Through the Line: Packaging and Processing

The Evolution of Digital Healthcare Packaging: Healthcare Packaging

Packaging World, ProFood World, Healthcare Packaging, Mundo EXPO Pack Season 2 Episode 79

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0:00 | 17:39

Will digital labels transform healthcare packaging?

The Sunrise 2027 initiative marks a global shift in the pharmaceutical industry from
traditional barcodes to advanced 2D digital labels and QR codes. This transition aims to modernize the healthcare supply chain by improving traceability, reducing
administrative errors, and providing patients with real-time medical information. 

While some regions have already mandated electronic labeling, others currently utilize a hybrid model that combines digital features with traditional paper inserts. Technologies like Digital Display Labels are especially transformative in clinical trials, as they allow for instantaneous updates to dosage and safety data without the need for manual relabeling. 

Ultimately, these digital innovations foster a more patient-centric approach by enhancing treatment adherence and streamlining the delivery of essential medicines.

This is an AI-generated episode. Read the full featured article on Healthcare Packaging.

SPEAKER_01

Welcome to Through the Line, the podcast exploring innovations and information across the packaging and processing landscape. From topics impacting consumer packaged goods and healthcare packaging to the latest technologies in food processing operations.

SPEAKER_00

Hi, Liz Cuneo here, editor-in-chief of healthcare packaging. What follows is an AI-generated podcast from a recent article on our site. It's all about the evolution of digital healthcare packaging, including digital labels. Listen in to learn more.

SPEAKER_02

So, welcome to the deep dive.

SPEAKER_00

Glad to be here.

SPEAKER_02

Today we are looking at a stack of new industry data ranging from packaging reports to global supply chain mandates. And our mission is to understand this massive, entirely invisible overhaul that is currently rewiring the global pharmaceutical network.

SPEAKER_03

It really is invisible to most people.

SPEAKER_02

We're going to track the death of the static paper label and the traditional 1D barcode and explore the rise of digital display labels or DDLs alongside those little 2D QR codes we're seeing everywhere.

SPEAKER_03

Aaron Powell What's fascinating here is that this transition is it's much more than a cosmetic packaging update. We are looking at a fundamental shift in how critical life-saving information travels.

SPEAKER_02

That's the factory straight to your medicine cabinet.

SPEAKER_03

Exactly. From the manufacturer's sterile floor through this highly fragmented global labyrinth directly into your hands.

SPEAKER_02

Okay, let's unpack this.

SPEAKER_03

Yeah.

SPEAKER_02

Because to really wrap your head around the scale of this packaging evolution, we have to look at the ticking clock that's driving all this momentum, right? Deadline. Yeah, the looming deadline known as Sunrise 2027. So this is a global initiative led by GS1. And for those who don't know, they're the nonprofit data standards organization that basically ensures a product scanned in Tokyo registers the exact same way in Toronto. Trevor Burrus, Jr.

SPEAKER_03

They set the universal language for barcodes.

SPEAKER_02

Exactly. And their goal is to transition the entire global pharmaceutical sector from the traditional vertical line 1D barcodes over to 2D barcodes by the end of 2027.

SPEAKER_03

Aaron Powell And honestly, the transition away from the 1D barcode is just long overdue when you look at the historical data limitations.

SPEAKER_02

I mean it just doesn't hold enough info.

SPEAKER_03

Aaron Powell Exactly. A traditional 1D barcode is essentially just a static product identifier. It tells the scanner, hey, this is a 200 milligram bottle of ibuprofen, and that is the absolute extent of its capability. It cannot tell the system which specific facility manufactured the bottle, what the expiration date is, or which specific batch it belongs to.

SPEAKER_02

So how do they track all that before?

SPEAKER_03

Aaron Powell To get that information in the past, companies had to print separate human readable text on the side of the box, which then required manual data entry at various checkpoints.

SPEAKER_02

Aaron Powell Which leaves a lot of room for human error.

SPEAKER_03

Oh, absolutely.

SPEAKER_02

Aaron Powell So think of the old 1D barcode like a basic car license plate, right? It just gives you an ID number. But the new 2D barcode, like a QR code, is like scanning a smart portal that opens up this dynamic miniature website right there on the box.

SPEAKER_03

Aaron Powell That's a great way to put it. It holds exponentially more data in a fraction of the physical space.

SPEAKER_02

But here's the thing that gets me. Looking at the GS1 mandate, this entire initiative is completely voluntary. It is. Nobody is legally forcing these highly regulated pharmaceutical companies to spend hundreds of millions of dollars to overhaul their global packaging infrastructure. So if this is entirely voluntary, why are massive pharmaceutical companies willing to spend the money to do this?

SPEAKER_03

The financial incentive to voluntarily overhaul these systems, it really comes down to the underlying architecture of serialization.

