Development of an 80IU variable dose injection device

Challenge

Create a variable dose insulin pen that built on the client’s existing brand identity, and increased the maximum dosage capacity from 60IU to 80UI.

Approach

We worked closely with the client’s team to define the look and feel of the device based on user insights, as well as ensuring the device was robust and suitable for industrialisation.

Outcome

We produced an elegant, functional and cost-effective device solution for our client, as well as developing product packaging and IFU.

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At a glance

Client
Haselmeier

Sector
Drug delivery

Services
Human factors
Mechanical
Industrialisation
Design verification

Project background

Development of an 80IU variable dose injection device

Haselmeier, a leading manufacturer of self-administered injection devices, came to Team Consulting to make use of our broad in-house capabilities and expertise in parenteral drug delivery device development. Starting with a prototyped injection device, Haselmeier needed a partner to help take its idea from concept to manufacture.

Haselmeier wanted an easy-to-use and robust insulin pen that built upon their existing brand identity. Their new device, named Axis-D, needed to increase capacity from a maximum dosage of 60IU to 80IU. The pen needed to anticipate changes in market demand and this increased dosage would allow a broader usage. In combination with this, Haselmeier required a device that was ready for automated manufacture of millions of units, yet still easily customisable for their future licensees.

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Our approach

Throughout the project we worked in partnership with Haselmeier and became an extension to their team. Working with their prototype, we defined the look and feel of the pen based on user insights, and our design guidelines ensured we found a brand identity that would fit with Haselmeier’s desires.

The straight, cylindrical form and black dial were consistent with existing pens in Haselmeier’s range, and further design decisions aimed to position the device as an elegant and robust device that all users could use with ease. Our designers and engineers worked in close collaboration 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 were able to deliver a successful cost per unit for their high-volume automated manufacturing needs.

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 taking the cap off. A raised dose window was designed into the device to ensure this scenario was eliminated. The protruding clip on the removable cap was designed to feature the same visual aesthetic as the dose window. Together, these features act as important anti-roll features, ready for injection.

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

Axis-D is an elegant and easy-to-use disposable, variable dose injection device designed for use with a 3ml cartridge for Haselmeier’s pharmaceutical licensees. 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.