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

Challenge

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

Approach

Working closely with our US based client, their manufacturing partners and suppliers, the program 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 (Adrenaline) for treatment of anaphylaxis.

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Our client, Meridian Medical Technologies (now part of Kindeva), came to us to develop their next-generation emergency use auto-injector. They wanted a solution, based on existing core technology and method of operation, which would offer integrated automatic needle protection (now a requirement of ISO 11608) and be easy to use in emergency situations.

Team Consulting was chosen as we offered a wide range of skills from ergonomics, industrial design and mechanical engineering to take the design from concept and prototyping through detailed engineering, industrialization and scale-up.

Our approach

Working in close 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 color-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
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Development process

During the project, we designed, optimized and verified a number of improved and novel components and mechanisms, utilizing 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, while 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 minimizing 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 handover 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 recognizable 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.

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

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

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