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Disposable device brands
High volume moulded components where the unit cost is small and the cost of a recall is not.
At a few cents a part, the temptation is to buy on price alone. The exposure sits elsewhere: a batch that fails in the field is a regulatory event, and its cost has nothing to do with the unit price of the component that caused it.
Typical Applications
- Certified to ISO 13485:2016 and ISO 9001:2015
- Validated volume production from the same tool
- 350 to 400 mold sets built a year
Related Products
IVD instrument makers
Consumables whose dimensional stability decides whether an analyser runs unattended for a full shift.
Ophthalmic and dental devices
Small, visually critical parts where a moulding mark is a defect rather than a cosmetic detail.
Contract manufacturers
Programs that need a molder who can also build the tool, so one supplier carries the dimensional responsibility.
Send us a drawing and we will tell you what it will cost to tool
Send the 3D data or the drawing with the annual volume and the material. You will get a tooling cost, a sampling schedule and an opinion on anything in the design that will be difficult to mould.