals, grounded flights, halted banking operations, and affected government services. Comparable to a major cyberattack, the incident caused more than…
William A. Levinson
A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…
Carl Lewis
Manufacturers are making more types of products than ever before. According to Deloitte’s Consumer Products Industry Outlook, 95% of consumer product executives report that launching new products is a top priority this year, and 67% are allocating more resources to developing truly novel offerings…