Risks and benefits associated with the primary functions of artificial intelligence powered autoinjectors

Area of Science:

• Medical Device Engineering
• Regulatory Science
• Artificial Intelligence in Healthcare

Background:

• Autoinjectors are critical for patient medication delivery, with standards like ISO 11608-1:2022 guiding their design and function.
• The FDA product code KZH classifies autoinjectors, ensuring they meet safety and efficacy standards.
• Current autoinjector technology faces challenges related to reliability and patient-reported issues.

Purpose of the Study:

• To assess primary functions of autoinjectors per ISO 11608-1:2022.
• To investigate risks in current autoinjector technology and evaluate AI-powered autoinjectors.
• To propose a risk mitigation framework for AI-enhanced autoinjectors.

Main Methods:

• Analysis of 500 medical device reporting events (FDA database, product code KZH, 2008-2023).
• Statistical frequency analysis of reported malfunctions and injuries.
• Incorporation of FDA, UK, European Commission regulations, and ISO standards.

Main Results:

• 188 of 500 events were confirmed autoinjector-related; none had AI capabilities.
• Traditional autoinjectors showed 72% malfunctions and 26% injuries.
• Device issues (45%) and patient problems like missed doses (10%) were primary concerns.

Conclusions:

• Traditional autoinjectors require enhanced quality control and design improvements.
• AI autoinjectors present cybersecurity and software risks, necessitating a comprehensive risk management framework.
• AI integration promises enhanced functionality, real-time monitoring, and personalized medical treatments.