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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…
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…
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…
How L&D Helps Leaders Retain Tech Employees in the Great Resignation
Christina Gialleli
The Great Resignation continues to have a major effect on the talent and skills shortage in the job market. People are still leaving their jobs at an unprecedented rate. Although the Great Resignation isn’t industry-specific, not all industries are affected the same. Although 55 percent of the U.S…
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…
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…
Important Factors in Implementing an Effective HACCP
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives. These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
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…
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…
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…
Should Employees Be Allowed to Choose What They Want to Do?
Phanish Puranam, Marlo Raveendran
As far as workplace trends go, several topics have dominated popular attention and discussion, from workspace design, digitalization, and Agile methodology to the pandemic favorite of remote working. But there’s another important aspect of work that is being pushed increasingly to the forefront of…
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…
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…
What Should Really Trigger a CAPA?
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…
The Hybrid Workspace, Societal Well-Being, and Productivity
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…
Tech’s Big Growth Spurt
Barnaby Lewis
Harran blinks in the sunlight, adjusting his eyes. He’s an inquisitive child, enthusiastic for all things new, yet still he struggles to understand what he’s looking at. A man is pressing marks—triangles or wedges—into a piece of clay, explaining that in this way he can speak to people, even when…
Giving Feedback That Works
Knowledge at Wharton
Most managers dread giving feedback. Offering a blend of praise and criticism is supposed to help your team members do more of what they’re good at and improve in areas where they’ve missed the mark. But research shows it rarely works that way. In her book How to Change (Ebury Digital, 2021),…
B2B Customer Behavior Is Changing. What Should Marketers Do?
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…
Medical Lab Staffing Shortages Have Reached the Breaking Point
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…
How to Close the Loopholes on Medical Device Cybersecurity
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…

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