Mechanical Engineering

OTHER SERVICES

Capabilities

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Design from concept through V&V to design transfer
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3D CAD Modeling
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Iterative Prototyping
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Mechanical Test Design & Data Analysis
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GD&T & Tolerance Stack-Up
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Material Science - Manufacturing Biocompatibility
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DFM & CM Collaboration
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DHF Assembly & Maintenance
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Packaging

G8WAY transforms concepts into manufacturable products, handling design through V&V, prototyping, and design transfer. We combine 3D CAD, mechanical testing, GD&T, and material expertise to ensure performance, manufacturability, and biocompatibility.

Case Study

Test Strategy & Protocols

Problem

A global MedTech organization was advancing a new surgical device through Phase 5 of its NPD process. The program required a comprehensive test strategy and execution of verification and validation (V&V) protocols to ensure compliance, reliability, and readiness for commercialization. With aggressive timelines and multiple global markets involved, the organization needed specialized engineering support to plan, develop, and execute test protocols while aligning with internal QMS and processes.

Solution

G8Way Services was engaged to provide engineering leadership and technical expertise. The G8Way team collaborated directly with the customer’s NPD team and test lab to:

  • Develop the overall test strategy and define sample size requirements.
  • Create and refine test methods in partnership with the internal lab and core team.
  • Verify test equipment appropriateness and align with quality standards.
  • Oversee submission, execution, and completion of test protocols, including managing corrective actions and compiling final test summaries.

By embedding within the customer’s workflows, G8Way enabled efficient planning, timely reviews, and systematic execution, while ensuring all deliverables were aligned to QMS and project milestones.

Results

Through structured methodology and close collaboration, G8Way delivered a fully developed test strategy and executed critical V&V protocols that supported key NPD phase exits. This accelerated readiness for commercialization of the new device across multiple markets. By leveraging G8Way’s subject matter expertise and project leadership, the customer enhanced testing efficiency, mitigated risks related to equipment and scope changes, and achieved project objectives within the planned extension timeline.

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