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Mission & Goals

The Alliance for Pediatric Device Innovation (APDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation. We bring together individuals and institutions that can support pediatric medical device progression through all stages of development – ideation, concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization.

Goals

  • Enhance the pipeline of high-potential pediatric device entrepreneurs while ensuring a balance such that considerations are given to all pediatric subpopulations – neonates, infants, children, and adolescents.
  • Through the implementation of demonstration projects, develop, verify, and operationalize methods of evidence generation and data use, and demonstrate scalability across pediatric device types and disease entities.
  • Through the implementation of demonstration projects, develop, verify, and operationalize methods of evidence generation and data use, and demonstrate scalability across pediatric device types and disease entities.

To achieve these aims, APDI has six functional cores to support the total pediatric devices product life cycle:

  • – Business
  • – Regulatory
  • – Reimbursement
  • – Medicine & Science
  • – Engineering & Prototyping
  • – Trials Design

Five Core Attribute

To achieve these aims, APDI has six functional cores to support the total pediatric devices product life cycle:

  • Integrated business, regulatory, and scientific methodology that informs the creation of a customized roadmap for each device innovator, based on where the innovator is in the total product life cycle;
  • The ability to guide device innovators through federal and non-federal funding sources;
  • An efficient program management necessary to run a multidisciplinary, multi-stakeholder Consortium;
  • A dynamic BioHealth Capital Region (Maryland, D.C., Virginia) innovation ecosystem;
  • Access to a robust pipeline of regional, national, and international medtech innovators.