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.

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.

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.

Robyn Metcalf’s picture

By: Robyn Metcalf

In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause.

NIST’s picture

By: NIST

A new measurement approach proposed by scientists at the National Institute of Standards and Technology (NIST) could lead to a better way to calibrate computed tomography (CT) scanners, potentially streamlining patient treatment by improving communication among doctors. 

Hubert Gatignon’s picture

By: Hubert Gatignon

Health and economics are linked in more ways than just health insurance. When we look past the obvious, research shows us how brain scans, the gig economy, or even hospital queues are all part of the expanding domain of health economics.

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling potential. If anything, the reliable, “clinically proven” analytical habits of former decades have hampered some manufacturers from leveraging data in new and needed ways.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms. The doctor looks at those symptoms, tests you in various ways (blood tests, X-rays, MRIs), and interprets the results based on experience with past patients or what is widely known in the medical community. Then she prescribes a treatment. There are two problems with this.

Mike Richman’s picture

By: Mike Richman

Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality? To you, the reader, it will likely mean little except some lost time. For me, as the writer, the reputational hit could be considerable. To Quality Digest, as the publisher of the piece, the fallout could be even worse—lost readers and advertisers.

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