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Jon Speer
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that medtech executives and company stakeholders should be…
Samantha Maragh
I didn’t understand what people were asking me when I was a kid. The question would come in several different forms. Sometimes it was, “What are you?” Other times it was, “Where are you from?” I would answer with things I knew to be true, like, “I’m a girl,” or, “I’m a person,” or, “I’m from…
Steven Brand
The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars,” supporting companies that align with their personal beliefs. To keep up with consumer demand—and…
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…
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…
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…
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…
Jennifer Lopez
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug…
Michael D. Williams
As I spoke recently with colleagues at a conference in Florence, Italy, about healthcare innovation, a fundamental truth resurfaced in my mind: the U.S. healthcare industry is just that. An industry, an economic force, Big Business. It is a vehicle for returns on investment first and the success of…
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…
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted…
Sarah Webb, Knowable Magazine
This story was originally published by Knowable Magazine.
What you see in the image above 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…
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…
Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS).
Well before these risk-based processes became a quality…
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…
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…
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…
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…
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. In response to food company recalls, more than …
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…
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.
The approach, detailed in…
Bruce Hamilton
Last February I had the opportunity to observe healthcare providers up close and personal at one the world’s premier hospitals. “Who Cares for the Caregivers?” was written from the perspective of a patient in a cardiac step-down unit, sympathetically watching caregivers as they grappled with many…
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
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.
Recently, professors and researchers from the Sorbonne…
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.
Because of…