Sending a drawing to a machine shop in another country is a routine step in medical device sourcing, and also the point where many engineering teams feel most exposed. The drawing shows geometry that took years of design and testing to settle. A medical device drawing NDA for machining is the obvious first step, but it is only one layer. The rest is about what you send, to whom, and what the contract says about the tools and files created along the way.
This article covers practical steps for protecting medical device IP when quoting overseas machine shops, with notes specific to shops in southern Vietnam. It is not legal advice. For contract wording and enforcement questions, use a lawyer qualified in the relevant jurisdiction.
Start with a mutual NDA, before review
A non-disclosure agreement should be in place before anyone opens the drawing. A mutual NDA suits most sourcing situations because both sides share information: you share drawings, and the shop may share process details, pricing and capacity.
Points worth covering in the NDA:
- Definition of confidential information: include drawings, 3D models, specifications, quantities, pricing, and the fact that the business relationship exists.
- Permitted use: only for quoting and, if awarded, producing parts for you. Explicitly exclude making, selling or quoting the parts for anyone else.
- Non-use as well as non-disclosure: a shop that never discloses your drawing but uses it to make parts for a competitor has not breached a pure non-disclosure clause. Non-use covers that.
- Return or deletion: files deleted or returned on request, and at the end of the quote if the job is not awarded.
- Governing law and dispute forum: discussed below.
- Duration: confidentiality obligations for technical information often run several years beyond the agreement term.
On request, a mutual NDA can be signed before any drawing review, and files are not shared with shops that are not assigned to your part.
Strip the quote package
A shop needs enough information to quote accurately. It does not need to know what the part does or which device it goes into. Before sending drawings for quotation, review what can come out:
- Device name and project code names in the title block, file names and notes.
- Company name and logo, if you prefer to stay anonymous at quote stage.
- Assembly drawings and assembly context: send the individual part, not the assembly it belongs to.
- Clinical use notes, such as “implant” or “contacts bone”, unless they drive a manufacturing requirement. If they do, state the requirement itself (for example “passivate per ASTM A967”, “no burrs at 10x”).
- Metadata in 3D files: STEP and native CAD files can carry author names, company names, file paths and part names in the header. Export clean files.
- Mating part geometry beyond what is needed to define datums.
What must stay: part geometry, tolerances and GD&T, material and standard, heat treatment, finish and secondary processes, marking content if it affects cost, quantities, inspection and documentation requirements. Removing these to protect IP only produces inaccurate quotes and surprises at first article.
Split components across suppliers
For a multi-part device, sending every component to one shop gives that shop the whole picture. Splitting components across two or three suppliers means no single shop holds the full set of geometry, and the assembly, which is usually where the know-how shows, stays with you or a supplier you control.
The trade-off is management effort: more purchase orders, more first articles, more shipments to consolidate. It works best when the parts differ anyway, for example titanium screws at one shop and a PEEK trial or a stainless instrument case at another. For small projects, splitting only the most sensitive component is often enough.
File handling after the NDA
Contracts matter less than day-to-day handling. Ask how files are handled and put the answers in writing:
- Access control: drawings go to the named engineers and inspectors working on the job, not to a shared folder.
- No reuse: your drawings and models are not used as templates for other customers’ parts.
- No forwarding: files are not sent to other shops, subcontractors or finishing vendors without your approval. If a heat treat or anodizing vendor needs a drawing, they get a reduced version showing only what they need.
- Revision control: superseded revisions are removed from the shop floor to avoid wrong-revision parts and uncontrolled copies.
- Deletion on exit: files deleted when the job ends or is not awarded, with written confirmation if you ask for it.
For our part, drawings received through the RFQ are reviewed and routed only to the shops being considered for that part, and are not shared with shops that are not assigned. More on how we work is on the about page.
Non-compete and non-circumvention clauses
A non-compete clause in a supply contract usually aims to stop the shop from making your parts, or close derivatives, for anyone else. Some buyers also add non-circumvention language, so that the shop does not approach your customers or your other suppliers directly.
Keep these clauses narrow and specific. “Shall not manufacture or sell parts made from or derived from the buyer’s drawings to any third party” is easier to apply than a broad ban on working in orthopedics. Very broad restrictions may be unenforceable and can make a capable shop decline the job.
