Our R&D team has extensive experience developing concepts for a wide array of medical applications: Balloon catheters, Steerable catheters, RF catheters, Implants and delivery systems, Introducers and dilators, Nitinol components, Surgical tools, Bio-absorbable material, Silicone devices, Medical textile.
We design components, sub-assemblies or full systems utilizing the latest computer-aided tool such as Solidworks™ and other proprietary calculators, to define and specify all the elements that will be part of the product.
Short Design Cycles
We maintain a stock program of all key materials in all sizes, available on demand. This allows us to quickly iterate before settling for a design path and ordering the longer lead time items, therefore saving precious time and reducing the overall cost of the project.
Handle and Injection Mold Designs
Over the years we have developed an expertise for the design and development of catheter system handles. Our philosophy is to focus on integrated functionality, robustness, simplicity and ease of use, and ergonomic features. Having hi-res 3D-printing in house allows us to shorten the development cycles and get immediate feedback from our customer. We also work very closely with our injection molding partners in order to debug and finailize all processes before release to production.
Project Management - PDP
Every R&D project goes through the same critical milestones under the guidance of Design Control: Project Planning, Product Specifications, Hazard and Risk Analysis, Concept feasibility (Laboratory Notebooks), GMP Documentations, Test Methods and Inspection Procedures, V&V Protocols and Technical Reports, DFMEA/PFMEA, Master Validation Plan, Design and Technology Transfer Validation.
• Concept Generation
• Intellectual Property Creation
• Product Development
• Catheter Design
• Handle Design
• Packaging Design