Product development microfluidic consumables

The process

1. Project definition
First, we get to know each other. We assess the requirements of the product you need in relation to our experience and capabilities. We take time to get to know the full depth of your project, in order to deliver an outstanding product. Together, we define the project and draw up an initial project plan.

• Enlisting of requirements
• Identification of risks
• CTQ (critical-to-quality) flowdown
• Product breakdown
• Initial project plan

2. Feasibility and concept
We thoroughly think things over before we start. This prevents delays in later stages of the process. In this phase, we focus on feasibility and make an inventory of all the requirements and specifications for this project. Out of a range of possibilities, we decide upon the optimal concept.

• Functional breakdown
• Proof of concept
• Estimation of the costs per product at volume production
• Finalized cost of goods overview
• Determination of the time range

3. Development
At this point, the actual product design starts. We think ahead about scalable manufacturing processes to keep options open for future volumes. A prototype of the product is presented that, together, we test and enhance until it meets the specifications and has all the required features. Meanwhile, we start the build-up of our manufacturing process.

• Product design
• Prototyping
• Iterations
• Product verification
• Signed supply agreement

4. Handover from design to manufacturing
Now that we have a final and satisfying design at hand, let’s start production! The design and manufacturing departments work together to safeguard the quality of the final product. They make sure all processes are set when the final ‘go’ is given.

• Availability of complete technical documentation
• Process validation
• Product validation

5. Manufacturing
The design is handed over to our in-house manufacturing department. As the production is up and running, we will produce the agreed-upon volumes, following the processes that ensure the quality of your product.

• Quality checks through SPS (statistical process control)
• Working towards GMP compliance
  • Risk Management
  • Change Management
  • Traceability

• One stop shop that guarantees a smooth transfer from design to manufacturing
• a reliable, solid partner with 20+ years of experience in microtech innovations
• ISO certified, working towards GMP compliance
• Our processes are organized according to the principles of the Lean Six Sigma strategy.

Whether you are running a prototype or a full product development process with Micronit, at one time or another the question of the protection of your IP will come up. What can you expect from Micronit on this matter?

Intellectual Property (IP) Protection comprises:

• Comprehensive nondisclosure agreements to protect your IP
• Validity far past the end of the project cooperation
• Complete protection of your ideas and designs
• Secure and independent work in the Micronit’s in-house cleanroom
• Professional exchange of knowledge with the team of Micronit – ensuring utmost secrecy from the beginning