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We’re Not Alone, Children Remind Us
David Schwinn
This month’s column results from my wife, Carole, asking me to “watch this.” This was a short video on her computer showing two young children brilliantly and inspirationally singing, “You Raise Me Up.” I was dumbstruck. Their song immediately took me to many places. I was reminded of the wisdom…
Improving FDA Reviews of Combination Products
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Is Customer Experience Really Everyone’s Job?
Annette Franz
Pundits and experts alike say that ensuring a good customer experience (CX) is everyone’s job. In fact, if you Google “customer experience is everyone’s job” or “customer service is everyone’s job,” you’ll find endless articles, blogs, and webinars with that very title. It’s true. Technically, it…
FDA Eases Up a Bit on Enforcement Gas Pedal
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
How to Prepare Your Team for Customer Service Training
Jeff Toister
You’re ready to send your team to customer service training. The big question is whether your team is ready. Chances are, they’re not. A 2010 McKinsey & Co. survey revealed that approximately 75 percent of training programs failed to measurably improve business performance. A lack of…
FDA Answers (Some) Medical Device Cybersecurity Concerns
Michael Causey
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users. However, the agency isn’t putting the entire onus on medical device manufacturers. The FDA “recognizes that…
Ten Tips to Prepare for Electronic Health Records Audits
Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure that you’re ready for an audit by the Office for Civil Rights (OCR). I recently wrote that the OCR…
Five Steps to Realizing Value in a Clinical Co-Management Agreement
Healthcare reform has undoubtedly created more integrated delivery and payment models based on a culture of quality-focused and cost-efficient clinical management. In one example, many healthcare systems have begun implementing clinical co-management arrangements (“CCMAs”) to accomplish the…
Does Every Good Analytical Chemist Need to Be a Statistician?
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…
Last Chance to Win
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…
Listen to Customers, Grow Your Business
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…
FDA Touts Improved IDE Review Stats
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…
ACSI: Customer Satisfaction With PCs Drops as Tablets Fall Out of Favor
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,…
Busywork vs. Real Work
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…
FDA’s 510(k) Guidance Emphasizes Software-as-Device Factor
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…
Exceeding Three Customers’ Expectations
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…
Evaluate How Well You Understand Your Customer
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.…
The Sizzle That Sells CRM Internally
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…
Four Signs You Really Don’t Know Your Customers
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…
U.S. Drug Shortage Hits Patients, Pharmacies Hardest
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…
Going Face to Face With Your Customers
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…
Recognizing Your Customers’ Moments of Truth
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…
Baldrige Tests Positive for Superior Patient Experience
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…
Cybersecurity—A Real Threat to Medical Devices
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…
Outside-In vs. Inside-Out Thinking
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…

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