All Features
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…
NIST
As a step toward improving our ability to identify and manage the harmful effects of bias in artificial intelligence (AI) systems, researchers at the National Institute of Standards and Technology (NIST) recommend widening the scope of where we look for the source of these biases—beyond the machine…
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,…
NIST
Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…
Adam Zewe
Multiple programs running on the same computer may not be able to directly access each other’s hidden information. But because they share the same memory hardware, their secrets could be stolen by a malicious program through a “memory timing side-channel attack.”
This malicious program notices…
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…
Sara Adams
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they should even initiate a CAPA.
When companies…
Adriana Lynch
If there’s anything the last decade has taught us—and the Covid-19 pandemic has punctuated in grand fashion—it’s that businesses must get digital or they may become invisible. Branding, formerly an exercise that involved plastic signs, billboards, and newspaper print ads, has now firmly taken up…
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…
Ryan E. Day
Chickens come home to roost, and canaries meet their demise in coal mines. But hey, we knew there was a high probability of each happening eventually, right? However, when a black swan shows up with severe impact and consequences, everyone is caught off guard. I’m wondering if it’s a black swan…
Chip Bell
It all started when we drove up to the speaker menu at a quick-service restaurant. “Can I take your order?” the attendant coldly barked. When my wife, on hearing the deep voice of the attendant, politely said, “Thank you, sir,” she got back a sharp, “It’s ma’am.”
The attendant bristled with…
Josh Wilson
Paraphrasing Winston Churchill, Rahm Emanuel, a former White House chief of staff and Chicago mayor, famously quipped that you never want a serious crisis to go to waste. Few of us will face the number of crises that a big-city mayor or a presidential aide may deal with in a day, but we still need…
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…
James Wells
The ISO 9001 standard talks about the relationship between the company and the customer in a couple of places. First is management’s responsibility to make sure that customers’ needs are a top consideration, and that their requirements are met. Then that customer satisfaction is improving, and…
Henrik Hulgaard
As customer demands for more customization and choice increase, the complexity of products and associated product design, manufacturing, and sales processes also increase. Product life cycles are also getting shorter, requiring a constant flow of new products with high-value features and…
Kari Miller
In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).
The primary goal of post-market…
Gleb Tsipursky
Any association would love a member-retention rate of 75 percent. Unfortunately, according to a 2017 report cited in the American Society of Association Executives (ASAE) publication, Associations Now, retention rates for all associations are falling. While in 2016, 73 percent of associations…
Quality Digest
Getting your product into customers’ hands is often an undervalued—and under-engineered—part of your organization’s value chain. If the pandemic’s effect on our supply chains has taught us anything, it’s this: Diligent reevaluation of our modus operandi is a must for success.
When the Covid…