Category Archives: Supply Chain



Delayed Enforcement Provides a Business Opportunity

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia 

On July 1st, FDA  published guidance stating that: “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.”

Last December, FDA published guidance informing industry that it did not intend to Supply-Chain-Squares (3)take action against manufacturers, wholesale distributors, or repackagers who did not, prior to May 1, 2015, provide or capture the product tracing information required by the new Drug Quality and Security Act (DQSA).

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With Growth Rates Stagnating In Developed Markets, What Is A Med-Tech Exec To Do?

Push for growth in emerging markets like Brazil, Russia, India and China (BRIC).
For some Med-Tech Companies, growth rates in emerging markets are double, triple and in some cases 10-fold those in the US and other developed markets. This trend was clearly evident as I listened to and reviewed transcripts from Q4 2012 earnings calls from Johnson & Johnson, Boston Scientific, and Medtronic.

While emerging markets continue to present significant growth opportunities, how can med-tech companies address the variety of needs and delivery models in these markets, while addressing increasing pricing pressures in developed economies?

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Are “Black Swans” Colliding with your Supply Chain?

How can med-tech organizations minimize supply chain disruptions and increase predictability resulting from events characterized by rarity, high impact and low predictability? blackswan

By Daniel R. Matlis

Black Swan events once seemed extremely rare and had little or no impact on med-tech supply chains. In recent years, however, natural disasters including super-storm Sandy in northeastern US, the earthquake and tsunami in north-east Japan, flooding in Thailand, and the ash cloud from the Grimsvotn volcano in Iceland have all had significant impact on global supply chains.

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