Monday, July 18, 2022

DSCSA 2023 Testing: A blind resume comparison

A popular sports analysis mechanism is known as a 'blind resume'.  The idea is to provide a set of characteristics of two anonymous athletes/teams and allow the viewer to guess which 'resume' belongs to which athlete/team.  For basketball fans, this method is often used in the lead up to the annual NCAA basketball tournament as a way to evaluate two teams competing for a final spot in the field.   

On a deeper level, the intent of a 'blind resume' is to demonstrate the power of perception from brand recognition. Sports fans normally have preconceived ideas about who is 'good' and who is 'bad' and, thus, when presented with a two sets of characteristics- one generally 'better' than the other- the natural reaction is to assign the perceived 'good' athlete/team with the good set of characteristics and the perceived 'bad' (or not as good) athlete/team with the 'bad' (or not as good) set of characteristics.

And for those who haven't seen a 'blind resume' play out- the correct assignment is almost always the opposite.  It's a sneaky, yet intriguing method and one, I think, applies well to the serialization L4/L5 vendor space which has long been rife with misperception as a result of marketing imbalance and, quite frankly, misleading advertising.

In particular this method can be used to show a noticeable disparity when it comes to manufacturers' ability to perform testing as part of upcoming DSCSA 2023 efforts. 

As you've heard me say numerous times before- testing is the most important phase of any serialization effort.   Testing is not only a critical phase in determining overall success/failure of an effort, but is also the phase that most directly drives the level of internal/external resource effort needed and overall cost of a serialization project.   This is because a lack of testing performed, or the inability to perform adequate testing, increases overall risk- and when risk increases, the likelihood of exceptions/failures, including very costly exceptions/failures, increases as well.

So the key message is that all manufacturers need to plan for extensive testing as part of DSCSA 2023 efforts and must take steps to ensure this testing can be performed efficiently and cost-effectively.  

Interestingly, simply looking at who your serialization L4/L5 vendor is plays a major part in determining your ability to test. Enter the 'blind resume'... Good Luck!!

Remember the rule: Manufacturers who don't test or can't test increase their risk.  And those who simply 'trust' their vendor to perform all necessary testing will experience this- -sooner rather than later.

I encourage everyone to leave their guesses in the comments!!  And feel free to reach out to Jennason for the blind resume answers and to hear more about our experiences testing against all serialization L4/L5 vendors.

Tuesday, July 12, 2022

A baseline for serialization L4/L5 pricing

Pricing of L4/L5 serialization systems has been a roller coaster over the past decade+.  The earliest adopters paid astronomically high fees (relatively speaking) only to see many vendors take on a 'race to the bottom' mentality during the height of system adoption ahead of DSCSA serialization and EU FMD milestones.

Unfortunately, a few factors persist which lead to wildly variable pricing- proving that L4/L5 serialization system pricing is still very much an art and not a science.

Pricing is once again a topic of discussion in the industry as many manufacturers are nearing the end of a contract term with their serialization vendor.  As such, the intent of this post is to offer a 'baseline' pricing scenario which manufacturers can use to assess whether they are paying market rates.

A key disclaimer:  Vendor fees is only one factor in the total cost of ownership of an L4/L5 serialization system.  Manufacturers who find themselves paying relatively low fees may still have a high total cost of ownership if they require significant internal resourcing to support the system, rely heavily on external resources to support the system and/or rely heavily on expensive vendor support resources.    

And to tease the topic of an upcoming post-  While system fees, of course, directly contribute to long term total cost of ownership (TCO), arguably, equally important to long term TCO is risk.  High risk with a serialization system increases the possibility of exceptions- and in the serialization world exceptions can mean product stops flowing and patients are at risk- in short- scenarios whose 'cost' can be business-altering.  Many manufacturers have justified paying higher vendor fees in return for having the perceived lowest risk (and lowest total cost of ownership) solution.  Unfortunately, in Jennason's experience, these manufacturers are in for a surprise when recognizing their higher cost vendor is, in fact, also the highest risk vendor.  (Much more to come on this topic)

The driver, and again intent of this post, is my belief that A LOT of manufacturers are drastically overpaying for their L4/L5 serialization system relative to current market rates.  The hope is more education will help manufacturers reevaluate and identify their best long term strategic partners or, at a minimum, give manufacturers leverage to renegotiate future contract terms.

A key challenge, historically, is that pricing has not been purely market-driven, but instead driven simply by what the customer was willing to pay.  Additionally many manufacturers are not gathering insight into current market-rates. This, in turn, creates a 'perfect storm' scenario where manufacturers end up paying outrageously high fees.

Vendors love this 'perfect storm' because it means that on any given deal, if all the factors align, they can score a big sale. 

In the industry's best interest, we need to change that.... 

Thus, in an attempt to define a 'baseline' pricing scenario for a pharma manufacturer we'll use the simplest serialization use case.   Fortunately, many manufactures will fit into this exact use case (and are many of the manufacturers who we believe are drastically overpaying).

The baseline pharma manufacturer use case:

  • 1 CMO partner
  • 1 3PL Partner
  • 1-10 downstream customers
  • Compliance for 1 distribution market (US DSCSA for example)
  • Standard data requirements
  • Standard quality/validation requirements
For this scope if you are paying at or greater than $100,000 in annual recurring fees, you have an opportunity to reduce costs, conservatively, by 30% on annual basis and potentially as much as 60%. If you are paying significantly more than $100,000 in annual fees for the scope above, red-flashing alarms should be going off.  

In those scenarios, manufacturers may be able to absorb the fees which come with making a system change  (e.g. new system implementation fees, project fees from CMO/3PL partners, external support fees) and still realize a positive ROI within the first 2-3 years of their new contract.

For manufacturers, the window to solidify long term, strategic serialization vendors is now.  With the upcoming DSCSA 2023 implementation efforts, significant scope will be added to many manufacturer's serialization systems.  Thus, for manufacturers who have concerns about their current vendor, it's in their best interest to do a long term, strategic vendor evaluation first and then dive into 2023 efforts. 

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