SPEAKER_02

Serialization. Yeah.

SPEAKER_03

So when a 2D barcode incorporates the GTIN, the global trade item number, alongside the batch number, the expiration date, and a unique serial number.

SPEAKER_02

It's tracking the individual bottle.

SPEAKER_03

Exactly. It creates a synchronized digital fingerprint for every single unit. There's a great quote from Ulrich Mayeski over at GS1 US. He points out that this level of end-to-end visibility actually aligns the healthcare sector with advanced retail capabilities.

SPEAKER_02

Oh, so like tracking an Amazon package, but for life-saving drugs.

SPEAKER_03

Basically, yeah. It creates a closed-loop system for traceability and authentication across the entire supply chain, from the manufacturer all the way to the point of use.

SPEAKER_02

Which means they have real-time geospatial awareness of a specific unit. But still, the initial capital expenditure for the new printing technology, the vision inspection systems on the assembly lines.

SPEAKER_03

The database integration.

SPEAKER_02

The database integration is astronomical. The return on that investment really has to come from back-end deficiencies.

SPEAKER_03

And it does. The ROI is entirely in that data integration. Think about it. When a pharmacist stands that 2D barcode today, the system doesn't just ring up a price, it pings a centralized database. Oh, wow. So if that specific serial number was marked as part of, say, a temperature excursion recall during transit.

SPEAKER_02

Like he got too hot in the back of the truck.

SPEAKER_03

Exactly. The scanner throws a hard stop. The pharmacist physically cannot dispense that medication. That level of automated unit level security is literally impossible with a 1D barcode.

SPEAKER_02

Which is why the industry is willing to shoulder those upfront infrastructure costs.

SPEAKER_03

Precisely.

SPEAKER_02

Here's where it gets really interesting. Because the 2D barcode is really just the gateway. It forces us to look at what that barcode actually connects to, which brings us right back to our opening scenario. The death of that giant folded piece of paper.

SPEAKER_03

The origami.

SPEAKER_02

The origami. Yeah. The industry is moving rapidly toward dynamic XML-based digital labels.

SPEAKER_03

Yeah. And as the industry transitions from physical paper to this digital architecture, the label stops being a static physical object and becomes a living digital document.

SPEAKER_02

Aaron Powell And these digital labels rely on standardized XML-based formats like structured product labeling or SPL, right?

SPEAKER_03

Yes, SPL. And the beauty of an XML structure is that it acts as a universal translator.

SPEAKER_02

Aaron Powell Between like totally different databases.

SPEAKER_03

Exactly. You could have a manufacturer running a proprietary ER key system in Switzerland and a local pharmacy running some legacy inventory software in Ohio. The XML format ensures the data is perfectly machine readable and universally structured.

SPEAKER_02

No matter what platform is interpreting it.

SPEAKER_03

The interoperability is the entire point. And Freyer Solutions notes that because the data is structured, it allows for seamless real-time updates.

SPEAKER_02

They were saying these labels can include hyperlinks, embedded videos, dosage calculator.

SPEAKER_03

And real-time safety updates pulled directly from regulatory databases. If a health agency like the FDA updates a contraindication warning, that XML structure allows the manufacturer to update the central file once.

SPEAKER_02

And instantly the digital label reflects that change globally.

SPEAKER_03

Instantly. It facilitates faster regulatory submissions and severely reduces the compliance risk of having outdated printed materials circulating out there in the market.

SPEAKER_02

But implementing a single digital standard globally has to be a massive geopolitical hurdle. Every country has its own regulatory body, its own language requirements.

SPEAKER_03

Oh, the global compliance puzzle is highly fractured. It's not uniform at all.

SPEAKER_02

Because looking at the data, Japan went all in. They basically eliminated all paper inserts for medical devices and medicines, moving almost entirely to a digital first labeling environment.

SPEAKER_03

Japan shifted the entire paradigm, yeah. And several other regions are following suit? Markets in Singapore, Saudi Arabia, the UAE, Qatar, and Bahrain have all mandated digital labeling in healthcare. Trevor Burrus, Jr.

SPEAKER_02

Pushing the industry away from paper. But meanwhile, the US, the EU, and Canada are lagging behind that fully paperless vision. They're currently utilizing a hybrid system.

SPEAKER_03

Requiring the digital 2D barcodes while still mandating the traditional static paper labels inside the box.

SPEAKER_02

And I look at this hybrid approach and I see a very necessary deliberate safety net. Wait, if the US and EU are keeping a hybrid system with paper, what happens to a patient who lacks digital literacy?

SPEAKER_03

Or doesn't have a smartphone.

SPEAKER_02

Exactly. If you eliminate the physical paper, you run the risk of isolating vulnerable demographics. Elderly patients, people in rural areas with poor connectivity, relying purely on digital access, could theoretically cut them off from critical safety information regarding their own medication.

