With the large number of new biologics, and the launch of biosimilar molecules, the demand for devices for the subcutaneous self-injection of biopharmaceuticals continues to grow. New devices focus on simpler self-injection procedures and improved patient therapy management for autoinjectors, pens and patch injectors. As the number of devices reaching the market increases, pharmaceutical and biotech companies are looking to source state-of-the-art platform products that are available quickly and at low risk for both clinical trials and commercial launch.
Ypsomed's platform strategy lowers risks and shortens timelines:
Ypsomed initiates new platform development independently of customers with the key focus of developing patient-friendly, easy-to-use patented technologies. Formative usability testing of each platform product is performed repeatedly with representative user populations. The results support Ypsomed in iteratively designing and modifying the platform, but also provide valuable data for future customers as a basis for their own usability testing. For example, formative testing of UnoPen and YpsoMate have been published in peer-reviewed magazines.
Building up the appropriate manufacturing infrastructure is key to Ypsomed’s platform strategy. Early in platform development, Ypsomed invests in manufacturing infrastructure offering customers flexible access to their required capacity. Ypsomed also supports customers in implementing end assembly, the assembly of the device with the primary packaging container, and collaborates with CMOs and machine suppliers to provide customers with the expertise they need to outsource or implement the appropriate process.
The customisation of a platform is a fast process. Once the customer specific design is implemented, further formative and summative human factor testing with the customer-specific design may be conducted. Once the platform is fully industrialised, verified devices for clinic are available within a short time. An important part of the customisation project is to provide dossier support for the customer’s regulatory filing.
Ypsomed provides all device-related information relevant for the submission. Ypsomed’s platform strategy allows faster and simpler development projects while minimising project risks and shortening time to market.