Inhaler for users with limited manual dexterity

Vectura

Challenge
Perform design amendments and develop a concept for a multi-use, single unit dose, dry powder inhaler device to ensure suitability for users with limited manual dexterity.

Approach
In collaboration with the client, our engineers, designers and human factors experts, developed an existing concept to be better suited to the target population. We carried out detailed risk assessments to inform usability changes and combined engineering analysis and device testing to improve reliability of key performance aspects. We also utilised Team and Vectura’s experience and expertise to enhance the design to make it suitable for high volume commercial manufacturing and assembly.

Outcome
The final design was taken through to pilot manufacture. We carried out formal design verification testing using methods in line with ISO 20072. On completion of the project the final device was ready for clinical trials use.

Vectura had created a concept for a multi-use, single unit dose inhaler that could be ‘pre-loaded’ and stored with a drug blister; this allowed the device to be ready for use by patients with limited manual dexterity. Vectura selected Team Consulting to help progress the development and detailed engineering of the final device.

We carried out an early technical analysis and detailed risk assessments (FMEA’s) of the device concept. These evaluations revealed opportunities for improvements in three areas: usability, performance and robustness. We worked with Vectura and drew on our core areas of expertise in human factors, industrial design and engineering to improve the design while preserving the original concept.




dry powder inhaler



Detailed design efforts focused on optimising performance, reliability and device manufacturability. We used a combination of analytical techniques such as: tolerance analysis, Finite Element Analysis (FEA), and Design for Manufacture and Assembly (DFMA) review. To prove design changes to critical areas such as blister retention and piercing, we carried out extensive testing on parts from rapid prototype injection mould-tooling. Devices produced from these tools were also used in ongoing human factors studies and assessments.

Multipul pill render

We worked closely with Vectura and shared expertise on various systems such risk assessment, design documentation, device testing and CAD database management. We also collaborated with Vectura’s industrialisation experts and commercial manufacturing partners; components were developed for automated handling and internal sub-assemblies created to simplify the assembly process. A tamper-proof, ultrasonically welded base and permanent laser marking were also introduced.

Following design freeze we supported the specification, optimisation and qualification of the pilot manufacturing systems. We also worked with the client to plan and carry out design verification testing in accordance to ISO 20072 (Aerosol Drug Delivery Device Design Verification – Requirements and Test Methods). Vectura performed analytical testing, while we took responsibility for the mechanical and functional testing including development of test methods (test jigs and fixtures), statistical analysis and reporting of results.

inhalers

We also documented the development route to the meet the requirements of Vectura’s quality management system. Using established templates, we generated a complete specification package of all components and assemblies in the device for transfer to Vectura’s manufacturing partners.

On completion of the programme, which took three years from initial concept review to the sign-off of pilot manufacturing systems, a final documentation package suitable for inclusion in the device technical file was handed over to the client. The ‘multi-use, single unit dose’ device is currently available in Vectura’s range of class-leading device technologies.