All Features
Taran March @ Quality Digest
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.…
Grant Ramaley
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…
Tonianne DeMaria
“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…
Lawrence Yu
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…
Ryan E. Day
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…
Norman A. Paradis
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…
Annette Franz
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…
Rachel E. Sherman, Robert M. Califf
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…
Jon Speer
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—…
Ken Miller
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),…
Kimberly Watson-Hemphill, Kristine Nissen Bradley
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…
Duke University
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…
NIST
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…
Jill Hartzler Warner, Thinh Nguyen
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…
FDA
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…
NIST
I
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…
John Nolan
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…
J.D. Power and Associates
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…
Hilke Plassmann
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…
Eston Martz
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…
NIST
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…
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Katherine Watts
Bundled payments. Volume-to-value. Cost accounting. Process improvement. Patient engagement. Population health. Organizational leadership. These are more than just the newest industry buzzwords: They’re the trends that will compel the healthcare industry to transform its business model. They will…
Arun Hariharan
The other day, I visited a retail outlet of a wireless services provider to get information about its international roaming packages. The company has a few thousand outlets nationwide; they’re called “relationship centers” staffed with half a dozen employees who try to up-sell products and…
Knowledge at Wharton
Today, design has a seat at the table. With the success of products like the iPod and the iPhone, businesses have realized that a good user experience is key for improving the bottom line. Yet even with this determined focus on design, most digital experiences fall short of user expectations.
Of…