Key Elements for Pen Development

In the fast-evolving world of medical devices, pen injectors play a pivotal role in ensuring accurate and efficient drug delivery. Drawing from the latest standards such as ISO 11608 series, here are the key elements critical to successful pen development:

1. System Design & Usability
– Human-Centric Design: Ensure systems are intuitive and easy to use for both patients and caregivers.
– Risk-Based Approach: Employ thorough risk management in alignment with ISO 14971 to address potential safety challenges.

2. Primary Functional Performance
– Dose Accuracy: Guarantee precise delivery of medication, assessed under varied conditions.
– Functional Stability: Ensure reliability over the product’s lifecycle through robust design verification.

3. Material Compatibility
– Utilize materials that are compatible with medicinal products and meet ISO 10993-1 for biocompatibility.
– Prevent adverse reactions or quality degradation during storage and delivery.

4. Needle and Cartridge Integration
– Double-ended needles must align with stringent flow rate and sterility standards.
– Cartridges should enable freedom from leakage and maintain dose accuracy even at the end of shelf life.

5. Resilience and Safety
– Leak Prevention: Design containers and plungers to resist leakage under various pressures.
– Durability: Pass tests like free-fall and vibration to ensure the pen injector remains functional during transport and use.

6. Interoperability
Focus on achieving compatibility between needles, cartridges, and injection systems to enhance user experience and reduce errors.

💡 Innovation for Impact


Standards like ISO 11608 guide us in crafting devices that prioritize patient safety, usability, and efficiency. By adhering to these benchmarks, we not only meet regulatory requirements but also set a foundation for improving healthcare outcomes.
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