Where it started
A biotech company had a biologic in phase 2, with higher volume and viscosity than most autoinjectors are built for. The formulation was set for phase 3, and clinical units for the pivotal study were needed in 24 months. Device, formulation, quality, clinical, operations and sourcing each had a view on the device, and no shared picture.
The strategic question
An existing injection platform, or a new device? The device could not be the reason the drug program waited.
What we found
The work followed four steps.
1. Ambition and assumptions. The starting point was written down: a biologic with high volume and viscosity, a formulation set for phase 3, and clinical units for the pivotal study within 24 months.
2. Specification. The requirements and constraints were set. Among them were the container, the volume and viscosity range, the maturity needed, user steps, scalability and the supply chain. Every activity from device choice to filing went on one map, with the critical path marked and the split between in-house work and partners settled. From here, the six functions talked about the same choice.
3. Screening and deep dive. Platforms on the market and in development were screened against the specification and on market access. Three candidates went forward. The deep dive took the three through platform fit (business, functional fit, patient experience) and baseline performance (post-market complaint data, supplier assessment, sustainability), with cost of goods and a roadmap to filing for each. The result was a scorecard:
Candidate | Time to filing-ready | Risk | New resources for the client | Future options |
|---|---|---|---|---|
X · Mature, many years on market | 12–15 months | Low | Medium. Client manages assembly and packaging partners | Limited. Volume range is fixed |
Y · Newer, strong supplier support | 15–20 months | Low–medium | Low. Supplier covers assembly, testing and human factors | Good. Higher volumes on the same platform |
Z · In clinic, not yet launched | 26–30 months | High | High | Best. Built for the volumes the next drugs need |
4. Decision platform. The scorecard became three directions, a ranked shortlist and a recommendation, walked through with the client’s team. The directions are below.