manufacturing medical devices 2 - 09/03/2018 13:38 EST

Here is our project. 1. Manufacture (or purchase) PICC lines (typically made from TPU) and external ventricular drains (silicone). 2. Apply silane to these devices per the attached method (or an optimized method.). (I have not given the specific silanes we use, but similar ones. We will get specific following an NDA.) 3. Apply liquid to the devices as stated in the last step of the described method. 4. Sterilize and package the wet devices. The liquids on the devices is important for their efficacy. ** I would love to hear your thoughts on cGMP manufacturing suitable for FDA approval of these devices. ** I would love help with step 1, the molding of the PICCs and drains, but am much more concerned about steps 2-4. I welcome your thoughts.