SmartDose® 10 On-Body Drug Delivery System for Self-Injection Platform
SmartDose® 10 Injector - Large Volume Wearable Injectors & Market

SmartDose® 10 On-Body Delivery System

One Device. Built to Advance Biologics.

A nurse preparing an injection for a patient using a syringe and vial
Overview

SmartDose® OBDS Key Benefits

1

Commercially Proven and Operationally Trusted

Has more than 5 million devices delivered across current and earlier on-body systems. The SmartDose® 10 OBDS, has an exceptionally low field complaint rate and demonstrates reliable real-world performance. Pharmaceutical partners gain confidence in supply continuity, manufacturing scalability, and platform durability across global markets.

2

Thoughtfully Engineered for Patient Experience

Informed by human factors engineering and real-world patient insights, SmartDose 10 is designed to simplify use, enhance comfort, and support adherence. From device placement to delivery feedback, every interaction is structured to simplify handling and minimize use error. Controlled delivery dynamics further contribute to a consistent and potentially more comfortable injection experience.

3

Integrated to Protect Biologics and Optimize Performance

Combines a dedicated Daikyo Crystal Zenith® (CZ) polymer primary container system with a device architecture developed specifically for complex biologics. Helps minimize residual hold-up volume, reduce drug waste, and optimize overfill requirements to support product value. Mitigates concerns related to protein aggregation, silicone-related interactions, and contamination risk—helping safeguard drug integrity from fill-finish through patient delivery.

4

Versatile, Software‑Defined Platform Architecture

Utilizes a software-controlled electromechanical architecture with pre-programmable delivery parameters to support a broad range of biologic requirements. Enables updates through software configuration rather than hardware redesign as volume, viscosity, or delivery needs evolve. Helps accelerate development timelines, deliver consistent performance, and support adoption across expanding portfolios and future combination product applications.

5

One Collaborative Partnership through the Drug Development Process

Engage with West to explore collaboration opportunities for expanding SmartDose® 10 device programs across high-volume biologics and advanced drug delivery applications. Evaluate feasibility, platform fit, and commercialization pathways through early partnership. Bring together cross-functional support across development, manufacturing, and launch planning to help reduce complexity and support a more efficient path to market.

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Note: West’s SmartDose® on-body delivery system is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, intended users and use environment(s), as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SmartDose® on-body delivery system’s compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or underdosing. Product misuse could potentially lead to needlestick injury, user and/or patient exposure to pathogens or infection, and/or suboptimal or delayed therapy.


SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Flurotec® is a registered trademark of Daikyo Seiko, Ltd.
SelfDose™ is a trademark of West Pharmaceutical Services, Inc. 
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