Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development
TUCSON, Ariz., January 14, 2021 — The Critical Path Institute (C-Path) in collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is proud to announce the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop to be held on February 9-11, 2021. The workshop will focus on the acceleration of medical device development for the unique needs of children.
The SHIP-MD Pre-Consortium, funded by a cooperative agreement through the FDA, is a collaboration between multiple key stakeholders including academic investigators, pediatric medical society representatives, pediatric patient advocates, the medical device industry, pediatric health system leaders and financing and reimbursement experts. The initiative is aimed at innovating the pediatric medical device ecosystem, streamlining developmental processes and incentivizing investment and innovation in the pediatric medical device market, while improving public health for children.
“We are thrilled to be part of this collaborative effort to aid in the optimization of this ecosystem,” said C-Path President and CEO Joseph Scheeren, Pharm.D. “This workshop will be the culmination of year-long efforts and goal-setting to help foster game-changing innovations in the pediatric and neonatal space.”
Currently, there are challenges to advancing promising new pediatric devices from ideation to clinical studies, to regulatory approval, to use for pediatric patients, including:
- The small numbers of children with any one condition, spread far apart across the world, making it difficult to conduct clinical trials;
- The need to consider children’s growth and unique disease progression;
- The lengthy development timeline and associated high costs;
- Perceived lack of return on investment;
- Lack of funding for small inventors and companies;
- Difficulty in identifying expert resources across the development-to-commercialization continuum.
The live, multi-day SHIP-MD event will offer a valuable forum focused on actionable plans to enhance safe and effective pediatric care options, including:
- Day 1: The plenary sessions will provide background and an overview of SHIP-MD, along with an introduction to days 2 and 3 interactive sessions focused on the five key Workstreams: Navigation, Finance, Hospitals, Regulatory and Reimbursement.
- Days 2 and 3: In-depth breakout sessions for each Workstream including focused presentations, Q&A and time for community feedback.
Utilizing the latest in virtual event technologies, the SHIP-MD workshop aims to reimagine the live workshop experience and push beyond the limitations of the standard webinar format. With live Q&A, real time polls and the ability to bring speaker/attendee interaction onto the main stage, this virtual workshop captures the energy and networking opportunities that are usually reserved for in-person events. At the same time, on-demand replay of workshops and materials gives the SHIP-MD virtual workshop a flexibility and reliability that traditionally isn’t available in real-world conference settings.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS), and is 69% funded by FDA/HHS, totaling $19,471,171, and 31% funded by non-government source(s), totaling $8,612,313. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit advamed.org.
The American Academy of Pediatrics (AAP) is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit aap.org and follow us on Twitter @AmerAcadPeds
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.