We provide high-precision injection molding manufacturing for healthcare devices that require proven processes.
Controlled environments, ISO-certified quality systems, and documented inspection protocols support consistent outcomes. We handle tight tolerances, complex geometries, and materials chosen for biocompatibility and sterilization performance.
Clients gain a single accountable partner for design reviews, first articles, bridge builds, and scaled runs. We also integrate molded parts into sub-assemblies to reduce supply chain steps and simplify downstream assembly for OEMs and startups.
Responsive project management and engineering collaboration help teams meet timelines, manage risk, and align with regulatory expectations across the industry.
Key Takeaways
- Precision manufacturing with validated processes for regulated device production.
- End-to-end support from design review to scalable runs and assemblies.
- Audited quality systems and cleanroom capability for consistent results.
- Materials and processes chosen for sterilization and clinical durability.
- Partners and certifications enable flexible tooling and global production.
Medical Plastic Injection Molding Services Tailored for High-Performance Medical Devices
Our team provides engineering-led services that move concepts from prototype to validated production. We blend expert DFM reviews, project management, and fast quoting to de-risk development and speed approvals for medical devices.
We cover plastic injection molding for rapid prototypes, bridge tools, and production intent programs. Engineering aligns design intent with manufacturing so wall transitions, gating, and critical features meet performance goals.
Advanced capabilities include overmolding, insert molding, assembly, and post-mold heat staking to combine materials and integrate metal inserts. These options reduce supplier count and deliver ready-for-integration components and sub-assemblies.
- Fast DFM feedback with material recommendations and risk mitigation.
- Traceability and documentation from first shot through sustained runs.
We support device designers with prototypes to validate changes, then transition efficiently to validated manufacturing. Our approach keeps costs predictable while protecting timelines and quality for regulated programs.
End-to-End Capabilities and Process Support
We combine design checks and iterative trials to turn complex concepts into consistent production parts.
Design for Manufacturability and Engineering Guidance
Our DFM workflow captures gate and venting strategies, draft and wall analysis, knit line mitigation, and tolerancing guidance.
Flexible Production: From Prototypes to High-Volume Programs
We run prototype and bridge molds for speed, then move to multi-cavity automated tools for high-volume production.
Iterative tool trials follow a T0/T1/T2 cadence with dimensional studies and tightened process windows to improve Cpk without harming device function.
Advanced Services and Assembly
Overmolding and insert molding combine materials and integrate metal features to boost ergonomics and strength.
Post-mold operations—heat staking, bonding, and fastening—deliver ready sub-assemblies that shorten OEM assembly time and improve supply reliability for customers.
Capacity, Global Tooling, and Precision
Presses range from 50 to 3,700+ tons and support micro features up to parts of 300 square inches.
Tooling and production options in the US and China enable balanced lead time, cost, and risk with managed tool transfer and maintenance plans.
| Capability | Typical Range | Benefits |
|---|---|---|
| Press Tonnage | 50 – 3,700+ tons | Scales from micro features to large components |
| Part Size | Micro to 300 sq in | Supports diverse device families and components |
| Tooling Options | Prototype, bridge, multi-cavity | Speed to market, then cost-effective volume runs |
| Advanced Services | Overmold, insert, assembly | Integrated components and tightened supply chains |
Quality Systems, Compliance, and Cleanroom Production
Our certified framework ties risk management, documentation, and traceability into a clear path from material receipt to final release.
Cleanroom and validation
We run ISO Class 7 and Class 8 cleanroom environments with strict particulate control and handling protocols. Incoming inspection, in-process checks, and final verification use FAI and PPAP routes with full lot traceability to resin batches, tools, and validated parameters.
Validation and change control
Process validation (IQ, OQ, PQ), gauge R&R, and documented control plans support repeatable runs and faster audits. Change control and nonconformance workflows protect device integrity and drive continuous improvement.
| Element | Coverage | Benefit |
|---|---|---|
| Quality systems | ISO 13485, ISO 9001, AS9100D | Consistent documentation, audits, and risk controls |
| Regulatory | FDA registration, 21 CFR 820 practices | Production records and CAPA aligned to audits |
| Cleanroom | ISO Class 7 / Class 8 | Lower contamination risk, improved yields |
| Inspection | FAI, PPAP, full traceability | Proven lot control and faster approvals |
Materials, Tooling Classes, and Finish Options
Selecting the correct materials, tooling class, and surface finish early reduces risk and keeps costs predictable. We match resin choice to mechanical properties, sterilization compatibility, chemical resistance, and clinical performance.
Common Materials and conditioning guidance
We work with PEEK, Ultem, Radel, PSU, ABS, polycarbonate (Lexan), Delrin, TPEs, and PEBAX to cover high-strength and flexible needs. Material conditioning, shrink rates, moisture sensitivity, and flow behavior are specified for each part to secure dimensional stability and repeatable properties.
Tooling classes and cost trade-offs
Choose tooling by forecasted volume: Class 105 for prototypes, 104 for low runs, 103 for medium volume, 102 for close-tolerance or abrasive resins, and 101 for multi-million-cycle programs.
| Tool Class | Cycles | Typical Investment |
|---|---|---|
| 105 | <500 | Aluminum ~$5k–$30k |
| 104 | <100k | Aluminum to low steel |
| 103 | <500k | Mid-range steel |
| 102–101 | <1M / >1M | Steel $15k–$100k+ |
Finishes and tool development workflow
Finish options range from SPI A-1 high polish to D-series matte, plus MoldTech textures and As-Molded surfaces to balance grip, aesthetics, and cleanability.
Our DFM/PEG tool design reports recommend gate types, parting lines, ejection strategies, venting, and cooling (including conformal where feasible). Iterative trials and disciplined maintenance protect uptime and part quality through the tool’s lifecycle.
Applications and Assembly Solutions for the Healthcare Industry
We focus on creating parts and assemblies that simplify device integration and speed assembly lines.
Core applications include lab equipment housings and user interfaces, patient monitoring components, surgical and orthopedic parts that need tight tolerances, and blood handling components with strict cleanliness demands.
Integrated assembly options
- Overmolded gaskets and insert-molded features that reduce OEM bill of materials and assembly steps.
- Durobal-style bearing sub-assemblies where molded components combine with machined elements and seals for ready-to-install units.
- Inserted metal parts and molded seals to improve permeation resistance and sealing performance.
We design parts and devices to resist common cleaning agents and to tolerate validated sterilization methods. DFMA principles guide datum strategies, snap-fit optimization, and tolerance stack-up control to improve line yield and reduce rework.
Traceability and clean handling are enforced from resin lot through final assembly to support regulatory submissions and post-market quality monitoring. Pilot runs and design iterations validate fit, sealing, and durability before full-scale manufacturing.
Conclusion
We combine traceable workflows and global tooling options to turn concepts into reliable products. Certified systems, ISO Class 7/8 cleanroom control, and documented DFM/PEG reviews support repeatable injection molding and verified process windows.
Our services cover material selection for clinical properties, tooling from prototype to high-cavitation classes, and inspection plans such as FAI and PPAP to meet standards and program requirements. That focus ensures each part meets manufacturability, safety, and performance goals across device applications.
With a broad materials range tuned for sterilization and chemical exposure, plus US and China production options, we compress timelines and reduce risk. Contact us for a technical review and DFM feedback to find the fastest path from concept to validated production with consistent quality.
