What does it require to bring a transformational innovation to patients? To address this question, the UCLA Biodesign Hub for MedTech and Digital Health has launched an industry-wide study to uncover the cost and time to achieve regulatory and reimbursement approval in the United States and to understand the impact of regulation and reimbursement on the advancement of medical technology and digital health innovation. The last time such a study was conducted was over ten years ago.

The study is led by a research team out of the UCLA Biodesign Hub, in partnership with the life science innovation ecosystem and with support from the U.S. Economic Development Administration. This independent study interviews medtech and digital health regulatory executives to examine trends, establish benchmarks for time and cost to bring transformative technologies to patients, and to inform future decision-making on regulatory and reimbursement.

The questions being explored include:

  • How long does it really take innovations to get to market?
  • Is breakthrough designation breaking down regulatory barriers to access?
  • Is the U.S. keeping pace with Europe, Japan and China?
  • Do digital health and AI/ML have a clear path to market?
  • Is reimbursement the new barrier to innovation?
  • What is next on the regulatory and reimbursement horizon?