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In the competitive world of additive manufacturing (AM), quality assurance is not simply a regulatory checkbox — it’s a defining element of customer trust, operational efficiency and market success. For orthopedic manufacturers in the highly regulated medical device industry, the ability to monitor and validate every stage of the AM process with precision is critical. Traditional process monitoring methods, including ASTM E8 tensile test bars, fall short in their sensitivity, efficiency and correlation to in-situ process variables. Overcoming these shortcomings, the patent pending SpiTrex 3D Enhanced E8 TM Tensile Artifact (Enhanced E8) offers a transformative advantage for AM process monitoring.
With the Enhanced E8, SpiTrex 3D can certify the mechanical and dimensional integrity of an entire build of 3D-printed medical devices without the need to destructively test or fully dimensionally inspect the parts themselves. This provides superior confidence for releasing product directly to customers, or to the specialized sites within the SpiTrex Orthopedics family for additional processing — SpiTrex CTE, SpiTrex MDI and SpiTrex Switzerland — each of which specializes in their own area of complex machining, surface finishes, compression molding, packaging and sterilization. Regardless of part destination, the Enhanced E8 enables a cost-effective, traceable and scalable quality pathway.
Engineered for maximum sensitivity, dimensional repeatability and statistical traceability, the Enhanced E8 Tensile Artifact redefined how SpiTrex 3D monitors the AM process. By providing mechanical and dimensional feedback that is both direct and representative of the printed environment, the Enhanced E8 is more than a test coupon — it becomes a strategic tool that delivers measurable competitive advantages across design, production, validation and compliance.
1. Superior Sensitivity to Process Variations. Traditional solid tensile bars offer limited sensitivity to subtle variations in energy input, material chemistry or environmental stability. Conversely, the Enhanced E8 is specifically designed to amplify small deviations in key AM variables. Its thin-walled gage region and internal hollow cannulation maximize surface area-to-volume ratio, turning minor shifts in variables such as laser power, scan movements or argon flow into measurable mechanical responses.
Supported by empirical data, the Enhanced E8 demonstrates a significantly higher detection of strength variations across AM variables, including Energy Density ranges, compared to standard solid bars. This responsiveness allows SpiTrex 3D to identify potential process drifts before they could affect actual components, turning the Enhanced E8 into an early warning system for production quality.
2. Native Surface Retention for True As-Built Evaluation. Conventional test artifacts are typically machined post-printing to meet geometric tolerances for testing. However, machining alters or eliminates the very surface features that capture rich process-related information, such as thermal artifacts, re-coater disturbances or soot accumulation.
The Enhanced E8 is tested as-printed, retaining native surface characteristics on both its internal and external surfaces; these act as sensors for build condition anomalies, reacting mechanically to factors like surface roughness caused by suboptimal gas flow or laser scatter. This is especially critical in powder bed fusion environments, where atmospheric and optical integrity can vary over time.
By representing actual print conditions, the Enhanced E8 enables true process monitoring, not just material validation.
3. Multi-Axis Dimensional Monitoring and Statistical Process Control. Beyond mechanical validation, the Enhanced E8 Artifact is engineered for high-precision dimensional inspection across all three build axes (X, Y and Z). The end sections of the coupon feature inspection flats and clocking features, enabling automated measurement and alignment using no touch vision measurement systems.
The defined geometry and repeatable orientation allow reliable detection of any dimensional changes due to drift in machine or material variables. This forms the basis for dimensional Control Charts, enabling proactive equipment maintenance and process tuning. Thus, historical data can be used to identify trends, assign root causes and validate the ongoing stability of both primary and secondary process systems.
4. Statistical Quality Framework (Six Sigma Integration). The Enhanced E8 additionally functions as a statistical tool. Tensile data from each build is plotted against established control and warning limits, with typical thresholds set at standard deviation intervals. Moving range and full range metrics are used to evaluate intra- and inter-build variation, offering clear insight into both short-term noise and long-term drift.
This data structure aligns perfectly with Six Sigma quality programs, which prioritize early detection, continuous improvement and quantifiable confidence in manufacturing processes. For rigorous supplier audits and FDA inspections, the ability to show a statistically controlled quality program using the Enhanced E8 is a key differentiator.
5. Optimized Equipment Qualifications and Re-Qualifications. AM equipment in regulated industries must pass stringent IQ/OQ/PQ requirements, for which the Enhanced E8 is ideally suited. Its combination of dimensional and mechanical sensitivity has allowed SpiTrex 3D to demonstrate equipment readiness, detect anomalies and validate processes with a high degree of statistical confidence.
Unlike ad hoc or lab-specific artifacts, the Enhanced E8 has become a repeatable, standardized and precise method for verifying machine performance at installation, after maintenance or during qualification of new print settings. This translates to faster deployment, improved customer audit readiness and reduced regulatory friction.
6. Reduced Cost and Time per Qualification Cycle. Every quality validation cycle comes with overhead, such as sample printing, machining, inspection and data processing. By integrating the Enhanced E8 as a component of standard builds, SpiTrex 3D reduces the need for separately machined test bars and minimizes time required to reach lot pass/fail determinations.
Furthermore, the direct tensile force measurement, automation-friendly geometry and elimination of post-machining reduces labor costs, resulting in leaner QA cycles with lower cost per test, faster release and improved scalability.
7. Enhanced Customer Confidence and Differentiation. In a competitive landscape where customers demand transparency and traceability, our patent pending, statistically controlled process monitor has become a strategic asset.
Our customers gain confidence knowing that each build includes test artifacts capable of detecting process deviations that would be invisible to standard test bars. When audits or technical validations are required, presenting statistical charts based on the Enhanced E8 data demonstrates quality maturity and operational excellence, granting our customers confidence in the long-term process stability.
8. Intellectual Property and Market Exclusivity. The SpiTrex 3D Enhanced E8 Tensile Artifact is protected under U.S. patent law, offering exclusivity and protection from commoditization. This intellectual property serves to reinforce the unique value proposition offered by SpiTrex 3D to our customers.
Where many service providers rely on generic QA protocols, the ability to integrate a proprietary process monitoring artifact, reviewed and accepted by FDA and other regulatory bodies, into customer programs provides strong differentiation.
Smart Solution
The SpiTrex 3D Enhanced E8 Tensile Artifact represents a leap forward in AM quality assurance. Its combination of mechanical sensitivity, dimensional repeatability and statistical traceability creates a distinct competitive advantage for our company and our broader organization.
By replacing traditional solid tensile bars with the Enhanced E8, SpiTrex 3D can detect process drift earlier, reduce time and cost for qualification and ongoing production, enhance compliance confidence and demonstrate manufacturing excellence to customers and regulators alike.
In a market that values innovation and accountability, the Enhanced E8 isn’t just a better test coupon — it’s a smarter strategy.
Nick M. Cordaro is the President of SpiTrex 3D
