Inhaler development enters Design Proving phase

We are excited to announce that we have just signed the contract on the fourth phase of a project to develop a Dry Powder Inhaler for a speciality generics organisation based in Europe.

Having developed several concepts earlier in the project, client consultation and early patient feedback from formative user studies then guided the selection and development of one preferred design. We asked one of our preferred suppliers to manufacture low-cost, cleanroom compatible tooling. Not only were the tools finished in an astonishingly short timescale, but the initial samples from the tools were the best we’ve ever seen, allowing us to build completely functional, although not yet optimised, devices without having to make a single tool modification.

In the Design Proving phase, we will refine the device to enable it to pass Design Verification. We need to demonstrate that the device is mechanically robust and tune the drug delivery engine to give optimal performance with the dry powder formulation. We will also carry out detailed user testing as part of our Usability Engineering process.

This is the most important phase of a device development. It is where we get to grips with every single parameter that affects how the device performs through rigorous testing, analysis and Design of Experiments (DoE). It is critical that the design and its sensitivity to manufacturing tolerances is well understood so that we can proceed to the next phase, Pilot Manufacturing, where we will scale up to multi-impression injection mould tooling, with the highest possible confidence.

We wish Arron and his team the best of luck with the new phase.