Medical Device Consortium at the Children's Hospital of Philadelphia

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Abstract/Summary Addressing unmet needs for treating childhood illnesses lead to the creation of the Philadelphia Pediatric Medical Device Consortium (PPDC) 4.5 years ago. Founded at the Children’s Hospital of Philadelphia (CHOP) with funding from the FDA Pediatric Device Consortia (PDC) program, the mission of the PPDC is to provide seed funding and business, legal, marketing, clinical, engineering and scientific resources to inventors of promising pediatric medical devices that will benefit children and have a strong commercialization potential. CHOP has national prominence in both clinical care and research, and combined with the vibrant medical device development ecosystem that is developing in our region, we have found success. Over the past 5 years, the PPDC has assisted more than 60 devices along the development pathway, and compared to our 7 peer PDCs, the PPDC has been responsible for responsible for half of the Investigational Device Exemption applications, 20% of 510Ks, and 71% of pre-submission meetings. The support offered by the PPDC network of preeminent experts in their field who volunteer their time to advise PPDC device innovators has allowed the PPDC to be a leader with parsimonious use of federal funds. From PPDC inception, NAMSA - the world’s largest contract research organization specializing in medical devices – has assisted every device project that the PPDC has considered for support. Our Clinical and Scientific Advisory Committee – clinicians and scientists who are thought-leaders in their fields – evaluate the technical merit of every device project. Our Oversight Committee – consisting of luminary CEOs, Investors, and other medical device business leaders – evaluate the value proposition, reimbursement, regulatory, marketing and business strategy of each proposed device. All of these services are provided free of charge by the PPDC. Building on the aforementioned success, we propose new initiatives and enhanced partnerships that will increase our ability to assist innovators. First, we are partnering with the University of Pittsburgh’s McGowan Institute, a global Class III medical device development enterprise which has been at the forefront of investigating, testing and translating medical devices that have played a critical role in regenerative medicine for the past twenty-five years. McGowan’s partnership brings two strategic advantages to the PPDC: 1) McGowan’s Class III device development capabilities expands the capability of the PPDC. 2) McGowan has a pediatric device initiative in which their outstanding faculty are adapting adult devices for the pediatric population. The PPDC will continue our partnerships with Philadelphia-based academic, engineering, business and medical experts. We will enhance our ties with the University of Pennsylvania and Drexel University. The University of Pennsylvania has just launched “Penn Health-Tech,” to catalyze medical device innovation, and the PPDC is partnering with this effort. Our productivity will also be enhanced by our real world data/results project building on CHOP expertise studying pediatric device endpoints concerning resuscitation outcomes.