All Features
Mike King
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
The landscape for quality and regulatory affairs (QARA) professionals continues to shift, driven by emerging AI capabilities, changing…
Melanie Morales
In modern manufacturing, the smartest factories know that safety comes first. Any injury, equipment problem, or unexpected stop can slow everything down.
The good news? The right equipment updates can reduce many of these risks. From tool balance systems to better cable management, the right…
Gleb Tsipursky
The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee. Promoters like McKinsey call it the agentic AI advantage.
Then you put these systems on real client work and the wheels come off. The newest empirical…
Dan Steele
For years, manufacturers have been told the future of Industry 4.0 lives in the cloud. Vendors promised plug-and-play AI that could analyze everything, automate anything, and transform the factory floor overnight. In theory, this appears to work, but operationalizing cloud-based AI isn’t always…
Maartje van Krieken
Performance rarely collapses with fanfare. More often, it flatlines quietly; sales soften, productivity slows, priorities blur, and yet teams run hard without moving the needle. In 2025, the RSM U.S. Middle Market Business Index slid from the low 140s into the low 120s in a short period, with fewer…
Bennie Caldwell
In manufacturing, failure isn’t an option—it’s a liability. A defective part or a missed delivery triggers a chain reaction that can disrupt schedules, undermine trust, and drain resources.
So when someone suggests a strategy with the word fail in it, skepticism is understandable, because…
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…
Leif Nyström
Management by objectives isn’t just a way to set direction for an organization. It’s a prerequisite for creating sustainable development and a culture of continuous improvement.
True success, however, comes not just from setting goals, but from ensuring they are actually achieved. Or, to…
Paul Hanaphy
Regular inspection is absolutely vital with industrial transmission systems. Just like the gearbox in an everyday car, components are prone to wear, misalignment, and fatigue—issues that can lead to machinery failure. This isn’t just a matter of downtime but operator safety, too.
Traditionally,…
Akhilesh Gulati
I’ve had this conversation countless times—sometimes with a frustrated client, often with a colleague, and occasionally with my own reflection.
We hear familiar calls for help:• “We need better communication.”• “People need to collaborate more.”• “We’ve lost our culture.”
These observations show…
Adam Grabowski
What’s truly holding your discrete manufacturing shop back from reaching its full potential? It’s often not the commonly cited culprits like labor shortages, razor-thin margins, or fierce competition. It’s more often paper: the unseen, insidious enemy.
Imagine your shop floor: stacks of traveler…
Gleb Tsipursky
The conversation about generative AI (gen AI) is unavoidable in today’s business landscape. It’s disruptive, transformative, and packed with potential—both thrilling and intimidating.
As organizations adopt gen AI to streamline operations, develop products, or enhance customer interactions, the…
Harish Jose
In this article I’m looking at a question that’s rarely asked in management: What if the most responsible course of action isn’t to maximize benefit, but to minimize harm? In decision theory, this is expressed as the minimax principle. The idea is that one should minimize the worst possible outcome…
Mike Figliuolo
Staff meetings can be incredibly productive. Or unproductive—and more often the latter. If your staff meetings are terrible, it’s your fault because you’re not structuring them well.
One of the most surreal business experiences I’ve ever had relates to a staff meeting. I’d joined a new team, and…
Bryan Christiansen
From manufacturing and mining to hospitality and healthcare, computerized maintenance management systems (CMMS) have become all but essential. Wherever there are assets to maintain, a CMMS plays a critical role in reducing downtime, controlling costs, and keeping operations running smoothly.
But…
Harish Jose
In this article, I want to explore an idea that often is framed in moral terms but is actually a cybernetic imperative: the necessity of diversity for viable systems. Whether we’re talking about societies, organizations, or even artificial intelligence systems, the principle remains consistent. A…
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…
Adam Zewe
What can we learn about human intelligence by studying how machines “think?” Can we better understand ourselves if we better understand the artificial intelligence systems that are becoming a more significant part of our everyday lives?
These questions may be deeply philosophical, but for Phillip…
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…
David Schwinn
I’ve been in and around the quality profession for decades. When I first started, we were most concerned about products failing in our customers’ hands... too often and too soon. I worked at General Motors in those days, in the Frigidaire division when Frigidaire was part of General Motors. We made…
CANEA
The role of quality leaders, and quality itself, is expanding. It includes thinking strategically, solving problems, implementing improvements, and driving change throughout the organization.
Quality leadership also requires managing challenges and anticipating what lies ahead regarding quality…
James Glover
Your facility has detailed standard operating procedures (SOPs), ISO certifications, and quality management systems that would impress any auditor. But operators still skip calibration checks when production is behind, modify machine settings without authorization during shift changes, and forget…
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…