Choosing STRATEC for your development and serial production means partnering with a leader in consumables manufacturing for the in-vitro diagnostics and life sciences industries. Our extensive experience and innovative solutions ensure your products are designed for optimal manufacturability, cost efficiency, and high performance. We draw on advanced processes, ranging from mastering, injection molding, coating, bonding, and content filling to semi/fully-automated assembly.
Our state-of-the-art manufacturing facilities and stringent quality control processes guarantee precision and reliability in every product. By collaborating closely with our expert team, you gain access to tailored workshops, early-stage prototyping, development and serial manufacturing, as well as benefiting from comprehensive support throughout your project’s lifecycle. Trust STRATEC to transform your vision into a successful, scalable reality.
Partner with STRATEC and experience the power of proven technology, accelerated innovation, and unwavering commitment to your success.
DESIGN FOR MANUFACTURING
Unlocking the full potential of your design
Improved Quality
Simplified designs are less prone to errors, leading to higher-quality products
Cost Reduction
By minimizing complexity and using standard components, production costs can be significantly reduced
Faster Time-to-Market
Products designed with manufacturing in mind can move through the production process more quickly
Design for manufacturing is crucial to your product’s success. It defines the selection of potential manufacturing strategies and is therefore a key driver of product cost, quality, and time to market. At STRATEC, our expert engineers review your designs, identify critical features, and suggest targeted modifications to ensure robust and efficient manufacturing. To support you early in the development process – or to unlock cost reduction potential in existing products – we offer specialized, customer-specific workshops focused on design for manufacturing. In these sessions, we work with you to optimize key aspects of your design:
Simplification: Minimize the number of parts to reduce assembly time and enable cost-effective production.
Standardization: Use standard components and materials to reduce costs and simplify inventory management.
Ease of assembly: Design semi-finished parts to ensure proper alignment and high reliability in subsequent assembly processes.
Material selection: Choose materials that meet your requirements and are well suited for processing.
Tolerance and fit: Define tolerances that are achievable with standard manufacturing processes.
Manufacturing steps: Select manufacturing technologies and quality control processes that best match your requirements and tolerances
Our expertise spans mastering, molding, coating, content loading, assembly, automation, quality control, and more, ensuring your product meets the highest standards. In collaboration with our engineers, our sales team will provide initial feedback on your request within a few working days. Based on your needs, we will propose the most suitable next steps – such as a design review call, a dedicated workshop, or the involvement of our specialist departments.
Together, we can successfully bring your product to market.
EARLY STAGE PROTOTYPING
Transforming innovative ideas into first proofs of principle
Today, many development projects for life science and in-vitro diagnostic applications have a need for early prototyping and a requirement for high quality micro and/or nanostructures. Quality is of the utmost importance, but so is the choice of an appropriate design and materials to facilitate mass manufacturing at a later stage. In view of this, the early involvement of injection molding companies like STRATEC is becoming an ever more important
factor to ensure a smooth transition from early prototypes to mass manufacturing later on. Of course, the regulatory documentation requirements for in vitro diagnostic devices render time and cost-efficient early prototyping almost impossible. To broach this issue, STRATEC now offers high-quality early prototyping, which is unencumbered by the need for full regulatory oversight.
Reliable Prototyping
All processes used, including mastering, molding, coating, bonding and assembly, are well within our know-how
Smooth Transfer
Typical issues when transferring from other prototyping techniques such as PDMS and/or printing or hot embossing to development and serial production are avoided
Drives Innovation
Our Protowerk uses standard processes and is also able to innovate in areas such as testing new materials, bonding methods, or coatings
Example of Protowerk
In the large majority of cases, we suggest working with a disc format so that our mastering and injection molding techniques create parts with this initial format. To accommodate your required footprint for the microfluidic chip, milling is the prototyping method of choice, generating the outer contour and through holes for your fluid connectors. Depending on the requirements of your application, we use solvent bonding, laser welding or PSA to create your fluidic device.
Different types of connectors are available to interface with your test setup, ranging from standard luer locks to STRATEC specific inlets. Applying these processes has achieved high-quality flowcells containing microwells – in this case, our customers successfully implemented their cell-sorting platform!
Providing an early-stage prototype can mark the beginning of a fruitful long-term collaboration with STRATEC! Our customers then typically need time to test the application and raise funds for the next development steps. We would be very pleased to support this phase with our expertise. Here, we can provide you with the data and facts you need for your business case, such as part price calculations, investment costs including planned workflow, and development effort. We would also be glad to support you with our extensive network of connections, putting you in touch with large diagnostic companies or investors – should this be of interest to you.
Returning to our customer case example: Our customer is currently applying for funds using our microfluidic device as a prototype for investor demonstrations. We wish them every success for the funding round and hope to continue the development work soon in our Development group!
Development Phases
cover the entire development lifecycle
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.
WHY STRATEC
Unlocking Innovation with Proven Technology and Expertise
Manufacturing knowhow for Faster, Safer Development of Cost-Effective Consumables
Expertise Across the Spectrum from Manufacturing and Material Science to Regulatory compliance
Streamlining Development and Beyond
Frequently Asked Questions
- What is Protowerk and how does it fit into the collaboration process?
Protowerk offers a unique and flexible entry point for initiating collaboration with STRATEC Consumables. It enables early-stage activities such as material evaluations, mastering, molding, bonding, coating tests, and content loading using existing STRATEC Consumables tooling and infrastructure.
The approach combines flexible prototyping methods — for example dicing to achieve the required footprint — with processes that are already comparable to later serial manufacturing. This allows rapid feasibility assessment and prototype development while minimizing the need for dedicated tooling and high upfront investments during the early research and development phase, yet still meeting the required application needs and specifications.
- What are the typical timelines involved when working with Protowerk?
Simple activities such as content loading tests or material evaluations — for example providing COP-based flow cells or slides — can typically be realized within a few working days. A more comprehensive dedicated prototyping run, including mastering, molding, bonding, coating, and assembly, is typically completed within approximately three months.
- What is the advantage of STRATEC’s prototyping approach?
The approach combines early feasibility testing with scalable manufacturing processes, enabling fast iteration while ensuring compatibility with later industrial production without requiring significant early tooling investments.
- What happens after Proof of Principle has been demonstrated?
Once PoP is successful, the project transitions into a structured development phase with defined stage gates. Here, design refinement, manufacturability assessment, and process development are progressively introduced.
- How is the transition from prototype to scalable manufacturing managed?
The transition follows a stage-gate approach where each development step (PoP → prototype → pilot → industrialization) must meet defined technical and manufacturing criteria before moving forward. This ensures robustness and scalability of the final product.
- How is risk minimized during development?
Risk is reduced by using iterative project reviews combined with early use of production-relevant materials and processes. This ensures that design decisions are validated stepwise before investing in full-scale tooling and automation.
- Do you have examples of successful development projects?
Yes. STRATEC Consumables has successfully demonstrated that product development is one of its core competencies and has realized successful manufacturing solutions for numerous customers. Application notes and project examples can be found here.
Several products developed together with customers have been successfully established on the market for more than 10 years, including applications such as the MALDI Target for bioMérieux and solutions for Unchained Labs. This demonstrates STRATEC Consumables’ long-term commitment to stable, reliable manufacturing and continuous customer support starting early on in development throughout the product lifecycle.
Development
Maximilian Pitzek, Deputy Head of Project Management
Yasaman Salajegheh, Teamlead Feasibility Projects
Georg Renk, Teamlead Development Projects
