All Features
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…
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…
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…
Scott Trevino
Nearly a quarter of surveyed healthcare cyberattack victims experienced increased mortality rates following a data breach, and more than half reported poorer patient outcomes due to longer hospital stays and delayed procedures. Healthcare has faced the highest average data breach cost—more than $10…
Amy Brown
Listening to customers is critical for healthcare organizations to ensure they’re delivering high-quality care to their patients. Sure, the traditional methodology of doing so via surveys can increase customer retention and profitability. But much like evolving from analog to digital, there’s a…
Gleb Tsipursky
One of the key stakeholders in stakeholder capitalism is the employee. You could argue that the employee is the key stakeholder, because without employees you’d have no stakeholders at all. This is why employers need to stay aware of today’s health environment and its effect on their employees.…
In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices…
Bhushan Avsatthi
The very nature of healthcare construction and its specific infrastructural and functional needs pose significant challenges to the architectural, engineering, and construction (AEC) sector. Crucial hospital spaces such as operation theaters and critical care centers need fail-proof connections to…
Angie Basiouny
In the hustle of a busy hospital emergency department, teams of doctors and nurses react quickly to determine whether a patient needs to be admitted, referred, or released. Providing such complex care requires a high degree of skill and seamless teamwork, the kind that usually comes from years of…
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes…
Dirk Dusharme @ Quality Digest
In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address. An unreasonable deadline, lack of notified bodies to…
Alex Waddell, Diki Tsering, Peter Bragge, Paul Kellner
Emergency medical workers, already at increased risk for burnout compared to other professions, continue to be challenged by the fallout of Covid-19.
Stretched to the breaking point by increased workloads, highly contagious and acutely ill patients, and limited resources, workers’ risk factors for…
James Gaines, Knowable Magazine
In 2004, the United States’ Defense Advanced Research Projects Agency (DARPA) dangled a $1 million prize for any group that could design an autonomous car that could drive itself through 142 miles of rough terrain from Barstow, California, to Primm, Nevada. Thirteen years later, the U.S. Department…
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 @ Quality Digest
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…
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…
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…
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…
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…
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…
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…
