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GO-Pen · Project

Affordable Refillable Insulin Pen for Low-Income Global Healthcare Markets

healthMarket-readyTRL 9

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.

By the numbers
60 million
People with diabetes requiring daily insulin injections
20 million
People using large insulin vials and single-use syringes
13 million
People using outdated syringe technology who cannot afford modern pens
100
Patients in clinical safety and usability study
The business problem

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Millions of diabetes patients in low-income regions cannot afford branded insulin pens and are forced to use outdated, inaccurate syringes.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.

The solution

What was built

A patented, refillable insulin pen (UNIPEN) that is compatible with any insulin type and cost-competitive with syringes.

Audience

Who needs this

Medical device distributors in developing countriesGeneric insulin manufacturersPublic health ministries in low-to-middle income regionsNGOs focusing on diabetes care
Business applications

Who can put this to work

Medical Device Manufacturing
SME
Target: Low-cost healthcare equipment producer

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.

Pharmaceutical Distribution
mid-size
Target: Generic insulin distributor

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project developed a device compatible with any insulin available, improving accuracy for the 13 million people using outdated technology.

Waste Management
enterprise
Target: Healthcare waste processor

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.

Frequently asked

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.

Consortium

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.

How to reach the team

Contact GO-PEN ApS in Denmark for licensing and distribution partnerships.

Next steps

Talk to the team behind this work.

Contact us to explore distribution partnerships for the UNIPEN in emerging markets.

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