Why does cost per device fall so much with bigger lots?

Because setup, seal testing and release cost the same for 250 devices as for 1,300, so each extra device dilutes them. Material and pack labor do not fall, and they set the floor.

Should packaging validation be in this number?

No, it is a one-time cost. FDA recommends validating package integrity and shelf life with simulated distribution, aging and seal strength testing to the ISO 11607 series. Spread that cost over the devices it covers and add it separately.

What goes in setup, seal test and release per lot?

Everything a lot costs once, whatever its size: line clearance, sealer setup and parameter check, seal strength and integrity tests, label reconciliation and the lot release review.

How do I measure pack and seal time per device?

Time a trained operator over a full run, from loading the tray to the verified label, and divide by devices packed. Setup and testing stay in the lot cost.

MedTech Manufacturing calculator

Medical Device Packaging Cost Calculator

Find what sterile packaging adds to each device at your lot size before you quote or set standard cost. You need barrier material cost, pack and seal time, a burdened rate, lot setup and release cost, and a budget.

What this calculator does

Sterile packaging cost per device from barrier material, pack time and lot setup, and the smallest lot that meets your budget.

Formula used

Pack and seal labor per device = seconds per device × burdened hourly rate ÷ 3,600
Lot share per device = setup, seal test and release per lot ÷ devices per lot
Packaging cost per device = pouch, tray and label cost + pack and seal labor + lot share
Smallest lot within budget = setup, seal test and release per lot ÷ (budget − material − labor), rounded up

Inputs explained

Devices Packaged per Lot: Devices sealed in one packaging lot, from the batch record.
Pouch, Tray and Label Cost per Device: Pouch, tray, lid, labels and instructions per device, from the packaging BOM.
Pack and Seal Time per Device: Load, seal, inspect and label time per device, from a time study.
Burdened Hourly Rate: Wage, benefits and overhead of the packaging operator.
Setup, Seal Test and Release per Lot: Line clearance, sealer setup, seal strength tests and lot release review.
Packaging Budget per Device: Packaging cost per device in your standard cost or quote.

How to use the result

Best suited to quoting a contract packaging lot, setting a minimum order for sterile product.
Excludes one-time packaging validation to ISO 11607; add its cost divided by the devices it will cover. Excludes sterilization, shipping cartons and freight.

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

Why does cost per device fall so much with bigger lots? Because setup, seal testing and release cost the same for 250 devices as for 1,300, so each extra device dilutes them. Material and pack labor do not fall, and they set the floor.
Should packaging validation be in this number? No, it is a one-time cost. FDA recommends validating package integrity and shelf life with simulated distribution, aging and seal strength testing to the ISO 11607 series. Spread that cost over the devices it covers and add it separately.
What goes in setup, seal test and release per lot? Everything a lot costs once, whatever its size: line clearance, sealer setup and parameter check, seal strength and integrity tests, label reconciliation and the lot release review.
How do I measure pack and seal time per device? Time a trained operator over a full run, from loading the tray to the verified label, and divide by devices packed. Setup and testing stay in the lot cost.

Last reviewed 2026-10-01.