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Pre-production Prototypes

Close-up view of a person's hands connecting a cable to a round electronic device labeled "FLO by ITL." Behind the device, two computer screens display 3D CAD models of the same product, confirming the physical prototype's match with the digital design. The setup appears to be part of a product development or engineering workstation.

Bridging Design and Full-Scale Manufacture

At G&H, the Pre-Production Prototype phase provides critical validation between the design improvement stage and formal manufacturing.

This stage confirms that every element - from supplier materials to assembly workflows - performs as intended in a controlled, production-simulated environment. Building pre-production prototypes enables us to identify and mitigate risk early, ensuring your medical device or instrument is fully ready for verification and validation builds.

Supplier and Process Readiness

Before prototype manufacture begins, our Supply Chain and Production Engineering teams conduct comprehensive readiness checks to ensure all approved materials and suppliers meet G&H’s quality and performance standards. Activities include:

  • Supplier Commodity Selection – reviewed under ITL's Supplier Monitoring Procedure to confirm material capability.
  • Approved Vendor List (AVL) Review – maintained and updated per ITL’s Vendor Approval Process and Supplier Evaluation Policy.
  • Supplier Risk Management – monitored through monthly performance scorecards evaluating quality, on-time delivery, and responsiveness.
  • Material Verification – confirming all components meet specification and compliance requirements before production sampling.

Prototype Manufacture

Pre-production prototypes are built by Production Engineering, supported by subject matter experts from R&D or the Legal Manufacturer. Each build simulates the conditions of full production – creating assembly instructions, tooling, and inspection methods. This approach confirms that the design can be manufactured reliably.

Even if your device has been previously manufactured elsewhere, a controlled pre-production prototype phase is required to confirm alignment with our processes, quality, and regulatory systems.

Outcome and Benefits

  • Verified design manufacturability under real production conditions.
  • Supplier and material readiness confirmed through documented processes.
  • Risk mitigation and early detection of potential assembly or tooling issues.
  • Optimized Design Master Record (DMR) and repeatable build documentation.
  • Shortened timeline to verification manufacture and regulatory submission.

By validating the complete build process before scale-up, G&H helps customers transition confidently from design to verified production.

Next Step: Verification Manufacture

G&H NPI Services