NEPDC leverages the expertise of multiple partner organizations to provide client assistance across all stages of commercialization, including:
- Early stage product and market evaluation
- Technology assessment
- Regulatory pathway planning and execution
- Prototype development
- Laboratory and animal testing
- Pre-clinical and clinical evaluation
- Comparative effectiveness clinical trial design
- Commercialization planning and execution within the pediatric research and innovation community
This network -which includes links to industry, academia, and the greater clinical community- has been created to help clients overcome the unique challenges surrounding the development and translation of pediatric and orphan products for clinical and consumer use.
Pediatric Technology Sourcing and Assessment Core
The Sourcing and Assessment Core, led by CIMIT, oversees evaluation and facilitation of device ideas and offers technology sourcing expertise based on over 15 years of medical device development experience. Members of this Core have experience evaluating technical and commercial feasibility, regulatory hurdles, clinical relevance, intellectual property and technology transfer, market evaluation, cost estimation, and financing opportunities.
Pediatric Device Clinical Evaluation Core
The Clinical Evaluation Core is comprised of the Institute of Pediatric Innovation, pediatricians, and representatives across multiple pediatric clinical sub-specialties. Members assist clients by helping to develop the infrastructure and tools needed for pre-clinical evaluations, including laboratory and animal testing. This group also provides clinical feedback and guidance on the “next steps” in the pathway from idea submissions through clinical testing. The Clinical Evaluation Core works closely with the Comparative Effectiveness & Clinical Research Core to develop a cohesive assessment plan that best addresses regulatory concerns.
Pediatric Technology Development Core
The Technology Development Core has existing capacity and expertise to work with and/or advise NEPDC clients to design, build, test, and transfer to manufacturing technology concepts. This team is comprised of members from Simbex and Thayer School of Engineering including professionals in electromechanical systems, materials research and testing, industrial design, software interfacing, and computer modelling. Simbex, as a medical device development company, has intimate knowledge of the development process. They facilitate navigating the full medical device regulatory and documentation requirements, inclusive of modules for Design History File development and maintenance, regulatory evaluation and submission to FDA, and manufacturing of medical devices to GMP requirements. Resources through the relationship with the Thayer School of Engineering at Dartmouth College provides additional means for prototyping design projects, academic engagement, and a link to the Office of Entrepreneurship and Technology Transfer at Dartmouth College.
Comparative Effectiveness Clinical Research Core
The Comparative Effectiveness & Clinical Research Core provides education, services and training to help clients develop and propose relevant and practical clinical trials to support the validation and translation of pediatric devices. This team is comprised of physicians and health care and policy professionals from The Dartmouth Institute for Health Policy and Clinical Practice who can dramatically improve the success rate of pediatric technology commercialization. Services include assisting clients collect data for FDA medical device requirements, clinical implementation and evaluation of efficacy, and providing necessary clinical data for reimbursement considerations. NOTE: This Core is well-positioned to provide advice to clients on appropriate trial design; however, execution of comparative effectiveness trials, which likely requires additional funding from third parties, is beyond the scope of NEPDC.