All Features
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…
John Tschohl
Speed is one of the most strategic elements a company can use to attract and retain customers and drive its revenues.
What do I mean when I talk about speed? In this context, speed means dramatically reducing the amount of time needed to complete a task by altering factors such as empowerment,…
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…
Jones Loflin
Recently, while driving through North Dakota on a crisp fall evening, I found myself surrounded by the sights and sounds of harvest. Combines and trucks moved through golden cornfields, reaping the season’s bounty. I imagined the farmers, exhausted but satisfied, reflecting on the season’s…
James Chan
Facility and equipment maintenance is most effective when performed proactively and regularly. This kind of routine maintenance can take many forms, ranging from the most basic approaches to complicated strategies using sensors and data to trigger maintenance. Time-based maintenance (TBM) is a…
Gleb Tsipursky
The recent $22.1 million verdict in the case of Billesdon vs. Wells Fargo Securities has cast a spotlight on the increasing legal risks companies face when they ignore work-from-home (WFH) requests under the Americans with Disabilities Act (ADA). This landmark case underscores the critical need for…
Bruce Hamilton
For an organization to develop a sustainable, continuous improvement culture, it must, as we say at Greater Boston Manufacturing Partnership, involve everybody, every day—i.e., process improvement must become an everyday part of everyone’s job. That’s the ideal.
The reality, however, according to…
Mark Graban
It’s a story I’ve heard too many times: An organization spends years, even decades, entrenched in a top-down, command-and-control culture. In this environment, employees are micromanaged, decision-making is reserved for those at the top, and when things go wrong, the finger-pointing begins. “Blame…
Mohammad Mahdi Zare
Remote work is now an essential part of the modern workplace, offering flexibility and convenience to millions of employees worldwide. However, with this shift to home offices and flexible workspaces comes a new set of security challenges. Remote workers face a unique set of risks, and businesses…
Joshua Zable
Everyone has their own favorite graph type or visual tool. I’m not ready to declare this my favorite yet, but this oldie but goodie has got to get more time and attention. That’s right: I’m talking about control charts with stages, also sometimes called before/after control charts.
If you’re not…
Mike Figliuolo
We’ve already talked about what a strategic plan is (and isn’t) in our discussion: “Strategic Planning Isn’t ‘Budget +10%.’” Hopefully, you’ve now got a direction mapped out and a list of initiatives to pursue, and you’re ready for a little tactical strategic advice. (Yes, that phrase is supposed…
Zach Winn
Most doctors go into medicine because they want to help patients. But today’s healthcare system requires that they spend hours each day on other work—searching through electronic health records (EHRs), documenting, coding and billing, gaining prior authorization, and evaluating services—that often…
Akhilesh Gulati
A few days after returning from a speaking engagement at the Innovate for Excellence Summit in Chicago last September, I spoke to Susan, an old classmate. We chatted for a while, and naturally the conversation drifted toward innovation—something we’re both passionate about. She asked me about my…
Mark Hembree
If you’re reading this, you probably read a lot. You’ve made your way through all our industry news, keeping tabs on trends in our feature stories and gleaning a greater understanding of your own business—at least we hope so.
And if you read this much, it may be that you do a fair amount of…
Harry Hertz
How do you treat signs when you’re driving your car? Are you a strict rule follower? Does a stop sign cause you to come to a full stop, or a rolling stop, or no stop at all if you see no traffic? What about that intersection you go through every day, where you never see a car approaching from any…
Scott Crow
W ithin the utility industry, regional entities increasingly focus on internal controls as a measuring stick for overall compliance performance.
Developing and executing rock-solid internal controls with an automated compliance management software solution can help maintain compliance, not only…
ISO
Modern-day security breaches, such as the SolarWinds or T-Mobile attacks, aren’t one-off events; they are prime examples of how someone can steal your organization’s credentials and use them to gain illegitimate privileged access to sensitive assets. Data breaches happen daily, and in too many…
Scott Ginsberg
Despite the industry’s push toward digital transformation, 95% of manufacturers use paper-based documentation, according to Forbes. But modernization doesn’t have to be overwhelming for manufacturing teams.
When implemented strategically, digital documentation can improve processes, enhance…
Gleb Tsipursky
Despite the clear benefits of hybrid work models, a significant number of managers still push for their teams to be back in the office. A KPMG report of responses from 100 CEOs of large companies shows that more than a third expect to have all corporate workers back to the office full time by 2027…
Donald J. Wheeler
All improvement efforts require a framework. No matter what we’re doing, we all need some way to align our efforts and focus on a specific objective. During my 50 years in this business, I’ve seen people use many different improvement frameworks. Most of these have been variations on either PDSA (…
Steve Ilmrud
As we approach 2025, one of the most pressing challenges manufacturers face is a growing labor shortage. Research anticipates that 1.9 million jobs will go unfilled during the next decade. This issue, compounded by the retirement of experienced workers and the lack of interest from younger…
Mike Figliuolo
This ain’t your daddy’s or mommy’s business world anymore. I’m sure you’ve figured that out already. First of all, people use cell phones. I keep reminding my father.
“Dad, turn on your cell phone when you’re not home.”
“Why? Then it will ring. I’m retired, and I don’t want to be bothered by…