Context
A Series A biopharma turned to iO Lifescience to create a platform autoinjector for high-viscosity biologics (1–1000 cP). Designed for multiple therapeutic areas and at-home use, the goal was a patient-preferred, connected device that reduces onboarding time, improves adherence, and generates real-world data for clinicians and payers.
Challenges
The program faced key hurdles:
- Delivering large-molecule drugs reliably with fine needles.
- Ensuring usability for elderly patients and those with dexterity or vision challenges.
- Developing secure, standards-based digital connectivity for adherence tracking.
- Meeting aggressive time-to-market goals while aligning with global standards (ISO 11608, ISO 14971, IEC 62366-1, IEC 62304, IEC 60601-1/-11).
iO’s scope covered systems design, firmware, drug–device interface, mobile app & cloud integration, cybersecurity, human factors, supplier sourcing, and pilot manufacturing.
Outcomes
- Time-to-prototype: development path shortened by 12 months, moving from concept to design feasibility in 6 months.
- Performance proven: delivered 1–1000 cP biologics in ≤15 minutes with ≤5% dose variance.
- User acceptance: ≥95% success in human-factors testing; >90% preferred the device to legacy options.
- Connected insights: ≥98% accurate event capture, integrated into sponsor dashboards.
- Regulatory readiness: full DHF, usability validation, and EU MDR technical file prepared.
- Value creation: pilot programs showed 90% better adherence and 85% less training time.
