Most 100-day plans for a device company set margin and capacity targets. Few include the exercise that shows where that margin and capacity can actually come from on the production floor.
What a value stream map shows
A value stream map follows a product from raw material to finished goods and records each step along the way: processing time, wait time, inventory, inspection loops, changeovers, and rework. The map is built by walking the line and watching the process, so it reflects how the line really runs.
Hands-on processing time is usually a small part of total lead time. Most of the time, product is sitting in a queue, a batch, quarantine, or inspection, and all of that waiting costs money.
I have mapped lines before production started and after they had been running for years. Both times, the map showed constraints that people on the line knew about individually but had never seen together in one place.
Why it matters to investors
A value stream map ties what happens on the floor to the numbers in the deal model.
Start with capacity. The real bottleneck is often a different step from the one everyone assumes, and adding equipment at the wrong step adds cost without adding output.
Margin is next. Rework loops, scrap points, and extra handling show up on the map as specific steps with specific costs. That gives the team something concrete to work on, which a single yield percentage does not.
Then there is working capital. Work in process and finished goods sitting between steps are cash the business has already spent. Shorter lead times reduce that inventory and free the cash.
Sorting improvements by regulatory impact
In medical devices, every proposed improvement has to be sorted by its regulatory impact before it goes into a plan. A useful way to sort them is into three groups.
The first group changes material flow, scheduling, staging, or layout and leaves the validated process untouched. These can often move quickly.
The second group touches documented procedures. These need change control but may not need revalidation.
The third group changes process parameters, equipment, or methods. These can trigger revalidation and sometimes a regulatory assessment.
A savings plan that skips this step will overstate how fast the savings arrive. The roadmap should start with improvements from the first group, then schedule the larger changes alongside the validation work they require.
Questions to ask before or after close
- Has anyone mapped this line end to end, on the floor, in the last two years?
- What is total lead time compared with hands-on processing time?
- Where does inventory build up between steps, and why?
- Which planned improvements require revalidation, and is that time in the plan?
If the answers are vague, the margin and capacity targets in the 100-day plan rest on assumptions that have not been checked on the floor.
What has a walk of the production line shown you that the operating reports did not?
Chris Steadham is the founder and principal of Truestead Advisors and has spent 30+ years in medical device product development, manufacturing scale-up and general management. Planning post-close improvements on a device line? Start a conversation.