A new delivery route, before the first prototype

Discretion comes first, so every case is illustrative. The method is real.

Where it started

A young company had a promising drug in development and saw a strong opportunity in home treatment. Getting there required a delivery device for a route no existing device was built for. Preclinical studies were the next step, and the next investor tranche depended on preclinical data within twelve months.

The strategic question

How much device should be developed for the preclinical studies? Too much, and device work crowds out the real question: does the route work at all? Too little, and the data won’t carry into first-in-human.

What we found

The scoping set the requirements for a device the preclinical studies could be run with. It settled who owns clinic, development and manufacturing, and at which documentation level each is run. And it checked the team against the plan: could this organization deliver it, on this budget, in this time?

Three directions

01CHOSEN

MVP

Bench-built proof-of-concept, lab-grade documentation

Time: 6–9 months
Cost: €0.4–0.8M
What it unlocks: Preclinical data inside the investor window
Risk: Medium. The device is rebuilt before first-in-human

Golden opportunity

Proof-of-concept on the intended architecture, with light design control from day one

Time: 9–14 months
Cost: €1–1.5M
What it unlocks: Preclinical data, plus a design base that carries into first-in-human
Risk: Low–medium. Tight on the investor window

Full ambition

Clinical-grade device under full design control

Time: 18–24 months
Cost: €3–5M
What it unlocks: Ready for first-in-human, but after the investor window
Risk: High. The design is locked before the route is proven

What was chosen

MVP, with a written trigger: the day the tranche is released, work moves to the Golden opportunity architecture. The budget was split into phases, each tied to a milestone that raised the company’s value.

What it gave the client

The board got a plan it could defend to investors. The company knew what it would build itself and what it would buy, before the first part was made.

← All illustrative cases