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Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
Having recently bought some furniture at a big box store, I couldn’t help seeing these three dreaded words were boldly printed on the outside of the carton: “Some Assembly Required.”
As I opened the box, I wondered what I’d find. Would there be lengthy assembly instructions and lots of different…
There’s a well-known quote by Henry Ford that goes like this, “If I had asked people what they wanted, they would have said faster horses.” It’s fair to note that some don’t believe he actually said that, but let’s go with it.
Ford is often cited when naysayers tell us that customers don’t know…
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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,…
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…
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…
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…
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 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…