OEM with defined specifications
Review drawings, model references and samples for tooling and manufacturing feasibility, then agree inspection and supply units.
← OEM/ODM overviewGLOONE / OEM · ODM
Medical device OEM/ODM
Precision-molded devices such as absorbable plates and screws require more than a target shape. We review the model, feedstock, tooling, inspection and supply configuration together.
From requirements to supply ↓
Define the development scope
ODM from a development brief
Define geometry and functional requirements, then allocate design, prototype evaluation and manufacturing preparation responsibilities.
Product-specific supply
Distinguish molded components from packaged finished products. Other families, including sutures, are reviewed against their own processes and configuration.
From requirements to supply
Applicable processes, acceptance criteria, documents and supply scope are agreed for each product, material and target market.
- 01
Confirm product requirements
Review models, drawings, reference samples, target markets and supply format.
- Review at this stage
- Scope, responsibilities and review criteria
- 02
Review feedstock and tooling
Check material identification and handling, mold design, product geometry and equipment requirements.
- Review at this stage
- Material, tooling and equipment plan
- 03
Trial molding and finishing
Inspect filling and appearance in molding trials and review required trimming and finishing.
- Review at this stage
- Prototype, geometry and appearance records
- 04
Condition and evaluate
Define applicable conditioning, including aging where required, and dimensional and mechanical checks. Link model-specific tests to manufacturing history.
- Review at this stage
- Dimensional, mechanical and process reviews
- 05
Define packaging and sterilization
Agree the product and packaging configuration and responsibilities for applicable outsourced sterilization and supporting records.
- Review at this stage
- Packaging, sterilization and document scope
- 06
Final review and supply
Check final inspection, product–packaging–label consistency and identification before supplying the agreed configuration.
- Review at this stage
- Inspection, lot, label and shipment records
03 / PROJECT BRIEF
What to bring to the discussion
- Drawings, model references or reference samples
- Feedstock, key dimensions and requested tests
- Target market, quantity and component or finished-product scope