Periodic Reporting for period 2 - GO-Pen (The first universal and price-neutral insulin pen)
Período documentado: 2024-03-01 hasta 2025-08-31
Today, more than 60 million of the 530 million people living with diabetes (PwD) worldwide require daily insulin injections for the rest of their lives. Most of these individuals rely on either traditional syringes — a system developed over a century ago — or on modern pre-filled insulin pens provided by major pharmaceutical companies such as Novo Nordisk. While pre-filled pens are often covered by public healthcare systems in the European Union, this level of access is not the global standard. In many countries, particularly in low- and middle-income regions, insulin pens remain inaccessible due to high cost or lack of public reimbursement. As a result, more than 20 million PwD resort to buying large insulin vials and administering their treatment with cheap, single-use syringes.
This project addresses the critical unmet need in diabetes care for affordable, accessible, and user-friendly insulin delivery devices for all layers of the socioeconomic pyramid. Our goal is to empower patients with a safe and effective alternative to syringes that does not increase their financial burden. By introducing a price-neutral refillable insulin pen system, we aim to offer PwD greater autonomy in managing their condition, while improving both treatment adherence and overall quality of life.
Beyond its direct health impact, the project has broader socioeconomic and environmental benefits. It supports local production and distribution infrastructures in developing countries, creating jobs and stimulating regional economies. Additionally, the UNIPEN represents a more sustainable alternative to syringes by significantly reducing the hazardous waste associated with disposable plastic and sharp materials. Through this project, we intend not only to democratize access to modern insulin delivery but also to establish a scalable model of equitable, patient-centered innovation in global healthcare.
This project addresses the critical unmet need in diabetes care for affordable, accessible, and user-friendly insulin delivery devices for all layers of the socioeconomic pyramid. Our goal is to empower patients with a safe and effective alternative to syringes that does not increase their financial burden. By introducing a price-neutral refillable insulin pen system, we aim to offer PwD greater autonomy in managing their condition, while improving both treatment adherence and overall quality of life.
Beyond its direct health impact, the project has broader socioeconomic and environmental benefits. It supports local production and distribution infrastructures in developing countries, creating jobs and stimulating regional economies. Additionally, the UNIPEN represents a more sustainable alternative to syringes by significantly reducing the hazardous waste associated with disposable plastic and sharp materials. Through this project, we intend not only to democratize access to modern insulin delivery but also to establish a scalable model of equitable, patient-centered innovation in global healthcare.
The project successfully developed and validated the patented UNIPEN device, a refillable insulin pen designed as an affordable and sustainable alternative to syringes. Technical development milestones included the completion of a cost-neutral design compatible with fast-acting insulin, successful preliminary durability studies, and optimisation of cartridge and pen performance. A clinical safety and usability study with 100 patients confirmed the device’s effectiveness, leading to FDA 510(k) clearance in April 2025. In parallel, the consortium achieved ISO 13485 certification, a key regulatory milestone enabling collaboration with professional distributors.
An independent Life Cycle Analysis conducted by the Technical University of Denmark demonstrated the environmental benefits of UNIPEN, confirming its lower ecological impact compared to conventional syringe-based insulin delivery. These findings strengthen the device’s positioning as both a clinically validated and eco-conscious solution for global deployment.
Recognition of the project’s achievements came through multiple channels: winning the American Diabetes Association Innovation Challenge 2023 and inclusion in StartupHealth’s T1D Moonshot program, highlighting the device’s innovative character and strengthening alliances within the diabetes care sector. Collectively, the project delivered a certified, user-friendly, and sustainable insulin pen that is now ready for international scale-up.
An independent Life Cycle Analysis conducted by the Technical University of Denmark demonstrated the environmental benefits of UNIPEN, confirming its lower ecological impact compared to conventional syringe-based insulin delivery. These findings strengthen the device’s positioning as both a clinically validated and eco-conscious solution for global deployment.
Recognition of the project’s achievements came through multiple channels: winning the American Diabetes Association Innovation Challenge 2023 and inclusion in StartupHealth’s T1D Moonshot program, highlighting the device’s innovative character and strengthening alliances within the diabetes care sector. Collectively, the project delivered a certified, user-friendly, and sustainable insulin pen that is now ready for international scale-up.
The UNIPEN device advances insulin delivery beyond the current state of the art by providing a refillable, user-friendly, and affordable alternative to syringes. Its FDA clearance and CE marking represent major regulatory milestones, enabling immediate entry into markets that recognize these approvals and paving the way for additional authorisations in other key regions. Combined with ISO 13485 certification, these achievements establish a strong foundation for distributor engagement, investor confidence, and quality assurance.
The project also delivered evidence of UNIPEN’s sustainability through an independent Life Cycle Analysis, confirming lower environmental impact compared to traditional syringe-based delivery. This dual emphasis on clinical validation and eco-conscious design positions UNIPEN as a disruptive innovation in diabetes care.
Market readiness has been reinforced through extensive stakeholder engagement, including feedback from patients, healthcare providers, and payers, which guided refinement of the market strategy. Recognition through the American Diabetes Association Innovation Challenge and inclusion in StartupHealth’s T1D Moonshot further underscore the device’s global potential and credibility within the innovation ecosystem.
Looking forward, successful uptake and impact will require financing for large-scale production facilities, the establishment of robust distribution partnerships, and continued regulatory alignment to ensure access across diverse markets. Localised manufacturing and targeted market access strategies will be crucial for reaching low-income populations who stand to benefit most from this innovation. Collectively, these results demonstrate that UNIPEN is not only ready for market entry but also equipped to transform global insulin delivery through accessibility, sustainability, and scalability.
The project also delivered evidence of UNIPEN’s sustainability through an independent Life Cycle Analysis, confirming lower environmental impact compared to traditional syringe-based delivery. This dual emphasis on clinical validation and eco-conscious design positions UNIPEN as a disruptive innovation in diabetes care.
Market readiness has been reinforced through extensive stakeholder engagement, including feedback from patients, healthcare providers, and payers, which guided refinement of the market strategy. Recognition through the American Diabetes Association Innovation Challenge and inclusion in StartupHealth’s T1D Moonshot further underscore the device’s global potential and credibility within the innovation ecosystem.
Looking forward, successful uptake and impact will require financing for large-scale production facilities, the establishment of robust distribution partnerships, and continued regulatory alignment to ensure access across diverse markets. Localised manufacturing and targeted market access strategies will be crucial for reaching low-income populations who stand to benefit most from this innovation. Collectively, these results demonstrate that UNIPEN is not only ready for market entry but also equipped to transform global insulin delivery through accessibility, sustainability, and scalability.