Focus | Drug Delivery
Background
eg technology has supported the development of platform drug delivery device architectures across multiple programmes, designed to deliver effective and consistent performance whilst accommodating different formulations, use cases and future development pathways.
Reusable drug delivery devices with replaceable cartridges or dose-containing components offer user benefits, sustainability responsibility and multi-formulation opportunities. This type of architecture can appear straightforward, but developing a device that feels simple to use whilst also being robust and repeatable requires careful engineering. Integrating naturally into a user’s routine is essential, along with meeting demanding technical, biocompatibility and manufacturing requirements.
Platform-based approaches enable flexibility and development efficiency whilst maintaining control over critical performance and reliability.
Challenge
Developing a platform technology presents the same challenges as any medical device, but with added complexity. The system had to deliver consistent performance whilst remaining simple, robust and adaptable to variation possibilities, so that different formulations, users and conditions could be catered for. In practice, this involved balancing a number of competing requirements.
Cartridge-based drug delivery devices must be intuitive for the user, whilst also delivering consistent performance across a range of operating conditions. In dry powder applications further complexity is introduced in relation to loading formulation, stability, evacuation of formulation and targeting. These characteristics had a direct influence on device design and therefore required careful evaluation throughout development.
Early-stage CAD Models and prototypes were used by the eg engineers to develop ideas, learn and iterate fast. However, prototype materials and build methods placed limits on how accurately some aspects of performance could be assessed. As programmes progressed, there was therefore a need to move beyond purely prototype-based learning and introduce more representative components in order to answer key technical questions with greater confidence.
As with all medical device development, verification testing was a key consideration from the early stages of development. As a platform technology, the device needed to demonstrate compliance with performance requirements in a way that separated intrinsic device performance from formulation-dependent characteristics wherever possible.
Solution
eg technology applied a structured development approach across these projects, combining platform thinking with detailed engineering analysis, prototyping and verification. Device architectures were developed around reusable platforms with interchangeable cartridge-based elements, allowing flexibility for different therapies whilst maintaining control over critical functional features. Particular attention was given to the interaction between the user and the device, ensuring that intended simplicity in form translated into practical usability.
We adopted a risk-based development approach, conducting multiple rounds of concept refinement, prototyping and technical testing, so that potential failure modes were identified early and mitigated through engineering changes. These iterations were used to investigate the highest risk aspects of device performance and to guide design decisions with evidence.
We used simulation tools to test virtually, made prototyped parts to carry out practical testing and defined specific test processes and procedures. This included using high speed photography, dispensed volume analysis and novel leak detection techniques. Conducting the right testing at the appropriate stages provided the evidence needed for the team to make informed technical decisions and progress the design with confidence.
Once the limitations of prototype materials and construction methods had been reached, the decision was made to manufacture components using injection moulding. Injection moulding requires significant investment and time but produces components in production materials with production geometry and surface finish, thus allowed the next level of quantitative verification testing.
eg technology’s comprehensive verification strategy directly linked testing to the defined product requirements. This ensured delivery of a well structured and fully traceable technical file suitable for regulatory submission.
Design for manufacture was also embedded from the start, as a core consideration, supporting the transition from iterative development into scaled production.
Robust verification and testing are key to ensuring consistent device performance across multiple applications.
Result
Through these programmes, eg technology developed platform-based drug delivery devices with enhanced technical maturity, supported by verification evidence and a clear route to manufacture.
The resulting designs delivered reusable architectures with reliable functional performance, supported by requirement-led verification. By addressing critical technical issues early, including those linked to actuation, powder behaviour and drug delivery, development could progress quickly and with greater confidence. The use of representative moulded components during development testing is justified by a smoother route into scale-up, bridging the gap between development and production.
These programmes provide a valuable demonstration of eg technology’s ability to apply detailed engineering, structured verification and design for manufacture to the development of reliable drug delivery platforms in a pragmatic way to ensure a valuable, agile and efficient development process for our clients.
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For further information on how eg technology can support in getting your technology or ideas to market or to chat with one of the eg team about your product design and development requirements, please get in touch.
