Oyster Point Medical specializes in reinforced catheter shafts for interventional medical devices. With our extensive in-house capabilities, we can braid, coil, laminate, tip, apply marker bands - all in our capable hands. We can also assemble in a clean room and deliver higher-level subassemblies.
We welcome inquiries on projects of all sizes. We pride ourselves in working with seed stage medical device startups and Fortune 500 companies alike. There are no minimum orders, and we believe in helping founders and early engineers realize their ideas. We continue to quickly scale and grow our capacity, and we plan to be able to support large production orders by early 2027.
Oyster Point Medical can deliver prototype catheter shafts in as little as 1-2 weeks for simple constructions. We recognize the importance of speed for early-stage R&D teams, so we strategically source raw materials from off-the-shelf sources and retain in-stock materials to keep our lead times as low as possible. More complex multilumen shafts or others needing custom materials will be delivered as soon as reasonably possible considering raw material lead times.
All of our quotations are based on a transparent “time and materials” basis. This typically works out to the $3,000 to $6,000 range for a basic single lumen reinforced catheter utilizing off-the-shelf materials.
Oyster Point Medical was founded to help interventional medical device companies move faster. The founders of OPM recognized the difficulty for early-stage R&D teams of sourcing quick-turn catheters. The specialized processes and equipment associated with catheter fabrication makes them difficult for small start-ups and clinical-focused finished goods manufacturers to prototype in-house. Our approach is to take as many processes in-house at OPM to avoid unexpected delays.
Yes, we have a robust QMS implemented which covers nearly all relevant aspects of ISO 13485 and FDA QMSR requirements. We have the ability to keep full traceability of materials, build and certify to released specifications, address nonconformances, quality raw material suppliers, etc. We expect to be fully certified to ISO 13485 by the end of 2026.
Absolutely. We have decades of experience taking catheter-based interventional systems from concept to clinic. Our phased system allows for conceptual and feasibility work without burdensome quality system requirements. Once a path to feasibility is established for the medical device, we can fill any gaps needed, including specification development, risk management, testing, and more.
