Concepts to Incentivize Pediatric Medical Device Development

Abstract Recent evidence demonstrating the lack of medical devices designed for children highlights the substantial hurdles to delivering life-altering pediatric technology. The market failure is not due to a lack of technology or innovator motivation, but rather a system that is not designed to enable development success and business sustainability for the many companies dedicated to these translational medicine breakthroughs. This article suggests ways to encourage the development of more products specifically designed for pediatric patients through established and novel policy mechanisms. The proposed solutions draw inspiration from existing programs for rare disease drug development and Medicare reimbursement. Specific policy recommendations include pathways to streamline reimbursement through coding, coverage, and payment, market-based fundraising opportunities through priority review vouchers and net operating losses, and leveraging learnings from the orphan drug ecosystem through sustainable pricing, tax credits, and market exclusivity.