All Features
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Mike Figliuolo
Most companies fail due to dumb mistakes made by senior managers. The biggest mistake of all: a hubristic unwillingness to accept that there’s plenty you don’t already know.
As we get more senior in our organizations, we get a lot smarter. Our wisdom grows. We understand the business better than…
Gleb Tsipursky
In an era when flexibility and autonomy are requirements, financial services leaders are ready to break the chains of traditional office norms. The results of a recent Deloitte and Workplace Intelligence survey make it clear: The future of the financial services sector is hanging in the balance,…
Phil Chadderdon
Workforce challenges these days are never-ending, not just for manufacturers but across the business spectrum. You have to be on top of your game to be successful building a talent pipeline, recruiting and hiring, onboarding and training, creating an engaging workplace culture, and promoting career…
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
Harry Hertz
I enjoy solving puzzles! I start each morning by doing at least two New York Times puzzles, Wordle, and Connections. My wife and sons and their spouses do the same, although not necessarily as part of their early-morning routine (except on weekends). We have a texting thread where we each report…
Aymen Saidane
As the manufacturing world pushes toward the goal of zero-defect production, part inspection is critical. Sheet metal’s thinness, coupled with its susceptibility to warping, demands precision inspection—even the most minor deviations have significant implications down the line. This underscores the…
Poornima Apte
When Alexander O’Brien sent in his application for graduate school at MIT’s Department of Nuclear Science and Engineering, he had a germ of a research idea already brewing. So when he received a phone call from Professor Mingda Li, he shared it: The student from Arkansas wanted to explore the…
Mike Figliuolo
Have you ever met someone who was fired from their job? I’ll bet you $50 they said, “Yeah, I never saw it coming.” For some reason, getting canned always comes as a shock to people. They’re clueless as to how bad they’re doing and how close to the door they are.
Makes you wonder: Are you close to…
Tim Heston
At Metalworks Inc.’s main plant in Lincoln, Nebraska, co-founders Rob Ernesti and Doug Swanson walked past a new punch/laser system being tested, complete with part removal and stacking automation. It’s one piece of a value stream dedicated to a family of parts. They next walked by a row of small…
ISO
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need for…
Bryan Christiansen
Deciding whether to repair or replace an asset can be difficult. That’s why maintenance and reliability managers perform an analysis to determine whether it’s more economical to repair a failing asset or replace it with a new one. This process helps minimize total costs while ensuring that your…
Adam Zewe
Imagine grasping a heavy object, like a pipe wrench, with one hand. You would likely grab the wrench using your entire fingers, not just your fingertips. Sensory receptors in your skin, which run along the entire length of each finger, would send information to your brain about the tool you are…
John Davis
Over the past decade, one of the biggest advances in enterprise resource planning (ERP) has been the ability to communicate and integrate with machines and external software programs to lower costs and increase efficiency. For example, BOM Compare software can reduce engineering costs and get jobs…
Mike Figliuolo
I’m going to take over the world! It’s really fun to say that. It’s even more fun to take action toward that goal.
Our world has gotten smaller. Way smaller. Globalization is an unstoppable trend. But as they say, the trend is your friend, so why not take advantage of it? I don’t care how big or…
Mark Rosenthal
This all happened nearly three decades ago. Since then, the company has been through a series of mergers and acquisitions. Thus, the only thing I can be certain of is that things are different today—at least I hope so.
It was Tuesday afternoon of a traditional five-day kaizen event. Monday morning…
Matthew Greenwood
It’s no secret the automotive sector is racing to find ways of tapping the potential of generative artificial intelligence (GenAI) to design and build the next generation of vehicles. This technology has promise, from redefining manufacturing processes to helping carmakers design smarter, safer,…
Sabine Terrasi
Robots do monotonous workflows and less pleasant, repetitive tasks with brilliance. Combined with image processing, they become “seeing” and reliable supporters of humans. They’re used in quality assurance to check components, help with assembling and positioning components, detect errors and…
Wael William Diab
Artificial intelligence (AI) is everywhere—and that’s something to marvel at. AI is powering everything from advanced web searches to social media recommendations and video game design. But it could do infinitely more.
AI has the potential to revolutionize our societies and economies. Discussions…
Guillaume Roels
In January 2023, Shopify deleted 12,000 recurring meetings from its staff’s calendars. The e-commerce firm also reinstated a no-meeting Wednesday policy. The idea wasn’t to prevent meetings from happening, but for staff to be intentional about them. In addition, it sent a clear message that it was…
William A. Levinson
Valuable American manufacturing jobs were sent offshore under the dysfunctional belief that low-wage labor would result in lower product costs and higher profits. Although it may seem counterintuitive, manufacturers do better with high-wage workers who will acquire skills, follow work standards,…
Chandrakant Isi, Francesco Rivalta
You’re in an early-stage hardware startup or a tinkerer in a toolshed with a product design set to shake up the market. Not sure how to turn your idea into a product? Here’s a step-by-step guide to the product development journey. From the initial design sketched out on paper to the final product…
Mike Figliuolo
Some people advocate giving good feedback before and after bad feedback. Doing so is actually harmful. Instead, good leaders deliver tough feedback directly.
Every once in a while history repeats itself—and those who fail to learn from it are doomed to repeat it. This post is in the spirit of that…
Kristopher Lee
A leader in asset integrity management and inspection services, Kakivik Asset Management recently held an intro to phased-array class at its Anchorage, Alaska, office. The training was attended by nearly two dozen ultrasound specialists and was conducted by Shane Walton from the University of…
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…