Healthcare Article Features

Etienne Nichols's picture
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be...
Aaron Smith's picture
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal...
Stephanie Ojeda's picture
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that...
Gleb Tsipursky's picture
Gleb Tsipursky
The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth. Frontline...
Etienne Nichols's picture
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications. But achieving that...
Stephanie Ojeda's picture
Stephanie Ojeda
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more. It’s also critical to ISO 9001, FDA...
Michael King's picture
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country...
Mike Morini's picture
Mike Morini
Following the turmoil of the pandemic, many salaried employees have had the opportunity to work remotely and enjoy newfound flexibility in their day-to-day work lives. For many, the ability to be...
Silke von Gemmingen's picture
Silke von Gemmingen
Rigid endoscopes are used in medical diagnostics and therapy to examine body cavities and hollow organs, and to perform minimally invasive procedures. To avoid risks for patients and medical staff,...
Melissa Phillips's picture
Melissa Phillips
The levels of contaminants in our food supply are, generally, decreasing. That’s the good news. But we still need to measure those contaminants and make sure our food is safe. And measuring tiny...
Etienne Nichols's picture
Etienne Nichols
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere...
Ophir Ronen's picture
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...
Martin Cottam's picture
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...
Matthew M. Lowe's picture
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...
Michael Glickman's picture
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...
Kari Miller's picture
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...
Etienne Nichols's picture
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,...
Grant Ramaley's picture
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...
Donald J. Wheeler's picture
Donald J. Wheeler
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...
Etienne Nichols's picture
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...