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A Better Way to Design Clinical Trials
Stephen Chick
Value has found a place at the heart of healthcare innovation. For money-conscious governments and other actors in the system, it’s not enough that a new treatment be beneficial and safe. It also needs to be cost effective. This emphasis on value is even changing the profile of the pharmaceutical…
Inside Quality Digest Live for Sept. 1, 2017
Mike Richman
On Friday, Sept. 1, 2017, QDL included news about the disaster in Texas and no apocalypse in retail, an interview covering a different approach to failure modes and effects analyses, a feature article on consumer views about for-profit social-benefit enterprises, and a great new Tech Corner demo.…
Seeing Without Eyes
Thomas Cronin
We humans are uncommonly visual creatures. And those of us endowed with normal sight are used to thinking of our eyes as vital to how we experience the world. Vision is an advanced form of photoreception—that is, light sensing. But we also experience other more rudimentary forms of photoreception…
Last Mile Delivery
Thomas R. Cutler
  Flawless order fulfillment from a distribution center or warehouse to the customer’s door is the neglected leg of the supply chain. Ironically, without careful attention to the last mile, e-commerce customers are disappointed with the quality, accuracy, and condition of the products being…
Leveraging FDA Resources to Encourage Students to Pursue STEM Careers
Richard Pazdur
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet, it is precisely those students…
The IRS Isn’t the Only One Monitoring Your Exempt Hospital
Amie Whittington
As discussed in my previous article, the Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under section 501(c)3. However, the IRS isn’t the only one monitoring your tax-exempt hospital. Other organizations have started policing these…
Inside Quality Digest Live for August 11, 2017
Dirk Dusharme
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more. “Climbing Stairs Just Got Easier With Energy-Recycling Steps” These stairs actually help you go up. “The Curious Case of the Fidget Cube” How a product…
What’s the Value of Innovation? Part 1
Greg Anderson
The Affordable Care Act created the CMS Innovation Center to allow Medicare and Medicaid programs to test innovative payment and delivery models that improve patient care and lower healthcare costs. The Innovation Center organizes models into seven categories. Some models are based on payment…
Why Market Competition Hasn’t Brought Down Healthcare Costs
Gerald Friedman
It’s easier than ever to buy stuff. You can purchase almost anything on Amazon with a click, and it is only slightly harder to find a place to stay in a foreign city on Airbnb. So why can’t we pay for healthcare the same way? My research into the economics of healthcare suggests we should be able…
Medical Device Manufacturers Warned for CAPA Noncompliance
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…
Is Your Customer Intelligence a Crystal Ball or Just a Rearview Mirror?
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…
Fostering Medical Innovation
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…
The Sugary Drink Tax
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…
What Are ISO 13485:2016 Validation Requirements?
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…
Upgrade After-Sales Service Technology, Watch Customer Satisfaction Soar
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,…
The Case for Customer Reactivation
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…
Dual Status Hospitals: Beware of IRS Compliance Audits
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…
Motivated Employees Deliver Great Customer Experience
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…
Beyond Just Promise, CRISPR Is Delivering in the Lab Today
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…
Medieval Medical Books Could Hold the Recipe for New Antibiotics
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…
A Time for Renewal
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…
Two New Commandments of Customer Engagement
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…
How Will Real-World Evidence Affect 2017 FDA Guidances?
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…
ACSI: Wireless Competition Boosts Customer Satisfaction While Pay TV Fades
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…
Lessons Learned From the WannaCry Ransomware Attack
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…

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