Implementation and Future Considerations
Getting your silicone molded product to market takes planning, risk mitigation, and long-term foresight.
You’ll need to align manufacturing with regulatory expectations, implement controls that catch issues early, and monitor processes to ensure lasting compliance.
With molding equipment ranging from 11 tons to 240 tons, we can find the right process to fit your project within our molding abilities:
- Shot size capabilities from 0.5ccm to 180 ccm
- LSR materials from 10 to 80 durometer (Type A)
- HCR materials from 20 to 80 durometer (Type A)
- Regulatory support from long term implantable to aerospace component applications
Planning, Execution & Future Opportunities
Manufacturing silicone components successfully hinges on thoughtful preparation. Start by thoroughly evaluating design, material compatibility, and required tolerances. Use prototype molding to validate early assumptions and inform full-scale production.
Ongoing quality and regulatory support make it possible to scale confidently while staying compliant in evolving markets.
Some crucial steps to ensure success are:
- Assessing compatibility with your device requirements
- Optimizing manufacturing processes for efficiency and precision
- Implementing rigorous quality control protocols
- Using prototype molding for validation
- Maintaining ongoing regulatory support
With the right strategy, you’ll have a successful launch while remaining prepared for future regulatory shifts and product evolution.
Conclusion
Manufacturing silicone medical device components demands more than technical capability—it requires proven processes, regulatory fluency, and deep material expertise. ProMed supports every stage of development with robust quality systems, precise engineering, and documentation aligned to ISO 13485 and FDA requirements. By investing in the right partnership early, you set a foundation for smoother validation, scalable production, and safer outcomes in the hands of patients.
Frequently Asked Questions:
Can ProMed Assist With Regulatory Submissions and Documentation?
Yes, within the limits of what a component manufacturer can provide. ProMed supports regulatory submissions through a robust quality management system and a strong understanding of FDA and ISO 13485 standards. Our team helps generate and organize essential documentation, such as validation protocols, material certifications, and lot traceability documentation, to minimize your quality and regulatory burden.
What Are the Minimum Order Requirements for Custom Silicone Parts?
Order volumes are based on your project’s complexity, regulatory needs, and commercial strategy. Whether you need early-stage prototypes or complete production runs, we tailor our batch sizes to meet your manufacturing and compliance objectives.
Are Prototypes Available Before Committing to Full Production?
Yes, ProMed offers prototype development before committing to large-scale production. Prototypes are manufactured using validated materials and precise molding techniques, allowing teams to verify fit, function, and regulatory compliance early in the process. This reduces risk and provides a clear path to full commercialization.