All Features
Laurel Thoennes @ QD
Traffic crawled. Ahead of me was a pickup, its bumper thick with stickers. From the one most cracked and faded, I saw the word “welfare.” Just before the driver switched lanes, I made out the rest: “Work harder—there are millions on welfare depending on you.” That triggered a memory so vivid I no…
Azadeh Shoaibi
The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data…
Chip Bell
Imagine a hotel proposing that the housekeeper put a goldfish in your guest room in a basketball-sized bowl filled with colorful rocks. All they ask is that you give it a name so you can have “your” fish join you again on your next stay. Visualize the bathrobe in the closet being zebra-striped or…
Volodymyr Bilotkach
On April 9, 2017, a passenger was forcibly removed from a United Airlines flight from Chicago O’Hare to Louisville after the carrier was unable to find volunteers to accommodate four of its employees on standby. Many articles have reported that airlines routinely overbook their flights, and…
Knowledge at Wharton
The mismanagement of bet-the-company business crises has become pandemic. Consider just the most recent examples.
In December 2016, Yahoo disclosed that three years earlier hackers had stolen confidential information from more than 1 billion accounts, including users’ names, birthdates, phone…
Brenda Stodart, Renu Lal
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are…
Mike Richman
On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap:
“SAE Institute Creates Webisodes to Benefit STEM Education” This piece demonstrates the good work that the San Jose, California, campus of the SAE…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Janet Forgrieve
Restaurant reservations systems such as OpenTable and Yelp Reservations may be one of the biggest areas where technology is working to help restaurants win new customers and build a bigger roster of loyal regulars. The services offer tools that help eateries customize the experience and add a…
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have found that the best tool available to enable price and value comparison is unit pricing—you know,…
Jon Speer
If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally…
Annette Franz
How well does your decision-making process work for you? Are you able to go from decision to solution to action with ease?
This is the second part of my two-part series on Peter Drucker’s five phases of decision making, which he outlines in his book, The Practice of Management (HarperBusiness,…
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as…
Suzanne Junod, John Swann
The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American health.
These…
Arun Hariharan
A mobile services company provides free mobile services to its employees. The employees never receive a bill for voice or data services. If an employee faces a problem, he just talks to a colleague in the relevant department (or somebody who knows somebody) and gets the problem fixed.
A chain of…
Mike Richman
If there’s one thing that separates those who do things in an average way and those who do those same things in an extraordinary way, it’s passion. This sense of intense interest, excitement, and focus drives the authentic pursuit of excellence, even (or perhaps, especially) in the rather mundane…
Ryan E. Day
Coffeepots and tires. All products should be built like coffeepots and tires. Awash in a sea of disposable products, these two durable goods stand out as icons of heresy against designed obsolescence.
I have long been amazed at the punishment automobile tires absorb and yet continue to perform as…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Dirk Dusharme
‘Made in the U.S.A.” Do people really care about those words on the label, and more important, how motivated are they to buy American-made products? The answer is yes... and sort of. Yes, consumers in the United States say they want to “buy American” and are willing to pay up for it. According to…
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an…
William A. Levinson
‘Sitting is the new smoking” is a common new adage. James Levin, M.D., of the Mayo Clinic explains, “Too much sitting also seems to increase the risk of death from cardiovascular disease and cancer.” He adds that sitting for four rather than two hours a day in front of a TV screen increases the…
Tom Scaletta
Quality improvement initiatives are a mainstay for hospital care teams. They can also offer a fresh approach for raising patient satisfaction scores. To achieve maximum effectiveness, however, they require timely patient feedback.
Nowhere is this truer, perhaps, than in the high-volume/short-…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Greg Anderson
Like it or not, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is here. MACRA created the new Quality Payment Program, comprised of two pathways to higher quality: the Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Models (Advanced APMs). MACRA…
Annette Franz
Do you know what it takes to stay ahead of the competition? Is that one of your business goals? Recently I was interviewed by someone for an article she was writing, and one of the questions was about competition and the best ways to research the competition. Other questions on the topic revolved…