iSpeak Blog

How the Uncertainty of the Unknown Affects Our Ability to Evaluate New Solutions

John Wirthlin

The uncertainty that comes with the introduction of a new idea has affected society for centuries. We all grew up hearing about how sailors of old feared sailing off the edge of the world before we accepted that the Earth was indeed round. Inventors are always ridiculed by naysayers until their ideas are adopted and become common place. It’s safe to say that most of us approach new ideas with a healthy dose of skepticism while others charge ahead. We want to know the risks and consequences of being wrong, especially in professional settings. What are the pros and cons of staying with something familiar as opposed to sticking our necks out to explore the next best thing that could potentially move the needle in our organizations?

Today’s Comforts were Yesterday’s Jokes

In my opinion, comfort is the enemy of innovation. Everyone reading this article benefited from an invention today that was initially ridiculed and dismissed by experts at the time. I bet a good portion drove a car today to drop the kids off at school, commute to work or run errands. Well, that’s an invention we now take for granted even though it was a big deal for the likes of Henry Ford at the dawn of the automobile. Everyone either walked or used horses to perform the aforementioned tasks, and the thought of an “automobile” (whatever that was) was considered absurd at best. It was only absurd because folks couldn’t get past what they were comfortable with to open their minds to something new.

If I had asked people what they wanted, they would have said faster horses.

Henry Ford

Global Disruptors Often Introduce the Best New Ideas

The pharmaceutical industry is working to combat counterfeit drugs on a global scale, and regulations have been established to achieve this goal. The Food and Drug Administration (FDA) has been leveraging Congress’ Drug Supply Chain Security Act (DSCSA) to introduce incremental milestones since 2013. The final milestone calls for supply chain partners to track serialized drug products throughout the supply chain by November 2023 to prove medications haven’t been compromised. The industry is leveraging GS1 standards to identify which physical “bottle of medication” is in which carton and loaded onto what pallet as it moves through the supply chain. This requires manufacturers to add a Serialized Global Trade Identifier (SGTIN) as a 2D barcode to each packaging unit. In 2023, workers will need to ensure they identify each shipping unit accurately so the shipment is represented correctly in a new electronic transaction file called EPCIS. This parent-to-child hierarchical data will be transmitted from shipper to receiver as an Advanced Shipping Notice (ASN) transaction. If the file is incorrect, the shipper and receiver have a limited time to reconcile any errors, which will prove costly and degrade the regulation’s chain of custody quality objective.

Most of Us Witnessed the Evolution of a New Invention – and Became Believers in the “Unbelievable”

Roughly 40 years ago, barcoding was a new technology introduced on a package of Wrigley chewing gum and trialed in a Kroger store as a way to better track sales. Despite the success of that first implementation, the retail industry was skeptical at best and continued to manually key in the purchase at the cash register for decades afterwards. Customer demand for faster checkout and more accurate tallies of their purchases ultimately drove adoption of the barcode at the register, as did the need for greater efficiency throughout supply chains everywhere. The pharma industry, like most others, has adopted barcoding as their default tool to capture transactions from manufacturer to point of care. But why did it take so long? Previous data capture methods weren’t better by any means, neither was reporting or track and trace. Maybe it was fear of the unknown or just a resistance to change. But we must learn from our past mistakes and not just settle for more of the same.

Case in point: the pharma industry is now challenged to meet the increased requirements of the DSCSA with its current barcode tool set, which has introduced cause for concern. The workgroups at GS1 and other industry organizations are working diligently to figure out how they are going to keep goods moving through their facilities at a high level of speed and accuracy given the new requirement to identify all the items and cases on a pallet.

Radio frequency identification (RFID) is a viable option that compliments existing barcode labels and scanning solutions. Yet, it is somewhat unfamiliar to pharma companies. But please don’t repeat history and deem it risky simply because it is unfamiliar. This technology has matured in capability and become feasible from a cost-benefit perspective in the last two-to-three years. Barcoding relies on “line of sight” to scan one item at a time, whereas RFID uses an antenna and microchip inlay embedded into the barcode label to allow energy to read hundreds of labels (i.e., RFID tags) in seconds across a large footprint. This is a critical advantage when addressing DSCSA’s requirement for item-to-case and case-to-pallet aggregation. There is RFID technology available now that can penetrate interior pallet carton labels containing product attributes such as dry tablets, foil blister packs, and liquid filled vials and syringes that are prolific in the pharma industry. And it can read those tagged items at high rates of speed and accuracy. I know this because I recently witnessed it personally at a real-world implementation with a pharma manufacturer.

Thoughts on Carefully Moving into the Unknown

Now that RFID can be deemed a proven solution for DSCSA compliance, and a better solution than barcode scanning alone, the pharma industry must decide if this “unknown solution” is worth the effort to explore further. Is there enough cost benefit to make the investment in more trials or full-scale implementations? Does it make sense for organizations to use valuable time and resources to reengineer processes and technology systems to integrate an RFID solution given the looming November 2023 deadline? The only way to get these answers is by coming up with a carefully planned experimentation and discovery strategy – and follow through.

Educate yourself on the technology and determine if it is relevant to your organization and the problem at hand. To do this, you need to identify a partner that understands the technology. But you must be willing to share your processes and pain points with that partner if you are going to get an honest answer to the above questions. So, identify the leaders in this space and invite them to “walk a mile in your shoes.”

Remember, when Henry Ford first introduced the automobile, he witnessed horses attached to the front of his automobile, which had to be frustrating. People simply didn’t “trust” his technology and wanted to apply it in a way they felt comfortable. You will need to have an open mind and be willing to entertain some process changes to effectively adopt any new technology. There is certainly some level of risk in any project. Find a partner that is willing to be patient with you and take those incremental steps to quickly prove, or reject, new solutions to your problem.


iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.