All Features
Rajesh Talpade
In April 2018, the U.S. Food and Drug Administration (FDA) permitted the marketing of the first medical device to use artificial intelligence (AI). The device, called IDx-DR, is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon…
Ann Brady
Better buying power, greater efficiencies, and more innovative ideas are not just for big businesses. The publication of ISO 44003 is helping smaller players flex their collective muscle by making the most of strategic partnerships.
How many of us cooped up at home during the lockdowns and travel…
Ravi Anupindi
Inoculating the planet from Covid-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison, but in this case, the enemy is invisible and everywhere.
Some of the vaccines require super-cold storage at virtually all…
Sara Adams
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.
For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS)…
Rick Gould
Ever since people could tie logs together to form rafts and use them to transport goods by water, seaborne trade has flourished and grown. Historians believe that the first international trade routes were developed 5,000 years ago between the Arabian Peninsula and Pakistan, while by the 18th…
Gleb Tsipursky
Recent surveys show, and many managers are learning, that their employees are often not interested in working from the office full time.
It’s easy to assume we know what they want due to a bias known as the false consensus effect, which causes us to perceive others whom we feel to be in our team…
Wade Schroeder
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers.
Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort…
Ann Brady
Innovation is the fuel that drives a successful business. Organizations that give their managers and employees the tools to respond to and make the most of opportunities, both internal and external, are well placed to grow profits, improve the health and well-being of their employees, and thereby,…
Mayank Kejriwal
Imagine you’re having friends over for lunch and plan to order a pepperoni pizza. You recall Amy mentioning that Susie had stopped eating meat. You try calling Susie, but when she doesn’t pick up, you decide to play it safe and just order a margherita pizza instead.
People take for granted the…
Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen
For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.
Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for healthcare…
Dileep Thatte
In 2018, the United Nations General Assembly proclaimed that, every year, June 7 would be celebrated as World Food Safety Day. In 2020, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations decided to jointly facilitate the observance.
The…
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
Gleb Tsipursky
Due to strong employee resistance and turnover, Google recently backtracked from its plan to force all employees to return to the office and allowed many to work remotely. Amazon also backtracked on its plans to have a fully office-centric culture and allowed employees to have a hybrid schedule.…
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital.
The community of two million people that AHWM…
Clare Naden
Travel and tourism took a beating during the Covid-19 pandemic, with borders closed, airlines grounded, and many establishments shut for months. Now as the industry attempts to recover in this new context, constantly changing rules and regulations are making it a far-from-simple task. What’s more,…
John Preston
‘This government is obsessed with skilling up our population,” said Boris Johnson in his recent speech on “leveling up.” There’s still a fair amount of uncertainty about exactly what the United Kingdom prime minister’s plan to level up the regions will involve, but manufacturing and skills seem…
Gleb Tsipursky
When a threat seems clear to you, it’s hard to believe others will deny it. Yet smart people deny serious risks surprisingly often.
A case-in-point example comes from my experience helping a midsize regional insurance company conduct a strategic pivot to thrive in the post-Covid world in January…
Silke von Gemmingen
Due to digitalization in Industry 4.0, internal logistics is subject to constant change. Internal traceability—i.e., tracking goods in the warehouse or production facility—increasingly plays a key role. Manufacturers and consumers are placing more emphasis on the safety and quality of products.…
Lawrence Livermore National Laboratory
A Lawrence Livermore National Laboratory (LLNL) scientist and collaborators have demonstrated the first-ever “defect microscope” that can track how populations of defects deep inside macroscopic materials move collectively.
The research, which appeared last month in Science Advances, shows a…
Adrian Hernandez, C. Michael White
T
he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.
But over the past few years, tens of…
Phanish Puranam
As businesses increasingly adopt AI-driven decision making, experts agree that the most interesting questions are not about whether humans can beat machines or vice versa, but how the two forms of intelligence can most fruitfully collaborate—and how organizations can best facilitate those…
Steven Severt
When it comes to ongoing certification of your quality management system (QMS), whether it’s certified to ISO 9001, ISO 13485, IATF 16949, or AS9100, how many times have you found yourself “preparing for an external audit?”
Picture the scene: You’ve got the dates set on the calendar months in…
Steven Stein
Supply chain management (SCM) has been defined as “the design, planning, execution, control, and monitoring of supply chain activities with the objective of creating net value, building a competitive infrastructure, leveraging worldwide logistics, synchronizing supply with demand, and measuring…
Terry Onica, Cathy Fisher
With recent disruptions critically impacting the automotive supply chain and costing manufacturers millions in lost production and sales, it is clear that supply delivery issues now need the same level of attention as vehicle safety and quality. What is really at the root of ongoing delivery…
Christopher Allan Smith
This series is about getting you through a catastrophe. The first three articles (see “All articles in this series”) were about preparing and responding to the world around you when it’s consumed by calamity. As our world here was. In this article, we deal with how to handle all the information,…
