Drug Track & Trace, Anti-counterfeit (part 2)

i began this series recently, discussing drug manufacturing, track & trace and accountability.  this entry is the next in a series of installments that describe the problems, issues, and solutions we faced in building this particular data vault.  in this entry i’ll dive in to some of the issues we faced right off the bat, which we needed to architect solutions for.  i’ll also describe some of the competitors in the space, by the way, near the end of this series i hope to release the dv model (yet another example) for free, and if you want to ask questions around the model, or want to implement it yourself, please register for my on line classes at: http://datavaultalliance.com

what is the business problem we are trying to solve?

the business problem is: people are dying from purchasing counterfeit drugs, they have no way to check authenticity of the drug once they have it in their possession, regardless of where they made the purchase.  we wanted to help keep people’s lives safe by offering a way for them to anonymously check the validity of the drug they hold in their hands.

what is the business key that every “consumable drug” has, or should have?

obviously, in order to provide traceability with anonymity (due to privacy laws we were not allowed to identify the individual checking the validity of the drug) on every single drug, we needed a manner in which to build and assign a fully qualified, world-wide unique business key at the time of packaging, and at several points in the aggregation of the supply chain.  this key would have to be non-bio-reactive, in other words, not emit signals that either rendered the drug inert, or started a negative chemical reaction.  in other words, rfid would not be a fit for all drug packages as rfid produces low level signals that can affect (bio-react) with specific drugs.

we were left to use a printed bar-code lable.

what are some of the other business problems we face?

  • drug manufacturers with world-wide packaging facilities have to implement the same solution
  • drug manufacturers wanted their data to be “safe” from each other (in other words, impenetrable, even though there was to be a global data store)
  • supply chain, logistics, and ultimately end-point delivery (pharmacies) are all independently owned and operated, they would have to implement common scanning devices at each point of drug transfer/ownership transfer, a signature would no longer be good enough.
  • no one wanted to “pay” a higher cost for manufacturing the drugs, shipping, supplying, or shelving the drugs, but all agreed that saving lives would be hugely beneficial
  • no one wanted to pay up-front costs for utilizing the system.
  • congress needed a view into all the data from all drug manufacturers (across multiple manufacturers) to run analytics on which drugs were most counterfeited, which seemed to be safest, what the trends were/are.
  • dealing with hundreds of manufacturers, hundreds of suppliers, and hundreds of individuals – we had to ensure the system was so simple to use, that “new training” would take maybe 5 minutes from everyone on the line who handled the drugs.

while these may seem as insurmountable problems at first, we had two things going for us that might have made this possible:

1) everyone agreed that it was costing more in pr, law-suits, and customer relations to handle a counterfeited drug than it would cost to implement a track and trace program, therefore the program did “not” introduce new costs, but was seen as a mitigation measure to managing costs of the above.

2) congress had a mandate: anyone selling drugs to consumers in the us (regardless of origin/manufacture or supply chain) must prove accountability, and traceability of each of their drugs by 2010 (which obviously didn’t happen once the lobbyists got involved)

we had an additional problem: how would we as a business make money from this effort if we couldn’t charge for new systems, couldn’t charge for data storage, etc…?  the answer was fairly simple: 5 cents (us currency) per label printed was the decidable charge.

what was in our purview of a business?  what did we have to provide?

as a business we were going to provide the following components:

  • machines capable of labeling, and garaunteeing quality of the labels through a system that could run 2x the number of labels per second than the current supply chain labeling systems (non-disruptive technology that could discard bad labels immediately without human intervention)
  • machines capable of “packaging” multiple labled cartons, boxes, etc.. with aggregation labels that indicated the contents of the aggregate container.
  • database that was to assign unique numbers to the labelers (this is where part of the intellectual property existed), connected to the labelers, that accepted real-time feed updates into a central and global data vault.
  • installation of scanners that communicated with the global data vault on the points of every supply chain transfer
  • installation of scanners (or modification of existing scanners) at every pharmacy in the united states
  • a universal web-interface, that allowed every consumer to type in the bar code (anonymously) to authenticate the drug they held in their hands

it was a huge undertaking, but in partnership with the drug manfuacturers it would have been a huge success.  i would argue that there is still huge value here for the first drug manufacturer to undertake this effort, contact me directly for more information…  the drug manufacturers actually volunteered to help train their people and partners in the supply chain on using the new scanner devices (hand-helds, etc…)

what about the competition?  who’s the competition in this space?

the big competition was: ibm with their anti-counterfeit applications, oracle with their supply chain management, and teradata with their supply chain management, along with one or two others.  the main differentiator?  none of these competitors had solved the global data warehousing problems (which i will specify in the technical problems section in the next entry).  the data vault model was the only model flexible enough, and powerful enough to provide the solution to this industry.

another key differentiator, the company i was working with had labeler machines already built, that performed at better than expected rates (beyond what the existing labelers could do on the supply chain), that were already hooked and talking to the global data vault database.  none of the other competition had the “labeler machines” nor the “aggregate” machines embedded in a global database that issued unique bar codes for tracking.

do you like this series?  does this interest you?  i want to hear from you, privately or publicly.  feel free to drop me an email if you wish…

dan linstedt

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2 Responses to “Drug Track & Trace, Anti-counterfeit (part 2)”

  1. Gul Muhammad Bawa 2011/04/18 at 7:01 am #

    I read part 2 of your article and am interested in further details about generation of unique numbers, types of scanners proposed to be used and their cost, data warehousing etc.
    Please also provide link to part-1 of your article and other published literature on the subject.
    While 5 cents per scanned label might sound economical for developed countries, it sounds high for developing countries.
    I believe Sproxil have developed a system based on unique numbers to be texed through cell phones for return SMS message confirming genuineness of the product or rejecting the product as counterfeit.
    Would appreciate receiving your response.

    Gul Muhammad Bawa

  2. dlinstedt 2011/04/18 at 7:24 am #

    Hi Gul,

    You can find part 1 here… http://danlinstedt.com/datavaultcat/drug-track-trace-anti-counterfeit-intro/ Part 3 is also listed in the archives.
    I have no idea who Sproxil is. The system we developed was to be world-wide, for all drug manufacturers.

    What is your background, and where are you working today?

    Thank-you kindly,
    Dan Linstedt

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