On-Body Drug Delivery System

10ml Drug Delivery System



 
 

Patient-Centric

  • User loaded, subcutaneous self-administration

  • Ability to deliver up to 10mL and a range of viscosities*

  • Easy to use, intuitive design

  • Intended for use by patients or caregivers in a non-healthcare environment or by healthcare professionals in a clinic setting

  • Visual and audible feedback to boost user confidence

* The SmartDose® On-Body Delivery System Platform has been designed with the potential for variations in functionality in several areas (e.g., potentially accommodate certain volumes and viscosities of drugs), and not all variations have yet been the subject of approved investigational or marketing applications

Flexible Technology

  • Formulation volumes up to 10mL

  • Address administration of a fixed dose of drug product from a prefilled container in a predetermined time

  • Continuous or pulsatile delivery modes

West’s SmartDose® On-Body Delivery System Platform 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, 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 platform’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.

 

3.7 ml Drug Delivery System

Patient-Centric

  • User loaded, subcutaneous self-administration

  • Ability to deliver up to 3.7mL and a range of viscosities*

  • Easy to use, intuitive design 

  • Visual and audible feedback to boost user confidence 

Flexible Technology

  • Formulation volumes up to 3.7mL

  • A wearable, single-use device intended exclusively for use with the co-packaged prefilled drug product container to deliver a fixed dose into subcutaneous (SC) tissue of the thigh or abdomen2, in a predetermined time.

  • Published studies3 indicate lower injection site pain associated with customizable delivery rates.