STRATEC’s Development Phases of Consumables

transforming innovative concepts

At STRATEC, we pride ourselves on being your reliable partner for innovative development and serial manufacturing solutions. With decades of experience, we specialize in creating high-quality smart consumables for in-vitro diagnostics and life science applications. Our team of experts collaborates closely with you to ensure your

designs are optimized for manufacturability, cost efficiency, and superior performance. Utilizing advanced tools and technologies, we deliver precision and reliability in every product we create. Trust STRATEC with its unparalleled expertise and dedication to support your journey from concept through to serial production.

Feasibility phase: Proof of Principle and Design Qualification Phase

The first part of the feasibility phase is the proof-of-principle phase, in which all product requirements are collected and reviewed. Critical requirements are verified through proof-of-principle manufacturing to deliver initial functional elements and feasibility parts, demonstrating that STRATEC's manufacturing processes can meet these needs. The goal of feasibility is to achieve design qualification (DQ), a key milestone in microfluidic consumable development. During the design qualification phase, product specifications are developed in collaboration between the customer and STRATEC's engineering teams. Each product requirement is linked/translated to a specification, ensuring comprehensive coverage. Tracking between requirements and specifications is documented to ensure regulatory compliance.

Prototype phase

In the prototype phase, the equipment and processes required for serial manufacturing at a later date are prepared. This includes purchasing new machines and/or product-specific tools, developing new processes, and setting up quality control. Prior to installation qualification, process window studies are conducted to understand the capabilities, risks, and interactions of production processes. These studies result in prototype parts that resemble the final product in form, fit, and function, allowing for verification against specifications. During this important prototype phase, close collaboration and communication with the customer is ongoing. This also results in prototype parts intended to ensure functionality for later applications in the in-vitro diagnostics or life sciences markets.

Pilot Production phase

The pilot production phase prepares for stable serial production. During installation qualification, initial prototype parts are made to meet specifications in line with the optimal process parameters. These pilot parts fulfill specifications without fully proven process stability. They are nevertheless typically used by our customers to qualify their assays, instruments, or any other processes needed to realize their application using our smart consumables. Operational qualification ensures that all critical processes have sufficient margin to produce functional products which meet the relevant specifications. Performance qualification ensures that select production processes are robust when confronted with expected influences, such as raw material variations or shutdown procedures. The parts manufactured during performance qualification demonstrate process stability and are viewed as the first sellable products.

Serial Production phase

Once the pilot production phase has been successfully completed, project responsibility is transferred from the project leader in Development Projects to our Lifecycle Management team. Our Lifecycle Management team handles communication with customers regarding any required changes, forecasts, and regular deliveries. This ensures that you have the best support throughout the product's lifecycle. We focus on maintaining process stability, quality control, and continuous improvement to meet your evolving needs. With keen attention to detail and proactive management, we ensure that your product consistently meets specifications and market demands.