Accelerate time-to-market with Ypsomed’s Clear-to-Clinic™ program and Syntegon’s flexible RMA assembly platform.
Key Takeaways
- Standardized device platforms can reduce development effort and shorten time-to-clinic by at least six months – contributing to a faster time-to-market
- Syntegon’s RMA platform provides a seamless bridge from Ypsomed device selection to clinical assembly
- Cocreation between the partners allows pharmaceutical manufacturers and CDMOs to reduce implementation effort and move faster toward clinical manufacturing
As demand for self-injection devices continues to grow – especially driven by GLP-1s for diabetes and obesity treatment – pharmaceutical manufacturers face increasing pressure to bring new drug-device combination products to patients faster. At the same time, device development and validation timelines need to be shortened without compromising on quality, flexibility, or regulatory compliance.
Ypsomed’s Clear-to-ClinicTM program addresses these challenges by providing clinic-ready YpsoMate® and YpsoMate® 2.25 autoinjectors with a proven technical baseline, submission-ready documentation, and a coordinated supply path. Rather than developing a custom device from scratch, pharmaceutical manufacturers can select from a portfolio of commercially available autoinjectors – in different housing types, sizes, spring types, and configurations designed for varying viscosities, injection volumes, and delivery requirements. This standardization can reduce time-to-clinic by at least six months, with the resulting efficiencies also contributing to a shorter time-to-market – a significant advantage in highly competitive markets.
“Standardized device platforms can significantly accelerate development timelines. But their full potential is realized when device and assembly solutions are aligned from the beginning. That is why our collaboration with Ypsomed focuses on creating a seamless path from device selection to clinical assembly.”
Otto Abildgaard, Business Development & Product Manager at Syntegon
From device selection to clinical assembly
To fully realize the benefits of the Clear-to-ClinicTM program, manufacturers also need an efficient path into clinical assembly. As Ypsomed’s preferred final assembly equipment partner, Syntegon supports them with a final assembly solution that is specifically aligned with the device portfolio. The close collaboration also ensures a seamless path beyond clinical assembly towards future commercial production.
At the center of this collaboration is Syntegon's RMA platform. Designed for small-scale production, it enables pharmaceutical manufacturers and CDMOs to assemble a broad range of device configurations on a flexible platform, including all housing formats and variants available from the Clear-to-ClinicTM program. Syntegon receives assembly documentation directly from Ypsomed, covering the specific process parameters and requirements. Combined with Syntegon's assembly expertise, this means faster validation and a lower risk of device malfunctions.
COCREATION turns standardization into a practical advantage
This close collaboration between Syntegon and Ypsomed is built on cocreation and is the result of ongoing joint testing and iterative design refinement to ensure that all available device configurations fit seamlessly with the RMA platform. “Our collaboration with Ypsomed is built around a common goal: helping pharmaceutical manufacturers move faster. This cocreation helps reduce complexity and accelerates the path to the clinic – and ultimately to market,” Sigurt Johnson explains.
For pharmaceutical manufacturers and CDMOs, this results in a coordinated solution package that is already aligned and ready to deploy. By combining standardized device platforms with pre-aligned assembly capabilities, customers can reduce project risks, simplify implementation, and accelerate their journey to clinic.
Benefits for pharmaceutical manufacturers and CDMOs
- Full RMA compatibility with all Ypsomed Clear-to-ClinicTM formats
- Time-to-clinic reduced by at least six months through standardized device platforms
- Reduced development and implementation effort
- Lower project risk through pre-aligned technologies
- Greater flexibility across different device configurations
For pharmaceutical manufacturers looking to accelerate clinical development, the combination of Ypsomed’s Clear to Clinic™ program and Syntegon’s RMA assembly platform provides a coordinated path to early clinical deployment. By combining clinic-ready YpsoMate and YpsoMate 2.25 devices with aligned assembly capabilities, manufacturers can reduce project risk, simplify implementation, and accelerate their journey to the clinic. If you want to learn more about how the RMA platform supports the transition from clinical assembly to commercial production, read our article on the collaboration with Ypsomed, the RMA platform and further final assembly solutions, contact our experts or download our brochure.
YpsoMate, YpsoMate 2.25, and Clear to Clinic are registered trademarks of Ypsomed AG. The product images shown are for illustrative purposes only. They are the property of Ypsomed AG and are used with permission. © 2026 Ypsomed. All rights reserved.
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