All Features
Melissa Burant, Marc Schneider
As a manufacturer, you understand that supply chain disruptions happen all the time. What you don’t know is when or how they will affect your operation and business. But assessing your supply chain risks and implementing good supply chain management practices can be daunting. This is especially…
Michael King
In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.
Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them to elevate…
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Mike Figliuolo
Is the customer really always right? We throw that comment around haphazardly without truly considering the ramifications of such an approach. I’d submit that they’re not. There are plenty of times the customer is wrong (and sometimes, very much so).
First, let’s explore the implications of a “…
Kristi McDermott
Technology has reshaped the healthcare industry, empowering clinicians, technicians, and executives to better serve patients and achieve their goals. However, technology doesn’t eliminate the need for human oversight and management. Healthcare technology will continue to advance at a rapid pace in…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Mike Figliuolo
If you have a new business idea, I’m excited for you. If you ever want to get it off the ground, however, be sure you have a problem. A real problem. I know that sounds cryptic. Allow me to explain.
When I hear a new pitch, the first question I ask is, “What’s the problem?”
You would be surprised…
Katia Savchuk
Since generative AI went mainstream in 2023, it has inspired an equal measure of hype and fear. Boosters of tools such as ChatGPT and DALL-E predict that they will transform our economy, while skeptics worry about their potential to produce inaccurate or harmful results and ultimately replace…
Scott A. Hindle, Douglas C. Fair
So far in this series our focus has remained on statistical process control (SPC) in manufacturing. We’ve alternated between more traditional uses of SPC that remain relevant in this digital era and discussing uses of SPC and its related techniques that are enabled by the marvels of modern…
Alonso Diaz, Maria DiBari
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
Mike Figliuolo
By eliminating low-value work from your life, you can focus on more important things. Get rid of difficult customers and focus on driving your business instead.
To get your new year started right, I’d like to share with you what I’ve been taught by homemade bread, lawn mowers, and cheap customers…
ComplianceQuest
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…
Industrial Inspection and Analysis
Unlike the traditional engineering process of designing a part, product, or component from the ground up, many times in life we need to start with an existing item and work backward to solve a problem. It’s a process known as reverse engineering, and it begins by obtaining accurate data about the…
Mike Figliuolo
Your legal department is screwing up. Royally.
You work hard to build relationships with other businesses. How many hours do you invest getting closer to partners, customers, and suppliers? And then that wonderful handshake happens, and it’s time to hammer out the agreements. That’s when Larry the…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Phil Geldart
When it comes to customer service, few companies do it better than the UPS Store, Chick-fil-A, and REI.
That’s not according to me. That’s according to a recently published Best Customer Service list, which was compiled in a partnership between Forbes and HundredX, a data analytics company focused…
Del Williams
To provide food processors with insight into the industry’s current challenges and opportunities, Cablevey Conveyors, a global specialty conveyor manufacturer, and Automated Handling Solutions, a service-focused subsidiary of Cablevey, have released results from an annual proprietary survey…
Kate Zabriskie
Although a fix-it-the-first-time approach may be the gold standard of customer service, addressing potential issues before they materialize is the true mark of an exemplary user experience.
Consider the pace of our modern world: Customers today want instant solutions, and any hurdle might be a…
Stephanie Ojeda
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.
In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective.
Today, document management has become the…
Brad Jobe
Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process. Nearly one-third of the world’s data volume is generated by the healthcare industry, and the volume of big data is projected to increase…
Leah Chan Grinvald, Ofer Tur-Sinai
Cars are no longer just a means of transportation. They have become rolling hubs of data communication. Modern vehicles regularly transmit information wirelessly to their manufacturers.
However, as cars grow “smarter,” the right to repair them is under siege.
As legal scholars, we find that the…
Gad Allon
Amazon’s incredible growth over the years has made it a textbook example of what it means for a business to scale, going from a scrappy startup in Jeff Bezos’ garage to a multinational corporation with more than 1.5 million employees.
The retailer recently announced it’s hiring 250,000 full- and…
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…