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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…
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…
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…
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-…
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…
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,…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
‘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…
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…
‘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…
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-…
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…
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…
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…
When the circus ringmaster wails, “...and children of all ages,” he is speaking to me. I love the circus. When it came to my rural hometown when I was a boy, it was an all-consuming experience that embedded “circus” in my heart before it appeared and well beyond its departure.
Long before the…
I recently had the privilege of attending the Health Care Advisory Board’s National Meeting in St. Louis. One of the topics that really struck me was the last presentation about the importance of building a consumer-focused organization and increasing consumer loyalty.
We hear so much about the…
When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally important to healthcare and life, and it is very volatile at the moment: the blood supply chain.
Human…