All Features
Elizabeth Weddle
Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options for outsourcing and new technology like 3D scanning…
Ken Eme
When I first became involved in lean (continuous improvement), I was the VP of operations at a privately held company in the Midwest. It was 2003, and as a newly promoted senior executive I was eager to find a strategy that could make a real difference in our operations.
I quickly realized that…
Harish Jose
In this article I want to spend time with Søren Kierkegaard. I’ve been interested in his ideas because he occupies an unusual place in the history of thought. He’s considered a pioneer of existentialism, and yet he was also a man of faith.
Most of the existentialist thinkers who followed him,…
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…
George Yang
Your IT team enabled Copilot and Gemini last quarter without checking with the lawyers. Now your employees are putting company secrets into systems that nobody owns, nobody governs, and nobody can reliably retrieve when opposing counsel sends a subpoena.
You have a discovery problem, and it’s…
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…
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…
ISO
In today’s digital age, the question isn’t whether you’ll experience a cybersecurity attack, but when this might occur. Cybercriminals strike when you least expect it, with devastating consequences for your day-to-day operations. If your organization is lucky, it can block the attacker and limit…
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…
Enver Yücesan
Digital twins have become indispensable tools across industries. Powered by AI, these virtual constructs mirror physical systems in complex manufacturing facilities, supply chains, and operational workflows. By continuously monitoring their physical counterparts and feeding back recommendations,…
Sierra Miller
Growing up in rural Pennsylvania, I didn’t have scientists for role models. In fact, I’m the first woman in my family to get a college degree, much less become a scientist.
I attended underfunded public schools where we didn’t have science, technology, engineering, and math (STEM) education beyond…
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…
ETQ—Part of Hexagon
Even the smallest manufacturer would never consider using a typewriter to develop an invoice, or manage a sales prospect list from a Rolodex. So why, when it comes to quality management, are they often still using manual methods or home-brewed software that was never intended for today’s quality…
Rick Herman
Amidst uncertainty in manufacturing, AI adoption, labor market fluctuations, and salary disparities across industries and geographic regions, quality professional compensation can be difficult to navigate.
Without current job-level salary benchmarks, quality professionals from technicians to…
Donald J. Wheeler
One of the principles for understanding data is that while some data contain signals, all data contain noise. Therefore, before you can detect the signals you’ll have to filter out the noise. This act of filtration is the essence of all data analysis techniques. It’s the foundation for our use of…
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…
Erdem Dogukan Yilmaz, Tim Meyer
From the internet and smartphones to 3D printing, recent decades have ushered in general-purpose technology that increases efficiency and collapses the cost of routine tasks. The latest general-purpose technology—you guessed it, generative AI (gen AI)—has the potential to also extend the frontiers…