If you are a medical device producer dealing with the lack of affordable delivery tools in developing regions — this project developed the UNIPEN that provides a price-neutral, refillable alternative to syringes for 20 million people.
Affordable Refillable Insulin Pen for Low-Income Global Healthcare Markets
Imagine if the only way to get a life-saving medicine was using a basic needle and a glass bottle, which is how millions still do it. This team built a reusable pen that lets you fill it with any available insulin, making it as cheap as those old needles but much easier and safer to use. It's like switching from a messy inkwell and dip-pen to a modern refillable ink pen for your health.
What needed solving
Millions of diabetes patients in low-income regions cannot afford branded insulin pens and are forced to use outdated, inaccurate syringes. This leads to poor treatment adherence and long-term health complications.
What was built
A patented, refillable insulin pen (UNIPEN) that is compatible with any insulin type and cost-competitive with syringes.
Who needs this
Who can put this to work
If you are a distributor dealing with low patient adherence due to expensive branded pens — this project developed a device compatible with any insulin available, improving accuracy for the 13 million people using outdated technology.
If you are a waste management firm dealing with massive amounts of single-use plastic sharps — this project developed a refillable system that significantly reduces hazardous waste compared to disposable syringes.
Quick answers
How does the pricing compare to existing solutions?
The UNIPEN is designed to be price-neutral and cost-competitive compared to traditional syringe solutions, ensuring it does not increase the financial burden on patients.
Is the device ready for industrial scale-up?
Based on available project data, the project focused on fine-tuning scale-up production and achieving ISO 13485 standards to support local production in developing countries.
What is the intellectual property status?
The project developed and validated a patented UNIPEN device.
Which regulatory approvals have been obtained?
The device received FDA 510(k) clearance in April 2025 following a clinical safety and usability study with 100 patients.
What is the project timeline for development?
The project period runs from 2023-03-01 to 2025-08-31.
Who built it
The project is led by a single Danish SME, GO-PEN ApS, which maintains 100% industry control. This lean structure allowed for rapid technical development, moving from a patented design to FDA clearance within a 2.5-year window.
Contact GO-PEN ApS in Denmark for licensing and distribution partnerships.
Talk to the team behind this work.
Contact us to explore distribution partnerships for the UNIPEN in emerging markets.