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.