Diagnostic Consumables
Reaction Cup
Molded reaction cups for automated analysers, where the optical path runs through the wall and a thickness variation reads as a result error.
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Buying Guide
How To Choose A Medical Injection Molding Partner
The questions that actually predict whether a medical molding program will run smoothly, and the ones that only sound impressive.
Ask Who Owns The Tool Room
The single most useful question is whether the molder can cut steel. A molder without a tool room can only ship the tool somewhere else when a dimension drifts, which turns a two day correction into a three week one. When tooling and molding sit on the same site, a correction is a machine booking.
Ask What Happens At Sampling
A good first shot proves very little. What matters is whether every cavity was measured against the drawing before the tool was released, and whether those results were recorded against the tool number. Ask to see the format of that record rather than asking whether it exists.
Ask Where The Part Is Packed
Clean room molding and clean room packing are two different claims. A part molded in an ISO 8 area and bagged in a corridor has gained nothing from the clean room. Ask specifically where the bag is sealed.
Ask About Certification Scope
ISO 13485:2016 is the relevant certification for medical device work, and ISO 9001:2015 alongside it covers the general quality system. Both should be current and both should cover the site doing the work, not a group headquarters somewhere else.
Ask What They Will Not Do
A supplier who says yes to everything is telling you they have not read your drawing. We do not sterilise, we do not release finished devices, and we will say when a material pairing is not going to bond. A clear boundary is more useful than an enthusiastic one.
Questions Buyers Ask
Questions On This Topic
Should the molder also build the tool?
For medical parts, usually yes. The cost difference is small compared with the schedule cost of moving a tool between companies every time a dimension needs adjusting.
Is ISO 13485 enough on its own?
It is the right baseline. What it does not tell you is whether the tool room, the clean room and the molding floor are on the same site, which is where schedules are actually won or lost.
Internal Links
Components Mentioned Here
Syringe And Catheter Components
IV Catheter Components
Molded hubs, wings and housings for intravenous catheters, shown here coming off the production line.
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Blood Separation Components
Blood Separator
Molded blood separator bodies, discs and internals, carried over from the original product catalogue.
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Related Pages
Case Study
Tooling A Multi Part Blood Separator
Thin clear sections warp as they cool, and a separator has to stay both dimensionally stable and optically clear across every cavity of every part in the assembly.
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Industry
Medical Device OEM
Single use delivery and access devices where the tool, not the moulding machine, decides whether the device works.
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Solution
Medical Mold Development
From your 3D part data to a sampled, released production tool, without the part leaving our site.
See The Stages →Put This Into Practice On Your Own Part
Send the drawing and we will apply exactly what this guide describes to your geometry, and tell you where it will not work.