All Features
Kelley Jacobsen
As global trade uncertainty intensifies, health systems should take steps to minimize the effect of this volatility on their medical equipment inventory. The evolving policies of the United States and its trading partners could strain global supply chains and make acquiring or maintaining medical…
Akhilesh Gulati
As director of quality at a manufacturing plant, James faced the reality of shift every day. As the plant embraced new technologies and adapted to changing global dynamics, he knew that quality management could no longer be reactive. The question was whether he could turn these shifts into…
Etienne Nichols
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations…
Gleb Tsipursky
Once hailed as both an ethical mandate and a strategic necessity after the upheaval of 2020, diversity, equity, and inclusion (DEI) initiatives now face intense scrutiny and pushback. Major corporations—ranging from Walmart to Google—are quietly retreating from these programs amid escalating…
Stephanie Ojeda
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.
This article explains the difference between a deviation and a nonconformance, and why…
Quality Digest
If you’re a corporate employer, you must know the importance of training and its effects on your firm’s growth. Teaching employees with the help of corporate training is an essential step that every firm should follow to reach its goals. Additionally, incorporating OSHA training ensures workplace…
Brookhaven National Laboratory
Researchers use a technique called resonant inelastic X-ray scattering, or RIXS, to study the electronic behavior of quantum materials. The image above illustrates an ultrabright X-ray striking a quantum material’s electrons (gray circles) and scattering off the sample. In this example, the X-ray’s…
Seb Murray
What happens when workers get a say in evaluating their managers? At one Chinese carmaker, the results speak for themselves: happier teams, better leadership, and a noticeable boost in productivity—without a single downside. Those are key findings of a recent study by Wharton associate professor of…
Akli Adjaoute
Keeping quality high in today’s fast-moving production world is a big challenge. Traditional quality checks have worked well, but they can be slow, require a lot of work, and are prone to mistakes.
AI could change this by making quality control faster, more accurate, and easier to scale. It could…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
Michael Mills
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…
Chip Bell
Innovation is vital to the success of all businesses. Innovate or perish is the new mantra. Leaders must perpetually reinvent their processes, products, and services, because they typically have multiple competitors offering similar offerings. Only through innovation can most organizations…
Scott Ginsberg
Manufacturers face a critical challenge: capturing, standardizing, and scaling workforce knowledge. Skilled workers are retiring, and labor shortages are persisting. Outdated, paper-based documentation can no longer keep up. These methods create bottlenecks that slow productivity and make vital…
Felipe Monteiro
Global risks are rising, and many companies are struggling to adapt. The World Economic Forum’s 2025 Global Risks Report makes it clear that challenges like escalating global tensions and conflicts, climate change, economic instability, and supply chain disruptions are interconnected and build on…
Gleb Tsipursky
One transformative strategy that can revolutionize how organizations embrace generative AI is peer mentoring. By leveraging the power of personal connections and shared expertise, peer mentoring accelerates learning, fosters collaboration, and fuels innovation. When mastering gen AI tools can mean…
Torsten Schimanski
Workforce development is an essential yet frequently overlooked aspect of supply chain management in manufacturing. Similar to how disruptions in material sourcing or logistics can halt operations, talent shortages and skill gaps create bottlenecks that jeopardize efficiency, quality, and growth. …
Donald J. Wheeler
Outliers are values that don’t “fit in” with the rest of the data. These extreme values are commonly considered a nuisance when we seek to summarize the data with our descriptive statistics. This article will show how to turn these nuisances into useful information.
The earliest statistical tests…
Steven Ouellette
Many industries, from aerospace to medical device manufacturing, are required to show customers, auditors, or regulatory bodies that their measurement devices are acceptable for use. But how do you prove that?
One of my clients needed to show the Biomedical Advanced Research and Development…
Oliver Franz
Maybe you’re pulling reports from three different platforms, trying to reconcile numbers that don’t quite match. Maybe you’re manually copying and pasting from multiple spreadsheets, hoping you didn’t introduce any errors along the way. Or maybe you’re waiting on IT to clean up, prep data, and…
IDS Imaging Development Systems
The slit-lamp examination is one of the most important diagnostic techniques in ophthalmology. It enables a detailed examination of the anterior, middle, and posterior segments of the eye. Ophthalmologists can use it to recognize the smallest changes, anomalies, or damage. This procedure is used…
Matt McFarlane
The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030. New technology, new opportunities, and, as always, the promise of improving patient outcomes around the world are major drivers of growth within…
Christine Schaefer
José Pires, founder and CEO of Global Excellence & Innovation, has helped large and small organizations across multiple industries transform their leadership to achieve better results. Based on his decades of experience guiding organizations toward performance excellence, innovation, and…
Oak Ridge National Laboratory
Working at nanoscale dimensions, billionths of a meter in size, a team of scientists led by the U.S. Department of Energy’s Oak Ridge National Laboratory (ORNL) revealed a new way to measure high-speed fluctuations in magnetic materials. Knowledge obtained by these new measurements, published in…
Mark Hembree
Some people don’t feel like they’re working unless their hair’s on fire. Somehow, they think it’s admirable to be feverish at a frenzied pace, breathless and full of urgency, turning tasks in record time and pushing the team to accelerate. Surely others will take notice and marvel at such hard work…
Angelina Rivera
Manufacturing is a fast-paced, constantly evolving, and dynamic environment, and the supply chain is at its heart. For small and medium-sized manufacturers (SMMs), navigating the complexities of the supply chain often feels like a high-stakes balancing act. From juggling fluctuating material costs…