SPEAKER_03

Aaron Powell This raises an important question regarding health equity in a digital age. And you're right, the hybrid model championed by the U.S. NEU absolutely serves as a protective buffer for those populations.

SPEAKER_02

Aaron Powell But there's pushback on that, right?

SPEAKER_03

Aaron Powell There is. International industry groups argue that clinging to the paper model ultimately restricts accessibility over the long term.

SPEAKER_02

Aaron Powell Because they think a smartphone democratizes the info more effectively.

SPEAKER_03

Aaron Powell Precisely. Sergio Cavallero Fio from the International Federation of Pharmaceutical Manufacturers and Associations, or IFPMA, he outlines how electronic labeling fundamentally increases inclusivity. Think about a physical piece of paper. It has hard spatial limitations.

SPEAKER_02

Yeah, you can only print a leaflet in what, one or two languages before the font size violates regulatory minimums.

SPEAKER_03

Exactly. But a digital label utilizing that XML backbone we talked about can offer the patient regulator-approved safety information in dozens of languages instantly.

SPEAKER_02

Oh, and it automatically defaults to their device's language settings.

SPEAKER_03

Exactly. And it opens up accessibility tools that paper simply cannot provide. It interfaces with screen readers for visually impaired patients, offers audio read aloud options, high contrast text.

SPEAKER_02

Oh wow. Yeah, the paper is technically accessible without a device, but it is entirely useless to a patient who doesn't read the printed language or has severe macular degeneration.

SPEAKER_03

Exactly. So the friction of requiring a smart device is weighed against these vast accessibility upgrades. The IFPMA perspective is that digital labels actually ensure safer, more effective use for a much broader, more diverse global population.

SPEAKER_02

Okay, so what does this all mean for you, the listener? It means the next time you pick up a prescription, scanning the box guarantees you aren't getting a counterfeit, and you might even get an instructional video on how to use it safely.

SPEAKER_03

Which is huge for patient compliance.

SPEAKER_02

But this instant updatability doesn't just assist the end user. It serves as a critical lifeline for the entire supply chain. Looking at the 2026 PMMI report in our stack, this digital shift offers a surprising solution to the crisis of global drug shortages.

SPEAKER_03

If we connect this to the bigger picture, the operational impact of separating the information from the physical packaging is just profound.

SPEAKER_02

Because the PMMI report highlights that, what, 67% of respondents are already utilizing QR codes and scannable features in their pharma packaging?

SPEAKER_03

Yep, 67%. For distributors, every single checkpoint becomes a data validation node. They scan the shipment to verify the origin, destination, product type, and authenticity.

SPEAKER_02

Aaron Powell Ensuring no counterfeits enter the supply chain.

SPEAKER_03

Exactly. And Sergio Cavallera Filio points out that reducing the reliance on printed materials provides greater flexibility in global supply chain management to help mitigate medicine shortages.

SPEAKER_02

Aaron Powell Okay, wait. How does swapping paper for a QR code stop a drug shortage?

SPEAKER_03

Aaron Powell When you think about the physical mechanics of a drug shortage, the bottleneck isn't always the manufacturing of the actual drug. Often it's packaging compliance.

SPEAKER_02

Like a label issue.

SPEAKER_03

Yeah. If a regulatory body mandates a slight update to a safety warning, the physical logistics in a paper-based system just grind to a halt. You have pallets of life-saving medicine sitting at international customs borders.

SPEAKER_02

Aaron Powell Because the piece of paper inside is suddenly out of date.

SPEAKER_03

Exactly. Suddenly noncompliant. So they have to be quarantined, shipped back to a repackaging facility, opened up, the old paper removed. Oh my God. A new paper inserted, resealed, serialized again, and shipped back out. It's a nightmare.

SPEAKER_02

And the administrative friction of that process can delay life-saving therapies by weeks or months. It artificially creates a shortage at the hospital level.

SPEAKER_03

But by transitioning to a digital label, the regulatory body approves the text change, the manufacturer updates the master XML file, and the compliance issue is resolved globally in milliseconds.

SPEAKER_02

So the physical pallets never have to stop moving. The customs agent scans the barcode, pulls the newly updated safety info, and the supply chain keeps flowing. The digital architecture basically removes the printer as the primary bottleneck. Okay, so while digital labels are fixing the commercial supply chain, their most transformative, like high-stakes application is happening behind the scenes, right, in clinical trials.

SPEAKER_03

Oh, absolutely. Clinical trials are an entirely different beast. The environment is highly regulated and deeply unpredictable.

SPEAKER_02

Because protocols pivot based on early data, dosing gets adjusted.

