MedTech Manufacturing worked example

Medical Device Unit Cost with production run volume of 1,300 devices: a worked example

This scenario runs the medical device unit cost calculation on the strong side: production run volume of 1,300 devices, with every other input held at its documented default. Use this when quoting a production run, comparing manufacturing scenarios, or building a cost model for a new device to present to finance or supply chain stakeholders.

The inputs for this scenario

  • Production run volume (devices built): 1,300 devices (raised for this scenario; the documented default is 500)
  • Variable cost per device (materials and components): 18.5 $ / device (unchanged)
  • Fixed costs (tooling, setup, process validation): 2,500 $ (unchanged)
  • Labor plus QMS compliance overhead: 1,200 $ (unchanged)

Working through the calculation

  • Applying the documented formula (Total medical device unit cost = production volume × variable cost per device + fixed costs + labor and compliance overhead) to the inputs above produces each figure below.
  • At this operating point the engine returns 27,750 $ / unit for total production run cost, the number this scenario is built around.
  • At this operating point the engine returns 21.35 $ / piece for cost per device.
  • At this operating point the engine returns 24,050 $ for total variable cost (materials and components).
  • At this operating point the engine returns 3,700 $ for fixed costs plus labor/compliance overhead.

How this compares with the baseline

  • Against the tool's baseline example, where production run volume sits at 500 devices and the headline result is 12,950 $ / unit, this scenario comes in 114% above the baseline at 27,750 $ / unit.
  • Use it during quoting, NPI cost modeling, make-vs-buy decisions, and when re-justifying price after a volume or BOM change. Treat this as a target state: the delta against the baseline quantifies what the improvement is worth before you commit to chasing it.

Results at a glance

  • Total production run cost: 27,750 $ / unit (headline result)
  • Cost per device: 21.35 $ / piece
  • Total variable cost (materials and components): 24,050 $
  • Fixed costs plus labor/compliance overhead: 3,700 $

Run it with your numbers

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

Last reviewed 2026-05-12.