Context
A pre-seed renal-care startup partnered with iO Lifescience to transform a clinical concept into pre-clinical-ready prototypes aimed at improving the reliability and safety of renal access during dialysis and related interventions. The objective: reduce complications and establish a scalable path toward manufacturing and early clinical studies.
Challenges
The development required balancing physiological performance, biocompatibility, and manufacturability:
- Rapid concept realization: Translate clinical sketches into CAD and EVT prototypes under ISO 13485 controls.
- Physiology-aligned design: Deliver target flow and stability while minimizing trauma and thrombosis.
- Materials & sterilization: Identify suitable polymers/metals, coatings, and sterilization paths (EtO/steam).
- Pre-clinical readiness: Design GLP-aligned large-animal protocols with custom fixtures and bench models.
- Human factors: Develop intuitive delivery tools with clear feedback for interventionalists.
- Scalable manufacture: Establish DFM/DFA rules, pilot tooling, and supplier qualification for future builds.
iO Lifescience led mechanical engineering, prototype fabrication, pre-clinical study support, usability testing, verification planning, and supplier sourcing.
Outcomes
- Concept-to-alpha in 8 weeks, beta and delivery tools in 14 weeks for animal testing.
- Bench-to-in-vivo correlation: Validated flow, sealing, and placement metrics predicting in-animal outcomes.
- Animal studies: Met all predefined success criteria, enabling transition to clinical planning.
- Manufacturing readiness: Scalable architecture and COGS model defined with qualified suppliers.
- Regulatory foundation: Initial risk file, usability analysis, and verification matrix completed.
- Investor traction: Pre-clinical data and manufacturing strategy supported follow-on financing.
