All Features
William A. Levinson
The ongoing relevance of the quality profession requires evolution and adaptation to meet the needs of the 21st century. Remember, the quality profession originated with the need for inspection to prevent poor quality from reaching customers; this was before it evolved to include metrology,…
Akhilesh Gulati
It was another busy morning at the monthly operations meeting. Lindsay, the operations manager at TechElectronics, a growing manufacturer of consumer electronics, called the meeting to order. As usual, they started with the routine updates—inventory levels, production schedules, and customer…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Mike Figliuolo
Everyone has goals these days. The one that causes more disconnects than any other is a sales goal. It’s a number to hit (either units or dollars or both—the better ones are actually measured in profit dollars rather than revenue dollars). They’re problematic because by their very nature they get a…
Marian Merritt
Cybersecurity is a fast-growing field with a constant need for skilled professionals. But unlike other professions—like medicine or aviation—there’s no clear-cut pathway to qualifying for cybersecurity positions. For employers and job seekers alike, this can make the journey to building a team (or…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
ISO
A customer calls asking for details about how they are registered in your company’s database so they can make sure their information is updated. You get a phone call from a business partner who needs to contact your colleague and asks you to check her calendar to see when she’s free. Although in…
Mike Figliuolo
As leaders, we say we want our people to be empowered to go out and make decisions. We say we’re OK with them making mistakes, and we’ll still support them making decisions on their own. But not really.
I’m lucky to have a huge leadership lab in the form of the SmartBrief on Leadership weekly…
Michael Sharp
Welcome knowledge seeker! Do you feel dazzled and awed by the great potential of artificial intelligence (AI)? Perhaps hesitant or lost when terms like convolution, deep learning, or autoencoder are thrown around? Well, fear not, for you’ve come to just the right place. You don’t need to be a…
Brett Farmiloe
Struggling with underperforming team members while trying to maintain a positive work environment? To help navigate this delicate situation, we’ve turned to insights from CEOs and human resources managers.
We’ll explore six effective strategies HR leaders use to support and guide underperforming…
ISO
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality.
Whether manufacturing a…
Donald J. Wheeler
Managers are commonly fed a diet of report-card data. These data have usually been aggregated into summaries, averages, and totals to characterize the big picture. As useful as such summaries can be, they can also be an obstacle to an effective analysis. Here, we’ll learn how to avoid this obstacle…
George Schuetz
Whether you’re a small machine shop or a large multimillion-dollar manufacturing giant, there’s no doubt you use dimensional gauges to maintain the standards for quality in your production.
The accuracy of these dimensional measuring instruments must be periodically checked to ensure that they’re…
Mike Figliuolo
We’re constantly seeking ways to both improve our business but save money at the same time. That can lead to the dangerous dynamic of “I’ll do it myself.”
Doing more with less can turn us into idiots. Our hubris and arrogance puts our idiocy into action. Sorry—I got a little ranty right out of the…
George Thuo
Data breaches and cyberattacks are things that small to medium-size manufacturers think won’t happen to them. Yet, according to the Verizon 2023 Data Breach Investigations Report, 43% of all cyberattacks are conducted against small businesses.
If that doesn’t grab your attention, consider this…
Enoch Li, Derek Deasy
Leadership happens in groups, as does most work. Without followers, who and what are we leading? Given that, leaders must understand what groups need if they want to maximize performance. Although most leaders should be familiar with executive coaching on an individual basis, they might know less…
Courtney Kinkade
At a time when Americans already owe more than $1.6 trillion in student loans, and the cost of college continues to rise, some young people are defying the traditional route of a four-year degree. Established professionals looking for a career change aren’t necessarily going back to college.…
Mike Figliuolo
I recently went to Kings Island amusement park with the kids. Beyond experiencing the thrill of $9 sodas and wicked awesome roller coasters, I learned a few things about professional development while I was there.
Some of you love roller coasters, and some of you hate them. I used to hate them,…
Donald J. Wheeler
An engineer once told me, “I work on project teams that have an average half-life of two weeks, implementing solutions with an average half-life of two weeks.” Time after time, and in place after place, our improvement efforts often fall short of expectations and fade away. In this article, I will…
Ronald Cowen
Even before Shamir Maldonado-Rivera graduated from the University of Puerto Rico in 2019 with an applied physics degree, she had already picked out her dream job working with semiconductors.
The only problem was that she lacked the hands-on experience.
Her university studies hadn’t given Maldonado…
Chris Rush
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Mike Figliuolo
Leadership is perilous territory. People’s lives are at stake (sometimes literally). Although avoiding the following seven deadly sins won’t guarantee you’ll be a great leader, succumbing to them will guarantee you’ll have a significant learning moment. (Translation: You’ll fail miserably, but…
Stephanie Ojeda
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Harish Jose
In this article, I look at the idea of “sweeping-in” in systems approach. Sweeping-in can be described as the process of opening up the inquiry of a system by expanding its boundaries. Philosopher and systems scientist C. West Churchman discussed this process in several works, including Thought and…
Adam Zewe
Despite their impressive capabilities, large language models (LLMs) are far from perfect. These artificial intelligence models sometimes “hallucinate” by generating incorrect or unsupported information in response to a query.
Due to this hallucination problem, an LLM’s responses are often verified…
