All Features
Greg Anderson
A s the market gradually moves toward value-based reimbursement, hospital payments to physicians have also been in transition from purely productivity-based pay to incentives based in part on quality, patient experience, and efficiency of care. This shift has taken place in employment,…
Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $…
Kevin Cundiff
Ask how you can help, always keep a smile, respond to requests promptly... the list goes on. You’ve probably been exposed to an abundance of tips and tricks about how to become more customer-friendly.
That kind of advice can definitely be valuable, but what you likely don’t hear—unless you’re a…
Arun Hariharan
Technology is a useful tool in quality. That said, there are limits to what technology can do. Here’s my summary of its advantages and disadvantages for quality professionals.
1. Data and measurements. Technology can help you automate measurements and analysis of data (Minitab statistical software…
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Annette Franz
What happens when we really understand our customers’ desired outcomes or the jobs they are trying to do? Something pretty incredible.
A few weeks ago I wrote about “Faster Horses... and Customer Outcomes” and the importance of asking the right questions to understand desired outcomes in order to…
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017.
Will…
Michael Webb
This month Quality Digest Daily welcomes Michael Webb, a noted author and consultant who writes about how the quality and productivity sciences improve sales and marketing departments.
How well does your company benefit from quality improvement and productivity? For instance, how well do you…
Katherine Watts
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas.
Here’s the first idea: New York Times bestselling author Bruce Feiler…
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation…
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second part of…
Stephen Ostroff
Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.
Tasked with overseeing products that account for about 20 cents of the consumer…
Robert M. Califf, Rachel E. Sherman
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…
Harry Hertz
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…
Annette Franz
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…
The QA Pharm
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…
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
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…
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…
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…
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…
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…
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…
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…
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…