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…
Ray Chalmers
All manufacturing companies must manage an ever-growing mountain of priceless inspection data. Yet measurement results, process iterations, and approval reports are scattered across hard drives and USB sticks. We live in a digital world that advances daily, yet obtaining, accessing, sharing, and…
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…
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…
Mike Zecchino, Mark Malburg
Choosing the correct instrument for surface texture measurement can be confusing, given the wide range of options. Stylus-based instruments are the most prevalent in manufacturing. Yet, measuring a surface with a sharp stylus can seem old-fashioned when so many noncontact optical techniques are now…
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…
Jeff Dewar
When we set out to film Episode 2, we faced a fundamental challenge: How do you make people care about errors they can’t see?
(See all the episodes here.)
Error propagation is critical to metrology, the science of measurement, but it’s abstract. These are mistakes measured in tiny amounts that…
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…
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…
Dirk Dusharme
In Episode 1 of The Quality Digest Roadshow, we talked about metrology standards and how those standards and traceability are the glue that holds industry together. While measurement standards are critical, they’re useless without the equipment, processes, and people that use the tools that measure…
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…
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…
George Schuetz
All gauging equipment must be calibrated periodically to ensure it can perform the job for which it’s intended (i.e., measuring parts accurately).
This is true for every hand tool or gauge used in a manufacturing environment that verifies the quality of parts produced—from calipers and micrometers…
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…