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AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Chip Bell
‘How ya gonna keep ’em down on the farm after they’ve seen Paree? How ya gonna keep ’em away from Broadway, jazzin’ around and paintin’ the town?” This 1914 song by Andrew Bird was a hit as soldiers returned home from World War I. The song captured the concern of farmers whose sons left their…
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By…
InfinityQS
On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as…
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer…
Gary Brooks
With the durable goods markets in flux—new orders rose 0.7 percent in March 2017, after declining as low as 4.7 percent just a few months prior—manufacturers are seeking alternate sources of revenue and profit. After-sales service, or the service delivered after the initial sale of a new product,…
Ruth P. Stevens
As marketing advances, most professionals are well aware by now of the importance of retention and reactivation in optimizing the value of the customer base. The facts are clear: We know that it costs far less to reactivate a dormant customer than to acquire an entirely new one; we know that…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Annette Franz
What motivates you to go to work every morning? What drives you to do good work every day? What motivates you to want to work for your employer every day? What are the things that your manager and your executives do that encourage you to work hard for them every day?
What motivates your staff? Do…
Ian Haydon
There’s a revolution happening in biology, and its name is CRISPR. CRISPR (pronounced “crisper”) is a powerful technique for editing DNA. It has received an enormous amount of attention in the scientific and popular press, largely based on the promise of what this powerful gene-editing technology…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
Harry Hertz
The title to this column probably has you thinking about some life-changing transition or a big vacation to refresh, or maybe a new exercise regimen. If that is the case, I am sorry to disappoint you.
I’m actually about those renewal reminders for annual donations you make to a charity or to…
Mark Lee Hunter, Luk Van Wassenhove, Maria Besiou
The digital revolution is transforming the relationship between consumers and companies. Nearly all business functions are feeling the effects, but conventional marketing sits squarely on the fault lines of disruption. Brand-authorized messages increasingly can’t compete with online customer…
AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).
Responding to the Center for Devices and Radiological Health’s (CDRH’s…
American Customer Satisfaction Index ACSI
Customer satisfaction with subscription television is down 1.5 percent to a score of 64 (on a 1–100 scale), tied with internet service providers for last place among 43 industries tracked by the American Customer Satisfaction Index (ACSI). New ACSI results show that wireless service is the only…
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile manufacturers, and government systems. The worm’s ominous red ransom screen, informing the user that…
Ryan E. Day
I remember my first trip to Michigan in 2012. I was covering the Ford Motor Co.’s annual Trend Conference and had the opportunity to meet Alan Mulally, who gave a compelling presentation explaining the vision, strategy, and implementation of the One Ford plan. I was impressed more with the man…
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it assesses a…
Ryan E. Day
Sponsored Content
Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
Rob Mitchum
People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where they can…
American Customer Satisfaction Index ACSI
Passenger satisfaction is up compared to a year ago, but airlines remain in the bottom third of industries tracked by the American Customer Satisfaction Index (ACSI). As the largest airlines lower their ticket prices to compete with discount carriers, the industry gains 4.2 percent to 75 on a 100-…
Mike Richman
It’s easy to sit here aghast at the big, attention-getting customer service missteps that have recently blown up into public relation nightmares for United Airlines and American Airlines. These issues aren’t limited to airlines, however. During the past few years, companies in the automotive, life…
Brooke Pierce
As high deductibles and escalating costs drive patients to take a more active role in their healthcare, providers are waking up to the fact that they need to pay attention to what buyers want. But uncovering those consumer insights and using them to drive organizational strategy remains a…
Annette Franz
In May 2016, I spoke at CallidusCloud Connections (C3); if you’ve never been to this event, be sure to check it out this year. The topic of my session was “The Seven Deadly Sins of Customer Experience.” Given the topic of today’s post, I seem to be on a bit of a spiritual customer-experience…
Dirk Dusharme
In last week’s Quality Digest Live: design digital assistance instead of digital assistants, how to make better beer, and closed-loop manufacturing.
“How Digital Media Will Bring Out Our Best Selves in the Workplace”
To improve the workplace, maybe we need a fewer digital assistants and lot more…