Needle-Free Injector

Project Overview

In 2023, the team collaborated with the client to develop a needle-free injector targeting diabetes patients in China and North America. 

The ODM/JDM hybrid project required a compact, disposable device capable of delivering insulin doses with consistent pressure (±5% variance). 

Manufacturing involved Class 10k cleanroom processes, and certifications targeted CFDA and FDA.

Technical Challenge

Pressure Consistency: Achieving uniform drug delivery across varying skin densities and injection angles.

Disposable Design: Balancing cost-efficiency with medical-grade material requirements for single-use components.

Regulatory Alignment: Navigating divergent FDA and CFDA labeling and usability standards.

Our Approach and Solution

Pressure Optimization: Incorporated microfluidic sensors and a pre-calibrated spring mechanism to auto-adject injection force based on skin resistance.

Material Sourcing: Partnered with regional suppliers to source FDA-compliant resins at scale, reducing material costs by 15%.

Dual-Language Labeling: Developed a modular label system to meet FDA’s English requirements and CFDA’s Mandarin mandates without redesigning packaging..

Results & Outcomes

The injector received CFDA approval in Q2 2023 and FDA clearance in Q4 2023.

Production efficiency hit 50,000 units/month, with a per-unit cost 20% lower than competitors.

A 95% patient satisfaction rate in trials, citing pain reduction and ease of use.

The project’s success led to discussions about expanding the partnership to include wearable drug delivery systems.