Developing a Variable Dose Insulin Injector Pen Device

Autoinjector development from concept to manufacture

Haselmeier, a leading manufacturer of self-administered injection devices, came to Team Consulting to help them develop a variable dose insulin pen. They needed a pen that would anticipate changes in market demand, with an increased dosage to allow for broader use. The pen also needed to be ready for automated manufacture of millions of units, yet still easily customisable for future licensees.

Working from their initial prototype, the Axis-D, we helped them increase the capacity of the pen from a maximum dosage of 60IU to 80IU, while making key design changes to improve its ease of use. The result was an elegant, functional and cost-effective injection device that built on Haselmeier’s existing brand identity.

Building on an existing brand identity

Working closely with Haselmeier, we helped them find a brand identity that fit with their needs. Using their initial prototype, we defined the look and feel of the pen based on user insights. The result was a straight, cylindrical form and black dial which were consistent with existing pens in Haselmeier’s range, with key design decisions positioning the device as an elegant and robust solution that promoted ease of use. Throughout the design process, our industrial designers and engineers collaborated closely to ensure that the complex internal engineering work could fit within the desired size limit of the device.

Testing and industrialisation

Our engineering test phase included a range of activities to ensure the pen’s robustness and its suitability for industrialisation. We undertook tolerance analysis, finite element analysis (FEA) and risk assessment, including user and product failure modes and effects analysis (FMEA).

Having identified a manufacturing partner early on in the project, we were able to work closely with them to optimise the Design for Manufacture and Assembly (DFMA), reducing press times and streamlining assembly operation. We helped Haselmeier deliver a successful cost per unit for their high-volume automated manufacturing needs.

Addressing design challenges

During design testing, we found a number of key use scenarios that helped evolve aspects of the design. For example, we found that some injector pens rolled off flat surfaces after removing the cap. To address this, we implemented a raised dose window, ensuring its visual aesthetic matched the protruding clip on the removable cap. Together, these act as important anti-roll features, helping to improve the device’s usability.

In this project, all aspects of the Axis-D pen were carefully planned and discussed to help reduce user error and facilitate onboarding of new users. The feel of the mechanical click feedback as well as the selection of the material and the injection force were chosen with this purpose in mind.
Oliver Harvey, Senior Engineering Consultant, Team Consulting

Packaging and IFU design

Alongside the device development, we also designed example product packaging and IFU documentation. The customisation options were developed to support the needs of Haselmeier’s clients.

Outcome

Our multi-disciplined approach ensured that Haselmeier could enter the market with a well-rounded and cost-effective insulin pen that could be marketed to potential pharmaceutical licensees.

Axis-D is an elegant and easy-to-use disposable, variable dose injection device designed for use with a 3ml cartridge. Its labelling can be highly customised and it features example product packaging and IFU documentation.