Present and future for technologies to develop patient-specific medical devices: a systematic review approach

Area of Science:

• Biomedical Engineering
• Medical Device Development
• Materials Science

Background:

• Patient-specific implants and devices require tailored design and manufacturing processes.
• Existing literature lacks a systematic analysis of the development methodologies for custom medical devices.
• Understanding the technological integration in custom device development is crucial for advancing medical solutions.

Purpose of the Study:

• To systematically review literature on patient-specific implants and devices.
• To analyze the development process of custom-made medical devices.
• To identify design methodologies and technological integration in custom device creation.

Main Methods:

• Systematic literature review focusing on case studies of patient-specific implants.
• Content analysis of identified case studies to extract design processes and methodologies.
• Analysis of technology interoperability within a product development framework.

Main Results:

• Identified key technologies: reverse engineering, computer-aided design, simulation, and rapid prototyping.
• Established a relationship between process scope/complexity and the stage of technology integration.
• Case studies highlighted the technical, scientific, and multidisciplinary nature of custom device development.

Conclusions:

• Patient-specific device development necessitates integrating advanced technologies.
• A structured process framework enhances the development of custom implants, biomodels, and surgical guides.
• Further research should focus on optimizing technology integration for efficient custom medical device production.