Technical Brief: Rapid Prototyping of a Critical Medical Device Assembly Using 5-Axis Machining
Manufyn partnered with a medical device manufacturer to rapidly validate a complex, multi-part medical assembly without early investment in injection molding tools. The assembly comprised six interdependent components manufactured from medical-grade polymers, including PEEK, requiring high dimensional accuracy and flawless fit.
Key Technical Highlights:
Advanced Machining Strategy: 5-axis CNC machining enabled single-setup manufacturing of complex PEEK components, eliminating re-clamping errors and preserving critical positional and angular relationships across features.
Material Control: Optimized tool paths and cutting parameters ensured dimensional stability and material integrity during PEEK machining, minimizing heat buildup and internal stress.
Integrated Manufacturing: A hybrid approach combining 5-axis machining, VMC operations, and CNC turning ensured precision across complex, planar, and cylindrical features.
Quality Assurance: In-process inspections, full dimensional reports, and material traceability supported production-level validation.
Outcome: The complete assembly was delivered and validated within 10 days, de-risking tooling decisions and accelerating the path to mass production.
How Manufyn enabled production-level validation of a complex medical assembly without early tooling investment
Client Overview
A domestic medical device manufacturing company was developing a critical product assembly intended for medical use, where fit, function, and dimensional integrity were of paramount importance. Before committing to high-cost injection molding tools for mass production, the client wanted to validate the complete assembly through rapid prototyping under real-world operating conditions.
The assembly consisted of six interdependent components manufactured from multiple medical-grade polymers, including high-performance PEEK. Given the complexity of the geometry, the critical nature of the application, and the aggressive development timeline, the client approached Manufyn to manufacture these components with production-level accuracy, complete quality documentation, and rapid turnaround.
Product Complexity and Engineering Challenges
The product design presented significant engineering challenges that could not be addressed using conventional prototyping methods.
The geometry involved:
- Multiple curved profiles and undercut-like features that required multi-directional machining.
- Tight positional and angular tolerances critical to assembly performance.
- Several mating interfaces where even minor dimensional deviation could affect fit and function.
- Internal features that were not accessible through standard 3-axis machining approaches.
Three of the six components were specified in PEEK, a high-performance polymer known for its strength, temperature resistance, and dimensional stability. However, PEEK is also challenging to machine due to heat generation, internal stress sensitivity, and accelerated tool wear. Achieving consistent accuracy across multiple planes and orientations made 5-axis machining a necessity rather than a preference.
Why 5-Axis Machining Was Critical
Single-Setup Accuracy
Manufyn deployed 5-axis CNC machining to manufacture the most complex PEEK components in a single setup. This approach eliminated multiple re-clamping operations that could have introduced cumulative positional and angular errors. Maintaining precise geometric relationships between critical features was essential to ensure correct fit and smooth assembly of the medical device.
Complex Surface and Angular Feature Machining
The product design included contoured surfaces, angled blades, and intersecting geometries that required simultaneous movement across multiple axes. 5-axis machining enabled continuous tool engagement, which ensured:
- Uniform surface finish across curved and angled profiles.
- Accurate blade and edge geometries.
- Precise angular control between mating features.
- Smooth transitions between intersecting surfaces.
These characteristics were essential for functional performance, repeatability, and assembly consistency.
Material Integrity in PEEK Machining
Machining PEEK requires strict control of cutting parameters to avoid internal stress, melting, or deformation. Through 5-axis machining, Manufyn optimized tool paths to maintain constant chip load and controlled heat generation. This ensured dimensional stability while preserving the mechanical and thermal properties of the PEEK components.
Integrated Machining Strategy
To complement 5-axis machining, Manufyn implemented a hybrid machining strategy, selecting the most appropriate process for each component while maintaining overall assembly accuracy.
- 5-axis CNC machining was used for complex PEEK components with multi-directional features.
- Torson VMC machining was deployed for precision-milled features, flatness control, and secondary operations.
- CNC turning and lathe operations were used for cylindrical and concentric features requiring tight runout control.
This integrated approach ensured that each part met its individual requirements while aligning perfectly at the assembly level.
Quality Control and Inspection at Every Stage
Given the medical application, quality assurance was treated as a core deliverable rather than a final checkpoint.
- In-process inspections were conducted after every critical machining stage.
- Dimensional verification was carried out for all functional and mating features.
- Detailed inspection reports were prepared for each individual component.
- Material Test Reports (MTRs) were provided for PEEK, HDPE, and PP raw materials.
This step-by-step inspection framework ensured full traceability and provided the client with complete confidence in both the manufacturing process and the final output.
Project Outcome
The project achieved all development objectives within a highly compressed timeline.
- All six components were successfully manufactured and assembled.
- Fit and function were validated without developing injection molding tools.
- Complex geometries were achieved with high precision using 5-axis machining.
- Complete inspection and material documentation was delivered.
- The entire project was completed within just 10 days.
Value Delivered by Manufyn
- Rapid validation of a critical medical device design.
- Elimination of early-stage tooling risk and associated cost.
- Production-like accuracy achieved through advanced 5-axis machining.
- High-confidence transition pathway to mass production tooling.
Manufyn’s Value Proposition
This project demonstrates Manufyn’s deep capability in handling critical medical components using advanced 5-axis machining and rapid prototyping.
- Manufyn combined precision engineering with material expertise to machine challenging polymers like PEEK reliably.
- Single-setup 5-axis machining ensured geometric accuracy and assembly integrity.
- A hybrid CNC strategy optimized both precision and efficiency across all components.
- Rigorous quality control and documentation aligned with medical industry expectations.
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