All Features
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…
David Dubois
Faced with a growing range of tech solutions in marketing, from AI to big data to blockchain, business-to-business (B2B) companies too often choose the status quo. Recent evidence suggests the divide between success and failure is not about how much companies spend, but how well they integrate…
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…
Alex Bekker
Do you know what a retailer and a tightrope walker have in common? They both have to balance. For the tightrope walker, the logic is clear. But what’s the balance that a retailer is looking for?
A typical dilemma of shortages vs. storage costs
Although the dilemma of shortages vs. storage costs is…
Annette Franz
I have been doing a bit of speaking lately, either about journey mapping or with journey mapping as part of the talk, and I’ve learned a lot, or rather, confirmed a lot. Namely, you might think you’re journey mapping, you call it journey mapping, but it’s not really journey mapping. Here’s what…
Bill Laverty
Operations management plays an important role in the manufacturing process, but similar to a stage crew at a theater, operations managers do all their best work behind the scenes. The best operations managers strive to go unnoticed, and why shouldn’t they? A seamless supply-chain process should…
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…
Tara García Mathewson
Once students learn how to sound out words, reading is easy. They can speak the words they see. But whether they understand them is a different question entirely. Reading comprehension is complicated. Teachers, though, can help students learn concrete skills to become better readers. One way is 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. 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…
Chip Bell
Parking lot. We use it in the meeting-management world to mean agenda items that are tabled for later discussion. These are generally posted on a sheet of flip-chart paper, taped on the meeting wall, and then placed on the agenda of the next meeting so they are not forgotten as topics for…
Vaishali Gopi
Customer experience has become pivotal to growth and profitability strategies of businesses worldwide. There is now a deeper understanding of customer experience as an incredibly important piece in the success (or failure) of any brand. Research states that by 2020, customer experience will…
Pierre Chandon
Whether you love or hate his work, Andy Warhol eating a Whopper for 45 seconds during one of the most expensive ad slots in television this year was astonishing.
Super Bowl Sunday—the most macho of American sporting events—coupled with the quintessential pop artist had people talking the morning…
Annette Franz
Core values are the fundamental beliefs of an organization; they guide executives and employees in identifying which behaviors and actions are right and which are wrong. Everything you do must be aligned with your core values, and core values should be integrated into everything you do. When in…
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…
Chanice Henry
According to CX Network’s latest “Annual Global State of CX Report,” showing return on investment (ROI) from customer experience (CX) projects is one of the top challenges troubling CX practitioners.
The report saw nearly 270 responses from the CX community, with each participant providing insight…
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…
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…
Dirk Dusharme
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…