Loop-assisted fine-needle aspiration

Purpose and goal:

Aim and objective with the project has been to start prototype manufacturing of our product to achieve manufacturing of 50 units according the Medical Device Regulation directive (MDR) for use in a clinical investigation. After completing project, we now have a fully functional prototype, a design that is ready to be manufactured, and an identified contract manufacturer that can produce the product.

We have also started a project with the healthcare system to carry out a clinical investigation of the product. Expected results and effects: We have developed the product design and manufactured prototypes. We have identified and begun collaboration with a manufacturer.

We have established a project with the healthcare system to conduct a clinical investigation of the product during 2024. Approach and implementation:

We have worked with a technical consultant to find a technical solution and design that met our requirements for ease of use and manufactorability for injection molding. With the help of the technical consultant, we have converted our product idea into a fully functional prototype, produced CAD drawings and assembly drawings in order to be able to produce the product in larger volumes at low cost.