All Features
Scott Trevino
The pandemic promises ongoing challenges for healthcare providers in 2022 as they cope with nursing shortages and cybersecurity threats amid shifts previously underway for the industry. How they manage their clinical assets, however, can present opportunities to overcome those challenges while…
Maggie Overfelt
Machine learning has the potential to drastically improve efficiency and the quality of care in hospitals by tackling hard-to-predict problems like ICU occupancy or which patients are likely to be readmitted.
Yet, a big barrier to any technology working optimally is getting full buy-in from its…
Sankesh Abbhi
Life science organizations play a vital role in healthcare’s technology revolution, with a key focus on identifying the right opportunities to scale digital transformation. Currently, life sciences leaders are leaning into areas such as automation, which was discussed at length at ArisGlobal’s…
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…
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…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
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…
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…
Chip Bell
It all started when we drove up to the speaker menu at a quick-service restaurant. “Can I take your order?” the attendant coldly barked. When my wife, on hearing the deep voice of the attendant, politely said, “Thank you, sir,” she got back a sharp, “It’s ma’am.”
The attendant bristled with…
Josh Wilson
Paraphrasing Winston Churchill, Rahm Emanuel, a former White House chief of staff and Chicago mayor, famously quipped that you never want a serious crisis to go to waste. Few of us will face the number of crises that a big-city mayor or a presidential aide may deal with in a day, but we still need…
Bill Marler
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
James Wells
The ISO 9001 standard talks about the relationship between the company and the customer in a couple of places. First is management’s responsibility to make sure that customers’ needs are a top consideration, and that their requirements are met. Then that customer satisfaction is improving, and…
Henrik Hulgaard
As customer demands for more customization and choice increase, the complexity of products and associated product design, manufacturing, and sales processes also increase. Product life cycles are also getting shorter, requiring a constant flow of new products with high-value features and…
Kari Miller
In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).
The primary goal of post-market…
Gleb Tsipursky
Any association would love a member-retention rate of 75 percent. Unfortunately, according to a 2017 report cited in the American Society of Association Executives (ASAE) publication, Associations Now, retention rates for all associations are falling. While in 2016, 73 percent of associations…
Quality Digest
Getting your product into customers’ hands is often an undervalued—and under-engineered—part of your organization’s value chain. If the pandemic’s effect on our supply chains has taught us anything, it’s this: Diligent reevaluation of our modus operandi is a must for success.
When the Covid…
Matt Fieldman
Some are calling it, “The Great Resignation.” Others are calling it “The Great Reshuffle.” After spending the past year as executive director of America Works, I’ve talked with more than 250 manufacturing workforce development professionals throughout the MEP National Network and our partners.…
Prashant Yadav, Antoine Désir
The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…
Andrea Luangrath
Consumers who see a product on sale being virtually touched are more engaged and willing to pay more than if the item is displayed on its own, according to a recent research paper I co-authored.
Behavioral economists have previously shown that people value objects more highly if they own them, a…
Annette Franz
A few weeks ago, I wrote about Seth Godin’s concept of Finding Your Who, which is all about identifying who your products are for. The Who isn’t defined by demographics but by psychographics: Their (customer) beliefs, their dreams, their desires. It’s a reminder that developing personas is so…
Chip Bell
One of my favorite Halloween memories was decorating the annual giant pumpkin with my son when he was young. As a toddler, he was primarily an observer as he watched me sculpt the face of the pumpkin with a scrimp knife. However, his commitment to the pumpkin-carving process ramped up dramatically…
Mark Greevan
China’s dominance in manufacturing has made it the factory for the world. The subsequent economic growth enriched an ever-expanding middle class, and the country’s retail industry has quickly adapted to supply a growing appetite for consumption.
Some of these developments in the way people spend…
David Gillum, Kathleen Vogel, Rebecca Moritz
The origin of SARS-CoV-2 remains a mystery. One theory is that the coronavirus that causes Covid-19 was transmitted from animals to humans—a fairly common occurrence. Another is that it came from a laboratory accident—a more infrequent circumstance.
Around the world, scientists conduct many kinds…
Nate Burke
With the rise of online shopping continuing to increase, thanks to the convenience and comfort of shopping from home, it's important for e-commerce businesses to look to their returns policy to ensure they’re not only catering to the tech-savvy, modern consumer, but also the environmentally…
Jeff Dewar
There are many endangered industries today, and publishing is certainly among them. In 2009 we didn’t know if we would survive the monumental changes that had torn through all areas of the publishing world.
W. Edwards Deming once said to me during an interview, “Pray that your competitors are…