All Features
Sara Adams
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they should even initiate a CAPA.
When companies…
Harry Hertz
Hybrid workspace, societal well-being, and productivity: On the surface, these three concepts aren’t obviously related. But permit me to explore each of them in the context of our current environment, and then conclude with a proposal for organizations to consider that could improve organizational…
David Dewhirst
Digital transformation initiatives that aim at getting manufacturers to Industry 4.0 have been around a while and will assuredly continue to be with us for quite a while longer. But what can often get lost by manufacturers in the push to digital transformation are the reasons why one would want to…
Mikhael Khaimov
Today thousands of technologies and solutions help businesses improve efficiency, create better products, evolve faster, and so on. A digital twin is a technology that deserves a closer look, especially if your goal is to improve business performance and reduce costs.
What’s a digital twin, and…
Adriana Lynch
If there’s anything the last decade has taught us—and the Covid-19 pandemic has punctuated in grand fashion—it’s that businesses must get digital or they may become invisible. Branding, formerly an exercise that involved plastic signs, billboards, and newspaper print ads, has now firmly taken up…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Shannon Karels, Kathy Miller
Many tools and concepts can be applied when implementing a transformation in a business. But what makes the transformation meaningful? What is the thing that will drive the transformation’s success?
It’s not how well standard work is written or the number of pull cards in the loop, although it’s…
Sana Kazilbash
The 3MF Consortium recently announced its latest volumetric design extension for encoding geometrical shapes and spatially diverse properties through a volume-based description. The organization, which seeks to advance a universal specification for 3D printing, is currently calling for public…
Theodoros Evgeniou, Caroline Zimmerman
This isn’t a new story: A novel technology disrupts society, bringing with it many benefits but also major risks and costs. We saw it during the Industrial Revolution, which vastly improved the average living standard but also led to poor labor conditions and environmental degradation, all within a…
Derek Hills
The importance of medical device cybersecurity is growing exponentially. As more devices become connected to the internet, threats to public safety mount. Cybercriminals, formerly interested in stealing financial or medical records, have begun to essentially hold healthcare providers hostage by…
Sachin Waikar
‘Diversity means lots of things,” says Amir Goldberg, an associate professor of organizational behavior at Stanford Graduate School of Business. “These days, it evokes the idea of race or gender, but it’s also about how people think.”
Beyond their demographic differences, people working in a group…
Tahira Reid, James Gibert
People interact with machines in countless ways every day. In some cases, they actively control a device, like driving a car or using an app on a smartphone. Sometimes people passively interact with a device, like being imaged by an MRI machine. And sometimes they interact with machines without…
Ryan E. Day
Chickens come home to roost, and canaries meet their demise in coal mines. But hey, we knew there was a high probability of each happening eventually, right? However, when a black swan shows up with severe impact and consequences, everyone is caught off guard. I’m wondering if it’s a black swan…
Rebecca Saenz
There are three key things cobot developers and employers using cobots must remember when considering implementation: 1) human life takes precedence, 2) human life takes precedence, and 3) human life takes precedence.
Dictionary.com defines cobot as “a computer-controlled robotic apparatus that…
Bert Thornton, Sherry Hartnett
The past two years have been tough. Many of us are feeling bogged down, burned out, and wary of what the future holds. But instead of creeping into 2022 with a sense of dread, what if you bounded into it with optimism and confidence?
Yes, there’s a way to revitalize your career, your outlook, and…
Megan Wallin Kerth
In the wake of manufacturing and chip shortages, some may think that Covid-19 slowed down production on the whole as supply chain issues and remote work presented significant obstacles for manufacturers. However, there were both struggles and some unexpected benefits that arose as professionals…
Katie Rapp
For manufacturers, artificial intelligence (AI) can be a game changer. Greater efficiencies, lower costs, improved quality, and reduced downtime are just some of the potential benefits. This technology isn’t just for large manufacturers. High-value, cost-effective AI solutions are more accessible…
Prasad Akella
We are a full two years into post-pandemic manufacturing life, with the omicron variant the latest cause for concern. It might sound hyperbolic, but I’m pretty sure manufacturing will never be the same as it was in 2019. In some ways, that’s a good thing.
One silver lining of the novel coronavirus…
Ben Bensaou
A manufacturer of the fabric used to reinforce car tires might not seem an obvious source of innovation inspiration. But in just a few years, Kordsa, a part of the Turkish industrial conglomerate Sabancı Group, transformed itself from a price-driven maker of commodity products into a provider of…
Etienne Nichols
If you’re looking for information on medical-device design controls and product development, you can find a practically endless number of articles, videos, and podcasts with a few quick online searches. Yet with so much out there on these topics, there’s a glaring omission of a closely related…
Bruce Hamilton
You may recognize the following quote from Friedrich Nietzsche, or more recently from Kelly Clarkson: “What doesn’t kill you makes you stronger.” I’ve thought about this often during the last 22 months in context of the horrible pandemic and, more parochially, in relation to the efforts of many…
Mike Richman
It’s hard to fathom that Quality Digest, a little Northern California media company respected by all and beloved by many, turned 40 in November 2021. For a human being, 40 may be the new 30, but it’s still just creeping up on middle age. For a small business, on the other hand, 40 years is…
Ryan E. Day
Quality Digest (QD) was born 40 years ago. Birthed as Quality Circle Institute (QCI), the organization was conceived as a consultancy focused on bringing the success of quality control circles at Lockheed to organizations that were beginning to awaken to the importance of employee involvement in…
Dr T Burns
I’m a chemical engineer. The fundamentals of the chemical engineering profession were laid down 150 years ago by Osborne Reynolds. Although chemical engineering has seen many advances, such as digital process control and evolutionary process optimization, every engineer understands and uses Reynold…
Dennis Bailen, Bob Sherlock
Manufacturing businesses small and large have had their hands full with the fallout of the pandemic, and although it seems the worst of the crisis is now behind us, companies will continue to grapple with how to keep both customers and employees on board despite supply chain issues, intense…
