82 Leveraging the biodesign process to create impactful medical technologies: A study in neurosurgery

Objectives/Goals: This study demonstrates the utility of the CBID biodesign process for identifying and prioritizing high-impact neurosurgical needs. The research emphasizes the process’s role in developing innovative medical technologies that align with the healthcare ecosystem’s demands and stakeholder priorities. Methods/Study Population: The CBID Spiral Innovation Model, integrating clinical, technical, business, and strategic considerations across clinical challenges in neurosurgery was employed over a 15-week period at a tertiary care center. The process involved three phases: (1) needs identification through 8 weeks of clinical immersion, (2) 7–8 weeks of stakeholder engagement via informational interviews, surveys, and conferences, and (3) iterative refinement based on evidence generation and market value. Stakeholders included over 70 clinicians (neurosurgeons, neurocritical care specialists, neurologists, etc.) across 15 institutions as well as more than 10 payers and hospital administrators. Data collection encompassed direct observation, structured interviews, and comprehensive literature review. Results/Anticipated Results: The initial list of 300+ identified neurosurgical needs was reduced to 271 after clinician and market input. High-level market and clinical evidence assessments further reduced this to 74 needs. Finally, through iterative evaluation of evidence generation, market opportunity, and stakeholder feedback, five critical unmet needs in stroke, traumatic brain injury, hydrocephalus, and epilepsy were identified for technological innovation. These needs met the criteria for clinical importance, economic viability, and market accessibility. The findings highlight the effectiveness of the biodesign process in creating a roadmap for innovation that is both clinically relevant and commercially viable. Discussion/Significance of Impact: This study underscores the effectiveness of structured need-finding and prioritization within neurosurgery. Integrating stakeholder perspectives and rigorous analysis, it provides a replicable framework for medical innovation to accelerate the development of impactful solutions across medicine.