Should lot yield be first pass yield or final yield?

Use final yield: devices released divided by devices started. First pass yield counts reworked devices as failures, so it overstates scrap when rework recovers them. Put rework minutes in labor minutes instead.

What if my sterilizer charges per unit instead of per load?

Multiply the per-unit charge by the units you send, add the per-lot release tests, and enter that total. It is then spread over released devices.

What belongs in the cleanroom shop rate?

Operator wages and benefits plus cleanroom overhead per operator hour: gowning, air handling and filtration, environmental monitoring, cleaning and floor space. Material and sterilization have their own inputs.

How much is one more point of lot yield worth?

About 41 cents per released device at the defaults: the headline falls from $39.05 at 95% to $38.65 at 96%. Yield loss drops 35 cents; the rest is sterilization and release spread over more devices.

MedTech Manufacturing calculator

Medical Device Unit Cost Calculator

Find what each released device costs when you set a standard cost, quote a customer or choose a lot size. You need the costed BOM, routing minutes, a burdened cleanroom rate, per-lot sterilization charges and recent lot yield.

What this calculator does

Cost of one released medical device from material, labor minutes at a cleanroom rate, per-lot sterilization and lot yield.

Formula used

Labor and cleanroom per device = labor minutes ÷ 60 × cleanroom shop rate
Total lot cost = devices started × (material + labor and cleanroom) + sterilization and release per lot
Devices released = devices started × lot yield; cost per released device = total lot cost ÷ devices released
Sterilization and release per device = sterilization and release per lot ÷ devices released
Yield loss per released device = (material + labor and cleanroom) × (1 ÷ lot yield − 1)

Inputs explained

Devices Started per Lot: Work order quantity, including devices later scrapped.
Lot Yield: Devices released ÷ devices started, from recent lot records.
Material Cost per Device: Costed BOM: components, packaging and labels for one device.
Labor Minutes per Device: Routing standard for assembly, inspection and packaging.
Cleanroom Shop Rate: Burdened operator hour plus cleanroom overhead, from your standard cost.
Sterilization and Release per Lot: Sterilizer load charge, lot release tests and line clearance.

How to use the result

Best suited to setting standard cost for a new device, choosing lot size against sterilization load charges, pricing the payoff of a yield improvement.
Excludes rework, tooling and validation amortization, freight and scrap credit; add rework minutes to labor minutes. A lot that fills two sterilizer loads pays two load charges; enter both.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

Should lot yield be first pass yield or final yield? Use final yield: devices released divided by devices started. First pass yield counts reworked devices as failures, so it overstates scrap when rework recovers them. Put rework minutes in labor minutes instead.
What if my sterilizer charges per unit instead of per load? Multiply the per-unit charge by the units you send, add the per-lot release tests, and enter that total. It is then spread over released devices.
What belongs in the cleanroom shop rate? Operator wages and benefits plus cleanroom overhead per operator hour: gowning, air handling and filtration, environmental monitoring, cleaning and floor space. Material and sterilization have their own inputs.
How much is one more point of lot yield worth? About 41 cents per released device at the defaults: the headline falls from $39.05 at 95% to $38.65 at 96%. Yield loss drops 35 cents; the rest is sterilization and release spread over more devices.

Last reviewed 2026-10-01.