Purpose <p>Impact1 at the Stanford Mussallem Center for Biodesign was established in 2019 through its core partnership with UCSF as an FDA-funded Pediatric Device Consortium. We hypothesized that providing innovators in pediatric and maternal healthcare with mentorship, connections to experts, and grant funding would promote development, validation, approval, and commercialization of safe and effective health technologies for pediatric and maternal patients, and lead to positive broader impacts, measured as patients treated, capital raised, and jobs created.</p> Methods <p>Data were collected from 180 innovation teams supported by Impact1 between 2019 and 2024. Sources included intake forms, annual surveys, and public data. Key metrics analyzed included team demographics, innovation stage, resource utilization, funding raised, patients reached, and jobs created.</p> Results <p>Impact1 supported diverse teams across various stages of development with key resources including coaching, connections to experts, and funding opportunities. Since 2019, supported innovations have collectively treated an estimated 88,000 patients, raised $240 million, and created over 400 jobs.</p> Conclusions <p>Evidence suggests that Impact1 resources positively influence the trajectory of early-stage medical device development in pediatric and maternal health. Future research will focus on establishing a more robust causal link between program resources and innovation outcomes.</p>

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Impact1: Supporting Innovation in Pediatric and Maternal Health—5 Years of Outcomes

  • Elisabet Rosàs Canyelles,
  • Juliana Perl,
  • Marta Arenas-Jal,
  • Antje Kirschner,
  • Ignacio Andrés Pérez Romero,
  • Mohit Singhala,
  • Manikantam Gaddam,
  • Anuradha Dayal,
  • Yair J. Blumenfeld,
  • James K. Wall,
  • Kunj Sheth,
  • Janene H. Fuerch

摘要

Purpose

Impact1 at the Stanford Mussallem Center for Biodesign was established in 2019 through its core partnership with UCSF as an FDA-funded Pediatric Device Consortium. We hypothesized that providing innovators in pediatric and maternal healthcare with mentorship, connections to experts, and grant funding would promote development, validation, approval, and commercialization of safe and effective health technologies for pediatric and maternal patients, and lead to positive broader impacts, measured as patients treated, capital raised, and jobs created.

Methods

Data were collected from 180 innovation teams supported by Impact1 between 2019 and 2024. Sources included intake forms, annual surveys, and public data. Key metrics analyzed included team demographics, innovation stage, resource utilization, funding raised, patients reached, and jobs created.

Results

Impact1 supported diverse teams across various stages of development with key resources including coaching, connections to experts, and funding opportunities. Since 2019, supported innovations have collectively treated an estimated 88,000 patients, raised $240 million, and created over 400 jobs.

Conclusions

Evidence suggests that Impact1 resources positively influence the trajectory of early-stage medical device development in pediatric and maternal health. Future research will focus on establishing a more robust causal link between program resources and innovation outcomes.