컴퓨터 지원 설계 소프트웨어를 활용한 수술기기 개발에서 혁신적 디자이너로서 외과의사의 역할 = The Role of Surgeon as an Innovative Designer in the Development of Surgical Devices Using Computer-Aided Design Software

다국어 초록 (Multilingual Abstract)

Objective: Medical device development faces unique challenges compared to other industries, including stringent regulations, high costs, and difficulties integrating Human Factors Engineering (HFE) to capture user needs—particularly for small and medium-sized manufacturers with limited resources. Surgeons hold a dual role as both primary users and potential designers of surgical devices. This study demonstrates how surgeon-led design using CAD software addresses these limitations by enabling rapid customization and precise reflection of clinical needs.
Methods: Five customized spine surgery devices—a windowed reamer, retractor blade for retroperitoneal/extrapleural approach, disposable sharp hook and holder, Protect-guider, and flexible-tip retractor—were designed using CAD software to resolve unmet clinical needs identified intraoperatively. Precise parametric 3D models were delivered to manufacturers. Production times were evaluated.
Results: All devices were produced in an average of 7.8 weeks (range: 2-26 weeks).
Conclusion: Surgeon-led CAD design bypasses iterative feedback loops with manufacturers limited by resources and surgical inexperience, enabling rapid customization to individuals. Benefits include parametric precision, 3D visualization, and comprehensive documentation, enhancing HFE user-centered outcomes while minimizing costs and time. This framework leverages surgeons' clinical expertise as innovating designers for efficient surgical device development.

목차 (Table of Contents)

• Abstract
• Manuscript
• 1. Introduction 1
• 2. Methods 8
• 2-1. Windowed reamer
• 2-2. Retractor blade for retroperitoneal or extrapleural approach
• 2-3. Disposable sharp hook and holder
• 2-4. Protect-guider
• 2-5. Flexible-tip retractor
• 3. Results 14
• 3-1. Reamer
• 3-2. Retractor for retroperitoneal or extrapleural approach
• 3-3. Disposable sharp hook
• 3-4. Protect-guider
• 3-5. Flexible tip retractor
• 4. Discussion 16
• 5. Conclusion 22
• References