A key area of expertise at Marble is the development of drug delivery devices. We have specialist knowledge and skills in both inhalation and parenteral drug delivery and also take on the challenge of less conventional drug delivery methods. In addition to device design, we also develop custom machinery to support the high speed manufacture and inspection of capsules.
Marble are experts in the design of auto-injectors, pen injectors, safety syringes and inhalers. Covering all stages of development from concept, usability, mechanical engineering, detailed design, test, assembly and scale up for manufacture. We have an expansive working knowledge of the IP landscape and are proud of our IP achievements in this area. We are experienced in device design within a regulated environment and frequently generate documentation for the design history file as a matter of course during device development.
At Marble we believe Usability Engineering is an inherent part of design and early concept development, not a regulatory hurdle once the design is fixed. We undertake multiple informal, formative user evaluations early on in the development to ensure the interface, form and function are correct. We regularly plan and implement 'voice of customer' programmes as input to specifications and to define key product attributes. We have experience in developing 'looks like, works like' evaluation models for user studies to understand user preference and uncover usability issues. We have specific experience in RA, oncology and paediatric auto injectors, diagnostics monitoring and blood draw.
Marble have worked on a number of collaborative drug delivery projects with Bespak on their Syrina™ range of devices. Activities included concept generation, mechanical design and engineering, development of 'looks like, works like' prototype models and IP generation.
Marble supported Oval Medical in the optimisation of their platform device for a specific drug application. During the project a number of changes were implemented resulting in improvements to the design of both the primary container and the device to align it with the requirements of the drug product. Marble worked with Oval to revise the design, commission the tooling to implement the changes, advise on the testing and generate documentation for the design history file.
Marble have designed a number of confidential, bespoke drug delivery devices for large pharmaceutical companies. Our experience includes human factors studies, agile design challenges, device development from concept to manufacture, IP navigation, concept generation, test rig development, technical transfer and design review projects.