Gyroscope (now a Novartis Company) has developed world-leading products for delivery to the subretinal space of the eye without the need for a vitrectomy or retinotomy.
Gyroscope wanted to refine the fluidic control elements of its innovative Orbit SDS™ medical device and approached TTP to identify potential ways to achieve this.
TTP reviewed the fluid control functionality of the device and generated alternative solutions for fluid control and sealing. Using an analytical approach, we were able to recommend a preferred solution from a number of concepts and to define the required tolerances to meet Gyroscope’s performance requirements. The use of an analytical approach also minimised the need for design iterations and enabled us to quickly create proof-of-concept test pieces for Gyroscope.
TTP then used a combination of rapidly prototyped parts and machined components to simulate final moulded parts that incorporated our understanding of manufacturing processes, tolerances and materials to provide compatibility with existing components of Gyroscope’s device.
These sample devices supported more detailed testing at TTP and Gyroscope, including accelerated aging and of overall fluidic and dosing performance using a test protocol and an absorbance assay developed by TTP.
When we received the new moulded parts incorporating TTP’s recommendations, all of them performed as intended and within specification. We were really excited.
By combining analytical design approaches with deep knowledge of medical devices and manufacturing techniques, Gyroscope was able to create moulded components to improve their ground-breaking medical device.
