@Risk

Recent drug shortages in the US underscore the complexities, interdependencies and volatility of modern global supplier networks.

According to an IMS Institute for Healthcare Informatics study released last week, most of the 168 products on the drug shortage lists compiled by the US Food and Drug Administration and American Society of Health-System Pharmacists have only one or two manufacturers. Thirteen companies have stopped supplying products on the shortages lists within the past two years. As Murray Aitken, executive director, IMS Institute for Healthcare Informatics, points out, this leaves a growing number of products open to possible production disruptions that cannot be offset rapidly by other manufacturers.

“Patients throughout the US, including hundreds of thousands being treated for cancer, may be at risk of treatment disruption due to drug shortages,” Aitken said. “Understanding the nature of these medicines, their suppliers and the supply volume dynamics – and focusing sharply on the market and supply chains that are most impacted – are essential to formulating meaningful solutions to this complex, and often misunderstood, issue.”

The new study, Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility, also found that: (more…)

No one wants to deal with a product recall.

But, for those in the medical device and life sciences industries, the challenges are more intense than ever before. Globalization has created elongated supply chains, and that elongation has decreased visibility and complicated communication. Obviously, that’s not a desirable combination at all, considering that delays in handling a medical device recall can literally mean the difference between life and death.

Fortunately, many medical device and diagnostic manufacturers are now taking a hard look at their existing processes so that they can improve the way they manage product recalls.

Denise Odenkirk and Tom Kozenski explore these issues in detail in their recent article, How to Handle a Medical Device Recall, at Medical Device and Diagnostic Industry Online.

I was pleased to see that Odenkirk and Kozenski recognize that both automation and integration have become critical components for effective supply chain management. They write: (more…)

A recent survey by Sparta Systems found that nearly half (45%) of industry professional at top medical device organizations feel their current quality systems are insufficient to mitigate compliance, risk and safety issues associated with their complex supply chains.

I suppose that’s no surprise –considering both the recent globalization of manufacturing and supply of medical products and the multiplicity of supply chain threats today. (more…)

With news of the impending flu season now making headlines every week, it’s no surprise that lately I’ve been thinking about supplier risk in the medical products supply chain.

The globalization of manufacturing and supply of medical products has created an array of significant supplier risk management challenges for the industry, for governing organizations like the FDA, and for the international health care community as a whole.

Chief among these challenges are questions like these: How can the safety of medical products be ensured? and Who, ultimately, is responsible for securing the global medical products supply chain?

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