All Features
William A. Levinson
Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from surviving people or products, extremely satisfied or dissatisfied customers, or propagators of bad…
The Un-Comfort Zone With Robert Wilson
In a recent column, I wrote about the power of suggestion. I stated, “When our subconscious mind is exposed to a constantly repeated message, it’s going to penetrate unless we are cognizant of it.” Becoming conscious of indoctrinating media messages is important, but recognizing your own internal…
Merilee Kern
Since the dawn of civilization, humans have used natural remedies for their healing properties. Some of the same treatments are still used by billions around the world, based largely on anecdotal evidence and lore. Clinical research on natural treatments is lacking due to costly clinical trials,…
Duxin Sun
When you hear the word “nanomedicine,” it might call to mind scenarios like those in the 1966 movie Fantastic Voyage. The film portrays a medical team and robotic submarine shrunk to microscopic size to travel through a man’s body to clear a blood clot in his brain.
Nanomedicine has not reached…
Dario Lirio
By now, it’s no secret that good clinical practice (GCP) guidelines used by FDA inspectors are expanding. These GCP guidelines are developed by the International Conference on Harmonization. The ICH last revised its GCP document, called ICH E6(R2), in 2016. It will be releasing a new version in…
Alexander Khomich
The digital transformation of healthcare is under the influence of trending technologies, from IoT devices to AI algorithms. Some healthcare providers are just getting acquainted with innovations. Others (93%, according to Accenture) are already actively implementing and creating software solutions…
Gary Shorter
Predictive and prescriptive insights driven by data analytics have risen to prominence as tools that can help research teams cut the time, complexity, and cost of clinical trials. At the same time, these insights can enhance the quality of a study and accelerate new drugs to market. But to uncover…
NIST
Tiny biological computers made of DNA could revolutionize the way we diagnose and treat a slew of diseases, once the technology is fully fleshed out. However, a major stumbling block for these DNA-based devices, which can operate in both cells and liquid solutions, has been how short-lived they are…
Knowledge at Wharton
More than a half-million healthcare workers in the United States have quit their jobs in recent months, driven to the breaking point by the Covid-19 pandemic. But greater use of technology could help save jobs by reducing the kinds of inefficiency and stress that lead to burnout for many hospital…
NIST
To combat Covid-19 amid supply shortages in 2020, healthcare facilities across the United States resorted to disinfecting personal protective equipment (PPE), such as N95 masks, for reuse with methods such as ultraviolet (UV) light. But questions lingered about the safety and efficacy of these…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have discovered a potential source of error when using acoustic waves to measure the properties of fluids such as blood. Their discovery raises the possibility of more accurate diagnostic tests for certain types of blood…
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.
It’s no secret that healthcare in the United States is…
Theodoros Evgeniou, Ludo Van der Heyden
Technology has always been a double-edged sword. While it’s been a major force for progress, it has also been abused and caused harm. From water power to Fordism, history shows that technology is neither good nor bad by itself. It can, of course, be both, depending on how it’s used.…
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.
Given that…
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety.
The heightened risk is drawing the attention of federal regulators, who warn that “it…
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years.
Now,…
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives.
These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Scott Trevino
The pandemic promises ongoing challenges for healthcare providers in 2022 as they cope with nursing shortages and cybersecurity threats amid shifts previously underway for the industry. How they manage their clinical assets, however, can present opportunities to overcome those challenges while…
Maggie Overfelt
Machine learning has the potential to drastically improve efficiency and the quality of care in hospitals by tackling hard-to-predict problems like ICU occupancy or which patients are likely to be readmitted.
Yet, a big barrier to any technology working optimally is getting full buy-in from its…
Sankesh Abbhi
Life science organizations play a vital role in healthcare’s technology revolution, with a key focus on identifying the right opportunities to scale digital transformation. Currently, life sciences leaders are leaning into areas such as automation, which was discussed at length at ArisGlobal’s…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Bill Marler
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
