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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…
Laurel Thoennes @ QD
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Teresa Purzner
Developmental biologist Matthew Scott and I went from purely basic biological research in our lab at Stanford University, to discovering a target for drug development, to identifying a drug for a pediatric brain cancer called medulloblastoma, to a clinical trial—all within five years and for just $…
Chip Bell
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage.
What do Bill Marriott, Ray Kroc, and Al Hopkins have in common?
No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Dirk Dusharme
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Manfred Kets de Vries, Katharina Balazs
The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market. Whether the lives of wellness consumers are improving at a comparable rate is another matter altogether.
Wellness products and services run the…
Jessica Higgins
“Although there’s an assumption that stress and pressure push employees to perform more, better, and faster, what cutthroat organizations fail to recognize is the hidden costs incurred.” —“Proof that Positive Cultures are More Productive,” Harvard Business Review
The timeworn industry standard is…
Annette Franz
I still love to hold and read physical books (as opposed to audible or Kindle). I don’t know how many books I added to my library this year, but it was a lot. I thought I’d share some good ones that I’d recommend you add to your reading list for 2019.
These books are not customer experience books…
Dirk Dusharme
In this episode we look at bioethics, next-gen manufacturing employees, and the death of Le Grand K.
What happens if customers want designer babies? We discuss the latest news about a Chinese researcher who claims to have edited the genes of two babies. Should society draw a line in the sand?
“…
Mike Richman
One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look:
Interview: Nicole Radziwill of Intelex
Radziwill is quality manager and data scientist along with the presenter of…
Annette Franz
I’ve written previously about 11 myths and mistakes about journey mapping, but I should add one more myth, which is really the umbrella myth that likely encompasses all the others: Journey mapping is just a tool.
Nope, it’s not just a tool; it’s not just a workshop: It’s a process. Journey mapping…
Dirk Dusharme
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.
“GE’s Lessons Won’t Determine Whether You Succeed or Fail”
Does the success or failure of GE’s CEO really matter that much when it comes to how most…
Chip Bell
I recently had eye surgery that required me to sleep on my back for two weeks following the operation. I have always slept on my side, ever since I was a kid. My back-sleeping attempts are so challenging, I am never able to nap on those United States to Europe flights. I usually end up burning a…
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has…
Dirk Dusharme
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
The Un-Comfort Zone With Robert Wilson
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
John Bell
To most of us, the phrase “work that matters” infers job satisfaction. The outcome is lower stress, lower turnover, and higher productivity—in business, a win-win for employees, customers, and shareholders. The logic is infallible. So, I ask you, why is there such a gap between the theory and the…