Ownership of fixtures, gauges and programs
Most medical parts need custom fixtures, soft jaws, and sometimes dedicated gauges. Decide ownership up front:
- Fixtures and gauges: if you pay for them as a separate line item, state that they are your property, marked with your part number, stored at the shop, used only for your parts, and returned or scrapped on your instruction.
- CNC and CMM programs: often treated as the shop’s process know-how. If you want copies, for example to transfer production later, write that into the purchase terms and expect it to affect price.
- Inspection data and FAI records: yours, delivered with the parts, and retained by the shop for an agreed period.
Clear ownership also helps if you ever move production, because a transfer does not turn into a negotiation over who owns the fixtures.
What Vietnam law generally offers
Vietnam has an intellectual property law that covers patents, industrial designs, trademarks and trade secrets, referred to locally as business secrets, and a civil code under which commercial contracts, including NDAs, are enforceable. Registered rights are territorial: a patent or design registered only in the US or EU does not by itself create rights in Vietnam.
In practice, a few general points apply:
- Enforcement is local and can be slow. Court action or administrative enforcement takes time and requires evidence of the breach.
- Forum and governing law matter. Cross-border contracts often choose arbitration in a neutral venue; whether that suits you depends on the contract value and where the other party’s assets are.
- Filing locally may be worth considering for high-value designs, trademarks, or where products will also be sold in the region.
This is general background, not legal advice. Get advice from a lawyer qualified in Vietnam before relying on any clause or deciding on a filing strategy.
Risks and mitigations
| Risk | How it happens | Mitigation |
|---|---|---|
| Drawing shared with other shops | Quote files forwarded or kept in shared folders | Mutual NDA before review; files routed only to assigned shops; deletion on exit |
| Parts made for a competitor | Shop reuses your drawing or programs | Non-use and narrow non-compete clause; split components across suppliers |
| Device identity revealed | Device name, logo or assembly in the quote package | Strip title block, file names and metadata; send single parts only |
| Uncontrolled revisions | Old drawings stay on the shop floor | Revision control requirement; return or destroy superseded copies |
| Fixture ownership dispute | Fixtures paid for inside the part price | Separate fixture line item; ownership and return terms in the PO |
| Weak enforcement | Breach in a different jurisdiction | Local legal advice; clear governing law and forum; prevention first |
| Sub-vendor exposure | Heat treat or finishing vendor receives full drawing | Approval for sub-vendors; reduced drawings for secondary processes |
What to send at quote stage vs order stage
| Item | Quote stage | Order stage |
|---|---|---|
| Mutual NDA | Signed before review | In place; referenced in PO |
| 2D drawing | Part only, neutral title block | Full controlled revision with your title block if needed |
| 3D model | Clean STEP, metadata removed | Same, plus native file only if required |
| Device name and use | Omit | Only if a requirement depends on it |
| Assembly drawing | Omit | Usually still omit |
| Material, finish, tolerances | Full detail | Full detail, plus process specs |
| Quantities | Prototype and forecast batch sizes | Firm PO quantities and schedule |
| Quality requirements | Documents you will need (FAI, certs) | Quality agreement, sampling plan, documentation list |
| Fixture and program terms | Ask for fixture cost as a separate line | Ownership and return terms in the PO |
Who carries which responsibility
IP protection sits alongside, not in place of, the device maker’s own responsibilities. Design controls, design history, biocompatibility, sterilization validation and regulatory submissions stay with the device maker. The shop supplies parts to your drawing and quality requirements; we review drawings and match them to shops. If your quality system requires supplier certificates such as ISO 13485, verify them yourself during supplier qualification. What can be requested for documentation and records is listed on the quality and documentation page. Drawing protection is one step of our guide to offshore medical device machining.
Starting a protected quote
A practical sequence:
- Ask for a mutual NDA before sending anything beyond a brief description.
- Prepare a stripped quote package: single parts, clean STEP files, neutral title blocks.
- Decide whether to split sensitive components across suppliers.
- Ask for fixture costs as a separate line so ownership is clear later.
- Add file handling, non-use and ownership terms when the order is placed.
When the package is ready, send it through the RFQ form and note that you want the NDA in place before review. You will get a first response within 24 business hours, with DFM feedback included in the quote at no charge.