Risks, and what to do about each
Nine risks, each typed by whether work can retire it and each carrying the treatment chosen rather than a study proposed.
- Treatment
- Start the gap assessment before the decision date. A certification body can quote a timeline against MERIDIAN's surviving quality system within weeks, and that quote converts this from an assumption into a fact
- Treatment
- Quote against two real customer specifications in the test program. This is cheap and it settles the largest driver in the module line
- Treatment
- Make the strategy robust: Line A does not depend on this and carries the fixed cost while Line B is proven
- Treatment
- Take the bet with eyes open. Line A is entered knowing it is commodity work; the reason to hold it is roll-to-roll utilization, not margin
- Treatment
- No treatment needed. The analysis has already assumed the 10-micrometer capability earns no premium, and the case does not rest on it
- Treatment
- Build an escape hatch: the base case does not assume an acquisition, so losing one costs the high scenario rather than the plan
- Treatment
- Contain exposure. Line C is entered last and smallest, and implantable liability is the reason to sequence it that way rather than lead with it
- Treatment
- Measure it during recertification, on the line that will carry medical work
- Treatment
- Robust by portfolio: three lines with different buyers. This is the risk medical entry actually reduces, and it is worth saying that plainly
Three risks the register would otherwise miss:
- Treatment
- Take the bet with eyes open, and size for it: the plan already assumes three quarters of the merchant pool is unavailable. If Phillips-Medisize and Nolato also take the turnover, the module line is worth about $20M rather than $28M and the case is worse but not different
- Treatment
- Make the strategy robust. Polyimide film alone runs 60% to 70% of a flexible circuit plant's operating cost and comes from a handful of suppliers. Contract the base film for the private-label line on multi-year terms before committing capacity, and hold a second qualified source
- Treatment
- Contain exposure. A component supplier's liability follows its contract terms rather than the device's risk class, so cap it contractually at contract value where the customer holds the clearance. EU MDR adds a technical documentation burden on the customer rather than on MERIDIAN for a non-device component, but it lengthens the customer's own clearance, which is already in the implant lane's 24 months. Confirm both with counsel before any commitment
The capacity position is worth stating separately, and worth stating carefully, because half of it is derived and half is not. The private-label line at 2032 volume needs about ten roll-to-roll lines. That figure comes from web speed, uptime and units per meter, and it holds. What it would have to be divided by does not: the brief gives no line count and no utilization figure for MERIDIAN's existing plant, so any statement about what share of capacity this consumes would be a statement about an assumed denominator.
So the honest position is that the requirement is known and the headroom is not. Ten lines is a large capital commitment and the single largest item any entry would carry. Whether MERIDIAN has ten lines to spare, or could free them without displacing work that currently earns, is a question its own records answer in an afternoon, and it is in the test program for that reason. The high scenario at $250M of revenue needs about sixteen, and the capital plan carries no new capacity for either figure.