All Features
Kevin Kanimyar
Amidst the rise of conscious consumerism, corporate social responsibility (CSR) programs are fast becoming an essential part of any business. With about $20 billion spent every year by Fortune 500 companies alone, businesses around the world are working to integrate CSR programs into their business…
Jon Speer
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product development and risk management share more than that.…
Dirk Dusharme
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…
Laurie Flynn
AStanford Medicine-led study has found that borrowing certain billing- and insurance-related procedures from other countries could lead to policies that drastically lower healthcare costs in the U.S.
The new study, published in the August edition of Health Affairs, compares costs of healthcare…
Matthias Gouthier
The ISO Foresight Trend Report highlights global trends across multiple industries that will shape strategic decision making for a better future. Drawing upon these insights, ISO reflects on some of the potential areas for standardization work. In a series of feature articles, we unpack some of the…
Bendta Schroeder
The first step in choosing the appropriate treatment for a cancer patient is to identify their specific type of cancer, including determining the primary site: the organ or part of the body where the cancer begins.
In rare cases, the cancer’s origin can’t be determined, even with extensive testing…
Dwayne Duncum
The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing. If we take any lesson from the Covid pandemic, it’s that the way we work, where we work, and how we work have fundamentally shifted…
Jason Bradshaw
As a busy leader or business owner, you’re faced with a seemingly endless to-do list to keep your business operating, as well as an ever-increasing list of ideas about how to improve it. However, I suggest you throw out those hundred-plus to-do items and ideas and instead focus on the experience…
Etienne Nichols
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”
The fact is…
Mona Rhodes
Standards of customer service rose in 2022, and your business needs to keep up if you want to be successful in the digital age. Each customer interaction is crucial, especially since PWC revealed that 32 percent of customers will stop doing business with a brand when they experience poor service.…
Gleb Tsipursky
Organizations need to incorporate constructive feedback from stakeholders to survive disruptions amid today’s turbulent economy. Securing constructive feedback is critical in helping you find which decisions are working and which ones aren’t. Yet, many organizations fail to engage effectively with…
Catherine Barzler
Falls are a serious public health issue that result in tens of thousands of deaths annually while racking up billions of dollars in healthcare costs. Although there has been extensive research into the biomechanics of falls, most current approaches study how the legs, joints, and muscles act…
Yosef Ayzencot
Starting a business is a costly investment. According to U.S. Bureau of Labor statistics, more than half of businesses fail within the first five years of opening. Adding to this pressure were the nationwide staffing challenges during the “Great Resignation” and then the “Great Reshuffle.” This…
Jennifer Chu
Ultrasound imaging is a safe and noninvasive window into the body’s workings, providing clinicians with live images of a patient’s internal organs. To capture these images, trained technicians manipulate ultrasound wands and probes to direct sound waves into the body. These waves reflect back out…
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.
But by 2003, ISO 13485 had changed so significantly that the FDA…
John Courtney
Customers are the lifeblood of any business. Without them, there would be no profits to distribute, no people to serve, and no reason to continue operating. To keep your business running on a path to growing success, you need to offer a customer experience that will make customers choose your brand…
Claudine Mangen
Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.
Not surprising, many of us are feeling burned out. Burnout—which often…
Jill Roberts
Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw or unpasteurized.…
Gregory Way
Drugs don’t always behave exactly as expected. While researchers may develop a drug to perform one specific function that may be tailored to work for a specific genetic profile, sometimes the drug might perform several other functions outside of its intended purpose.
This concept of drugs having…
Adam Zewe
Physicians often query a patient’s electronic health record for information that helps them make treatment decisions, but the cumbersome nature of these records hampers the process. Research has shown that even when a doctor has been trained to use an electronic health record (EHR), finding an…
Karina Montoya
Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer. On average, a 50-year-old man in India with asymptomatic liver damage who doesn’t receive treatment is expected to…
Alixandra Barasch
If you’ve ever played Wordle, learned a new language on Duolingo, or worked out with Peloton, you may be familiar with daily app notifications that nudge you to keep at it—or risk breaking a streak of consecutive efforts. Do you or don’t you heed the clarion call?
If you do, you’re in good company…
Tom Rish
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the…
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.
They are also being driven by…
Mike John
This article has been republished with permission from Medical Plastics News.
While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of…