Ypsomed
Ypsomed is a leading developer and manufacturer of self-injection systems for liquid medicines, offering the most comprehensive and innovative platform portfolio for pens, autoinjectors, and wearable injection systems. With over 40 years of experience, Ypsomed provides tailored self-treatment solutions that simplify therapies and improve the quality of life for millions worldwide. The company emphasizes sustainability, digital health integration, and a broad range of services supporting all development phases from conception to market launch.
Industries
Nr. of Employees
Very Large (1000+)
Ypsomed
Products
Prefilled and reusable pen injector platforms
Modular pen-injector platforms designed for prefilled and reusable formats, engineered to support a range of doses and formulations and to accelerate regulatory submissions via pre-validated components.
Autoinjector platforms (single- and multi-volume)
Autoinjector device platforms engineered for a range of fill volumes and viscosities, with options for two-step operation and connectivity add-ons.
Wearable/patch large-volume injector platforms
Body-worn patch injectors designed for large-volume subcutaneous delivery with patient‑centred ergonomics and validated usability data.
Connected device modules and digital health services
Add-on connectivity modules and digital-health services for adherence monitoring, data generation and integration with therapy management solutions via cloud-based services.
Platform intellectual property portfolio
A platform-level patent portfolio used to protect core device innovations while allowing program-specific differentiation; public material references ~200 active patent families.
Prefilled and reusable pen injector platforms
Modular pen-injector platforms designed for prefilled and reusable formats, engineered to support a range of doses and formulations and to accelerate regulatory submissions via pre-validated components.
Autoinjector platforms (single- and multi-volume)
Autoinjector device platforms engineered for a range of fill volumes and viscosities, with options for two-step operation and connectivity add-ons.
Wearable/patch large-volume injector platforms
Body-worn patch injectors designed for large-volume subcutaneous delivery with patient‑centred ergonomics and validated usability data.
Connected device modules and digital health services
Add-on connectivity modules and digital-health services for adherence monitoring, data generation and integration with therapy management solutions via cloud-based services.
Platform intellectual property portfolio
A platform-level patent portfolio used to protect core device innovations while allowing program-specific differentiation; public material references ~200 active patent families.
Services
Human Factors Services
End-to-end HF support including use-related risk analyses, IFU and labelling design, formative and validation studies, and preparation for regulatory correspondence and HF validation.
Regulatory and submission support
Regulatory classification, strategy development and preparation of submission-ready technical dossiers and design verification documentation for global authorities.
Design verification & testing services
Laboratory-based mechanical, functional and dosing tests, end-assembly for design verification, ISO 11608-aligned verification and reporting performed in a dedicated Competence Center Laboratory.
GMP manufacturing & assembly services
Clinical-to-commercial GMP manufacture including precision injection moulding, automated assembly, inline quality control and full product traceability across multiple sites.
Tooling and precision mould services
In-house tooling production and mould design to support injection-moulded component manufacture and rapid iteration during development and industrialization.
Quality management and audit support
QMS implementation support aligned to ISO 13485, MDR, MDSAP and 21 CFR Part 820 and preparation for regulatory and partner audits.
Human Factors Services
End-to-end HF support including use-related risk analyses, IFU and labelling design, formative and validation studies, and preparation for regulatory correspondence and HF validation.
Regulatory and submission support
Regulatory classification, strategy development and preparation of submission-ready technical dossiers and design verification documentation for global authorities.
Design verification & testing services
Laboratory-based mechanical, functional and dosing tests, end-assembly for design verification, ISO 11608-aligned verification and reporting performed in a dedicated Competence Center Laboratory.
GMP manufacturing & assembly services
Clinical-to-commercial GMP manufacture including precision injection moulding, automated assembly, inline quality control and full product traceability across multiple sites.
Tooling and precision mould services
In-house tooling production and mould design to support injection-moulded component manufacture and rapid iteration during development and industrialization.
Quality management and audit support
QMS implementation support aligned to ISO 13485, MDR, MDSAP and 21 CFR Part 820 and preparation for regulatory and partner audits.
Expertise Areas
- Drug-delivery device development
- Modular platform engineering
- Manufacturing and scale-up (GMP)
- Human factors and usability engineering
Key Technologies
- Injection moulding (single- and two-component, hot-runner)
- Automated assembly and inline inspection
- SAP/ERP-integrated manufacturing systems
- Human-factors usability testing (formative and validation, eye-tracking)