Our 7-Phase Approach

Flexan New Product Introduction processes cover a range of items, including molded and extruded products, components and finished medical devices, and even the equipment and processes employed by Flexan. For the benefit of our customers, we adhere to a strict seven-phase approach that eliminates inefficiencies, errors and missteps while maximizing predictability.

Phase I: Concept

We begin by determining overall manufacturing feasibility of your new product.

Phase II: Quotation

Once feasibility is determined, we develop a customized quote for the manufacturing services of your product, including all custom tooling, engineering and validation requirements.

Phase III: Contract Review

In this phase we oversee formal acceptance of the purchase order, reviewing all contract terms and conditions to ensure we are aligned with your expectations.

Phase IV: Manufacturing Transfer

We receive all relevant design details and documents (including prints, specifications, regulatory filing requirements, audits, etc.) to ensure we can comply with your complete product design requirements and expectations.

Phase V: Process Design/Verification

This phase describes the efforts of our cross-functional teams to design the tools, equipment and processes to manufacture to your specifications.

Phase VI: Process Validation

This critical step includes a robust IQ/OQ/PQ methodology to ensure that our production processes can achieve your process capability requirements. Validation includes all manufacturing equipment and/or manufacturing processes as well as for other elements, including facilities, software and special processes such as sterilization.

Phase VII: Production

In this final stage all manufacturing processes are confirmed and transferred from development status to locked production status, ensuring stability and consistency in all future production orders.