Process Development

Not all production processes are plug-and-play; process development is required to produce most medical devices or components for commercial or clinical use. Sometimes we must adjust the product design, design and produce tools, and purchase or optimise equipment.

Equipment Selection

When we do not have suitable production equipment in-house, customers can purchase and place the required equipment at Vosfox Medical. We can support or fully organise the selection and purchasing of the equipment. The new equipment will be fully incorporated into our Quality System, but the ownership stays unchanged. In our customer property form, we arrange who is responsible for maintenance, repair, and calibration, both the execution and the expense of it.

Tool Development

At Vosfox Medical, we have equipment that requires to be used with tooling. Examples are blister forming, which requires a blister mould (metal block with the required shape milled in it), or moulds for injection moulding machines.

Other examples of tools are product holders or cutting tools. Vosfox Medical can design the tools using a CAD program and produce the tools. Depending on the requirements, we could 3D print these tools or have them produced by trusted partners.

Optimisation of Equipment

Preferably, we purchase ready-to-use equipment when possible, but if this is not possible, we will optimise the equipment to fit its purpose. This can be equipment you own and placed in our facilities or equipment we own. We will monitor the equipment’s performance and produce good quality products. Optimisation of equipment can entail adding sensors (e.g. temperature or press), making tools, replacing parts with stainless steel parts, etc. If you want more examples of the equipment optimisation we have done, don’t hesitate to contact us.

Defining Work Methods

With new, optimised or standard equipment, we still need to define the optimal way of producing the products to fulfil the product specifications. The equipment settings must be defined, such as temperature or pressure and washing, drying, cutting, printing orientation, coating, assembling methods, etc. These work methods are validated during the process validation.