Daniel Hess’s picture

By: Daniel Hess

We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals.

Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just that before the arrival of Hurricane Irma in 2017.

With more than 300 hospitals and a higher share of older adults than any other state, Florida had a critical issue facing emergency planners during those storms.

As a professor of urban planning, I have studied emergency planning and evacuation and also co-authored an extensive report on how hospitals coped with the aftermath of Hurricane Katrina and Hurricane Gustav. Hospitals plan for catastrophic events, but there are always lessons to be learned.

Hospitals try to stay open and care for patients already hospitalized as well as those who suffer injury or illness from a storm. Here’s how they do it.

Sharona Hoffman’s picture

By: Sharona Hoffman

A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.

That should worry all of us. The physician burnout crisis is likely to affect our quality of care and our access to healthcare providers.

According to a recent study, 44 percent of U.S. doctors suffered at least one symptom of burnout, and some studies have identified even higher burnout rates. By contrast, researchers have found only a 28-percent burnout rate in the general working population.

Peter Rose’s picture

By: Peter Rose

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and be fully compliant under EU MDR.

This statement alone may be surprising to certain Class I manufacturers, who assume that their products’ classification as low-risk devices under the previous directive will exempt them from all this EU MDR commotion. These presumptions are misguided because classification requirements listed in the EU MDR are relevant to all manufacturers, irrespective of past classification.

With this deadline in sight, it is crucial that all manufacturers familiarize themselves with these regulatory changes and promptly make a start on implementing necessary measures. Those that fail to achieve compliance on time will be left behind, and their products removed from the market. In light of this industry bustle, this article aims to advise Class I manufacturers about the primary alterations that the EU MDR will enforce, as well as offer practical steps that manufacturers can begin to follow.

David L. Chandler’s picture

By: David L. Chandler

As a cucumber plant grows, it sprouts tightly coiled tendrils that seek out supports to pull the plant upward. This ensures the plant receives as much sunlight exposure as possible. Now, researchers at MIT have found a way to imitate this coiling-and-pulling mechanism to produce contracting fibers that could be used as artificial muscles for robots, prosthetic limbs, or other mechanical and biomedical applications.

Although many different approaches have been used for creating artificial muscles, including hydraulic systems, servo motors, shape-memory metals, and polymers that respond to stimuli, they all have limitations, including high weight or slow response times. The new fiber-based system, by contrast, is extremely lightweight and can respond very quickly, the researchers say. The findings have been reported in the journal Science.

The new fibers were developed by MIT postdoc Mehmet Kanik and MIT graduate student Sirma Örgüç, working with professors Polina Anikeeva, Yoel Fink, Anantha Chandrakasan, C. Cem Taşan, and five others. The group used a fiber-drawing technique to combine two dissimilar polymers into a single strand of fiber.

Multiple Authors
By: Sarah Webb, Knowable Magazine

What you see in the image below is a lobe of a liver, times two. On the right, a flesh-and-blood one, removed from a transplant donor; and on the left, one created from plastic to represent bile ducts, arteries, and veins, which were laid down, layer by layer, by a 3D printer. The goal of such technology is to help surgeons plan and practice complex procedures, and train new surgeons with simulators that respond as a patient would.

Surgeons navigate complex anatomical terrain as they manipulate scalpel and suture to cut and stitch precisely and quickly. Their job is made harder by the fact that human anatomy is far from uniform. To properly prepare, they routinely use two-dimensional images from computerized tomography (CT) scans or magnetic resonance imaging (MRI) to plan.

But increasingly they are turning to realistic 3D models that are specific for individual patients.

Such models are already used to educate patients, to do general training, and to plan and practice especially difficult procedures. But in the future, 3D models, be they physical or virtual, could become routine tools for training surgeons or mapping procedures in advance.

Grant Ramaley’s picture

By: Grant Ramaley

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region. 

This could be more problematic for dental products, which are inherently lower risk. Rubber dams and dental operating lights will have to comply before MRIs and pacemakers. 

To ensure that medical device manufacturers of class 1 devices understand that they must comply immediately on May 27, 2020, when the new regulation goes into effect, the European Commission states this plainly in its “Fact Sheet to Medical Device Manufacturers.”

Matthew M. Lowe’s picture

By: Matthew M. Lowe

While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that 75 percent of CIOs and IT executives in life sciences and healthcare fields surveyed said that security risks were their primary reason for opposing cloud technologies.

Cloud-averse attitudes are slow to change, and industry research shows that companies that manage health information continue to show major resistance to cloud technology.

Jon Speer’s picture

By: Jon Speer

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency: The MDR represents brand-new regulations with significant changes.

For those seeking to better understand why the regulations have changed, and what some of the major changes are, let’s take a look at some of the most common questions we hear from our users.

1. Why did the MDD need an update?

There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, software as a medical device (SaaMD) did not yet exist. Software was something that controlled electric machines, and apps that patients could use to monitor their own health were still nearly 20 years away.

AssurX’s picture

By: AssurX

Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” [ASR] repository, instead of being described individually as device-adverse events in the public database known as MAUDE.”

Medical experts trust the Manufacturer and User Facility Device Experience (MAUDE) to identify problems that could put patients in jeopardy—making products that are not in that database essentially concealed.

In 2017 alone, 480,000 injuries or malfunctions were reported through the ASR. The FDA has declined to provide a complete list of the approximately 100 devices that have been granted reporting exemptions. Requests for those data through the Freedom of Information Act could take up to two years.

Critics have pointed out that many of those devices, which include staplers, vaginal mesh devices, robotic surgical devices, breast implants, and heart valves, come from medical device industry leaders.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

Despite the life science industry’s infatuation with modernity and trend chasing, even its most forward-thinking organizations have struggled to fully digitize and integrate their operations.

Yet, while the industry lags behind most other sectors in implementing business-streamlining digital technologies, many shrewd life science companies are working to close the digital gap so they can capitalize on the competitive advantages digitization affords.

As digital initiatives gain more traction, and as advanced technologies increasingly perform more of our mundane tasks, skilled life science professionals’ fears about job displacement are intensifying. Their digital apprehensions are undeniably intertwined with the global workforce’s general anxieties about automation, as highlighted in a 2017 PwC survey that reports 37 percent of the world’s workers are worried about eventually losing their jobs to automation. The unease is worsening, it seems, as only 33 percent of workers reported concerns about job-eradicating automation in the same survey in 2014.

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