A virtual public meeting on pediatric medical device development is scheduled for Feb. 9-11, 2021.
Sponsors include the FDA, AdvaMed, the American Academy of Pediatrics and the Critical Path Institute, a public-private partnership that receives FDA funding.
The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop will focus on the acceleration of medical device development for the unique needs of children. The SHIP consortium includes 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 providing incentives for investment and innovation in the pediatric medical device market, while improving public health for children.
According to the Critical Path Institute, challenges to advancing new pediatric devices include:
- 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.
More information is available here.