Axiom Injection Pen

We partnered with long standing client, Shaily Plastics, to develop a fixed dose injection pen suitable for delivering a number of different medical treatments. The brief was to design a high quality, affordable injection pen that Shaily could manufacture and sell to pharmaceutical companies as their own drug delivery device.

The product needed to be capable of delivering a wide variety of treatments such as Teriparatide, Human Growth Hormone (HGH), Follicle Stimulating Hormone (FSH), Glucagon-Like Peptide-1 (GLP-1), and more. Each device would deliver a daily drug dose over a 28 day period.

Having worked with IDC on the development of similar products, Shaily were well aware of IDC's ability to create devices with unique IP. This was an important consideration as drug delivery devices have a history of development challenges with many of the mechanisms being patent-protected.

Our engineers worked closely with our designers to ensure the best design for patients, with the final pen offering a discreet, quick and easy dosage system for users. Safety of drug delivery was a key focus of the design and the device was designed with features to ensure it was completely fail-safe and protected against user error. A pull-to-dose mechanism was developed that ensured it would only release medication when it was correctly used.

Prototypes were made throughout the development by IDC Models. Rapidly developed SLA prototypes were invaluable in refining the form and testing mechanisms in a realistic way. IDC was responsible for the entire product development lifecycle, providing testing and verification with partners across Europe. Full traceability and documentation was provided by IDC to achieve medical certification in Europe and the US. This included FDA and the ISO 11608 quality standard.

The pens are manufactured almost entirely from medical grade plastics in Shaily’s world-class facilities, with a combination of PC, PCM, PC/ABS and glass-filled materials. The Axiom injector platform is already enjoying commercial success thanks to the combination of IDC’s unique IP and the highest quality manufacturing from Shaily.

Our involvement in the development of Axiom:

• Existing patent and product review
• Regulatory planning & Technical file documentation
• Risk Management including detailed DFMEA
• RLD benchmark protocol development and testing
• Mechanical engineering
• Industrial design & CMF
• Prototyping & initial testing
• Full CAD design for manufacture
• Tolerance stack analysis
• 2D Engineering drawings
• Patent drawings & application
• Pre-production sample review
• Dose accuracy and force testing
• Design verification protocol development