Related Experiment Video
Updated: Aug 11, 2026
Development of a Hepatitis B Virus Reporter System to Monitor the Early Stages of the Replication Cycle
Published on: February 1, 2017
Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By
Sara Takahashi1, Nicole Ibrahim2, Satoshi Yasukochi3
1Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency.
Insights
The Harmonization By Doing-for-Children program streamlines pediatric medical device development through global collaboration. This initiative aims to accelerate the availability of innovative devices for children, addressing a critical gap in pediatric healthcare.
Area of Science:
- Biomedical Engineering
- Regulatory Science
- Pediatric Healthcare Innovation
Background:
- The Harmonization By Doing (HBD) program, established in 2003, is a multi-stakeholder initiative involving academia, industry, and regulatory agencies in Japan and the United States.
- Initially focused on cardiovascular medical devices for adults, HBD expanded its scope in 2016 to address the lagging development of pediatric medical devices.
- The "HBD-for-Children" program was created to bridge the gap in medical device development for pediatric populations, which historically lags behind adult device development.
Purpose of the Study:
- To establish a global initiative focused on the timely introduction of pediatric medical devices.
- To foster collaboration among academia, industry, and regulatory agencies to facilitate innovative pediatric device development.
- To encourage industry partners to invest in and develop medical devices specifically for pediatric use.
Main Methods:
- Conducted industry surveys to identify challenges in pediatric medical device development.
- Categorized pediatric medical devices into five global availability groups to devise targeted solutions.
- Facilitated international clinical trials for pediatric medical devices across Japan and the United States.
Main Results:
- Identified key challenges hindering pediatric medical device development through industry surveys.
- Developed a categorization system for pediatric devices to guide regulatory approval strategies.
- Successfully facilitated global clinical trials, promoting cross-border regulatory alignment.
Conclusions:
- The HBD-for-Children program represents a significant global effort to expedite pediatric device availability.
- Multi-stakeholder collaboration is crucial for advancing innovative pediatric medical device development.
- The program's activities are expected to incentivize greater industry investment in pediatric device innovation.
Background:
The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.
Methods And Results:
Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries.
Conclusions:
The establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.
More Related Videos
05:19Author Spotlight: Advancing Protein Glycosylation Research Using a Fully Automated System
Published on: June 28, 2024
05:45Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
Published on: October 10, 2025
Related Concept Videos
01:30Preventive Healthcare Services
01:28Preclinical Development: Overview
01:29Drug Dosing: Infants and Children