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.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing processes.

In fact, while the rest of the world continually vies for digital differentiators, only 21 percent of LSOs even view digital disruption as a potential threat, according to PwC’s most recent Digital IQ survey. The causes of LSOs’ digitization reluctance are abundant and legitimate—security, cost, data integrity and validation concerns are just a few—but fears about regulatory compliance are usually at the top of that list.

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.

First, diagnosis relies on the doctor’s or medical profession’s interpretation of an examination and test results. Second, treatments themselves target populations, not people: This is the treatment that worked for most people in the past, so this treatment should work for you.

This isn’t to bad-mouth the medical or pharma community. But medicine has been, and still is, essentially statistical in nature. It’s based on populations, not individuals. That has been the most cost-effective way to treat the most people in the most efficient way possible. It hasn’t been possible, either technologically or, more important in terms of time, to test every patient for every possible pathogen that he might ever have been exposed to, or personally interview every family member to understand the patient’s family health history.

Multiple Authors
By: Nicole Radziwill, Graham Freeman

In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths.

Although a burger is only required by law in that region to contain 47-percent beef, some meat products contained up to 80-percent horsemeat, and 85 percent of products contained traces of pork.1 In addition to potential health incidents due to allergic reactions, religious dietary guidelines and restrictions may also be violated when labels are incorrect.2 The bottom line is this: People should be provided with accurate information so that they can decide for themselves what, and what not, to eat.

A crisis like this can have far-reaching impact. In addition to product recalls, safety alerts, and expensive market withdrawals, there can be loss of reputation among consumers as well as the general public. And since the food supply chain is extensive, global, and highly interconnected, a failure introduced by one supply chain partner can lead to adverse effects on a company that isn’t even directly responsible for the problems.3

Kelly Kuchinski’s picture

By: Kelly Kuchinski

Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel all this investment.

Nike found that out the hard way when Duke University superstar Zion Williamson ripped through the sole of his Nike sneaker 33 seconds into the grudge match with North Carolina. Williamson ended up leaving the game with a knee sprain, Duke went on to lose the game, and millions of viewers were left wondering if Nike’s quality was up to par. The immediate reaction by investors the next day was a more than 1-percent drop in shares, equating to $1.1 billion in market value. Ouch... on so many levels. It’s a reminder of how important product quality is to a company, the brand, and consumers.

Why quality management is critical

Quality is a foundation in the development and delivery of a safe and reliable product to consumers, which can be a key differentiator in the marketplace. It’s important for organizations to create a formalized system of processes, procedures, and systems to manage quality policies on a continuous basis.

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.

Now consider the risks of poor quality for a company operating within the life sciences sector. For these organizations, poor quality can lead to deadly outcomes for customers. That’s why U.S. Food and Drug Administration (FDA) agents won’t hesitate to shut down organizations that have been warned about faulty procedures and bad quality but can’t or won’t correct the situation.

Quality Digest’s picture

By: Quality Digest

Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science organizations can’t thrive.

The following short timeline offers a broad summary of how these elements have interacted during the last several decades. The industry has come a long way.


Thou shalt obey the FDA

The U.S. Food and Drug Administration (FDA) first prescribes current good manufacturing practices (cGMP) requirements for medical devices, including quality management system (QMS) requirements.

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