Biocompatible Medical Polymer Prototypes

I need a hands-on polymer chemist—ideally someone who can leverage a well-equipped university lab—to turn my bench-top concept into 10 to 50 fully functional medical prototypes. The end use is clinical, so every formulation and process choice must keep a clean FDA path in mind. Core requirement • The material must be demonstrably biocompatible; cytotoxicity and sensitization screening will be part of our acceptance tests. Helpful but not mandatory Flexibility and straightforward sterilization would make downstream validation easier, so if you can bake those qualities in without compromising biocompatibility, that’s a bonus. What I’ll supply • 3D CAD files of the device geometry • Performance targets and use-case data • Any subcontracted test reports already completed What you’ll deliver • Lab-scale formulation file (with exact monomer/initiator ratios) • Process sheet covering mixing, molding/printing, and cure schedules • 10–50 finished units, cleaned and packaged for initial bench testing • A brief memo summarizing preliminary biocompatibility data and notes on future FDA submission needs The equipment route is up to you—solution casting, injection molding, UV-cure 3D printing, or another method—so long as the final pieces meet the biocompatibility benchmark and are dimensionally within ±0.2 mm of the supplied CAD. If you can start within the next few weeks and are comfortable documenting work to FDA-ready standards, let’s talk specifics.

Projektin tunnus (ID): 40246887