BD Vystra™ is a disposable pen injector designed for the self-administration of complex biologic medications, particularly for chronic diseases. Its patient-centric design, informed by over 100 patients, healthcare professionals, and experts, ensures ease of use and adaptability for a wide range of drug therapies requiring variable dosing.
Key Features:
•Compatible with standard pen needles and standard 3.0 mL drug cartridges
•Simple, light, and compact design for portability
•Interval dose dialing with audible clicks for accurate dosing
•Large, clear dose markings and transparent cartridge holder for visibility
•Supports multiple injections and variable dosing (up to 0.8 mL per dose)
•Easy cap removal and attachment
Regulatory Compliance & Documentation:
•Compliant with ISO 11608, US 21 CFR 820.30, and ISO 13485 standards
•Comes with comprehensive regulatory and technical documentation, including Human Factors Engineering Report, validated Instructions for Use (IFU), Device Master File (MAF) for US, and Technical Dossier (TD) for global markets
Global Experience:
•Used in marketed drug combination products across Europe, Australia, India, Japan, and the United States
•Launched for pharmaceutical development in 2012
•Protected by over 100 patents worldwide
Availability:
•Samples are readily available
•Offered in pre-configured combinations through the BD PartnerPath™ Program (requires a services agreement)
Benefits:
•Adjustable features and clear dose markings support self-injection and patient independence
•Designed for integration with reliable drug delivery systems
BD Vystra™ is not available off the shelf and requires a services agreement for access. For more information, visit bd.com or contact BD Medical Pharmaceutical Systems.
