Medical Device Prototyping: Materials & Rules
Where the tolerance is not the hard part — the documentation and the material certification are.
Discuss your partWhat we build for medical devices
Send a drawing and a target quantity. We will come back with material, process and a realistic date, or tell you what we would change first.
| Parameter | Value |
|---|---|
| Typical parts | Housings and covers · Surgical instrument components · Diagnostic jigs · Connector blocks |
| Common materials | SS 316L · PEEK · PC · ABS · Al 6061 |
| Achievable tolerance | ±0.02 mm on critical features available, ±0.05 mm typical |
| Typical lead time | 5–12 working days depending on material |
| Industry requirements | ISO 13485 manufacturing quality systems (partner factories) · ISO 16061 passivation for medical stainless · Material certification per lot where specified · NDA and IP handling available on request |
What actually goes wrong in medical devices
These are the three problems that decide whether a medical devices prototype succeeds or gets scrapped on arrival.
Every lot needs a traceable certificate
A medical part has to be traceable back to the mill certificate. That means the material has to be ordered with certification, and the certification has to travel with the batch — which constrains what can be substituted later.
Surface finish is a cleaning validation issue
A machined pocket with a rough surface is harder to clean and holds residue. Ra specification is a regulatory concern before it is a cosmetic one, and it drives the finishing route.
Tight tolerance on a soft material
PEEK holds a tolerance well when it is fresh, but the same tolerance on ABS or PC is a different problem. The tolerance and the material have to be chosen together, not sequentially.
Our approach on medical devices parts
- 01 We review the drawing for material, tolerance and finish together, and flag any combination that will not hold in production before we quote it.
- 02 Certification is confirmed at order, not assumed — if a grade cannot be sourced with a certificate we say so rather than substituting quietly.
- 03 Passivation on stainless parts is offered under ISO 16061 where the drawing calls for it.
- 04 We keep the drawing revision and the agreed inspection criteria in writing before the first part is cut.
The numbers that matter
Related pages
Where a prototype stops short
A prototype answers geometry and fit. It does not qualify a product, and we will not pretend otherwise. These are the questions that need a test programme.
- Biocompatibility — that needs its own evaluation, not a machined sample
- Production qualification of the supply chain and the process
- The design verification and validation plan