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Nimax
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had…
Robyn Coward
In life sciences, every decision carries weight—and speed to market is an ever-present consideration. Scientific innovation is moving faster than ever, yet regulatory demands are growing more complex, and supply chain fragility has become the new normal. Within this volatile landscape, the role of…
Jennifer King
Although patient safety is paramount in healthcare settings, about 1 in 10 patients is harmed in healthcare, and more than 3 million deaths occur due to unsafe care, says the World Health Organization (WHO). The reality is hospitals and healthcare facilities face numerous challenges in managing…
Etienne Nichols
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device to a…
Akhilesh Gulati
Complacency won’t show up on a control chart. But its damage is real. Can AI and systems thinking help us detect it and respond before trust is lost?
As customer expectations evolve, one question remains: Are customers still at the core of your company’s operations?
Back in 1999, a simple but…
Harish Jose
I’m further exploring the notion of models and mental models. We often speak of mental models as though they’re neat packages of knowledge stored somewhere in the mind. These models are typically treated as internal blueprints and as simplified representations of the world that help us navigate and…
John Tschohl
Why do customers patronize one company over another? Many of you might say that the quality and price of the products or services are key factors. But while those things might play into a purchasing decision, they aren’t the most important consideration.
So, what is? Customer service. How you and…
Hexagon Manufacturing Intelligence
Did you know that shutdowns, turnarounds, and outages (STOs) can consume up to 50% of a plant’s annual maintenance budget? That’s according to a report by the Boston Consulting Group.
STOs are among the most complex and high-stakes events in industrial operations. They’re costly, especially when…
Bryan Christiansen
Facility teams are constantly balancing urgent repairs, preventive tasks, asset tracking, and compliance, all while ensuring smooth day-to-day operations. But when processes are manual, fragmented, or unclear, even simple tasks can spiral into delays, miscommunication, and wasted time.
The…
Harish Jose
Readers of my blog might be aware that I appreciate the nuances of cybernetic constructivism. Cybernetic constructivism rejects the idea that we have access to an objective reality. It doesn’t deny that there’s an external reality independent of an observer. However, we don’t have direct access to…
Cornelia C. Walther
When artificial intelligence burst into mainstream business consciousness, the narrative was compelling: Intelligent machines would handle routine tasks, freeing humans for higher-level creative and strategic work. McKinsey research sized the long-term AI opportunity at $4.4 trillion in added…
Etienne Nichols
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the…
Stephanie Ojeda
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
In contrast…
Sanath Hegde
For quality heads, compliance officers, auditors, and engineering leaders, audits have been a time-consuming, resource-intensive process, yet necessary to build resilient operations, prevent costly failures, and maintain competitive advantage.
The question isn’t whether to audit, but how to…
Harish Jose
In this article I’m exploring the need for ethics in systems thinking using the ideas of Heinz von Foerster and Russell Ackoff. The two come from different traditions within systems thinking. Von Foerster comes from physics and second-order cybernetics, and Ackoff from operations research and…
Gleb Tsipursky
As companies and government agencies push forward with return-to-office (RTO) mandates, they risk exacerbating a workplace problem that many have failed to address adequately: gender discrimination.
New research from the University of Toronto’s Rotman School of Management highlights how in-person…
Prasant Prusty, Arundhathy Shabu
A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…
Etienne Nichols
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF): • “AI-enabled device…
Cornelia C. Walther
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators investigated the…
Heidi Drafall
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.
The…
Jones Loflin
This past weekend I engaged in one of my favorite activities as a beekeeper. I got to catch a swarm of bees.
If you haven’t seen it before, it’s wild. About half of the bees leave with a queen and set up somewhere temporarily while they’re looking for their new permanent home. In the case of this…
William A. Levinson
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility…
Bryan Christiansen
The cornerstone of efficient industrial and facility management, maintenance, repair, and operations (MRO) cover all activities related to equipment maintenance, procurement, upkeep, and inventory management. This includes spare parts, consumables, lubricants, cleaning supplies, safety equipment,…
Harish Jose
I am a longtime admirer of George Spencer-Brown’s “Laws of Form.” In this article, I explore how his notion of reentry helps illuminate the paradoxes and blind spots in modern ideologies, especially the rise of xenophobia and extreme nationalism. These rigid ideologies depend on distinctions…
Matt McFarlane
One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Report was that economic uncertainty is playing a large role in the decisions medical device companies make this year.
The report surveyed more than 500 medical device professionals across quality, regulatory, product…