All Features
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…
Annette Franz
You’re listening to customers. You’re combining their feedback with those bread crumbs of data that they leave with every transaction and interaction with your brand. You’ve developed customer personas to better understand who they are, what problems they are trying to solve, and what jobs they…
Barnaby Lewis
Put in the terms of this article’s title, most of us would run a mile, whatever the proposition. But the popularity of online reviews, and the trust we place in persons unknown when making major decisions about where to stay, what to eat, and how to get the most from a trip, tells a different story…
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…
Knowledge at Wharton
A recent family biking vacation in the Dolomites region of Italy had my family and I all swept up in the charms of Northern Italy. Snow-capped peaks near the Austrian border, endless apple orchards, award-winning Chenin Blanc, and quaint Italian villages with healthy doses of affogato (strong…
Annette Franz
There’s a lot of bad press out there about journey mapping. And there’s a lot of bad journey mapping (or what people think is journey mapping). A few months ago, I shared my six-step journey mapping process. Remember, journey mapping isn’t just a tool; it’s also a process. Know the tool and create…
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…
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…