All Features
Karina Montoya
Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer. On average, a 50-year-old man in India with asymptomatic liver damage who doesn’t receive treatment is expected to…
Tom Rish
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the…
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.
They are also being driven by…
Mike John
This article has been republished with permission from Medical Plastics News.
While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of…
Gleb Tsipursky
The pandemic has made organizations aware of the need for a new C-suite leader, the CHO, or chief health officer. This has been driven by recognizing the importance of employee health for engagement, productivity, and risk management, along with lowering healthcare insurance costs. At the same time…
Ann Brady
Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s world is how to achieve this. Global food systems, already under pressure before the pandemic, are now…
Jamie Steiner
Ultra-low temperature freezers became popular due to the storage of Covid-19 vaccines, but they have been important components of laboratories for many years. There’s a lot, however, to think about—quality, productivity, maintenance, different types of technology, warranties, etc. And if you end up…
Prashant Yadav
During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives.
However, these developments haven’t…
David Stevens
The United States has more than 6,000 hospitals, and each one has thousands, if not tens of thousands, of clinical assets, such as imaging machines, ventilators, and IV pumps. Managing this equipment becomes a mighty task when hospital staff must handle the monitoring, repair, and maintenance of…
Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.
Pharmaceutical manufacturers must ensure that the…
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…
