From Concept to pre-clinical trial in 6 months

Concept Development & Prototyping

The client needed an experienced partner to aid in product development. One with deep clinical knowledge and sufficient vertical integration to enable rapid iteration cycles. OxDevice’s partnership began by implementing a project plan to move from concept to the pre-clinical trial stage.

Concept designs were generated and prototyped in-house by OxDevice. Key aspects of implant performance were analysed using state of the art testing equipment. Prototypes were deployed into silicone vascular models connected to pulse duplicator equipment, allowing for flow characteristics and fluid pressure to be measured at different regions of the model, indicative of device performance.

The pre-clinical trial

1. In-house manufacturing and assembly

For the duration of the testing period, Laser-cut nitinol stents were designed, shape-set and electropolished by OxDevice and assembled onto complex ePTFE membrane features. Custombuilt 8F catheter delivery systems were manufactured using a combination of FDM and SLA 3D-printed and off-the-shelf components.

2. From benchtop to in-vivo

After rounds of benchtop vascular model testing, the project was ready for in-vivo testing. OxDevice’s experience with clinical methods allowed for the development loading and deployment methods for the implant with the delivery system. 9 devices were manufactured for use in pre-clinical testing.

3. The pre-clinical trial

A pre-clinical trial was organised in a top US lab. OxDevice attended the study in person and supported the investigators with guidance on device operation. The results from the trial proved the initial concept and the client is extremely optimistic in securing funding for the project’s next stage.