SPEAKER_03

And every single time an operational change occurs, it triggers a massive relabeling cascade for the experimental supplies. Paper labels in the clinical environment are just a crippling logistical hurdle.

SPEAKER_02

And that brings us to the active collaborations we're seeing, like between Merck and Janssen Pharmaceutica NV, they're collaborating to modernize trials using digital display labels or DDLs on investigational medicinal products.

SPEAKER_03

Right, IMPs. And the digital display label community of practice, which is part of the Clinical Supply Leadership Forum, they acknowledge the heavy investment required here, but insist the benefits just far outweigh the barriers.

SPEAKER_02

Let's give this some context. A crucial use case here is updating an IMP's expiry date. When a new drug is made for a trial, they might initially stamp an expiration date of, say, six months on the bottle, right?

SPEAKER_03

Because the long-term stability data is incomplete at that early stage, yeah.

SPEAKER_02

But as the trial progresses, testing might prove the drug is perfectly safe for an additional 12 months.

SPEAKER_03

Historically, extending that expiration date required a global recall of the experimental supplies. Clinical personnel all over the world would have to locate every single dispensed bottle, print new physical stickers, and manually relabel them.

SPEAKER_02

Which introduces high risk for physical errors and just administrative burden.

SPEAKER_03

It distracts from actual patient care, but DDLs allow on-demand updates for study personnel, caregivers, and patients without any manual relabeling.

SPEAKER_02

So it's exactly like your smartphone or your car getting an over-the-year software update while you sleep. But in this case, it's a software update to the expiration date on an experimental life-saving trial drug.

SPEAKER_03

That is the perfect analogy. Instead of recalling the physical bottle, the centralized system pushes a secure update directly to the hardware on the bottle itself. The physical screen on the label literally changes to display the new date.

SPEAKER_02

Wait, so there's an actual digital screen on the physical pill bottle.

SPEAKER_03

Yes. And the hardware engineering required for these DDLs is intense. They have to maintain battery life for years, survive extreme cold chain storage.

SPEAKER_02

Like the sub-zero temps for complex biologics?

SPEAKER_03

Exactly. And they have to integrate seamlessly with the clinical site's wireless infrastructure. It's a massive upfront investment in hardware and software.

SPEAKER_02

But the agility it provides is incredible. And this agility extends into the broader social implications mentioned in our sources, right? Yeah. Like addressing the need to promote diversity, equity, and inclusion in healthcare.

SPEAKER_03

Yes. DEI and clinical research is a massive priority. Historically, trials have really struggled to recruit diverse patient populations, and that's heavily impacted by localized language barriers.

SPEAKER_02

Aaron Powell Because if the legally mandated consent forms, the dosing instructions, the contraindications, if those are only printed in a single language on a static paper label, you are effectively barring non-native speakers from safely participating.

SPEAKER_03

Aaron Powell And your trial data is fundamentally compromised if it doesn't accurately reflect the demographic reality of the broader population that will eventually consume the drug.

SPEAKER_02

So the DDL solves this.

SPEAKER_03

Yeah. The dynamic multilingual capabilities of DDLs mean clinical trials can safely include a much wider, more diverse demographic. Sites can instantly provision instructions in the native language of the participant at the point of dispensing.

SPEAKER_02

Lowering the barrier to entry that was previously blocked by the physical limitations of a paper label.

SPEAKER_03

Exactly.

SPEAKER_02

Wow. So to recap our journey today, we've gone from GS1's ambitious Sunrise 2027 goal of killing the 1D barcode to Japan going entirely paperless.

SPEAKER_03

The 67% adoption rate in the PMMI report.

SPEAKER_02

And finally, this high-stakes implementation by Merck and Jansen in clinical trials. It's wild to think that the next time you hold a medicine bottle, you are holding a piece of a transitioning digital network. It's a literal frontier of efficiency.

SPEAKER_03

It really is incredibly efficient. We've talked about how 2D barcodes and DDLs allow patients to connect directly with the brand and allow manufacturers to monitor patient compliance. Yeah. But it leaves you with a question to ponder. As our medicine packaging becomes a fully interactive two-way digital street, where exactly is the line between a helpful digital healthcare assistant and a pharmaceutical manufacturer having real-time direct surveillance over exactly when, where, and how you take your medication? Wow.

SPEAKER_02

Yeah. A fine line between helpful and invasive. Something to mull over the next time you point your camera at a QR code on a box of pills. Thank you for joining us on this deep dive. It's been great. We will catch you on the next deep dive.

SPEAKER_03

Until next time, keep questioning the world around you.

SPEAKER_01

Thank you for listening to Through the Line Packaging and Processing. You can listen to more episodes on all streaming platforms. Be sure to visit us at packworld.com, Profoodworld.com, and healthcarepackaging.com for more packaging and processing news. This podcast was edited by Bree Guns.