Rapid catheter prototyping for medical device innovators

Box Shadow One
// SINCE - 2023 //
Based in: Boston, Massachusetts

From concept to production, Oyster Point Medical delivers high-quality and cost-effective medical device manufacturing solutions. With deep R&D expertise, we are uniquely suited to working with medical device startups and early-stage engineering teams within larger organizations. Our flexibility, ingenuity, and experience with prototyping interventional medical devices allows us to deliver on rapid timelines with fewer iterations to success.

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Interventional Cardiology
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Structural Heart
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Coronary Intervention
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Urology & OBGYN
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Neurovascular
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Extensive in-house capabilities

Medical Braiding

Fully customizable braid constructs and reinforced shafts

  • Variable pick count
  • Reel-to-reel "braid on mandrel"
  • 304V stainless steel
  • Nitinol
  • Polymer thread & monofilament

Medical Coiling

Full-length coiled shaft reinforcement

  • Variable coil pitch
  • 304V stainless steel
  • Nitinol
  • Polymer monofilament

Catheter Lamination

Variable speed and temperature-controlled catheter reflow for complex composite shaft structures

  • Up to 6ft catheter length
  • High-throughput equipment for future scalability
  • Pebax, Nylon, Polyurethane, Heat shrink, etc.

Tipping, Shaping, Marker Bands

Custom catheter finishing per customer specifications, including custom in-house tooling

  • Custom tip-forming
  • Precision hole-punching
  • Custom shaping
  • Hot air box operations

Clean Room Assembly

ISO Class 8 qualified clean room for medical device assembly

  • Adhesives bonding
  • Finished goods capable
  • Packaging design

Balloon Blowing (coming soon)

Custom medical balloons

  • Non-compliant
  • Semi-compliant
  • Compliant
  • Necking/Pre-forming

Prototype Fabrication

Other processes needed to fabricate full interventional systems

  • Laser spot-welding
  • Stereolithography 3D printing
  • FDM 3D printing
  • CNC mill and lathe

Quality Inspection

General adherence to ISO 13485 & FDA QMSR practices

  • Design control and full DHF management
  • Material traceability, inspection, and lot history records
  • Systems in place for non-conformances, RMAs, CAPAs
1000s of Catheters Delivered

State-of-the-art catheter engineering

Get in touch

Start your catheter manufacturing journey

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