Accelerating Commercialization of Safe and Effective Technologies for Pediatric Clinical CareA well-known medical mantra permeates the clinical world: “Children are not just small adults.” While this sentiment has been generally adopted for identifying disease states and administering bedside care, it can be a challenging requirement for medical device developers. The development complexity, which extends beyond simple “down-sizing,” combined with the relatively small population size and high regulatory burden, has historically created an undesirable commercial proposition. This leaves most innovators either uninterested or unable to pursue pediatric device development. In 2013, the U.S. Food and Drug Administration (FDA) enlisted the New England Pediatric Device Consortium (NEPDC), which includes Massachusetts General Hospital as a member institution, to help offset this limited value proposition and accelerate commercialization of devices addressing the needs of children suffering from disease or disabilities.
Commercialization Assistance Program
Through an open-invitation Grant Award program, NEPDC competitively evaluates product concepts across the commercialization spectrum — from “ideas” to “near-to-market devices”. If selected, awardees receive both seed funding and access to NEPDC Core personnel, who provide rapid and targeted commercialization assistance. Depending on each client’s unique background and project requirements, the collective of engineers, researchers, clinicians, and entrepreneurs provide expert guidance in the form of:
- Engineering design and transfer to manufacturing
- Development of intellectual property and regulatory strategy
- Pre-clinical and clinical trial design and execution
- Strategic market planning and business development
- Identifying co-funding opportunities
Target Challenge Competition
NEPDC partners with other pediatric organizations to hold an annual Target Challenge competition. The theme changes each year, with past competitions focusing on devices for pediatric pressure ulcers, sleep apnea, and rehabilitation. Through this opportunity awardees may receive up to $75,000 in funding and 200 hours of commercialization service and support from NEPDC and its partner organizations.
Submit a Target Challenge idea: We invite individuals, parents, caregivers and others who have recognized a pediatric need that could potentially be addressed by a new commercial device to share their ideas. Ideas can be submitted directly by sending an email to NEPDC.
NEPDC offers unique services and capabilities to the Massachusetts General Hospital community that can help accelerate the translation and commercialization of pediatric medical technologies. Whether you have an existing device concept, know of a pediatric problem that needs an innovative solution, or simply want to assist with the process of helping others bring their products to market, we encourage you to get involved. Opportunities include:
- Focus group participation
- Clinical evaluation of novel medical devices
- Abstract/grant reviewing
For more information, contact the Mass General on-site coordinator for NEPDC, Eleanor Crawford (email@example.com), who is available to meet with you and answer any questions.