MedTech Manufacturing worked example

Validation Batch Cost with validation batch size of 750 devices: a worked example in medtech manufacturing

Push validation batch size up to 750 devices and the picture changes. This example computes every intermediate figure at that operating point. Use this when budgeting for process validation activities, justifying PQ batch sizes to management, or comparing validation cost across manufacturing sites.

The inputs for this scenario

  • Validation batch size: 750 devices (raised for this scenario; the documented default is 300)
  • Variable cost per device (validation): 22 $ / device (unchanged)
  • Fixed validation costs: 8,500 $ (unchanged)
  • Additional testing and documentation labor: 4,200 $ (unchanged)

Working through the calculation

  • Applying the documented formula (Total validation batch cost = validation batch size × variable cost per device + fixed validation costs + additional testing and documentation labor) to the inputs above produces each figure below.
  • At this operating point the engine returns 29,200 $ for total pq batch cost, the number this scenario is built around.
  • At this operating point the engine returns 38.93 $ / piece for validation cost per device.
  • At this operating point the engine returns 16,500 $ for total material and direct labor.
  • At this operating point the engine returns 12,700 $ for fixed validation and testing costs.

How this compares with the baseline

  • Against the tool's baseline example, where validation batch size sits at 300 devices and the headline result is 19,300 $, this scenario comes in 51.3% above the baseline at 29,200 $.
  • It sums variable per-device cost across the batch plus fixed validation costs and added testing and documentation labor, then divides by batch size for cost per device. The value of this scenario is the size of the gap it exposes: that gap, priced out over a year, is the budget you can justify spending to close it.

Results at a glance

  • Total PQ batch cost: 29,200 $ (headline result)
  • Validation cost per device: 38.93 $ / piece
  • Total material and direct labor: 16,500 $
  • Fixed validation and testing costs: 12,700 $

Run it with your numbers

  • Every input above is editable in the live Validation Batch Cost calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.