E-Pedigree Vendor Selection

davidvsgoliathOn Friday after 5pm I received a call from a potential consulting client.  At least I thought that’s what they were.  It turned out, it was a headhunter looking for warm bodies to work on serialization and pedigree projects to fill a quota he has from the consulting arm of one of the big-4 accounting firms.  The people he’s looking for would probably work on projects under the direction of one of their long-term senior consultants.  I’m not looking for that kind of opportunity.

My impression is that this is a sign that we are entering the “Y2K” phase of the California E-pedigree deadlines.  That is, it is time for lots of “staff augmentation” companies to staff-up to offer “expertise” in droves.  As many of you will recall, as the year 2000 approached, companies became aware that their corporate systems had abbreviated the “year” in transaction date fields to only two digits.  When the year 2000 would hit, these systems would think they were back in 1900 instead of 2000.  It was a real problem that had to be found within source code and fixed before the turn of the century.  As January 1, 2000 approached, more and more companies got into the business and the hype took off.  Even before my call from the headhunter, a friend of mine told me last week that he is seeing signs of exactly this kind of thing starting to happen with the approach of the California pedigree dates.

I’m sure the big accounting firm is a reputable company and they probably have very high standards in their hiring of people to work on their serialization and pedigree projects, but I don’t recall anyone from this particular firm participating in any of the industry work I have participated in since I began focusing on this area 10 years ago.  (As another small measure, no one from that company has ever subscribed to RxTrace—at least not using the company domain.)  Accenture, Deloitte, Wipro, Cognizant, Booz Allen Hamilton, HP, IBM and Tata have all had at least one senior consultant paying attention to what has been going on for a while now, and a few of them have had a number of people participating over the years.  And that doesn’t include a long list of smaller consulting companies.  So my impression is that this new entrant and others are jumping in now so they can capture some of the overflow business.  Watch for the hype to get pumped.


But what about other types of vendors besides consulting firms?  I co-led my first pedigree software vendor selection back in 2005 at Cardinal Health to help meet the 2006 Florida pedigree law.  Our team drew up a very large and detailed request-for-proposal (RFP) and invited all of the software companies at that time who had made it clear that they intended to offer pedigree solutions.  That included:

  • Cyclone Commerce
  • Raining Data
  • rfXcel
  • SupplyScape
  • VeriSign

The company eventually selected VeriSign, partly because they were viewed as the largest company in the list and, based on their responses to the RFP, they seemed to fully understand the company’s needs, and they seemed to have software that was pretty far along.  But about 2 ½ years later, despite having won the Cardinal Health business, VeriSign withdrew their pedigree software product from the market.

As for the other companies in the list above, Cyclone Commerce was purchased by Axway, which continued their ePedigree product line and continues to offer it today.  Raining Data exited the pedigree software space and changed their name to TigerLogic (too bad too…I always liked the name “Raining Data”).  I left Cardinal Health and went to work for SupplyScape, but after California pushed out the effective dates of their pedigree law, the company looked to new solution opportunities while supporting existing pedigree customers.  The following year the original founding members of SupplyScape started a new company named TraceLink, found new venture capital, and acquired SupplyScape and all of its assets, including their original pedigree product (NOTE:  I have corrected the SupplyScape-TraceLink history in this version).  rfXcel was able to find business in related areas during the lean years and remains a pedigree vendor today.

During the time I worked for SupplyScape I helped my teammates respond to RFPs issued by several major potential customers in the US pharma supply chain.  I was amazed to find that I was now helping to answer the same questions I had helped create—most with the identical wording that we had created at Cardinal Health back in 2005.  Those original RFP questions we created apparently were spread around the industry by consulting companies and solution providers.  Rather than come up with new questions, companies simply reissued the ones we originally created—those questions were that good—and, bonus…I knew all the “right” answers!   😉

After that time I was very graciously offered a job back at Cardinal Health where I worked until last July.  IBM entered the ePedigree business only to sell their product last fall to Frequentz, a much smaller company.  Oracle has marketed a pedigree solution but I don’t know how the market has received it.  One of the key developers from Raining Data landed at rfXcel, then left to start FastPoint Technologies which offers their own pedigree solution.

The lesson from this history is that ePedigree is a niche need and is best fulfilled by boutique solution providers who can focus a lot of their energies toward developing true expertise in meeting the requirements of these unique laws.  Big companies don’t do that so well.  In general they do best when their solutions can be sold across multiple supply chains spanning many product types and all around the globe.  As VeriSign found out early, IBM found out more recently, and small companies like rfXcel discovered (probably to their delight) in the interim, a big company can’t make enough money focusing on a solution that is applicable only in a single supply chain and only in a single State within a single country—even when that supply chain is pharma, that country is the United States and that State is California–but apparently a smaller company can.

Today, any drug pedigree solution vendor who is serious about serving their customers through the coming years will have products that are certified for both the GS1 Drug Pedigree Messaging Standard (DPMS) and GS1 Electronic Product Code Information Services (EPCIS) standards.  That’s because there is just too much uncertainty yet about which direction the supply chain will go.  See GS1’s software certification list here.  If your vendor isn’t on both lists, I suggest you ask them why.

Selecting the right pedigree solution vendor for your company is one of the most important steps you will make on your journey to compliance and visibility.  Your vendor will become your partner, monitoring the regulations on your behalf as they evolve over time and ensuring that their solution is able to keep you in compliance.  They will also be the most important factor in your ability to take advantage of the data you collect for purposes other than compliance.  So, select well.


