4. SUCCESSFUL INDUSTRIALIZATION
OF A NEW PRODUCT

Ensuring succesful industrialisation of a product starts in the design phase.

To ensure that the product will be approved and manufactured according to the required quality level, we start planning this in the design phase. In the actual phase of industrialisation, we focus on verification and production. Prior to this phase, documentation is a critical step for many industries like MedTech.

We cooperate with testing institutes and manufacturing sites around the world to ensure the product approval process.

We set up test routines, do trials and part approvals, and define golden samples, and do the final quality agreements with the suppliers and manufacturing sites.

In parallel with the industrialisation activities, our marketing, and brand management team finalize the commercial launch plan and media strategy. Through our graphic and digital designers, we can create all visual identity collateral for the product. Doing these steps in parallel removes the risk of late or incomplete commercial launches.

DOCUMENTATION

Producing technical documentation in-house is crucial. We have the necessary understanding of the product and the component production to ensure the highest level of precision and quality.

Our engineers cooperate with producers around the world to set up the item specifications and achieve the optimal tolerances to meet the required component price target.

Our technical writers and design engineers are involved throughout the process to maintain a high level of consistency in all technical documentation. Userguides, assembly instructions, brochures, and service manuals are all developed in-house through the development phase and released in the industrialisation phase.

Developing the EpiShuttle gave us valuable insight into documentation requirements for the MedTech industry.

VERIFICATION AND VALIDATION TESTING

We cooperate with testing institutes around the world. Verification tests to verifying that the product meets the customer or legal requirements are done from an early stage in the development process until the industrialization phase.

We build fixtures and do strength tests, impact tests, vibration tests, and cycle tests in-house or at test institutes. Each product enters through a final round of rigorous functional and environmental tests to be certified.

We organize user tests on random users to ensure that the product meets their requirements. The required validation tests are done in the relevant markets to produce the necessary tests leading to the final product certification.

PRE-PRODUCTION AND TRANSFER PROCESS

Our process minds are set all the way to the production line of the product. We have the skills and facilities to do the first small-scale assembly of the prototypes and the pre-production of the unit in-house.

We manage all file revisions, BOM, part numbering, assembly manuals, and quality inspection documentation to prepare the product for mass production transfer. The transfer from developing the product to a «hand-over» to the manufacturing site is crucial for the quality.

Fixtures and jigs are all fine-tuned to meet the requirement of high or low volume production. Logistic parts of all components are established through the pre-production phase. The production line can easily be adapted to the next level of production volumes at the final manufacturing site.

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