A new dose for a new patient group

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

Where it started

A pharma company had a successful injectable on the market as a combination product in a pen. The next step was a broader patient group, which needed a larger dose. A new dose strength needs a regulatory submission in any case. The aim was to keep the pen unchanged, because changing it would trigger a new round of V&V.

The strategic question

A larger dose can be split into two smaller ones. In some markets, doctors are encouraged to do so. If the large dose was priced below two small ones, the product would undercut its own market. Should splitting be prevented in the pen, next to the pen, or outside the device altogether?

What we found

The first step was a shared rule set: what could change in the pen without reopening the device documentation, and what could not. Within those rules, three directions were developed and priced on device complexity, user steps and production cost.

Three directions

01CHOSEN

MVP

Same pen. The large dose is sold in a pack size and prescription format that makes splitting impractical

Time: 3–6 months
Cost: €0.2–0.5M
Risk: Medium. Splitting stays technically possible

Golden opportunity

A dose-limiting accessory that clips onto the pen, on its own regulatory pathway. The pen is untouched

Time: 12–18 months
Cost: €1–2M
Risk: Medium. An extra user step and a second regulatory process

Full ambition

A new pen variant designed for the new group

Time: 30–42 months
Cost: €6–10M
Risk: High. A full development project with new V&V, including a human factors study

What was chosen

MVP. The company took the chance and launched the large dose in the leanest form, controlling splitting through how it was sold. The accessory was kept ready with a trigger: if market data showed splitting, it would be introduced.

What it gave the client

The new patient group was reached within a year, with the pen unchanged. The company knew exactly what the next step would cost if it became necessary.

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