10 thoughts on “E-Pedigree Vendor Selection”

  1. Thanks Dirk. Very informative as always. Any chance you may publish the list of “good questions”?

    1. Jamie,
      Sorry, no. But all of the consulting companies who’ve been in this line of business for a few years will have them.


  2. Dirk,

    Another excellent post that shows you continue to have your finger on the pulse of the industry.

    The software dilemma you describe is the exact model we have seen in the technology markets the past two decades- the innovators dilemma and disruption. Newer software/technology vendors can nibble at the fringe (e-Pedigree compliance as an example) of the business of larger players who will look down and choose not to defend that market as the margins are lower and the profits aren’t worth expending the resources. The hope by these smaller vendors, in the meantime, is not just to capture the e-Pedigree market, but establish themselves in the pharmaceutical industry and begin to nibble on the next least profitable area of the larger firms. The revenue and profits that are inconsequential to one firm are significant to the smaller ones and a spring board to brighter days.

    A personal example is my firm, we are being selected by mid and large pharmaceutical companies for e-pedigree strategy development, independent vendor selection and systems integration project work due not only to our experience the last 7 years in this space for California and ex-US compliance, but also due to the larger consulting firms turning their nose at a 1, 2, 3 resource projects. We will gladly service the needs of these clients.

    My bigger fear, is that this rash of entrants in the market for “consulting” and “solutions” do not have the understanding of the requirements, impact of quality in the industry, nor understand the business processes and may do more harm than good. I hope they follow the physician’s credo of “Do no harm.”

    In the interim, you and I will continue to assist the industry in moving forward to comply. Keep up the great work and congratulations on the Healthcare Packaging column.


  3. Dirk,
    Thanks as always. Good review of what has happened with vendors but an interesting parallel is contract software for the industry. Over the years we’ve seen companies come and go, rise up and slide down.

    I’d be interested in your thoughts on outsourcing instead of buying…a SAAS model. Much has changed recently with distributed computing, connectivity, etc. that would seem to make this MUCH more viable.

    1. Al,
      Thanks for your comment. In fact, I think a Software as a Service (SaaS) model is a great way to go for companies that don’t have a dedicated and professional IT team or that don’t want to be forced to grow their existing IT departments to support the big increase in data that ePedigree will bring. Vendors who support a SaaS model (most do) can ensure that your data is protected from disasters by maintaining a copy in a different physical location, and ensure that your data is always highly available. Growth in the size of the data held and the throughput necessary become the problem of your SaaS vendor, not yours. These are very appealing benefits and should be considered by all companies, large and small.


  4. I can comment on the status of the Oracle product – I helped define the functional requirements for the product (and I should declare here that I now work for an Oracle partner).

    Oracle’s “problem” is that they took time to work with a range of pharmaceutical and medical device companies in a customer focus group (including medical device companies, because they also have pending serilaization requiremens from the FDA – UDI).

    Oracle took the time to develop a product that handles serial numbers at multiple levels, including randomisation AND manages ePedigrees AND can submit the data to regulatory agencies and/or other third parties AND can be integrated via web services to provide comprehensive automation – but as the market requirements developed, the functionality of the product was subject to much ‘scope creep’ and this delayed the launch.

    They ended up with a very powerful product BUT it was relatively late to market and Oracle missed the boat wrt to many of the early pedigree/serialization trials. The result is they have only a small installed base when compared to what I consider to be less capable and less scalable products.

    This is (and continues to be) a rapidly changing market. As many companies are finding, what worked functionally as part of a non-integrated pedigree and/or serialization trial 2 years ago may no longer meet current requirements (e.g. support for GS1) and may not have the ability to scale to become an Enterprise wide solution.

    My advice to any company who is now starting to ‘panic’ (Y2K style) is to still take the time to revisit the market even if you have a trial system already in place. Take the lessons you learned from the trial to revise your requirements, but accept that that’s different from taking the same software forward.

  5. Dirk,
    My thanks to you [again] for your insightful comments. There are indeed multiple lessons to be learned by both end-users and vendors in the LS supply chain ecosystem, and not limited to the present near focus of CA pharma ePedigree compliance. There have been some notable advances in the solution offerings and nature of AIDC capabilities “at the edge”, as well as the increasing acceptance of cloud-centric solutions, standards ratification, et., all topics which you cover so well in your column. I would urge end-users to revisit assumptions concerning requirements and capabilities, by engaging with their “trusted advisors” who have proven domain expertise and clear objectivity.

  6. Hi Dirk,

    As usual a great article and blog postings, which brings back many memories similar to your notes from when I was the Program Manager for the serialization initiative at Genzyme.

    We selected Verisign who conducted our first evaluation and then exited the arena. We then went the RFP route and chose Accenture who “guided” us from there on out.

    All I can offer in the way of additional comments and advice to what you have written is:
    * Look at all options and there are now a few more vendors in the mix even though some have dropped out, or morphed.
    * Get to know very clearly the impact on the product lines from an operations point of view.
    * Make sure you have enough money in your budget.
    * If you are going to choose a guiding advisor make sure they have done this before – and do good reference checks.
    * Be aware of the fact that the rules around serialization, e-Pedigree etc., are subject to change, so flexibility and scalability are key in your selection of a product vendor.

    Finally don’t think you know all the answers when you begin as this project could take some time to get to completion.


  7. Dirk,

    I hope your readers know that Dirk Rodgers Consulting is available to assist with e-pedigree and serialization strategy and planning. They should go directly to the expert (you), not to the other consultants who are learning from the expert!


    1. Thanks Adam. I’m assuming my readers know that, but it doesn’t hurt to make the point once in a while. Thanks for doing that for me!

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