Medtech provides engineering solutions for each step in the production of a medical device: from technical support for assessing a new product, its prototyping, low volume test lines, to serial production lines, our teams control all of the processes.
Each step has its specific requirements, objectives and challenges. This is why Komax Medtech implements the tools and experience required for the success of your projects. Our unique approach permits us to ask you the right questions and to analyse the results to ensure the smooth performance of your project, from concept to production.
Through the development of its unique Predictive Analysis Approach, Medtech uses quite separate subjects of analysis with the aim of providing the development team with key information. These subjects cover the analysis of the product’s functions, component feed constraints, optimisation of flows, the assembly sequence and tests, intermediate assessment and recommendations.
- Product Design Study
- DFF Design For Feeding
- DFA Design For Assemby
- DFM Design For Manufacturing
- PFA Process Flow Analysis
Once the prototypes have been successfully produced, new questions have to be asked, in particular with respect to the key processes wanted by our customers. Komax Medtech helps with these steps by supplying tools that demonstrate the proof of principle, leading to process validation.
By working in collaboration with us from the prototype phase, you ensure that the compatibility of tools and solutions are also suitable for future High Volume production.
- Proof of Principle
- De-Risking / Risk Mitigation
- Process Development & Process Validation
- Pilot Production
At Medtech, we have a low volume line approach which automates the most critical tests and processes, in High Volume production conditions.
We continuously develop our work in both a reactive and reliable way, by anticipating technical and product changes and bringing them together in the product’s current version, with a view to future variants.
Medtech places great importance on this key Low Volume phase which effectively underpins the development of the project’s High Volume phase, and ensures that customer’s specifications are specifically validated.
Our Low Volume platforms are created to permit the combination of manual and automated stations in a single unit. This approach considers and values these two configurations equally, in the development of a logical ergonomic design, with operator safety and compliance as the standards in force.
The logical compatibility between our platforms ensures an effective synergy between Low and High Volumes. It simplifies training and maintenance of the mechanical, electrical and software interfaces, whether using a rotary, linear, or power-free pallet platform. Station compatibility increases the amount of time and money saved, and above all, it helps limit the risks associated with a foreseeable increase in production rates.
Clean room production (ISO 7) of medical devices at a rate of 20 to more than 200 parts a minute calls upon very specialised knowledge.
Medtech, with its experience covering more than 45 years and its complete range of proven solutions, ensures the success of your project: compliance with the specifications and commissioning of your assembly line, within the agreed lead times.
We analyse each of your criteria and requirements in order to propose the ideal assembly solution.
As a supplier of complex, turn-key assembly units, Medtech often incorporates OEM equipment such as cartridge or PFS feeders, palletisers and labeling and packaging systems.
You have just one partner who manages the process from component feeding to the final packaging of your device, assembled, tested and ready for shipment.
Our expertise extends from engineering to the integration of complete systems, including remote monitoring and critical data acquisition (SCADA), for all the assembling, testing and packaging processes of your product.
We offer compliance with 21CFR – part 11. Our commitment when choosing the OEM guarantees that your line will correspond to your specifications and that there will be no problems with its validation by the official authorities.