Scale a new product launch without downtime surprises or yield surprises. In a regulated environment you can't buy your way out of either one with overtime — and the systems that could tell you what's actually causing them don't talk to each other.
Launch stumbles in regulated manufacturing rarely come from one broken machine. They come from four symptoms that all trace back to the same cause: nothing is carrying what the equipment knows to the people and systems that need it in time to act.
You are chasing ramp targets while unplanned downtime eats the capacity you promised. Nobody can tell you which stoppages are the expensive ones, because the stoppage reason is whatever the operator had time to type.
Scrap and rework are slowing time-to-market and eroding margin at exactly the point where every unit matters. The yield number arrives after the lot is gone, which makes it a report rather than a control.
MES knows one thing, ERP knows another, the historian knows a third, and none of them reconcile. The blind spot sits precisely where the ramp problems live: between the machine and the system of record.
Leadership wants the ramp, regulators want the evidence, and both want it flawless. Every workaround that gets you through the week creates a data-integrity question you will answer later, in writing.
“Lives depend on medical devices — but our systems are holding us back from delivering at the standard patients deserve.”
The sentence we hear, in some form, in almost every first conversation.
We stabilize production ramps in environments where the audit trail is part of the product. The integration and visibility work is designed for validated systems from the start — change control, traceability and data integrity are inputs to the design, not things we retrofit after a finding.
“A leading med device manufacturer cut ramp downtime by 35% within 90 days using our IT/OT playbook.”
VP Manufacturing Systems
Fortune 500 medical device company
Deep bench on both sides of the boundary: controls engineers who have commissioned the equipment, and integration engineers who have made ERP, MES and quality systems agree with each other without a rewrite.
What sits behind the work
In that order, every time. You get a deliverable at each step and you can stop after any of them. Nothing gets ripped out — we overlay the systems you already paid for.
Find the downtime and yield drivers.
We map what you have — MES, ERP, historian, shop-floor connectivity, quality — against what the ramp actually requires, and we identify where downtime and yield risk is concentrated. Non-intrusive: we do not take a line down to go look at it.
What you receive
Fix visibility and uptime fast.
We deploy against the top drivers first: get the machine data flowing, get the stoppage reasons honest, get the yield signal to the shift that can still act on it. One change at a time, so you can tell which change produced the gain.
What you receive
Make the second plant easier than the first.
The stabilized line becomes the standard: documented, owned by your team, and repeatable at the next site. A phased roadmap for the rest of the network, sequenced so each phase funds the next rather than waiting on one big program.
What you receive
Every engagement has both, plus a named owner inside your plant. If we can't measure the before, the first thing we fix is the measurement.
35%
reduction in ramp downtime within 90 days
Reported by a Fortune 500 medical device manufacturer after applying the IT/OT playbook.
Real-time
visibility across the IT/OT boundary
OEE, cycle time and downtime read from what the machines actually did, not from a shift report.
4-12 weeks
to ROI per plant with Magic FactoryEye
FactoryEye reads via Magic XPI and overlays the systems you already run. It is early — one production customer today.
The ramp stabilizes
Nothing changes
Lives depend on medical devices. Make sure the systems around the line deliver at the standard patients deserve. Because of the senior involvement each one takes, we run roughly three ramp engagements at a time — if your dates are fixed, say so early.
Almost every ramp we are called into has the same underlying shape: the board number and the floor number never match, and the report lands a shift late. Fix the visibility and the downtime and yield conversations stop being arguments about whose number is right.
See What's Actually Happening on the FloorAlso useful during a ramp
The playbook referenced in that 35% result, written out: start with the data your mechanics already trust, and don't hand a live line to a black box.
When finance asks what the ramp cost, cost genealogy answers in days instead of at close — from machine events, not from an allocation.
Assess, Target, Execute, Sustain — and an explicit refusal to build a dependency on us after handover.
A ramp workshop is thirty minutes and no slides. Tell us the line, the target rate and what you're currently missing it by, and we'll tell you which of the four problems is actually yours.
