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Software Bill of Materials for Medical Devices
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product. Given that…
Too Happy Too Soon
Bruce Hamilton
The level of excitement was high in our machine shop as we drew closer to our goal of less than 9-minute changeovers on the BNC lathe. (See Part One of this story for how we got there.) Setup improvements had so far reduced changeover time to 20 minutes, cutting the economic order quantity from…
Why Sometimes You Need to Source Locally
Jonathan Gilpin
The world of procurement is often tricky. It involves choosing one appropriate candidate, ultimately benefiting them while rejecting and disadvantaging others. That said, it isn’t just the businesses picked that will profit from winning the contracts; it’s also their supply chain, their local…
There’s More to AI Bias Than Biased Data, NIST Reports
NIST
As a step toward improving our ability to identify and manage the harmful effects of bias in artificial intelligence (AI) systems, researchers at the National Institute of Standards and Technology (NIST) recommend widening the scope of where we look for the source of these biases—beyond the machine…
Managing Medical Device Vulnerabilities With Compensating Controls
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety. The heightened risk is drawing the attention of federal regulators, who warn that “it…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Do Your Job
Bruce Hamilton
We had been working with the Toyota Production System Support Center (TSSC) for two years to build a model line in our assembly department. As we moved from small batch production to one-by-one, the results had been astounding: Customer lead time reduced from two weeks to one day, crew size cut in…
Realistic Expectations of Artificial Intelligence
Susanne Tedrick
Although we’re still a few decades out from seeing most businesses and industries use artificial intelligence (AI) in their operations, there is certainly greater adoption than there has been in years past. It behooves business leaders to learn all they can about AI. According to a top IT training…
Safely Studying Dangerous Infections Just Got a Lot Easier
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years. Now,…
Manage Hybrid and Remote Teams Through Revised Performance Evaluations
Gleb Tsipursky
The pandemic forced leaders to reconcile with the need for effective hybrid and remote team management strategies, including in performance evaluations. Research has shown the benefits of moving away from large-scale quarterly or annual performance reviews. Instead, systematic, frequent, and brief…
Aligning Domestic Sourcing Efforts With Business Success
Gary Steinberg
Disruptions in the global supply chain have led to a new dynamic for many small and medium-sized manufacturers (SMMs)—the need to be more strategic about “second sourcing” and reshoring. The biggest increase is in what’s referred to as second sourcing, which adds redundancies such as a second…
Bridging the Gap Between Strategy and Execution
Ryan E. Day
Business is changing at a faster rate than ever before, forcing companies to find ways to adapt and pivot. Keeping the entire organization aligned with current goals can be a daunting task, but surviving and thriving depends on it. One popular method to ensure enterprisewide alignment of assets is…
With a Shrinking Talent Pool, How Do Companies Do More With Less?
John D. Patterson
A record number of employees have or plan to quit. Already hobbled by the pandemic, businesses are now looking for new ways to balance investment in talent attraction, professional development, and finding tools to increase productivity. With more people reconsidering their careers, many companies…
Three Predictions for Clinical Asset Management in the Year Ahead
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…
The Answer to Manufacturing’s Waste Problem is Hidden in Data
V R Vijay Anand
As the world moves toward a new, post-pandemic normal, industries must leverage digital transformation at an accelerated pace. This is already happening. According to IBM, 67 percent of manufacturers have accelerated digital projects since Covid-19. Although improved operational efficiency is…
How Classifying and Fixing Dirty Data Can Help Even Those Using Spreadsheets
Tristan Mobbs
All too often the topic of fixing dirty data is neglected in the plethora of online media covering artificial intelligence (AI), data science, and analytics. This is wrong for many reasons. To highlight just one, confidence in the quality of data is the vital foundation of all analysis. This topic…
OK, Computer: Building Trust to Make Machine Learning More Effective
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…
Bad Management, Burnout, and Health Fears
Andrew Moreo, Imran Rahman, Lisa Cain, Trishna Mistry
About 3.5 million people have at least temporarily left the U.S. workforce since March 2020. More than one-third of them—1.2 million—are in the leisure and hospitality industry. This has created huge problems for restaurants, hotels, and other leisure and hospitality businesses that have struggled…
Eight Marketing Mistakes to Avoid at All Costs
Atul Minocha
Do you ever feel like you’re spending money like crazy on marketing and getting little or nothing in return? If so, you might be tempted to pull the plug on marketing altogether. That would be a big mistake. An effective marketing strategy can mean the difference between your organization’s success…
From Industry Experts: The Road to Digital Success in Pharma
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…
A QMS Gap Analysis Pays Off
Pennsylvania Manufacturing Extension Partnership
Founded in Carbondale, Pennsylvania, in 1876, Hendrick Manufacturing provides custom metal solutions to a wide range of industries. As a family-owned and operated business, Hendrick has come a long way from its origin as the first commercial manufacturer of perforated metal screens. During the…
Consolidating 27 Software Systems Drives Greater Production Control, Scrap Reduction
Anthony Murphy
Kendrick Plastics is an IATF/TS 16949-certified, tier one and tier two supplier of interior decorative trim components and assemblies to the automotive industry. Located in Grand Rapids, Michigan, its 300,000 sq ft engineering and manufacturing facility has more than 50 presses serving fully…
Data Are the Key Drivers for Quality 4.0
Sébastien Breteau
Although previous industrial revolutions were driven by steam machines and the dawn of electricity, the unfolding fourth industrial revolution is being powered by digital technologies, such as cloud computing, machine learning, and the internet of things. Accompanying the fourth industrial…
Explained: Why Your Supply Chain Needs Diversity Now
Jonathan Gilpin
The Chartered Institute of Procurement & Supply, a United Kingdom-based global professional body working for the purchasing and supply professions, suggests that every supply chain should enhance its diversity because this “can not only bring new ideas and solutions to an organization, but also…
Using the Cost of Quality to Guide Manufacturing Improvements
Gregg Profozich
Delivering high-quality products and experiences for your customers is usually the top priority for manufacturers. But how can you improve your operations to deliver better results while reducing costs along the way? Keep reading to explore how leveraging cost of quality (CoQ) at your manufacturing…

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