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A Swiss medical technology start-up company is developing an implantable neuroprosthetic medical device that will allow amputees to feel again from missing limbs. For the manufacturing of the implantable neural electrode the SME is seeking a medical device manufacturing company. The manufacturing should be compliant with ISO standards for implantable medical devices. A manufacturing or technological cooperation agreement is sought.
An internationally awarded Swiss medical technology start-up company is developing a neuroprosthetic device. The prostheses equipped with the neuroprosthetic device allow amputees to feel again from missing limbs. The device will be implanted within the residual or healthy part of the nerves and restore the flow of the neural sensory information.
The SME is seeking an original equipment manufacturer (OEM) able to produce implantable neural electrodes in a certified environment (compliant with ISO standards for implantable medical devices). Neural electrodes are the leads connected to the stimulator that can be found at this link: https://www.neurosmedical.com/about/the-altius-system/. The company would have to be able to execute 3D-printing, laser cutting, as well as printed circuit board (PCB) development.
Ideally, the company has know-how in engineering and design to support the development of the prototype into an industrial producible medical device.
The neural electrode consists of two portions:
The interface is constituted by an external nerve cuff and a number of wires (connected to passive electronics). The external cuff is an insulating rigid structure with an internal cavity where to place the nerve. Since the structure is rigid, it shapes the nerve when it encloses it. The two largest faces have holes through which 10 wires are inserted. These wires are constituted by a conductive core, which is shielded with an insulating material. The insulating layer presents a hole that allows the contact between the conductive material and the nerve. The cables, which are inserted through needles, cross the cuff and the nerve so to contact the internal fascicles. The holes in the wires are put at different lengths so to permit the connection with fascicles disposed at different profundities with respect to the base of the cuff.
The Swiss company is seeking a partner for a manufacturing or technical cooperation agreement.
Currently, the electrode is produced following the steps described below.
1. Printing all 3D computer aided design (CAD) parts (electronics support) in Visijet Crystal 3M: mold of the supporting portion of the electrode, and inserting portion of the electrode.
2. The 3D printed molds are used to build the supporting portion of the electrode with SILBIONE RTV 4407.
3. Soldering 10 or 18 lead wires (according to the version of the electrode with 10 or 18 active sites) to PCB (to connect the electrode to other devices).
4. Gluing (with BONDIC, UV glue) the PCB to the inserting portion of the electrode.
5. De-insulation of Pt90/Ir10 Wires (ø 0.050mm with PTFE coating), with laser machine to create the active sites of the electrode.
6. Inserting de-insulated Pt/Ir wires into 32 G needles (2x each).
7. Inserting 32 G needles into the holes of the inserting portion of the electrode.
8. Liquid bounding of Pt wires to PCB (with Ag glue).
9. Covering PCB (with soldered wires and cables) with BONDIC UV glue.
10. Covering of inserting portion of the electrode with Nusil 1000 Silicone.
The specific area of activity of the partner:
Medical device company, manufacturer of implantable medical devices.
The tasks to be performed by the partner sought:
ISO compliant manufacturing of implantable neural electrode