Improving the safety and usability of a life-saving emergency auto-injector

Meridian Medical Technologies

Challenge
Improve the safety and usability of an established auto-injector without changing the sequence of use or core technology.

Approach
Working closely with our client, their manufacturing partners and suppliers, the programme ran from initial concept generation and user research through to pilot verification and scale-up, focusing on mitigating known use-related risks.

Outcome
The Truject® was launched in 2009 and remains the market-leading device for emergency injection of epinephrine.

Our client, Meridian Medical Technologies, came to us to develop their next-generation auto-injector. They wanted a solution, based on existing core technology and method of operation, which would offer integrated automatic needle protection and be easy to use in emergency situations.

Team were chosen as we offered the wide range of skills from human factors, industrial design and mechanical engineering, and could take the design from concept and prototyping through detailed engineering, industrialisation and scale-up.

EpiPen development

EpiPen development

 
Our approach

Working in partnership with our client, the team carried out user research around the existing EpiPen® and identified a number of ways in which we could improve usability and safety of operation. As a result we developed a device with:

  • automatic sharps protection, before and immediately after use
  • easy-to-read on-board pictorial instructions and clear colour-coding that encouraged correct orientation
  • a design which helped communicate the needle end, prevent the device from rolling off surfaces and aid grip
  • a flip-top, durable carry pack that could be operated single-handed

 
Development process

During the project we designed, optimised and verified a number of improved and novel components and mechanisms, utilising a range of analytical and empirical engineering tools and techniques. As a result we:

  • developed a high-volume, platform product offering the opportunity to accommodate a range of drug container and needle sizes, whilst leaving the existing primary pack technology unchanged
  • reduced the magnitude and variability of activation force, while also reducing production costs
  • integrated an automatic needle protection system while minimising the impact on device size
  • delivered a device technology which resulted in new intellectual property for our client

Following pilot scale design verification, we worked very closely with Meridian’s manufacturing partners and suppliers to support scale-up to high-volume manufacture of the device, including validation of production tooling and the development, build and commissioning of automated assembly equipment. Finally, we provided a comprehensive hand over of design history and technical file documentation including CAD database and risk management file.

As part of the project we also developed, in parallel, a low-cost training aid. This trainer is recognisable as an EpiPen but distinguishable from the active drug-filled product, allows repeated reuse and features a minimal number of components.

 
Outcome

The Truject® – the next-generation EpiPen® auto-injector device is currently on the market through Meridian’s marketing partner, Dey Pharma.

EpiPen development

 
From our client

“Team were able to offer the assistance we needed, from conceptual development through industrialisation providing valuable, creative and rigorous expertise throughout. Their approach to design created a novel product which met the end user requirements, resulting in a product, which is carried by patients on a daily basis all over the world.”

John G. Wilmot, Sr. Director Technology Applications
Meridian Medical Technologies