PT&C specializes in rapid prototyping tailored for the highly specialized field of implantable and interventional medical devices. Our service ensures prototypes are delivered with unmatched speed, precision, and adherence to medical standards, helping innovators accelerate development cycles.
Advanced manufacturing technology enables the production of prototypes with fast turnaround times while maintaining exacting precision.
Our expert engineers collaborate closely with clients, ensuring all components are optimized for their intended application.
Designs are validated against the stringent demands of the medical device industry.
Prototypes undergo thorough testing to confirm compliance with both client specifications and regulatory standards.
Performance metrics such as durability and biocompatibility are key focuses during inspections.
We offer a broad selection of biocompatible materials, ranging from advanced polymers to medical-grade metals.
Material recommendations are based on the prototype’s intended use and performance requirements.
Detailed discussions to understand specifications, materials, and performance goals.
Creation of technical blueprints and validation with the client.
Recommendation and procurement of biocompatible, medical-grade materials.
Precision fabrication using tools like CNC machining to create prototypes aligned with designs.
Dimensional and visual checks to ensure the sample adheres to design parameters.
Physical and chemical assessments, including tensile and pressure tests, to verify reliability.
Iterative refinement based on test outcomes.
Client reviews and validates the prototype's compliance with requirements.
Transition to full-scale production upon final approval.
What materials do you use for prototyping medical catheters, and how do you ensure their biocompatibility?
We use biocompatible materials such as stainless steel, polyurethane, PEEK, silicone, and PTFE, depending on the catheter’s intended application. Biocompatibility is ensured by adhering to ISO 10993 standards and conducting tests for cytotoxicity, sensitization, and other biological interactions to confirm safety for medical use.
How quickly can you turn around a prototype once we've provided the specifications?
Our rapid prototyping services typically deliver a functional prototype within 1-2 weeks after receiving finalized specifications. Turnaround time may vary slightly depending on the complexity of the design and material requirements.
What kind of quality control measures do you have in place for the prototyping process?
Our quality control system includes:
1. Dimensional Accuracy Checks: Ensuring precise adherence to the design specifications.
2. Visual Inspections: Identifying any surface or structural defects.
3. Performance Testing: Verifying tensile strength, flexibility, and pressure resistance against medical standards.
4. Compliance Audits: Confirming adherence to regulatory guidelines like ISO and FDA standards.
Can you accommodate custom design requests for specialized catheter features?
Absolutely! We specialize in custom solutions. Our engineers work collaboratively to develop prototypes with tailored features such as unique lumen configurations, tip shapes, or coatings. This ensures your prototype aligns perfectly with your application requirements.
What happens if the prototype doesn't meet our expectations in the first iteration?
If the initial prototype falls short of expectations, we’ll promptly address your feedback and revise the design or manufacturing process. Prototyping often requires iteration, and we are committed to delivering a solution that fully satisfies your needs.
For more detailed inquiries, feel free to contact us. Our team is ready to assist with all aspects of your medical device prototyping needs!
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