Engineering Today’s Smart Packaging: An Evolution of Security and Connectivity
Technology is allowing for more intelligent package solutions. Integrating tools that will satisfy regulatory requirements while addressing clinical needs is helping to keep patients more connected with products.
Schreiner MediPharm’s labels include digital first-opening indication. The labels wrap around part of the cap of an autoinjector or pen to prompt an irreversible digital sealing function. During the smartphone scanning process, an automatic check is performed to verify that the product is still intact.
Schreiner MediPharm
It wasn’t that long ago that the true purpose behind healthcare smart packaging ended once the product securely reached the patient. But much like the concept itself, the reasons for which smart packaging is utilized today continue to broaden. What was once intended primarily to maintain product safety and supply chain management along the pathway of production and delivery has since evolved to support a range of initiatives including anti-counterfeit measures, waste reduction, environment friendliness, and medication adherence. Not coincidentally, compliance and regulatory requirements for smart packaging are also expanding. As the technology involved continues to become more advanced, smart packaging has become more “intelligent,” achieving more goals through direct engagement and “connectivity” with patients that extends beyond the time in which products simply reach their hands.
“Smart packaging is no longer just a container; it’s a multifunctional platform that underpins product compliance and patient trust,” says Tiffany Overstreet, global innovation director at MM Pharma & Healthcare Packaging, a global pharmaceutical packaging solutions company. As capabilities for digital tools such as near field communication (NFC) and radio frequency identification (RFID) become more sophisticated, suppliers of primary and secondary packaging are more successfully integrating smart methods that help to achieve compliance and other patient-related needs.
Connecting Technology to Adherence and Compliance
With the way in which packaging technologies are utilized today and becoming more intertwined between various stakeholders along the supply chain, the idea of “connected packaging” is becoming a preferred term for those involved in the process at Resource Label Group, a producer of secondary packaging. “Connected packaging captures how advances in technology make both regulatory compliance and patient adherence easier to manage,” says Kevin Frydryk, vice president of markets and products. “Healthcare is one of the most highly regulated industries, and packaging is central to compliance. Smart and connected packaging are becoming integral to care and compliance, transforming packaging from a passive container into an active tool. It can extend to technologies like RFID, which streamline inventory management, or NFC tags that allow a patient to tap their phone and instantly access dosage instructions, safety details, or product authentication.”
NFC use cases being developed at Resource Label Group enhance the value of customers’ printed patient information on pharmaceuticals and medical devices while providing additional security and product authenticity by sharing personalized promotional and educational materials in real time. With a combination of RFID and Bluetooth, these smart labels are helping patients interpret embedded content to allow for more creative sharing, such as branded videos to improve clinician education and patient adherence.
“With NFC, a simple tap [of the product on the patient’s phone] can open a process to validate that a product is authentic, along with highlighting chain-of-custody information,” explains Frydryk. “The patient can also be brought into an added journey that can be customized and fully owned by the manufacturer. This can include product use instructions, important information on interactions, or any other pertinent information in a healthcare setting.”
At MM Group, NFC is geared toward direct patient engagement to improve security and authentication, as well as to offer patients additional resources to support their health journey, said Overstreet. “Most patients are familiar with NFC through mobile commerce or other taps with their phones,” she said. “The key is to educate patients about the benefits of engaging with a smart packaging feature.”
The Smart Syringe Box from Schreiner MediPharm enables digital tracking and temperature monitoring in clinical trials.Schreiner MediPharmFor patients who are responsible for self-administered injectables, new technology developed by Schreiner MediPharm, a global provider of innovative functional label solutions, has introduced NFC-equipped labeling that offers an added layer of protection against counterfeiting. Each label contains an integrated chip with an encryption function whose codes can neither be faked nor manipulated. End users hold smartphones against the labels to confirm the product’s authenticity. In addition to the assurance provided by point-of-use verification, the labels enable interactive instruction and support. According to Sebastian Münscher, senior product manager of RFID and NFC solutions at Schreiner MediPharm, among the benefits of this approach is that patients receive a message when tapping the NFC label, which creates additional touchpoints and is comparable to two-factor authentication security.
“And the various touchpoints that we’re introducing may be unbeknownst to someone who might attempt access without authority,” said Münscher. “You also instantly have an online connection to the patient, meaning you can tie it into the world of apps, websites, and the tracking of data that is generated by using the smartphone. It is a perfect physical link between the drug and the online world.”
Schreiner MediPharm’s labels also include digital first-opening indication. The labels wrap around part of the cap of an autoinjector or pen to prompt an irreversible digital sealing function that complements authentication. During the smartphone scanning process, an automatic check is performed to verify that the product is still intact and has not been previously opened. In addition to elevated safety, the NFC technology enables tracing of gray market activities, allowing manufacturers to monitor the supply chain.
On the hospital pharmacy side, Schreiner MediPharm is also partnering with Bluesight, a healthcare software company that provides medication intelligence to hospitals and health systems, on RFID technology that optimizes digital inventory control for the KitCheck™ medicationsystems. Specifically tailored for high-speed labeling systems in pharma production, these labels can be reliably applied to primary containers with narrow radii, such as vials or syringes, and offer a variety of functions including integrated hangers, removable documentation labels, and tamper-evident seals. Within the application, the labels can automatically be read out in KitCheck scanning stations using tracking software. The systems capture the drug name as well as batch numbers, expiration dates, missing or expired drugs, or indications of previously opened drugs. The specially developed label-integrated RFID structure also permanently protects chips against mechanical stress and functional failures.
