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
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
- 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
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