All Features
Ophir Ronen
From the health histories of patients to the effectiveness of different healthcare services, hospitals are sitting on a treasure trove of historical data. Unfortunately, most of these data go unused, often because they are so difficult to store or format for actionable use.
Due to inconsistencies…
Martin Cottam
It’s tempting to attribute the increased profile now given to occupational health and safety (OH&S) to the Covid-19 pandemic. But while in many organizations the pandemic shone a spotlight on OH&S management, there are other issues that will keep OH&S at the fore throughout the next…
Matthew M. Lowe
Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in a regulated industry, processes tend to get more locked in because compliance is at stake.
That was…
Chip Bell
‘I write children’s books because there are no unicorns in adult literature, and today’s world needs unicorns.” The quote came from renowned children’s book author Jackson Pearce at a weekend writers retreat sponsored by Georgia Writers Museum. The sentiment could be equally applied to a great…
Michael Glickman
Artificial intelligence (AI) is revolutionizing the healthcare industry by enhancing decision-making capabilities, improving quality of care, and reducing costs. In the age of supercomputers and technological advancement, the health sector generates vast amounts of data, which AI can process and…
Rajas Sukthankar
Digitalization is transforming all areas of life as well as existing business models. It’s enabling the manufacturing industry to implement its product ideas by taking advantage of technology trends such as generative design and intelligent models. Production has become more innovative through…
Kari Miller
Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal QMS that is not purpose-built for the life science industry, they must execute additional steps to…
Stephanie Ojeda
Quality management and environmental health and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces that have shaped quality and safety during their history.
Modern quality management was born from the post-World War…
(EstateSpace: Great Falls, VA) -- In uncertain economic times, finding ways to save money is more important than ever. When you think of your valuable assets, you may think of investments, such as stocks, bonds, or trusts. But there is another type of asset to consider: nonfinancial assets such as…
Joshua Zable
Optimizing inventory, like most problem-solving, requires a thoughtful process and a few steps. Naturally, the easiest way to prevent back orders is to always have a lot of inventory on hand. There are ramifications for not optimizing inventory, though. Overproducing and maintaining high inventory…
Mark Hembree
Does this sound familiar? “Welcome to [insert company name here], the [corporate slogan or superlative]. All of our agents are busy serving other customers. Your call is important to us. Please stay on the line for the next available agent. Your call will be answered in the order in which it was…
Rip Stauffer
A couple of years ago, my wife decided to surprise me by taking me over to our local Tesla dealership so I could test drive a Tesla. We put a deposit down to hold our place in line, and two months later took delivery of a Model Y Performance. I loved everything about it, took everyone who asked…
Etienne Nichols
I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices, a well-defined CAPA program provides a framework…
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely on ISO 13485 to provide critical support to world…
Bryan Christiansen
When it comes to maintaining the critical infrastructure and machinery of your facility, choosing the right maintenance contractor can make all the difference. It's essential to find a contractor who not only has the knowledge and skills to keep a maintenance program running smoothly, but also the…
Donald J. Wheeler, Al Pfadt
In memory of Al Phadt, Ph.D.
This article is a reprint of a paper Al and I presented several years ago. It illustrates how the interpretation and visual display of data in their context can facilitate discovery. Al’s integrated approach is a classic example not only for clinical practitioners but…
Etienne Nichols
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.
The drafted guidance is…
Kate Zabriskie
‘They’re hit or miss: Sometimes the service is marvelous. Other times it’s simply meh. I’m afraid to recommend the place because I can’t trust them to deliver.”
“Maybe I’m just boring, but I don’t like surprises. They’re great one day and disappointing the next. I don’t need to be delighted. I…
Trupti Dhere
The healthcare industry is known for rapidly adopting advanced technologies that offer improved treatment for various diseases. Consequently, digital twin technology in healthcare has gained popularity during the past few years, owing to the range of advantages it offers.
Digital twin technology…
Greg Kihlström
Customer loyalty and lifetime value are highly prized in today’s competitive environment. Smart businesses know that a major point of competitive advantage (or failure) can be the type of customer experience they provide.
The need to balance what customers want with what the business needs to…
Etienne Nichols
In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?
Verification and validation are two different…
Jon Munnery
When choosing to spend money, customers will likely investigate the brand behind the name to get an idea of whom they’re building ties with as well as an impression of service quality. Customer reviews must point to a genuine interaction with the company to be valuable and influence purchasing…
Liza Dzhezhora
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.
The trend is not fading away…
Lisa Apolinski
A not-so-surprising fact, according to HubSpot: 65 percent of consumers state that the experience they encounter on a website is a “very important” factor in recommending a brand. If that statistic’s not enough, HubSpot also reported that 75 percent of consumers expect new technologies to be used…
Shabnam Azimi
Consumers who have a personality that scores high in terms of openness—such as being open to new adventures and intellectually curious—have better success at spotting fake reviews than other personality types, according to our recently published research. Extroverted people, on the other hand, tend…