Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other...
Johns Hopkins University
More than one-third of Americans say they don’t have enough time in their day to get things done, and the majority of Americans who report not having enough spare time also say they battle stress,...
Patrick Runkel
What does the eyesight of a homeless person have in common with complications from dental anesthesia? Or with reducing side-effects from cancer? Or monitoring artificial hip implants?
These are all...
Mike Figliuolo
Work is a convenient excuse for not taking care of yourself. Not exercising, poor diet, and stress are a bad combination. You’ve got to make time for you. Work will always be there when you get...
Jennifer Marshall
For as long as we have had automobiles, we have had traffic accidents. Even the vehicles that we depend on to take care of us in the event of an accident—ambulances—get into accidents nearly every...
Rachel E. Sherman
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “...
Brooke Pierce
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 (...
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...
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...
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...
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...
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...
Rachel E. Sherman
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...
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...
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...
Kimberly Watson-Hemphill
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...
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...
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...
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...
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...