All Features
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Akhilesh Gulati
In the world of operations and quality management, the pressure to act quickly can feel overwhelming. Senior executives are constantly racing against time to meet customer demands, solve problems, and keep shareholders satisfied. In the rush to address immediate challenges, “Ready, aim, fire!” gets…
Silas Fulsom
In today’s highly competitive global markets, lean manufacturing is no longer something that’s nice to have—it’s a way of life. You can either reduce costs, simplify operations, and improve productivity on a continual basis—or you can lose business to competitors that do.
Lean manufacturing starts…
Megan Wallin-Kerth
It’s 2024, and the age of automation has largely taken over our phones, computers, and businesses. This isn’t entirely a bad thing, you understand. It gives us the ability to spend time and money elsewhere—from investing in staff to spending more time on innovating technology rather than whittling…
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,…
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…
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…
Etienne Nichols
A quality management system (QMS) is at the heart of every successful medtech company. A QMS comprises all the policies, processes, and procedures that ensure the production of safe and effective medical devices—which means that problems with your QMS can quickly become problems with your products…
Chip Bell
Is your organization about fun? How often do your customers giggle? How much of your business strategy is about funniness—not just entertainment, but customer experiences made joyful by design? What are your customers’ principal memories of their encounters with your organization?
Before we go too…
Akhilesh Gulati
In the ever-changing world of quality management, the intersection of innovation and standardization offers both exciting opportunities and tough challenges. Maria, a dedicated and certified quality professional, struggled with the concept of “standardizing innovation”—something that seemed like an…
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…
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…
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…
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…
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…
Quality Digest
(CIMdata: Ann Arbor, MI) -- CIMdata, a global PLM strategic management consulting and research firm, announces the release of a new white paper, “SSI Shipbuilding PLM: PLM Tailored to Unlock Shipbuilding Transformation.” The paper describes the evolving capabilities of SSI’s Shipbuilding PLM as…
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…
Mei Lee Ngan
I once transformed my face to look like Ron Swanson—for science.
I never thought disguising myself with wigs and makeup would be part of my job, but as a NIST facial recognition researcher I sometimes do just that. To make myself look like the gruff character from the show Parks and Recreation, I…
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…
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…
