JMIR Publications

Background:

The integration of artificial intelligence (AI) in medical devices is transforming health care by enabling enhanced personalization and precision medicine. AI-driven medical devices can tailor treatments based on individual patient profiles, including genetic data, medical history, and physiological parameters. This advancement holds the potential to refine therapeutic interventions, improve patient outcomes, and streamline health care delivery. However, challenges such as data quality, algorithmic bias, patient privacy, and regulatory complexities hinder the full realization of AI-driven personalization. By 2030, the global AI in health care market is projected to exceed US $187.95 billion, growing at a compound annual growth rate of 37% from US $15.1 billion in 2022.

Objective:

This review aims to explore the scope and impact of AI-driven personalization in medical devices. It seeks to analyze key technological innovations that have enabled AI integration, identify the critical challenges impeding progress, and evaluate strategies to address these challenges. Additionally, it highlights future research directions and innovation opportunities in this evolving field.

Methods:

A systematic review was conducted, drawing from scholarly literature, industry analyses, and regulatory advisories. Relevant studies and case examples were analyzed to assess the current applications of AI in medical devices, the barriers to its implementation, and best practices for overcoming these barriers. Ethical, technical, and regulatory considerations were also examined. The review included studies published between 2016 and 2023, covering over 100 peer-reviewed articles and reports.

Results:

The review highlights significant advancements in AI-driven medical devices, including applications in diagnostics, treatment personalization, wearable health monitoring, and smart prosthetics. AI-based diagnostic tools have achieved up to 98.88% accuracy in multiclass disease classification from X-ray images and 95% accuracy in insulin injection site recognition. It identifies key challenges such as data security risks, algorithmic biases, regulatory constraints, and integration issues with existing health care infrastructures. Currently, more than 70% of clinical decisions rely on diagnostic tests, yet AI-driven automation could reduce diagnostic delays by up to 50%. Several strategies, including improved data validation techniques, regulatory frameworks for AI approval, and ethical guidelines, were found to be effective in mitigating these challenges. Case studies demonstrate how AI has enhanced medical device functionality and patient outcomes.

Conclusions:

AI-driven personalization in medical devices holds immense potential to revolutionize health care, offering more precise, adaptive, and patient-centered solutions. However, successful implementation requires addressing technical, ethical, and regulatory challenges. Emerging technologies such as quantum computing could improve AI-driven medical diagnoses by 10‐20 times in processing efficiency, while blockchain-based patient data management could reduce security breaches by more than 30%. This review serves as a valuable resource for researchers, health care professionals, policymakers, and industry leaders, fostering informed discussions and guiding future advancements in AI-enabled personalized medicine.