Healthcare Features

Jon Speer's picture
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...
Taran March @ Quality Digest's picture
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...
Dirk Dusharme @ Quality Digest's picture
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,...
Zach Y. Brown's picture
Zach Y. Brown
Imagine there was a store where there were no prices on items, and you never knew what you’d pay until you’d picked out your purchases and were leaving the shop. You might be skeptical that the store...
Stephen McCarthy's picture
Stephen McCarthy
I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences...
Mike Richman's picture
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...
Quality Digest's picture
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...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
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...
Laurel Thoennes @ Quality Digest's picture
Laurel Thoennes @ Quality Digest
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...
Taran March @ Quality Digest's picture
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...
Graham Freeman's picture
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...
Teresa Purzner's picture
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...
Manfred Kets de Vries's picture
Manfred Kets de Vries
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...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
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...
Ryan E. Day's picture
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...
Taran March @ Quality Digest's picture
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...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
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...
Mike Richman's picture
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...
Ryan E. Day's picture
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...
Matthew M. Lowe's picture
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...