Split the Quote Into NRE and Recurring Price
OEM buyers expect to see non-recurring engineering separate from piece price, and you should want that too. NRE covers fixture and tooling design, programming, first article inspection, gauge R&R for critical dimensions, and process validation protocols. If you fold NRE into piece price and the OEM cuts volume, you never recover it.
Quote NRE as a milestone-billed line (for example 50 percent at PO, 50 percent at validation report approval) and state what triggers a re-validation charge: a material lot change, a new tool cavity, or an OEM drawing revision. Say plainly that validation scope is based on the drawing revision and risk classification supplied at quote time.
- Tooling and fixtures: owned by the customer or amortized, stated explicitly
- IQ/OQ/PQ or process validation protocol and report writing
- First article inspection and measurement program development
- Quality plan, control plan and traveler or DHR template creation
Material, Certifications and Outside Processing
Implant and instrument work calls for specific grades, such as ASTM F138 stainless, F136 Ti-6Al-4V ELI, F67 commercially pure titanium, PEEK-Optima or USP Class VI silicones, and each lot needs a mill cert that stays tied to your lot number. Price material with the cert premium, minimum buys and the cut-off waste for bar stock that must be lot-segregated. Outside processing is where quotes quietly go wrong: passivation to ASTM A967, electropolish, laser marking, anodize, cleaning and packaging in a controlled environment all come from approved suppliers with their own lead times and minimum lot charges.
Build the supplier lead time and shipping both ways into the quoted lead time, not just the price.
Inspection, Cleanroom and Documentation Labor
Run labor for device parts is rarely the largest cost driver. Inspection frequently is: 100 percent inspection of critical features, optical or CMM measurement, and the time to record results per unit or per lot. If the part is assembled or packaged in an ISO 14644 Class 7 or 8 cleanroom, add gowning time, cleanroom hourly burden and environmental monitoring cost.
Documentation is real labor too: the device history record has to be assembled, reviewed and signed before lot release. Estimate minutes of record review per lot and charge for it. Quoting inspection and records as a percentage of run time is a common shortcut, but pull actual hours from recent jobs of the same part family when you have them.
Try it here, free
Lot Size Price Break Table Generator
Enter setup, material, run cost, scrap and target margin for each quantity and get the cost-based unit price and lot price for a quote.
Scrap, Yield and Lot Size Assumptions
Device parts have tight tolerances and no-rework policies on some features, so yield matters more than on commercial work. State the yield assumption in the quote, for example 92 percent on a Swiss-turned bone screw family or a specific first-pass molding yield, and state what happens to overage. Many device buyers also require that rejected material be segregated and dispositioned under your nonconforming product procedure, which costs time.
Quote lot sizes with price breaks tied to full validated lot quantities, because a half-lot still carries the same documentation and release labor. Include a minimum lot charge and say it covers records and release, not just machine time.
Where AI Helps and When It Is Not Worth It
The slow part of a device quote is reading the RFQ package: drawing notes, material specs, the supplier quality agreement, packaging and labeling requirements, and the validation expectation. A private AI assistant over your ERP and past quotes can extract those requirements, find similar parts with actual hours and yield from completed jobs, and draft the cost buildup for your estimator to approve. It does not replace the estimator's judgment about risk or the quality manager's review of the SQA.
If you quote fewer than a handful of RFQs a month and your product mix is a few repeat families, a well-maintained spreadsheet and a quote template are probably enough.
Frequently asked questions
What should be included in a medical device contract manufacturing quote?
Separate NRE (tooling, fixtures, programming, first article, validation protocols and reports) from recurring piece price (certified material, run labor, inspection, cleanroom and records labor, outside processing, scrap allowance). Add lot size price breaks, lead time including outside processors, and the conditions that trigger re-validation or re-quote, such as a drawing revision or material change.
Should validation costs be in the piece price or quoted separately?
Quote them separately as NRE with milestone billing. If validation is buried in piece price and the customer reduces volume or moves the program, you absorb the cost. A separate line also makes it easy to quote re-validation when a drawing revision or process change triggers it later.
How long should a device contract manufacturing quote take?
For a repeat part family with good history, a day or two is realistic. For a new part with validation, outside processing and a supplier quality agreement review, a week is common. Most delay comes from reading the package and waiting on outside processor pricing, not from the arithmetic.
If your estimators spend days reading RFQ packages and digging for similar past jobs, Netray can show a draft device quote built from your own ERP history, produced on your own hardware, with every number traceable.