There is little doubt that the demand for Serialization providers is greater than the supply. Pharmaceutical manufacturers are trying to meet the current deadline of November 2017 to serialize their lines. The last time in recent memory the marketplace experienced such an imbalance of supply and demand was the “Y2K” initiative. Remember? Everyone in the IT space was rushing to be sure their systems could handle a four digit year scheme so that the apocalypse would not occur prematurely. And of course we all got ready – and there was no substantial impact – unless you worked in IT. After the demand bubble burst, the fallout within the IT industry was significant.
We may be on the verge of such a circumstance. If you are a pharmaceutical company that has not secured a provider with a detailed plan to implement serialization on all your lines, at least at a plant level, there could be consequences. Here are a few scenarios:
FDA penalties to your company – There will be unprepared pharmaceutical manufacturers who will likely incur fines, with the costs ranging widely. The question is will the FDA simply “work” with those firms overlooking the missed deadline? If so, at what cost? There seems to be no way to know until we’re there. It’s your risk to take.
Loss of an account – Major pharmaceutical distributors are on board not only with the idea of unit level serialization but also with aggregation, which most manufacturers seem to be incorporating with their current implementations. However, if your firm misses the deadline and there is another competitive product in the marketplace that is compliant, well, your product could be replaced.
Bubble burst – What will happen to the handful of “leading” firms hired to implement serialization projects after the initial demand is met? How will they continue to maintain the growth and health of their businesses once the bulk of these projects have dried up? Will they be around to help with lifecycle support of their software? Good question.
One solution to the above dilemma is to choose a supplier for your serialization project that has a diverse offering of products, a long history in serving the pharmaceutical market and has the capacity to take on your project with the limited time remaining before the deadline. Things to look for are:
Product diversity: What is the supplier’s product mix? What is the percentage of all products versus serialization-related products?
Market experience: How long has the supplier served the pharmaceutical packaging market? What percentage of the total business is in life sciences? Are there referenceable clients in that market you could talk to?
Capacity: Ask about the resources (people) available as compared to the number of projects currently in their backlog. Can they dedicate a person to be on your project without he/she being overrun with other priorities?
An honest triage of your situation is required. As difficult as that might be, the consequences for your company could be worse without a realistic plan in place soon.
MGS Machine has 35+ years of experience in the pharmaceutical and life sciences packaging industry. Our product mix is diverse, ensuring we will be here to continually support your serialization solution far past the November 2017 deadline. As always, your project will have a dedicated Project Manager to see your serialization implementation from start to finish. Don’t risk it. November will be here sooner than you think.