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Elizabeth Weddle
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they…
Stephanie Ojeda
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…
Stephanie Ojeda
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting there can be a misstep. Without the right…
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.
One notable…
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…
Amy Knue
Health systems across the country are unknowingly paying multiple times for the same medical equipment—once to own it, and again to rent it. The issue isn’t always an increase in clinical demand; it’s often availability and visibility to medical device inventory. The cost of these unnecessary…
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…
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…
ISO
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their workplace…
John O'Kelly
Warehouses are the backbone of supply chains, ensuring that goods move efficiently from suppliers to consumers. However, the physical demands of warehouse work—heavy lifting, repetitive motions, and prolonged standing—can take a toll on employees, leading to fatigue, injuries, and long-term strain…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
Joshua Zable
Everyone has their own favorite graph type or visual tool. I’m not ready to declare this my favorite yet, but this oldie but goodie has got to get more time and attention. That’s right: I’m talking about control charts with stages, also sometimes called before/after control charts.
If you’re not…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Bruce Hamilton
As years roll on, I’m noticing more parts of me breaking down: Teeth, eyes, knees, cardiovascular, stomach—the list keeps getting longer, as does the list of docs I see. I’m blessed to be living in an area with the world’s finest medical care and lucky that healthcare innovation (and Medicare) have…
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average of…
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…
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…
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital.
The community of two million people that AHWM…
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.
It’s no secret that healthcare in the United States is…
Jane Bianchi
Let’s pretend, for a moment, that you’re a primary care physician and you refer one of your patients to another doctor for a colonoscopy. Will the patient follow through? If not, how will your team know to remind him or her? If the patient does receive a colonoscopy, will your team be alerted so…
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case?
In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Carrie Van Daele
Crossing the street or stepping backward when you encounter another person has already become a habit, as has a routine elbow bump, instead of a handshake.
And that is definitely what is needed during a health crisis. But when the time is right, as a society we must bounce back to social…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…