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The healthcare industry is in a state of constant change, and with change comes opportunity. With the passage of the Affordable Care Act (ACA) and the Medicare Access and CHIP Reauthorization Act (MACRA), healthcare providers are, or will be, paid differently for their services. No longer can they…
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…
“It is a common experience that a problem difficult at night is resolved in the morning after the committee of sleep has worked on it.” —John Steinbeck
In Personal Kanban (Modus Cooperandi Press, 2011), Jim Benson and I discuss how workflow should be optimized for throughput, not capacity. Work…
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques being used. That’s because not much has changed in…
Ihave never been accused of being an early adopter of cutting-edge technology. On the other hand, I don’t dance the Luddite jig, either. True to my own type, I hung on to my old M-1A tank, aka a Motorola flip phone, for as long as I could, but was pleased as punch when circumstances led me to…
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
I have written many times about the importance of the employee experience, both on its own in terms of retention and performance, and with regard to the effect of the employee experience on the customer experience.
Sadly, many companies still aren’t focusing on the employee experience. IDC’s 2015…
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.
A new report from the planning board for a national medical device evaluation system (NMDES) describes how the…
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
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n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
According to the recently released J.D. Power 2016 Member Health Plan Study, critical factors of health plan member satisfaction are highest in areas of the country that have more competition between different health plans.
On a nationwide basis, member satisfaction with their health plans has…
The holy grail of marketing—a universal predictor of customer behavior—may be closer than ever, thanks to recent advances in the field of neuromarketing.
Even at its best, traditional market research has built-in limitations. First of all, consumers may be biased or unwilling to reveal their true…
There’s plenty of noisy disagreement about the state of healthcare, but when you look beyond the controversies, a great deal of common ground exists.
Many agree that the way we’ve been doing things is wasteful and inefficient, when healthcare should be delivered as efficiently and effectively as…
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting…