Healthcare components
Custom Silicone Components for Medical & Healthcare Applications
WYD manufactures custom silicone seals, covers, soft interfaces and related components for medical, healthcare and equipment applications.
We do not treat “medical grade silicone” as a complete specification. Before material selection and tooling, the buyer should define the intended use, contact type, required documentation and device/program requirements.
Typical Project Scope
Depending on the project and required documentation, our scope may include:
Implantable components are outside the scope described on this page. For other medical and healthcare components, send the intended use, contact type and supplier-qualification requirements so we can confirm project feasibility.
- silicone seals and gaskets
- protective covers
- soft interfaces and cushions
- equipment boots
- wearable/skin-contact components
- molded accessories
- tubing or extruded components
- overmolded silicone features
Define the Contact Type First
Tell us whether the component is intended for:
Also identify contact duration, sterilization/cleaning method, temperature, fluids/chemicals, target market and required testing or certificates. These details affect material selection and qualification.
- equipment-only use
- indirect contact
- skin contact
- mucosal contact
- food contact
- another specified contact type
Manufacturing Routes
LSR Injection Molding
Often considered for medical/healthcare silicone parts requiring an LSR material system, controlled injection geometry or repeat production.
HCR/HTV Compression Molding
Can be appropriate for seals, covers and other molded components depending on material and geometry.
Silicone Overmolding
For silicone integrated with suitable plastic or metal substrates.
Extrusion
For custom tubing and profiles where extrusion is the correct process.
RTV silicone mold making is also available when the purchased item is a casting mold rather than a regulated finished component.
DFM and Critical Requirements
Before tooling, review:
- critical dimensions
- mating components
- sealing surfaces
- flash-sensitive edges
- wall thickness
- undercuts
- insert position
- cleaning/sterilization exposure
- material traceability requirement
- cosmetic requirement
- measurement method
For flexible parts, the inspection method must be defined so the measurement fixture or caliper force does not create the variation.
Material Documentation
Material documentation is reviewed against the selected silicone compound, manufacturing process and intended application. Please provide your material specification, required reports and supplier-qualification checklist. We will confirm which documents are available and which additional evaluations the project requires.
Contact type, contact duration, sterilization or cleaning method, and dimensional inspection still belong on the RFQ.
Prototype Validation
The prototype or first article should verify the agreed CTQs and functional requirements, for example:
- fit
- seal
- hardness
- dimensions
- surface condition
- insert retention
- assembly
- cleaning/sterilization compatibility
- customer-defined functional test
The validation plan depends on the component.
Name the contact before the grade
What to Send for a Quote
- 3D model and drawing
- device/component function
- contact type and duration
- requested silicone/material spec
- Shore hardness
- sterilization/cleaning process
- critical dimensions
- first order / annual quantity
- target market
- required test reports / CoA / material documentation
Request a Medical/Healthcare Silicone Project Review
Send the drawing, contact type and documentation checklist. We confirm feasibility before tooling.