Abstract
Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. Methods: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. Results: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. Discussion/Conclusion: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.
| Original language | English (US) |
|---|---|
| Article number | 9465164 |
| Journal | IEEE Journal of Translational Engineering in Health and Medicine |
| Volume | 9 |
| DOIs | |
| State | Published - 2021 |
Funding
The process of securing approval for pediatric devices will be straightforward for companies that have pediatric expertise and position themselves in this niche market. However, such companies must still compete for funds with the innovators of adult devices. While removing the barriers identified above will help to reduce the risks associated with pediatric device development, even if the perceived risk is reduced to match that of developing an equivalent adult device, the smaller pediatric market cannot match the ROI for adult products. Therefore, if companies seeking to innovate pediatric devices are to compete successfully, the costs and risks for pediatric devices must be less than those for adult devices. Financial incentives could include reimbursement guarantees through both Medicaid and Medicare, extended patent protection, special grant programs through the NIH, incentivizing tax credits, and pediatric innovation or venture philanthropy funds. Notably, the FDA does not charge filing fees for some devices designated solely for pediatric use [9]. Roundtable participants believe that such measures should be continued and/or expanded. Non-financial incentives could include: • a fast-track approval process • expedited and pediatric-specific FDA review panels • allowing requests for specific reviewers and recommen-dations for outside reviewers with pediatric expertise • increased staffing of pediatric device regulatory offices (including OOPD) • additional pre-review guidance and support prior to reg-ulatory submission • expedited response to resubmissions • support for programs to educate participants on the reg-ulation of pediatric device development • pediatric-specific guidelines for clinical trials • the use of post-market as well as pre-market and post-market data for predicate devices approved for use in adults • a pediatric-specific registry for real-world data.
Keywords
- Device
- FDA
- guidelines
- pediatric
- regulatory
ASJC Scopus subject areas
- Biomedical Engineering