All Features
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…
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…
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…
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…
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…
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…
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…
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…
Dirk Dusharme @ Quality Digest
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…
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…
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-…
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…
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…
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…
Laura Gillenwater
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…
