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

Published online by Cambridge University Press:  11 April 2025

Arjun Menta
Affiliation:
Johns Hopkins School of Medicine
Arjun K. Menta
Affiliation:
Department of Neurosurgery, Johns Hopkins University School of Medicine Baltimore Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Ava Taylor
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Kenny Nova
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Sofia Garcia del Barrio Cervera
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Shreya Jindal
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Anders Sideris
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
William S. Anderson
Affiliation:
Department of Neurosurgery, Johns Hopkins University School of Medicine Baltimore
Soumyadipta Acharya
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
Youseph Yazdi
Affiliation:
Center for Bioengineering Innovation & Design (CBID) Whiting School of Engineering, Johns Hopkins University, Baltimore
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Abstract

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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.

Type
Biostatistics, Epidemiology, and Research Design
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2025. The Association for Clinical and Translational Science