Packaging Lessons Learned from the First FDA-Cleared OTC Continuous Glucose MonitorsPackaging Lessons Learned from the First FDA-Cleared OTC Continuous Glucose Monitors

Medtechs are pursuing consumer markets by transitioning some devices, like continuous glucose monitors (CGM), to the over-the-counter (OTC), non-prescription market. In this market segment, big players entering the US market include with OTC CGMs were Dexcom and Abbott.

The US Food and Drug Administration granted its first clearance for this product category to Dexcom for its Stelo Glucose Biosensor System last March followed by clearances in June for Abbott’s Lingo and Libre Rio CGMs. Dexcom’s Stelo is designed for those with diabetes not using insulin and people without diabetes or prediabetes. Abbott’s Lingo is for general use in people wanting to improve their health, while Libre Rio is designed for adults with type 2 diabetes who do not use insulin.

These sensor-and-smartphone GSMs are part of a fast-growing product category, as Grandview Research noted in its latest glucose monitoring market report. Medtech marketers now must align their designs and packaging to suit consumer needs.

Stelo (L) and Freestyle Libre 2 (Images: Dexcom; Abbott Laboratories)

Consumer considerations

MedTechs in this market space will need build sustainability and social responsibility into their commercial strategies, “recognizing that these qualities can drive differentiation and positive brand perception,” according to EY’s 2024 EY’s Pulse of the Medtech Industry report As a result, manufacturers have been designing smaller and smaller CGMs, as well as longer lasting devices (currently up to 15 days before the OTC device needs to be replaced).

Related:Continuous Glucose Monitoring Competitors Gear up for OTC

How might the change impact packaging for these technologies that include a biosensor to detect blood glucose levels, a microneedle that regularly takes measurements, and a transmitter that sends readings to a receiver, which might be a smart phone or touchscreen?

Medtech packaging pros weigh in.

FDA regulations for glucose monitoring product packaging often include stability storage and accelerated aging, according to Keri Lindenmuth, sales and marketing coordinator at packaging testing, design, and engineering company Purple Diamond.

“Stability storage helps manufacturers determine at which temperature and humidity products and packaging can be stored while remaining effective and accurate. Meanwhile, accelerated aging helps manufacturers assess the shelf-life of their product under anticipated storage conditions,” Lindenmuth told Packaging Digest.

She added that whether products ship to a home or hospital, they face the same distribution dangers such as drops, vibration, shocks, and compression, “which is why package testing is vital.”

The biggest difference between the two consumer groups is storage capabilities. Hospitals have the space and tools to store medical devices at recommended temperatures. Medical professionals understand the implications of high humidity or direct sunlight. The average consumer may not, which is why any product delivered directly to the consumer should have clear directions and storage recommendations on its packaging to ensure the product remains functional, Lindenmuth says.

Protecting sensitive medical devices is critical. Wayne Mills, head of operations at UK-based Seven Seas Worldwide, explains that primary packaging typically uses medical-grade materials like foil or thermoformed plastic to keep sensors and other components sterile and safe. He adds: “It’s often designed for convenience, with features like easy-peel seals or clear labeling to help users apply the CGM correctly.”

Secondary packaging for extra protection during transit might be a sturdy paperboard box or recyclable rigid plastic. “Shipping plays a big role, too. Home or pharmacy deliveries require durable and compact packaging to handle more handling and varied conditions,” Mills says. “This is why bulk packaging is more common when shipping to healthcare facilities.”

Packaging designs for OTC devices should include clear, simple instructions as part of the packaging and the UX/UI — user experience and user interface — of the device, according to Bradley Skaggs, partner and creative director at New York-based Skaggs Creative. He says that while he hasn’t designed packaging for CGMs, his agency has designed at-home medical devices such as Freespira and Össur and notes: “People tend to get nervous when using a device for the first time, especially when it’s associated with a health issue.”

Commenting on Stelo’s packaging, Skaggs says: “In my opinion, I find it strange that the logo and device picture is on the side and not at the top of the box. The top and side need to be swapped, with the ‘benefits’ of the product being the main callouts at first glance. Consumers intuitively look at the side of the packaging to read more about the product — after all, it has more real estate to toy with copy — and this area could be better utilized to highlight the product’s benefits.”