All Features
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Katherine Watts
The HORNE Healthcare team has been blogging recently about the necessary business model changes we think are inevitable to healthcare transformation. We’ve focused on the macro level, urging healthcare organizations to take action. Although I believe our advice is sound for large systems, I am…
Annette Franz
A couple weeks ago, I wrote a post about emotionally unavailable customers. Hat tip to James Lawther for inspiring me to actually flip the tables here and think about emotionally challenged employees, instead.
The question I posed in response to his comment on that post was: Why do we transform…
William A. Levinson
ISO 9001:2015, Clause 4.2—“Understanding the needs and expectations of interested parties” requires the organization to determine the “requirements of these interested parties that are relevant to the quality management system.” When customers block an organization’s content, it is a sure sign…
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 victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
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, reports the Johns Hopkins Health Review.
Busyness is a badge of honor for those who equate a packed…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
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 subjects of recently published studies that use statistical analyses in Minitab to improve…
Annette Franz
Ihave written and talked about journey mapping so much this year, even suggesting back in January that we make it the year of the journey map. I think customer experience professionals have made great progress toward this goal so far in 2016! I hear so many people talking about mapping, and many…
Ruth P. Stevens
As the initial wild enthusiasm for customer relationship management (CRM) begins to plateau, and companies become increasingly skeptical of inflated claims for success, it’s time to take a hard look at how CRM projects should be measured. What is “successful” CRM, anyway? How will you know it when…
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 back.
Just over a year ago, I had a heart attack. My second heart attack. Yep. Two. The first one…
Annette Franz
Do you know the 12 Laws of karma? And did you know they can be applied daily to your customer experience (CX) efforts? If not, no worries, just read on. I’ll define them for you and tie them to this CX world we live in.
I came across these recently and thought they made sense—for life and for…
Barbara A. Cleary
Trivia question of the day: What do toilet paper, sugar, coffee, cheese, ice cream, and sugar have in common? Two things, actually. Their prices are up, and their packaging units are down.
A can of coffee is now likely to be only 11 ounces, diminished from a full pound several years ago. Likewise…
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 day. Because ambulances are basically a small emergency room on wheels, the occupants in the back are…
Hubert Gatignon
There can be little argument that consumers are growing more suspicious of business. They question its motives, and increasingly, its marketing, which recently has been said to be manipulative. Consumers are ever more aware of the Internet pop-ups and exaggerated claims they receive in a targeted…
Rachel E. Sherman, Robert M. Califf
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 “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
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 (MACRA), healthcare providers are, or will be, paid differently for their services. No longer can they…
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…