Framework for creating a qualified medical device development tool of autoinjectors

Area of Science:

• Biomedical Engineering
• Drug Delivery Systems
• Regulatory Science

Background:

• Autoinjectors are crucial for self-administering medications, but lack a dedicated Medical Device Development Tool (MDDT).
• This absence can lead to inconsistencies in autoinjector quality and regulatory compliance within combination products.
• Existing FDA resources and ISO standards provide a foundation for developing specialized tools.

Purpose of the Study:

• To develop a comprehensive MDDT framework specifically for autoinjectors.
• To leverage the Primary Functions defined in ISO 11608-1:2022 for autoinjector development.
• To address the gap in standardized development tools for autoinjectors in combination products.

Main Methods:

• Analysis of existing FDA-approved MDDTs.
• Review of FDA's design controls regulations and autoinjector guidance.
• Application of Primary Functions from ISO 11608-1:2022 (e.g., Holding Force, Dose Accuracy).

Main Results:

• Identification of key Primary Functions for autoinjectors: Holding Force, Cap Removal Force, Activation Force, Extended Needle Length, Injection Time, Dose Accuracy, and Needle Guard Lockout.
• Proposal of a structured framework for autoinjector MDDT development.
• Bridging the gap by integrating Primary Functions with the FDA's MDDT approach.

Conclusions:

• A novel MDDT framework tailored for autoinjector development is presented.
• The framework enhances predictability and effectiveness in autoinjector development and regulatory review.
• This approach aims to expedite FDA approval for autoinjectors used in combination products.