Case study · Mouldings + Products
A medical OEM that prototyped fast and moved to overmoulded production.
A device manufacturer needed a soft silicone grip overmoulded onto a hard housing. We prototyped in weeks, ran regulatory validation samples, then built production tooling.
The brief
What the customer arrived with.
A medical device OEM was developing a handheld unit with a soft grip section. They needed prototypes in the hands of clinical evaluators quickly, and a clear path to production tooling if the evaluations went well.
How it went
Stage by stage.
Prototype stage — Mouldings
We hand-cast the soft silicone grip in a food-grade platinum-cure silicone (the same grade the production part would use) around printed hard shells. Ten units in less than two weeks. Enough for clinical evaluators to feel and handle.
Validation samples
Once the geometry was refined, we produced a small production-representative run using cast tooling. These were sent for the customer's own validation testing.
Production tooling — Products
Once validation cleared, we built an injection tool. Two-shot overmoulding, silicone onto the plastic housing. Standing tooling, monthly release. The engineer who built the prototype tool led the production build too.
Documentation
The material spec, batch records and first-off approvals were retained from the prototype stage onwards. When the customer's own regulatory work needed evidence of material continuity, the record was there.
Lessons
What we took from the job.
What we took from it
Regulated development benefits enormously from continuity of material — using the production grade at prototype stage removes a change-of-material question later.
What we took from it
The paperwork trail from prototype through to production, without any supplier changeover, was the deciding factor when the customer picked us.
What we took from it
Cross-division work under one quality system meant the regulatory evidence held together.
Related
Where to read next.
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Which divisions worked on this
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No call centre and no middlemen. When you contact TCI Group, you speak to the team who design, build and check your mould.
- A real Warwickshire workshopUnit 15, Waterloo Park, Bidford-on-Avon, Alcester B50 4JG.
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- Five brands, one teamMoulds, culinary, construction and contract products, all run from Bidford-on-Avon. See the divisions.
Thomas LaneManaging Director
George PrestonDesign & Project Manager
Kelly BallingerHead of Partnerships
Jim AndertonProduction Manager
TheodoreEmployee Welfare