Keystone’s Key-Pak® child-resistant blister cards are integrated with a medication adherence prompting and monitoring application that transforms packaging into an interactive, real-time adherence data solution for clinical trials.KeystoneOverstreetadds that customers at MM Group are also opting for ultra-high frequency (UHF) RFID for facility inventory monitoring of ongoing product availability. “UHF RFID is being used to confirm product for use on crash carts and is making it easier to monitor supply inventories,” she said. “It saves nurses time compared to doing physical stock counts by hand, time that can be better spent with patients.”
Data Deliverables
The benefits of today’s digital technologies go beyond the patient-product relationship as well. A newly formed partnership between Keystone Folding Box Co., a provider of secondary paperboard packaging solutions, and Med-Con Technologies, a global clinical trial adherence technology solutions company, has enhanced Keystone’s Key-Pak® child-resistant blister cards by integrating a medication adherence prompting and monitoring application that transforms packaging into an interactive, real-time adherence data solution for clinical trials.
With this modality, each Key-Pak card includes a unique 2D data matrix barcode that’s printed on the clinical label or directly on the package. Trial participants use the Med-Con app to scan barcodes to verify dosage and log events to a secure cloud server. This real-time data collection ensures accuracy and improves trial integrity by reducing reliance on self-reporting and manual pill counts, an increasingly complicated challenge for patients and providers, says Ward Smith, director of marketing and business development at Keystone. “If patients don’t take every dose correctly, or skip doses altogether, it becomes nearly impossible to assess the true efficacy and safety of the drug,” he said. “In clinical research, even modest deviations in adherence can distort trial outcomes, leading to misleading data about whether a treatment is working as intended. For decades, clinical trials relied on patient-reported paper diaries, but these are notoriously inaccurate. Patients often over-report adherence — sometimes unintentionally — introducing significant noise into the dataset.”
With this technology, reminders are sent to patients via customizable push notifications and the app is customizable overall to support protocol variance. Study staff members are alerted if patients fail to follow protocol. Marketed as a cost-effective, scalable tool, there’s no integrated electronics or embedded components. However, study coordinators gain immediate access to adherence data, allowing them to identify dosing deviations early and intervene when necessary while addressing a core component of today’s compliance standards — data capture, integrity, and protection per Code of Federal Regulations Part 11.
“From a regulatory standpoint, the primary concern is whether the system can reliably capture, store, and retrieve adherence data,” says Smith. “Compliance isn’t just about creating a ‘smart’ package — it’s about aligning with broader electronic data standards. Regulators want assurance that the system maintains integrity, security, and traceability throughout the trial, so that adherence data can be trusted in the same way as other critical endpoints.”
This solution, from Schreiner and Keystone, utilizes integrated electronics to convert blister packs into a real-time e-diary for capturing dosing history data. KeystoneSchreiner and Keystone have also jointly released a smart blister pack that is specially targeted to feature child-resistance safety and senior-friendly design for clinical trials. The solution utilizes integrated electronics to convert blister packs into a real-time e-diary for capturing dosing history data. The novel, customizable blister wallet combines child-resistant paperboard with technology for digital adherence monitoring in an attempt to improve trial reporting accuracy. A distinguishing characteristic is the integration of conductive trace-patterns that are linked to each wallet card cavity. As a result, data is generated immediately when patients remove a dose. Details such as time, date of removal, and specific cavity location are then stored within the interior electronics and can be transmitted by means of NFC or Bluetooth for precise tracking.
Similarly, Frydryk says he is encouraged bythe overall sophistication of RFID and NFC for connected packaging as it relates to supporting ongoing unique device identification (UDI) regulations that also continue to evolve for accurate tracking through the lifecycle. It can also extend to technologies like RFID, which streamline inventory management, or NFC tags that allow a patient to tap their phone and instantly access dosage instructions, safety details, or product authentication. “UDI regulations have been in place for years and are frequently supported with barcodes, but alternatively the use of RFID both simplifies the information capture required and improves the accuracy of tracking,” he says.
Future Integration Insights Moving forward, incorporating smart and connected technologies into secondary packaging could most often prove easier and cost-effective, says Overstreet. “I think secondary packaging also offers a greater degree of flexibility, as direct drug contact requirements present technical challenges when trying to incorporate smart elements into primary solutions.”
She sees the next steps in the evolution likely being adoption growth by pharma companies. “I believe we will see improved apps that help patients track their journey on any given treatment while making it easier to refill prescriptions,” she says. “I also believe we will see cost-effective dual-frequency chips come to market, which will allow engagement via NFC and supply chain monitoring to help companies better manage inventories through the value chain. The industry is currently working toward a dual-frequency chip that enables improved patient engagement, authentication, and supply chain monitoring all in one inlay.”
To Frydryk, the biggest challenge remains keeping full chain of custody. “RFID provides clear benefits in ease of use and item-level accuracy and efficiency, but implementation can be complex,” he says. “Return-on-investment modeling is key to building the case, and dual-tag technology will simplify adoption by bridging regulatory and patient needs in one solution. Continuing improvements in chip technology will open the window to more information being trackable through the chain of custody and richer data capture. While regulatory changes may not define specific required technology, the benefits of connected packaging will continue to increase use and adoption of these technologies.”
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