All Features
Eston Martz
I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.
Recently I read a great blog post by Tony Taylor, an analytical chemist with a background in…
Taran March @ Quality Digest
As a sort of character-building exercise, I recently opened an unsolicited email from my health insurance provider. I was intent on doing a quick purge of sham, spam, and flimflam, and I figured this one would be no different. But I also know I’m biased against health insurers, so I decided to set…
Annette Franz
Are you listening to your customers? Do you understand what they’re trying to achieve? Are you using what you learn to actually design a better experience for them?
I was thrilled to be interviewed by Leah Berry and to a be part of her 30 Experts in 30 Days series; she asked me questions about…
Michael Causey
Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials Program at the Center for Devices and Radiological…
American Customer Satisfaction Index ACSI
Customer satisfaction with personal computers is down for a third straight year, according to new data from the American Customer Satisfaction Index (ACSI). The ACSI Household Appliance and Electronics Report 2015 includes desktops, laptops, and tablet computers, as well as household appliances,…
Annette Franz
Think about the things that you’re doing to transform your organization and your customer experience. Are you doing busywork, or are you doing real work?
Today’s article is inspired by this quote from Thomas Edison:
“Being busy does not always mean real work. The object of all work is production…
Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and it just released its new acceptance policy. This new standard, which will be effective…
Harry Hertz
Some of my friends commented that Harry the “Cheermudgeon” was too “mudgeonly” in my most recent Blogrige post. So I decided it was time to cheer. Here is a cheer to getting older. The topic came to me this past week, when I was given a senior-citizen discount at the supermarket without asking for…
Dick Wooden
Many organizations talk about understanding customers and their needs, but few truly understand what customers value most. As we approach the end of the year, it’s a good time to reflect back on this year’s customer experiences and consider the following aspects of understanding your customer.…
Nawal Mohsina
The difference between a good product and a great solution isn’t just the quality of the technology but how the solution is presented and marketed internally. We all have personal technology devices that we love. Whether it’s a Microsoft Surface, iPhone, or Bose noise-cancelling phone, users line…
Dick Wooden
Now let’s be real here and take a big-picture look at your company’s knowledge about its customers. For instance, when my firm reviews how a client uses its customer relationship management (CRM) system, invariably we find knowledge gaps in the operational processes it follows.
These gaps make it…
Patrick Stone
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug Administration (FDA) “officially” list the shortage of drug products as less than 200; however, the pharma…
Ryan E. Day
‘Would you care to participate in a quick survey to help us serve you better?” I suppose many people enjoy filling out surveys—their chance to sound off and all that. Personally, it’s not my favorite part of any transaction. Ford’s recent Customer Clinic in Irvine, California, though, was a…
Annette Franz
Do you know the moments of truth for various tasks customers attempt to achieve with your organization? Before you can know or identify your moments of truth, you must first know what that means.
So, like I usually like to do, I'll start by defining the concept.
BusinessDictionary.com defines…
NIST
A newly released study comparing 34 U.S. healthcare organizations that received the Baldrige National Quality Award with their 153 geographically closest competitors found that the Baldrige Award recipients matched or exceeded their competitors’ measures of healthcare quality and outperformed them…
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. The pump is mostly used in hospitals or other acute…
Annette Franz
In the world of customer experience, what’s the difference between outside-in and inside-out?
Inside-out thinking means your focus is on processes, systems, tools, and products that are designed and implemented based on internal thinking and intuition. The customer’s needs, jobs, and perspectives…
Michael Causey
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us under the industry’s financial hood.
The GAO, the nonpartisan counting-house arm of the federal…
Michael Causey
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto threat by President Obama.
Not so fast, say opponents who want to eliminate the 2.3-percent excise tax on…
Michael Causey
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of the year tallying up where he had guessed correctly—and where he’d missed the mark. Not many columnists…
Annette Franz
One of the arguments against journey mapping I often hear is that it’s an exercise in futility. You map. You put it on the wall. Nothing changes. To that I answer, “You’re doing it all wrong.”
You map because you need to understand the customer experience; you know that you can’t transform…
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device…
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data are directly related to patient care.
Examples of small data include: • Missed clinic appointments…
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.
If…
Alex Morris, Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…