Dirk Dusharme @ Quality Digest’s picture

By: 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 Succeed or Fail”

Does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead, manage, and plan each day? Not necessarily.

Ryan E. Day’s picture

By: 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 science industry, like BBG, operate in a heavily regulated environment. This is the story of how one company delivers world-class products and stays on the right side of compliance while doing it.

Taran March @ Quality Digest’s picture

By: 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 kept an eye on the FDA’s progress toward these goals. How well has it done? For a sprawling bureaucracy, marvelously.

Dirk Dusharme @ Quality Digest’s picture

By: 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 certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell their products in Canada. This mandate could have consequences for Canadian citizens.

Mike Richman’s picture

By: 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 pundits, and writers of science fiction. Yet people keep trying to project trend lines and read tea leaves, maybe because we like to wonder about the moral and ethical choices that some future state will force us into. Or maybe these kinds of stories just make good copy.

Ryan E. Day’s picture

By: 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, and it also has the freedom to not exercise that authority (enforcement discretion) as it sees fit.

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Matthew M. Lowe’s picture

By: 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 share a common need as a prerequisite to success: regulatory compliance.

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Mike Richman’s picture

By: Mike Richman

IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of Hexagon Manufacturing Intelligence captured at IMTS. Let’s take a look:

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Multiple Authors
By: Bita Kash, Stephen L. Jones

Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to exchange healthcare information are little different than they were 5,000 years ago, when physicians caring for the same patient exchanged scrolls of papyrus and clay tablets.

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Knowledge at Wharton’s picture

By: Knowledge at Wharton

‘How is it that in the middle of a relatively small town of about 125,000 people in Minnesota, you’ve got the No. 1-rated healthcare system probably in the world?”

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