Keeping a Swiss medtech's US export on schedule
A 60-person medtech from French-speaking Switzerland is preparing to enter the US market, but its workstreams move one after another. We aligned regulatory, quality, commercial and finance work on a single roadmap, to shorten the time the launch structure costs money without generating revenue.
The company
A medical technology company from French-speaking Switzerland with 60 employees, whose main product is ready to be presented to the US market.
The problem and its cost
The US launch workstreams run in sequence: regulatory file, adaptation of the quality system, choice of distribution channel, then logistics and financial preparation. Each team waits for the previous one's decision, nobody owns the overall timeline, and trade-offs reach management case by case. The result is a delay of about six months compared with what better coordination would allow.
This delay has a direct cost. The launch structure (dedicated resources, external advisors, local presence, tied-up inventory) costs CHF 38,000 per month, whether or not it sells. Six months of delay therefore represent 6 months × CHF 38,000 = CHF 228,000 per year. This figure does not include deferred revenue, which we deliberately did not estimate.
The strategy
We first settled what everything else depends on: the chosen regulatory pathway, the product scope of the first launch and the decision criteria at each stage. Without this frame, teams keep waiting for one another and every question goes up to management.
We then organised execution. The choice of US channel is handled in parallel with the quality work that does not depend on it, followed by the financial and logistics calendar. Monthly steering comes last, because a roadmap without follow-up quickly slips back into the original sequence. This order moves from the most structuring decisions to the most operational ones.
The execution
Team: A dedicated contact, the WALVIS core team (strategy, finance, operations) and two sector expert profiles: US regulatory affairs for medical devices and US medical distribution.
- →A single launch roadmap linking regulatory, quality, commercial and logistics milestones, with the real dependencies between them.
- →A decision file on the US channel, with explicit criteria and a reasoned recommendation.
- →A responsibility and decision matrix: who decides what, by when, and with which information.
- →A monthly dashboard built in the company's existing tools, tracking milestones, variances and the cost of the launch structure.
We used AI to compare the existing documentation with the expected requirements and bring out the gaps to address first, which speeds up the preparation of the files. Every output is reviewed and validated by the regulatory expert before use.
Most of the gain comes from organisation: a single owner of the timeline, decisions taken on fixed dates, and work started in parallel whenever possible. None of this requires new technology.
The result
Expected annual saving: 60% of CHF 228,000, about CHF 137,000. For an investment of about CHF 70,000, payback comes in 6 months.
The rate used is 60% and not 100%, because part of the delay cannot be planned away (review times at the US authority, third-party lead times, internal decisions that cannot be rushed).
- A management team that spends less time on one-off trade-offs and more on the choices that matter.
- Regulatory, quality and commercial teams working on the same priorities and aware of their dependencies.
- Better visibility for investors and partners on a realistic market entry date.
The assumptions
- Months of delay avoided: 6
- Monthly cost of the launch structure: CHF 38,000, or CHF 228,000 over the delay period
- Expected gain: 60% of this cost, about CHF 137,000 per year
- Investment of about CHF 70,000, with payback in about 6 months
Scenario type, built from real missions and anonymized.
In the same cocoon
