Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners.
An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world.
Dirk is the author of "The Drug Supply Chain Security Act Explained".
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In an essay published in April, I explained my theory that “RFID is DEAD…at Unit-level in Pharma”, which, if true, would mean that most drugs in the U.S. supply chain would be serialized by manufacturers with 2D barcodes by 2015 for California. In my last essay, “Inference in the Pharmaceutical Supply Chain”, I carried that theory one step further by showing how the widespread reliance on 2D barcodes to serialize at the unit level would lead directly to the widespread use of the practice of inference in the supply chain. This would be out of necessity since the unit-level serial numbers would not be readable without opening their containers, something that can’t happen because it is so inefficient that it would cripple the supply chain. So let me say it this way, the widespread use of 2D barcodes for unit-level serialization will necessitate the widespread reliance on inference. The former leads to the latter just like excessive sunshine leads to sunburn.
But the projections of widespread reliance on inference lead directly to a new concern. Let me explain. Successful use of inference for determining the contents of cases is totally dependent on the accuracy of the aggregation information established and provided by the manufacturer, or whoever packed them. If a packer uses a casepacking process that is incapable of yielding highly accurate aggregation information, inference will not work well.
In a mixed-but-predominantly-barcode-serialized U.S. pharmaceutical supply chain, companies will not be able to tell which unit serial numbers are inside of each sealed case at receiving or at shipping. Because barcodes are a “line-of-sight” technology, the only way to tell with absolute certainty what the sealed-up unit serial numbers are will be to cut the tape seal, open the case, expose the barcodes, scan each unit and tape the case closed again.
The modern pharmaceutical supply chain is an amazing thing. No other supply chain handles the combination of volume, variety, value and complexity, and does it as efficiently and accurately as the U.S. pharmaceutical supply chain. And it does it on an overnight order-to-delivery cycle from wholesaler to pharmacy. Wholesalers are the key to the efficient operation of the pharmaceutical supply chain, and that’s why I am personally drawn to that segment.
The heart of the modern drug wholesale business—the thing that makes it live, kicking or screaming—is the modern pharmaceutical distribution center (DC). That magical combination of people, processes, data and automation produces a dance every night across the country where individual drug packages are picked from cases and combined with other individual drug packages to fulfill the orders of pharmacies everywhere. It is musical to watch and understand, and the crescendo occurs around 10:30pm every night local time at every pharma DC. Today’s successful wholesalers have figured out how to deal with this specific complexity by organizing their people, processes, data and automation in a stabilizing way to make it all manageable, repeatable and very efficient, and thus making it possible to carve out a thin but well-earned and reliable profit.
I have my own theory of innovation. Almost everyone agrees that innovation is a key ingredient in growth and prosperity but in our current times, few companies are able to cause it to happen. I think that’s because people misunderstand innovation, and particularly how to get it going. With all the belt-tightening going on as the result of lean times, innovation could not be more essential, but at the same time, seemingly more out of reach.
In my view, there are three main stages to innovation: experimentation, enlightenment and transformation. Experimentation is the most assured pathway to innovation but it is also one of the first things to get cut when belt-tightening occurs. It requires an organization to spend time on lots of things that eventually get discarded because they end up never taking root. To an accountant, experimentation looks a lot like “play-time” activity that isn’t needed. Innovation can occur without an experimentation stage, but reliance on “bolts-out-of-the-blue” to kick-start innovation will ensure that you will almost never actually get there.
Enlightenment is nothing more than an improved understanding of reality. It occurs when a series of experiments from the experimentation stage are accepted by a group as having special significance because they reveal a part of reality that was previously hidden from view. Enlightenment is the removal of blind-spots. Once the blind-spots are removed, easier or more profitable paths become more obvious—or at least one of them becomes less foggy.
That’s right. And it comes from an economic reality that was evident even six years ago. That was when a small group of people with various pharmaceutical supply chain backgrounds had an informal discussion of the relative costs and impacts that each of the three primary business segments in the supply chain would face in a full deployment of Radio Frequency IDentification (RFID). As I recall, this conversation may not have even been part of the official proceedings of the project we were assembled to work on at the time. It may have actually occurred during one of the social hours after a day of meetings, but it stuck with me. Ever since that time I kept meaning to get around to creating the graphs that we envisioned at that time but have never gotten around to it, until now. Continue reading RFID is DEAD…at Unit-Level in Pharma→
The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.