Medical Injection Molding Capabilities
Integrated medical injection molding, LSR molding, injection mold tooling, cleanroom production, validation, and molded-part finishing.
Medical Injection Molding & LSR Solutions
The medical device industry continues to evolve rapidly, with technological advancements driving increased demand for precision, customization, and biocompatibility in components.
As healthcare providers seek more effective diagnostic and treatment options, medical device manufacturers require manufacturing partners who understand the unique challenges of this highly regulated industry.
- ISO 13485 scope reviewed for the selected production site
- Quality-system scope matched to the selected production site
- DFM and product validation
- Real-time Process Tracking System
- One-stop service for manufacturing, finishing and logistics
Why Choose FECISION for Medical Manufacturing?
Strict Quality Control
Robust quality control processes ensure every part meets strict standards for accuracy, consistency, and reliability.
Medical-Grade Resin Expertise
Support for engineering thermoplastics, transparent medical resins, elastomers, PEEK, and LSR selected around sterilization and device requirements.
Complex Molded-Part Solutions
Injection molding solutions for complex geometries, tight tolerances, inserts, seals, micro-features, and specialized molded-part finishes.
Mold Trial & Scalable Production
Controlled mold trials and qualified processes support first articles, validation lots, and high-volume medical device production.
Integrated Injection Molding Program
DFM, injection mold tooling, cleanroom or LSR molding, validation, traceability, finishing, and assembly are coordinated as one program.
Medical Manufacturing Expertise
At FECISION, we understand the critical importance of precision and reliability in medical device manufacturing.
The selected manufacturing partner and its quality-system scope are reviewed for the component, material, process and documentation required by your program.
Medical Mold Tooling
Custom-designed molds for complex medical components with tight tolerances
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Cleanroom Injection Molding
Controlled molding for qualified medical plastic and LSR component programs
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Medical Injection Molding
Production of biocompatible plastic components for medical applications
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Medical LSR Parts
LSR molded components with production environment and documentation reviewed for the medical application
See MoreMedical-Grade Plastics at a Glance
| Material | Properties | Applications | Sterilization Methods |
|---|---|---|---|
| Medical-Grade LSR | Biocompatible, flexible, temperature resistant | Seals, gaskets, tubing connectors | Autoclave, Gamma, ETO |
| PEEK | High strength, chemical resistant, radiopaque | Implantable components, surgical instruments | Autoclave, Gamma, Steam |
| PPS (Ryton) | High temperature, chemical resistant | Autoclavable components, sterilization trays | Autoclave, Steam |
| PEI (Ultem) | High heat resistance, sterilizable, transparent | Medical housings, sterilization containers | Autoclave, Steam, ETO |
| PC (Polycarbonate) | Transparent, impact resistant, sterilizable | Fluid chambers, viewing windows | ETO, Gamma (limited) |
| PP (Polypropylene) | Chemical resistant, low cost, sterilizable | Disposable components, packaging | Autoclave, Gamma, ETO |
Medical-Grade Injection Molding Capabilities
FECISION coordinates plastic and LSR component molding through manufacturing partners. The intended medical application determines material selection, contamination controls, inspection and any validation work. Cleanroom molding alone does not establish sterility or product approval.
Our Medical Molding Expertise Includes:
- Production-Site Quality System — Applicable ISO 13485 manufacturing scope reviewed per project
- Controlled-Environment Manufacturing — Required class, operating state and supporting report reviewed per project
- LSR Silicone Molding — Medical-grade liquid silicone rubber for seals, gaskets, and components
- High-Temperature Engineering Plastics — PEEK, PPS, PEI (Ultem) for sterilization-resistant parts
- Tight Tolerance Precision — Dimensional accuracy to ±0.005mm for critical components
- Full Traceability — Lot tracking, material certificates, and comprehensive documentation
Medical Manufacturing from Prototype to Production
Fecision offers a highly efficient and simplified supply chain solution. Whether you're in the stage of creating prototypes, moving on to test units, initiating mass-production, or dealing with subsequent phases, Fecision has got you covered.
Prototype
- For the purpose of validating your materials and designs, get prototypes that come as close as feasible to your final design.
Material Selection
Choose materials that closely mimic the properties of those intended for the final product testing and validation.
Functionality Testing
- Comprehensive functionality testing on the prototype
- Identify any flaws or areas for improvement in the design
Precision in Manufacturing
Ensure high-precision manufacturing processes to replicate the exact dimensions and features of the final design.
Applications in Medical Industry
Our precision manufacturing capabilities serve diverse medical applications:
Surgical Instruments
- Minimally invasive surgical tools
- Endoscopic device components
- Surgical stapling device parts
- Electrosurgical instrument components
- Robotic surgery system components
Diagnostic Equipment
- Medical imaging device housings
- Point-of-care testing device parts
- Laboratory diagnostic equipment parts
- Patient monitoring device components
- Medical sensor housings and fixtures
Implantable Devices
- Orthopedic implant components
- Cardiovascular device parts
- Neurological implant housings
- Drug delivery system components
- Dental implant components
Medical Wearables
- Wearable monitoring device housings
- Drug delivery device components
- Patient compliance monitoring systems
- Rehabilitation device components
- Remote patient monitoring systems
Production-Site ISO 13485 Scope
Reviewing the selected site and covered component-manufacturing activities
Application Requirements
Material, intended use and required validation reviewed for the project
Clean Room Manufacturing
Class 8 clean room facilities for critical medical components
Quality Assurance for Medical Manufacturing
Quality is paramount in medical device manufacturing
Validation Processes
Verification of component performance under simulated conditions
Material Traceability
Complete documentation and traceability for all medical materials
First Article Inspection
Comprehensive verification of initial production parts
Biocompatibility Testing
Coordination with certified testing laboratories for material biocompatibility
Medical Manufacturing Case Studies
Minimally Invasive Surgical Instrument
We developed precision components for a next-generation minimally invasive surgical instrument, meeting tight tolerances and biocompatibility requirements while reducing assembly complexity by 30%.
Diagnostic Testing Device
Our team manufactured critical components for a point-of-care diagnostic testing device, delivering parts with exceptional consistency and reliability for accurate test results.
Implantable Medical Device
FECISION produced high-precision components for an implantable medical device, utilizing biocompatible materials and clean room manufacturing to ensure patient safety and device longevity.
Our team of experienced engineers and manufacturing specialists will work closely with you to develop custom solutions that meet your specific requirements and regulatory standards. From prototype to production, FECISION ensures medical components with the precision, quality, and reliability that the industry demands.
Request a Medical Injection Molding Quote
Tell us about your project. Our engineering team will review your requirements and provide DFM feedback.
Injection Molding by Industry
Explore injection molding and injection mold tooling capabilities for automotive, aerospace, electronics, robotics, and industrial applications.
