Steve McCarthy’s picture

By: Steve McCarthy

The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in order to achieve proactive quality as a differentiator. Many of those are cultural, but the majority require quality technology and innovation to reach the disruptive levels they have today.

Quality 4.0 is defined as the application of Industry 4.0’s advanced digital technologies to enhance traditional best practices in quality management. With the advent of such innovations as AI and IoT in the quality management ecosystem, the promise of proactive quality is finally a reality. Today the industry faces unprecedented challenges but also opportunities to serve patients like never before; both require innovation in business and product as well as in how companies approach quality.

This article highlights just one of these key challenges and opportunities: the increasing complexity and diversity of the supply chain itself. It emphasizes the reasons why recognizing and embracing bimodality is so vitally important, and how quality technology is a critical enabler for life sciences companies under these unique pressures.

Rich Press’s picture

By: Rich Press

Researchers at the National Institute of Standards and Technology (NIST) have produced synthetic gene fragments from SARS-CoV-2, the virus that causes Covid-19. This material, which is noninfectious and safe to handle, can help manufacturers produce more accurate and reliable diagnostic tests for the disease.

Tests for an active infection—as opposed to antibody tests that indicate a past infection—work by detecting the virus’s genes on a nasal swab. But a negative result does not necessarily mean that a person is disease-free. It could be that the amount of virus is too low for the test to detect, which is especially possible during the first days after catching the virus.

“Having better data on test sensitivity will help us understand how often tests for Covid-19 produce a negative result for people who are actually infected,” says NIST research scientist Megan Cleveland.

Merilee Kern’s picture

By: Merilee Kern

As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or guidance.

So important are the concerns amid this rapidly proliferating product sphere, that the FDA recently issued a consumer advisory regarding UVC light technology that’s applicable for industrial, business, travel, and residential use. Although the FDA says that “UVC radiation has been shown to destroy the outer protein coating of the SARS-Coronavirus,” it explains that the current SARS-CoV-2 virus is not exactly the same virus mutation. The FDA does, however, concede that “UVC radiation may also be effective in inactivating the SARS-CoV-2 virus, which is the virus that causes the Coronavirus Disease 2019 (Covid-19).”

Multiple Authors
By: Tinglong Dai, Guihua Wang, Ronghuo Zheng

The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes.

It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can put a life-saving kidney or heart out of reach.

Our research shows just how valuable each flight route can be for connecting donor organs with people in need of transplants. It also suggests that the industry’s great rebooting in the coming years can be an opportunity to help make the U.S. organ transplantation system more equitable.

As business scholars specializing in the fields of healthcare operations management, business analytics, and economics of information, we believe policymakers need to understand the potential impacts of the airline network on organ transplantation as they guide the post-pandemic recovery of the airline industry.

Donald J. Wheeler’s picture

By: Donald J. Wheeler

On Sept. 29, 2020, the recorded worldwide death toll from Covid-19 reached 1 million. Six days earlier the United States reached 200,000 Covid-related deaths. So how did the United States with only 4 percent of the world’s population manage to capture 20 percent of the world’s deaths in this pandemic?

The 19 countries listed in figure 1 account for 85 percent of the Covid-related deaths worldwide, as reported by the European CDC. Here we can see how the U.S. death toll exceeds all others.

 
Figure 1: Number of Covid-related deaths reported by 19 countries as of Sept. 26, 2020

The short explanation for this dubious achievement is that between April 1 and the present, the United States had an average of 27 percent of the worldwide total number of confirmed cases of Covid-19. With that kind of market share, the high death toll was sure to follow. But a more detailed answer requires that we look at the number of deaths per capita and the rate at which these death tolls are growing.

Jon Speer’s picture

By: Jon Speer

Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry. Risk is a critical factor to consider throughout the life cycle of a medical device because it can mean the difference between life and death for patients.

Industry resources like ISO 14971 exist to help medical device professionals define and clarify risk management best practices. According to the internationally recognized standard for medical device risk management, risk is defined as “the combination of the probability of occurrence of harm and the severity of harm.”

There are varying levels of risk factors medical device companies must consider in practicing effective risk management. By following the established processes outlined in ISO 14971 and leveraging the best quality management tools, medical device companies can improve their overall risk management system.

Jennifer Mallow’s picture

By: Jennifer Mallow

Covid-19 has led to a boom in telehealth, with some healthcare facilities seeing an increase in its use by as much as 8,000 percent. This shift happened quickly and unexpectedly, and has left many people asking whether telehealth is really as good as in-person care.

During the last decade, I’ve studied telehealth as a Ph.D. researcher while using it as a registered nurse and advanced-practice nurse. Telehealth involves the use of phone, video, internet, and technology to perform healthcare, and when done right, it can be just as effective as in-person healthcare. But as many patients and healthcare professionals switch to telehealth for the first time, there will inevitably be a learning curve as people adapt to this new system.

Thomas R. Cutler’s picture

By: Thomas R. Cutler

About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints that result in pain and can affect activity (e.g., carpal tunnel syndrome, tendonitis). About 140 million Americans live with an MSD. The total of direct and indirect costs for people who have both musculoskeletal disorders and other conditions such as diabetes, heart disease, or obesity is $874 billion, according to the report.

Jennifer Lauren Lee’s picture

By: Jennifer Lauren Lee

While awaiting full access to their labs due to Covid-19 restrictions, scientists at the National Institute of Standards and Technology (NIST) have taken this rare opportunity to report the technical details of pioneering research they conducted on the disinfection of drinking water using ultraviolet (UV) light.

Back in 2012, the NIST scientists and their collaborators published several papers on some fundamental findings with potential benefits to water utility companies. But these articles never fully explained the irradiation setup that made the work possible.

Now, for the first time, NIST researchers are publishing the technical details of the unique experiment, which relied on a portable laser to test how well different wavelengths of UV light inactivated different microorganisms in water. The work appears in the Review of Scientific Instruments.

“We’ve been wanting to formally write this up for years,” says Tom Larason, an electronics engineer in the Sensor Science Division at NIST. “Now we have time to tell the world about it.”

Multiple Authors
By: Stephen M. Hahn, Anand Shah

Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an emergency, and contribute to the high cost of medical products.

For the past several years, the U.S. Food and Drug Administration (FDA) has sought to encourage and facilitate the adoption of “advanced manufacturing,” which refers to new and emerging approaches for the production of medical technologies. These approaches are applicable to different medical product areas. For example, process intensification methods, such as continuous manufacturing, can simplify and centralize the production of many essential medicines. Likewise, techniques such as 3D printing can help produce patient-specific medical devices. Furthermore, digital and smart technologies for designing and manufacturing processes also promise to increase efficiency and reduce uncertainty.

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